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 16, 2023
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. ☐
Item 1.01 Entry into a Material Definitive Agreement.
The information reported in Item 2.01 is incorporated by reference into this Item 1.01.
Item 2.01 Completion of an Acquisition or Disposition of Assets.
On February 16, 2023, Oncocyte Corporation (“Oncocyte” or the “Company”) completed its sale of 3,188,181 shares of common stock of its wholly-owned subsidiary Razor Genomics, Inc. (“Razor”), which constitutes approximately 70% of the issued and outstanding equity interests of Razor on a fully-diluted basis, pursuant to the previously announced Stock Purchase Agreement (as amended by the First Amendment to Stock Purchase Agreement, the “Agreement”) with Dragon Scientific, LLC, a Delaware limited liability company (“Buyer”), and Razor, a Delaware corporation (the “Closing”).
In connection with the Closing, Oncocyte transferred to Razor all of the assets and liabilities related to DetermaRxTM, a test used to predict a patient’s risk of cancer recurrence following surgery and response to chemotherapy in early-stage lung cancer. While no monetary consideration was received for the sale of 70% of the equity interests of Razor, the transaction allows the Company to eliminate all development and commercialization costs with respect to DetermaRx. Following the Closing, Oncocyte continues to own 1,366,364 shares of common stock of Razor, which constitutes approximately 30% of the issued and outstanding equity interests of Razor on a fully-diluted basis. The unaudited pro forma consolidated financial information included as Exhibit 99.1 to this report reflects the Closing.
On February 16, 2023, in connection with the Closing, the Company, Buyer and Razor entered into a Second Amendment to Stock Purchase Agreement (the “Second Amendment”), pursuant to which, (i) in lieu of a transition services agreement, Razor entered into certain transitional consulting agreements with two employees of Oncocyte, (i) the Company entered into a Records Custody and Services Agreement with Razor and Buyer, and (ii) certain representations, warranties and covenants were modified. No other provisions of the Agreement were otherwise amended or waived by the Second Amendment, and the Agreement remains in full force and effect.
The foregoing description of the Second Amendment does not purport to be complete and is qualified in its entirety by reference to the complete text of the Second Amendment, which is filed as Exhibit 2.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item 7.01 Regulation FD Disclosure.
On February 22, 2023, Oncocyte issued a press release announcing the completion of the Razor transaction, a copy of which is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
The information under this Item 7.01 and the accompanying Exhibit 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 9.01 Financial Statements and Exhibits.
| Exhibit Number | Description | |
| 2.1 | Second Amendment to Stock Purchase Agreement, dated February 16, 2023, by and among Dragon Scientific, LLC, Oncocyte Corporation and Razor Genomics Inc. | |
| 99.1 | Unaudited Pro Forma Consolidated Financial Statements | |
| 99.2 | Press release announcing the Completion of Razor Genomics Transaction, dated February 22, 2023. | |
| 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: February 23, 2023 | By: | /s/ Anish John |
| Anish John | ||
| Chief Financial Officer | ||
Exhibit 2.1
Second AMENDMENT TO
STOCK PURCHASE AGREEMENT
THIS SECOND AMENDMENT TO STOCK PURCHASE AGREEMENT (the “Amendment”) is adopted as of the 16th day of February, 2023 (the “Effective Date”), by and among Oncocyte Corporation, a California corporation (“Seller”), Dragon Scientific, LLC, a Delaware limited liability company (“Buyer”), and Razor Genomics, Inc., a Delaware corporation (the “Company”). Seller, Company, and Buyer are referred to herein individually as a “Party” and collectively as the “Parties.” Capitalized terms used and not otherwise defined herein shall have the meanings ascribed to such terms in the Stock Purchase Agreement (as hereinafter defined).
WHEREAS, Buyer, Seller and the Company have entered into that certain Stock Purchase Agreement, dated as of December 15, 2022 and amended the same pursuant to that certain First Amendment to Stock Purchase Agreement entered into as of January 30, 2023 (collectively, the “Stock Purchase Agreement”), pursuant to which Seller has agreed to sell to Buyer, and Buyer has agreed to purchase from Seller, the Purchased Shares of the Company; and
WHEREAS, the Parties wish to modify the Stock Purchase Agreement as set forth herein.
NOW THEREFORE, each of the Parties, who acknowledge that this Amendment is undertaken in accordance with Section 9.6 of the Stock Purchase Agreement, hereby agree as follows:
1. The following changes are made to the Stock Purchase Agreement to delete any reference to a Transition Services Agreement and to reference instead independent contractor agreements between the Company and two employees of Seller:
(a) The fifth Recital of the Stock Purchase Agreement is hereby deleted and the following substituted in its stead: “WHEREAS, at the Closing (as defined below), the Company is entering into those certain Transitional Consulting Agreements with two employees of Seller whereby such individuals will each assist the Company in the transition of the Business, the form of which is attached hereto as Exhibit A (the “Transitional Consulting Agreements”).”
(b) The list of Exhibits appearing as part of the Table of Contents to the Stock Purchase Agreement and the title page to Exhibit A are each modified to identify Exhibit A as the “Form of Transitional Consulting Agreements.”
(c) Section 2.2(a)(iv) of the Stock Purchase Agreement is hereby deleted and the following substituted in its stead: “each of the two Transitional Consulting Agreements duly executed by the employees identified therein.”
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(d) A new Section 2.2(b)(i) is added to the Stock Purchase Agreement to read as follows: “(i) each of the two Transitional Consulting Agreements duly executed by the Company.”
2. Section 4.8(a) of the Stock Purchase Agreement is hereby deleted in its entirety and a new Section 4.8(a) is added to the Stock Purchase Agreement, which is to read as follows: “(a) Except as set forth in Section 4.8(a) of the Seller Disclosure Schedules, the Company is, and has since September 30, 2019 been, in compliance with all Laws applicable to the conduct of its operations as currently conducted or the ownership and use of the Company’s assets, except where the failure to be in compliance would be material to the Company, taken as a whole.
3. Section 4.11(f) of the Stock Purchase Agreement is hereby deleted in its entirety and a new Section 4.11(f) is added to the Stock Purchase Agreement, which is to read as follows: “(f) Except as set forth in Section 4.11(f) of the Seller Disclosure Schedules, Company’s collection, storage, use and dissemination of personal computer information and personally identifiable information in connection with its businesses has, since September 30, 2019, been conducted in accordance with all applicable Laws relating to privacy, data security and data protection that are binding on the Company and all applicable privacy policies adopted by the Company.”
4. A new Section 6.12 is hereby added to the Stock Purchase Agreement, which is to read as follows: “6.12 Accounts Receivables. Buyer and the Company hereby agree that all reimbursements and receivables received by either the Buyer or the Company after the Closing for laboratory or other operations conducted by Seller or the Company prior to the Closing are the property of Seller, and Buyer and the Company, as the case may be, hereby covenant and agree to deliver such reimbursements and receivables to Seller within five (5) Business Days of receipt thereof.”
5. The following changes are made to the Stock Purchase Agreement to incorporate the concept of a custodial agreement concerning records pertaining to Business operations:
(a) The eighth Recital of the Stock Purchase Agreement is amended by deleting the word “AND” appearing at the end thereof and a new ninth Recital is added to the Stock Purchase Agreement to read as follows: “WHEREAS, Seller is entering into a Records Custody and Services Agreement with the Company and Buyer, the form of which is attached as Exhibit E hereto (the “Records Custody and Services Agreement”).
(b) The list of Exhibits appearing as part of the Table of Contents to the Stock Purchase Agreement is modified to add an Exhibit E and identify it as the “Form of Records Custody and Services Agreement.”
(c) (c) A new Section 2.2(a)(vii) is added to the Stock Purchase Agreement to read as follows: “(vi) the Records Custody and Services Agreement duly executed by the Seller.”
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(d) A new Section 2.2(b)(iii) is added to the Stock Purchase Agreement to read as follows: “(vi) the Records Custody and Services Agreement duly executed by the Company and Buyer.”
6. A new Section 6.13 is hereby added to the Stock Purchase Agreement to read as follows: “6.13 No Referrals. The Parties acknowledge and agree that none of the consideration paid or given under this Agreement or any Transaction Document is conditioned on any requirement or expectation that any Party make referrals to, be in a position to make or influence referrals to, or otherwise generate business for any other Party, and in fact, no Party shall make referrals, position or influence referrals, or otherwise generate business for any other Party. The Parties further acknowledge that no Party is restricted from referring any services to or providing services for any other entity of their choosing. Notwithstanding any unanticipated effect of any provision of this Agreement or any Transaction Document, the Parties intend to comply with 42 U.S.C. § 1320a-7b (commonly known as the Anti-Kickback Statute), 42 U.S.C. §1395nn (commonly known as the Stark law) and any other federal or state law provision governing fraud and abuse or self-referrals under the Medicare or Medicaid programs, as such provisions may be amended from time to time.”
7. The following definitions appearing in Section 1 of Annex 1 to the Stock Purchase Agreement are hereby amended as follows:
(a) The definition of Trade Secrets is amended to delete therein the phrase “data,” in the definition of Trade Secrets.
(b) The definition of “Transaction Documents” is amended to delete the reference to Transition Services Agreement and add references to the Transitional Consulting Agreements, and the Records Custody and Services Agreement.
8. Wherever new sections, subsections or Exhibits have been added to the Stock Purchase Agreement pursuant to this Amendment, subsequent section, subsections and Exhibits are re-numbered as appropriate.
9. Except as set forth in this Amendment, the Stock Purchase Agreement, as modified hereby, remains in full force and effect.
10. The provisions of Sections 9.1, 9.2, 9.4, 9.5, 9.6, 9.10. 9.11, 9.13 and 9.14 of the Stock Purchase Agreement are deemed incorporated into, and made a part of, this Amendment, mutatis mutandis.
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IN WITNESS WHEREOF, each of the Parties has caused this Second Amendment to Stock Purchase Agreement to be duly adopted, executed and delivered as of the date set forth above.
| BUYER: | ||
| DRAGON SCIENTIFIC, LLC | ||
| By: | /s/ Michael Mann | |
| Name: | Michael Mann | |
| Title: | Managing Member | |
| SELLER: | ||
| ONCOCYTE CORPORATION | ||
| By: | /s/ Josh Riggs | |
| Name: | Josh Riggs | |
| Title: | Chief Executive Officer | |
| COMPANY: | ||
| RAZOR GENOMICS, INC. | ||
| By: | /s/ Josh Riggs | |
| Name: | Josh Riggs | |
| Title: | Chief Executive Officer | |
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Exhibit 99.1
ONCOCYTE CORPORATION UNAUDITED PRO FORMA
CONDENSED CONSOLIDATED FINANCIAL INFORMATION
On February 16, 2023, Oncocyte Corporation (“Oncocyte” or the “Company”) completed its sale of 3,188,181 shares of common stock of its wholly-owned subsidiary Razor Genomics, Inc. (“Razor”), which constitutes approximately 70% of the issued and outstanding equity interests of Razor on a fully-diluted basis, pursuant to a previously announced Stock Purchase Agreement (as amended, the “Purchase Agreement”) with Dragon Scientific, LLC, a Delaware limited liability company (“Buyer”), and Razor, a Delaware corporation (the “Closing”).
In connection with the Closing, Oncocyte transferred to Razor all of the assets and liabilities related to DetermaRxTM, a test used to predict a patient’s risk of cancer recurrence following surgery and response to chemotherapy in early-stage lung cancer. Following the Closing, Oncocyte continues to own 1,366,364 shares of common stock of Razor, which constitutes approximately 30% of the issued and outstanding equity interests of Razor on a fully-diluted basis.
The following sets forth the unaudited pro forma condensed consolidated financial statements of Oncocyte after giving effect to the Closing. The Company’s accounting and financial reporting in these unaudited pro forma financial statements is based on its preliminary assessment of the appropriate application of Generally Accepted Accounting Principles (“GAAP”). The final application of GAAP to the Purchase Agreement may differ from what is presented in these unaudited pro forma financial statements.
The unaudited pro forma condensed consolidated financial statements of the Company presented in this Exhibit 99.1 were derived from the Company’s historical consolidated financial statements and are being presented to give effect to the Purchase Agreement. The presentation of the unaudited pro forma financial information is prepared in conformity with Article 11 of Regulation S-X rules effective January 1, 2021.
The unaudited pro forma condensed consolidated balance sheet assumes that the Purchase Agreement occurred on September 30, 2022. The unaudited pro forma condensed consolidated statements of operations are presented as if the Purchase Agreement had occurred on February 24, 2021, the date the Company fully acquired Razor Genomics. The unaudited combined consolidated pro forma financial statements presented in this Form 8-K should be read in conjunction with the accompanying notes. The following unaudited pro forma condensed consolidated financial statements were based on and should be read in conjunction with the Company’s historical consolidated financial statements:
| ● | Oncocyte audited consolidated financial statements and related notes thereto as of December 31, 2021 and for the year ended December 31, 2021 as reported on Form 10-K; |
| ● | Oncocyte unaudited consolidated financial statements and related notes thereto as of September 30, 2022 and for the nine months ended September 30, 2022 as reported on Form 10-Q. |
The pro forma adjustments are based on the best information available and assumptions that management believes are (a) directly attributable to the Purchase Agreement, and (b) are factually supportable. The pro forma adjustments are described in the accompanying notes to the unaudited pro forma condensed consolidated financial information.
The unaudited pro forma condensed consolidated financial information is provided herein for illustrative purposes only and is not necessarily indicative of the results of operations that would have occurred had the Purchase Agreement occurred on February 24, 2021. The unaudited pro forma condensed consolidated financial information does not reflect future events that may occur after the sale.
ONCOCYTE CORPORATION
UNAUDITED PROFORMA CONDENSED CONSOLIDATED BALANCE SHEETS
As of September 30, 2022
(In thousands, except per share data)
ONCOCYTE CORPORATION
UNAUDITED PROFORMA CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the Nine Months Ended September 30, 2022
(In thousands, except per share data)
| Consolidated | Transaction | |||||||||||
| Company, as | Accounting | Proforma | ||||||||||
| Reported (A) | Adjustments (C) | Consolidated | ||||||||||
| Net revenue | $ | 4,508 | $ | (2,784 | )(4) | $ | 1,724 | |||||
| Cost of revenues | 3,641 | (3,280 | )(5) | 361 | ||||||||
| Cost of revenues – amortization of acquired intangibles | 2,888 | (2,815 | )(5) | 73 | ||||||||
| Gross profit | (2,021 | ) | 3,311 | 1,290 | ||||||||
| Operating expenses: | ||||||||||||
| Research and development | 15,123 | (9,709 | )(6) | 5,414 | ||||||||
| Sales and marketing | 10,764 | (9,966 | )(7) | 798 | ||||||||
| General and administrative | 16,927 | (122 | )(8) | 16,805 | ||||||||
| Change in fair value of contingent consideration | (17,157 | ) | - | (17,157 | ) | |||||||
| Total operating expenses | 25,657 | (19,797 | ) | 5,860 | ||||||||
| Loss from operations | (27,678 | ) | 23,108 | (4,570 | ) | |||||||
| OTHER INCOME (EXPENSES), NET | ||||||||||||
| Interest expense, net | (65 | ) | - | (65 | ) | |||||||
| Unrealized gain (loss) on marketable equity securities | (485 | ) | - | (485 | ) | |||||||
| Other income (expenses), net | 304 | - | 304 | |||||||||
| Total other income (expenses), net | (246 | ) | - | (246 | ) | |||||||
| LOSS BEFORE INCOME TAXES | (27,924 | ) | 23,108 | (4,816 | ) | |||||||
| Income tax benefit | - | - | - | |||||||||
| NET LOSS | $ | (27,924 | ) | $ | 23,108 | $ | (4,816 | ) | ||||
| Accretion of Series A redeemable convertible preferred stock | (294 | ) | - | (294 | ) | |||||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS: BASIC AND DILUTED | $ | (28,218 | ) | $ | 23,108 | $ | (5,110 | ) | ||||
| Net loss per share: basic and diluted | $ | (0.26 | ) | $ | (0.05 | ) | ||||||
| Weighted average shares outstanding: basic and diluted | 108,158 | 108,158 | ||||||||||
ONCOCYTE CORPORATION
UNAUDITED PROFORMA CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the year ended December 31, 2021
(In thousands, except per share data)
| Consolidated | Transaction | |||||||||||
| Company, as | Accounting | Proforma | ||||||||||
| Reported (A) | Adjustments (C) | Consolidated | ||||||||||
| Net revenue | $ | 7,727 | $ | (2,475 | )(4) | $ | 5,252 | |||||
| Cost of revenues | 4,185 | (3,273 | )(5) | 912 | ||||||||
| Cost of revenues – amortization of acquired intangibles | 3,354 | (3,124 | )(5) | 230 | ||||||||
| Gross profit (loss) | 188 | 3,922 | 4,110 | |||||||||
| Operating expenses: | ||||||||||||
| Research and development | 13,631 | (9,798 | )(6) | 3,833 | ||||||||
| Sales and marketing | 11,167 | (10,623 | )(7) | 544 | ||||||||
| General and administrative | 22,336 | (15 | )(8) | 22,321 | ||||||||
| Change in fair value of contingent consideration | 27,266 | - | 27,266 | |||||||||
| Total operating expenses | 74,400 | (20,436 | ) | 53,964 | ||||||||
| Loss from operations | (74,212 | ) | 24,358 | (49,854 | ) | |||||||
| OTHER INCOME (EXPENSES), NET | ||||||||||||
| Interest expense, net | (209 | ) | - | (209 | ) | |||||||
| Unrealized gain (loss) on marketable equity securities | 229 | - | 229 | |||||||||
| Pro rata loss from equity method investment in Razor | (270 | ) | - | (270 | ) | |||||||
| Gain on extinguishment of debt (PPP loan) | 1,141 | - | 1,141 | |||||||||
| Other income (expenses), net | (37 | ) | (23,198 | )(9) | (23,235 | ) | ||||||
| Total other income (expenses), net | 854 | (23,198 | ) | (22,344 | ) | |||||||
| LOSS BEFORE INCOME TAXES | (73,358 | ) | 1,160 | (72,198 | ) | |||||||
| Income tax benefit | 9,261 | - | 9,261 | |||||||||
| NET LOSS | $ | (64,097 | ) | $ | 1,160 | $ | (62,937 | ) | ||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS: BASIC AND DILUTED | $ | (64,097 | ) | $ | 1,160 | $ | (62,937 | ) | ||||
| Net loss per share: basic and diluted | $ | (0.72 | ) | $ | (0.71 | ) | ||||||
| Weighted average shares outstanding: basic and diluted | 88,920 | 88,920 | ||||||||||
The proforma adjustments are based on preliminary estimates and assumptions by management that are subject to changes
(A) Amounts as originally reported by Oncocyte Corporation in its Quarterly Report on Form 10-Q as of and for the period ended September 30, 2022.
(B) Adjustments to present the pro forma effects of the Razor Genomics disposition as if it had occurred on the balance sheet date. These include the following:
| (1) | Proforma adjustment represents the estimated clinical trial cash reserve account associated with the sale of Razor. | ||||||||
| (2) | Pro Forma adjustments include the elimination of DetermaRx related accounts receivable $1.9 million, prepaid expenses and other current assets of $0.4 million, fixed assets of $0.3 million, net intangible assets of $26.7 million, other current assets of $0.1 million, accounts payable of $0.1 million, accrued compensation of $0.6 million, and accrued expenses and other current liabilities of $2.1 million. | ||||||||
| (3) | Pro Forma adjustment to record Oncocyte interest in Razor Genomics after disposition | $ | 9,600 |
(C) Adjustments to present the pro forma effects of the Razor Genomics disposition as if it had occurred on February 24, 2021. These include the following:
| Statement of Operations | |||||||||
Nine Months Ended 9/30/2022 | Year Ended 12/31/2021 | ||||||||
| (4) | Pro Forma adjustment to remove DetermaRx revenue | $ | 2,784 | $ | 2,475 | ||||
| (5) | Pro Forma adjustment to remove cost of revenues associated with Razor | $ | 6,095 | $ | 6,397 | ||||
| (6) | Pro Forma adjustment to remove research and development cost | $ | 9,709 | $ | 9,798 | ||||
| (7) | Pro Forma adjustment to remove sales and marketing cost | $ | 9,966 | $ | 10,623 | ||||
| (8) | Pro Forma adjustment to remove general and administrative cost | $ | 122 | $ | 15 | ||||
| (9) | Pro Forma adjustment to record loss from disposal of Razor Genomics | $ | 0 | $ | 23,198 | ||||
Exhibit 99.2
ONCOCYTE COMPLETES RAZOR GENOMICS TRANSACTION
Feb 22, 2023
Company retains 30% stake while eliminating operating expense and future development obligations
Represents next step in plan to focus product strategy
IRVINE, Calif., Feb. 22, 2023 (GLOBE NEWSWIRE) — Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, today announced that it has completed the sale of 70% of its ownership stake in wholly-owned subsidiary Razor Genomics to Dragon Scientific. The deal eliminates an estimated $8M of annual operating expense and $13M of future milestone and development obligations, while allowing Razor Genomics to maintain continuity of service for DetermaRxTM patients and clinicians. Oncocyte retains a 30% equity stake. The transaction involved the transfer of all the assets and liabilities related to DetermaRx.
“Maintaining access to DetermaRx for the clinical community was critical to us and we are happy to report that we achieved this important goal” said Joshua Riggs, Oncocyte’s Interim CEO. “We believe that this transaction preserves upside opportunity for Oncocyte shareholders while eliminating nearly $30M of estimated operating expense, future milestone and development obligations in the aggregate over the next two years. This announcement reflects our continued progress in focusing our product strategy and reducing our cash burn. Oncocyte is well positioned to achieve 2023 commercial and developmental milestones in its key product lines.”
About Oncocyte
Oncocyte is a precision diagnostics company. The Company develops and markets assays that are designed to help enable groundbreaking research and provide clarity and confidence to physicians and their patients. The Company is currently focused on development and commercialization activities in three areas. DetermaIO™ is a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies, VitaGraft™ is a blood-based solid organ transplantation monitoring test, and pipeline test DetermaCNI™ is blood-based monitoring tool for monitoring therapeutic efficacy in cancer patients.
DetermaIO™, DetermaCNI™, and VitaGraft™ 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, the expected elimination of an estimated $8M of annual operating expense and $13M of future milestone and development liabilities, the expected elimination of nearly $30M of estimated expense, future milestone and development obligations in the aggregate over the next two years, the expectation that Razor Genomics will maintain continuity of service for DetermaRx patients and clinicians, the expectation that access to DetermaRx will be maintained for the clinical community, the anticipation of continued progress in focusing the Company’s product strategy and reduction in cash burn, the expected achievement of 2023 commercial and developmental milestones in key product lines, 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 & Media Contact
Caroline Corner
ICR Westwicke
Tel: 415.202.5678
caroline.corner@westwicke.com