8-K
Insight Molecular Diagnostics Inc. (IMDX)
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 11, 2023
OncocyteCorporation
(Exact name of registrant as specified in its charter)
| California | 1-37648 | 27-1041563 |
|---|---|---|
| (State<br> or other jurisdiction | (Commission | (IRS<br> Employer |
| of<br> incorporation) | File<br> Number) | Identification<br> No.) |
15Cushing
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<br> Stock, no par value | OCX | The<br> 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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> 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. ☐
Item2.02 Results of Operations and Financial Condition.
On May 11, 2023, Oncocyte Corporation (“we,” “us,” “our,” the “Company” or “Oncocyte”) issued a press release announcing its financial results for the three months ended March 31, 2023. A copy of the press release is furnished as Exhibit 99.1, which, in its entirety, is incorporated herein by reference.
The information in this Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. Such information shall not be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as otherwise expressly set forth by specific reference in such filing.
Item5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements ofCertain Officers.
On May 11, 2023, Oncocyte announced that Anish John, our Chief Financial Officer, will be leaving the Company on June 15, 2023. Mr. John intends to pursue other opportunities, and there were no disagreements between the Company and Mr. John on any matter regarding its operations, policies or practices. The Company has commenced a search for a qualified replacement for Mr. John.
Item9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description |
|---|---|
| 99.1 | Press release dated May 11, 2023. |
| 104 | Cover<br> 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:<br> May 11, 2023 | By: | /s/ Joshua Riggs |
| Joshua<br> Riggs | ||
| President<br> and Chief Executive Officer |
Exhibit99.1
ONCOCYTE REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS
-nearing manufacturing start up of first KITTED product-
May 11, 2023
IRVINE, Calif., May 11, 2023 (GLOBE NEWSWIRE) — Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, today reported financial results for the first quarter 2023, ended March 31, 2023.
FirstQuarter 2023 and Recent Highlights:
| ● | Completed<br> an equity capital raise of $13.86 million from the sale and issuance of common stock to strengthen the balance sheet and further<br> support the Company’s product portfolio. |
|---|---|
| ● | Implemented<br> additional cost cutting initiatives to accelerate our transition to a capital-light business model based on commercializing kitted<br> product versions of our novel diagnostic tests. |
| ● | Published<br> a peer-reviewed article in Clinical Cancer Research on the results of a study applying DetermaIO™ to samples collected<br> from the randomized Phase II AtezoTRIBE clinical trial in metastatic colorectal cancer. |
| ● | Presented<br> five abstracts at the Annual Meeting of the American Association for Cancer Research. |
| ○ | Four<br> explored the tumor microenvironment and its potential implications for therapeutic response, leveraging the expertise and technology<br> behind DetermaIO. |
| --- | --- |
| ○ | One<br> abstract highlighted exciting study results applying DetermaCNI to metastatic pancreatic cancer. |
| ● | Completed<br> sale of 70% of ownership interest in Razor Genomics. |
| --- | --- |
“In the first quarter we completed the major steps in committing the company to a kitted product driven commercial model,” said Josh Riggs, CEO. “Our novel diagnostic tests have continued to generate compelling clinical data in studies that strongly suggest superiority to currently marketed diagnostic tests that generate hundreds of millions of dollars of revenue. And our development team is making rapid progress getting kitted versions of our tests to market. As a result of our new capital-light business plan, our strong clinical data, and our steady progress toward market, we raised $13.86 million in April from the sale and issuance of our common stock to existing and new investors who share our long-term vision to create value for both patients and shareholders.”
FirstQuarter 2023 Financial Results
Consolidated revenues for the three months ended March 31, 2023, were approximately $0.7 million, a 50% decrease compared to the first quarter of 2022. Excluding DetermaRx revenue, the continuing operations revenue was $0.3 million for the three months ended March 31, 2023.
Consolidated cost of revenues for the three months ended March 31, 2023, was approximately $0.8 million, a 59% decrease compared from same period in 2022.
Net consolidated operating income for the three months ended March 31, 2023, was $2.9 million, compared to consolidated operating loss of $9.4 million, an increase of $12.3 million from the same period in the prior year.
Research and Development expenses for the first quarter of 2023 were $2.8 million compared to $5.1 million, a decrease of $2.3 million from the same period a year ago. The decrease is primarily due to the decrease in CLIA laboratory expenses and clinical trial expenses in the three months ended March 31, 2023.
The General and Administrative expenses for the first quarter of 2023 were $3.7 million compared to $5.7 million from the same period in the prior year, a decrease of $2.0 million.
Sales and Marketing expenses in the quarter were $1.2 million compared to $3.2 million from the same period in the prior year; a decrease of $2.0 million year over year, primarily attributable to the decrease in product development and commercialization efforts of DetermaRx due to the sale of Razor Genomics during the first quarter of 2023.
For Oncocyte’s complete financial results for the first quarter ended March 31, 2023, see the Company’s Quarterly Form 10-Q filed with the Securities and Exchange Commission on May 12, 2023 .
Webcastand Conference Call Information
Oncocyte will host a conference call to discuss the first quarter 2023 financial results prior to the market open on Thursday, May 11, 2023 at 6:00 a.m. Pacific Time / 9:00 a.m. Eastern Time.
Participants may access the live call via telephone by dialing (877) 317-6789 for domestic callers or (412) 317-6789 for international callers. Once dialed in ask to be joined to the Oncocyte Corporation call. The live webcast of the call may be accessed by visiting the “Events & Presentation” section of the Company’s website at https://investors.oncocyte.com.
AboutOncocyte
Oncocyte is a precision diagnostics company. The Company’s tests are designed to help provide clarity and confidence to physicians and their patients. 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. For more information, visit www.oncocyte.com
DetermaIO™, DetermaCNI™, and VitaGraft™ are trademarks of Oncocyte Corporation.
Forward-LookingStatements
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 commercialization of our kitted tests and our progress toward market, 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.
ONCOCYTE CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
| December 31, | |||||
|---|---|---|---|---|---|
| 2022 | |||||
| ASSETS | |||||
| CURRENT ASSETS | |||||
| Cash and cash equivalents | 11,803 | $ | 19,993 | ||
| Accounts receivable, net of allowance of 172 and 154, respectively | 1,901 | 2,012 | |||
| Marketable equity securities | 553 | 433 | |||
| Prepaid expenses and other current assets | 970 | 977 | |||
| Assets held for sale | 421 | - | |||
| Current assets of discontinuing operations | - | 2,121 | |||
| Total current assets | 15,648 | 25,536 | |||
| NONCURRENT ASSETS | |||||
| Right-of-use and financing lease assets, net | 2,021 | 2,088 | |||
| Machinery and equipment, net, and construction in progress | 6,403 | 8,763 | |||
| Intangible assets, net | 56,661 | 61,633 | |||
| Restricted cash | 1,700 | 1,700 | |||
| Other noncurrent assets | 367 | 371 | |||
| TOTAL ASSETS | 82,800 | $ | 100,091 | ||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | |||||
| CURRENT LIABILITIES | |||||
| Accounts payable | 1,395 | $ | 1,253 | ||
| Accrued compensation | 2,227 | 1,771 | |||
| Accrued expenses and other current liabilities | 2,374 | 3,839 | |||
| Accrued severance from acquisition | 2,314 | 2,314 | |||
| Accrued liabilities from acquisition | 109 | 109 | |||
| Right-of-use and financing lease liabilities, current | 775 | 815 | |||
| Current liabilities of discontinuing operations | 236 | 2,005 | |||
| Total current liabilities | 9,430 | 12,106 | |||
| NONCURRENT LIABILITIES | |||||
| Right-of-use and financing lease liabilities, noncurrent | 2,550 | 2,729 | |||
| Contingent consideration liabilities | 27,355 | 45,662 | |||
| TOTAL LIABILITIES | 39,335 | 60,497 | |||
| COMMITMENTS AND CONTINGENCIES | |||||
| Series A Redeemable Convertible Preferred Stock, no par value; stated value 1,000 per share; 6 shares issued and outstanding at March 31, 2023; aggregate liquidation preference of 6,182 and 6,091 as of March 31, 2023 and December 31, 2022, respectively | 5,532 | 5,302 | |||
| 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; 119,279 and 118,644 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 295,533 | 294,929 | |||
| Accumulated other comprehensive income | 43 | 39 | |||
| Accumulated deficit | (257,643 | ) | (260,676 | ) | |
| Total shareholders’ equity | 37,933 | 34,292 | |||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | 82,800 | $ | 100,091 |
All values are in US Dollars.
ONCOCYTE CORPORATION
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
| Three Months Ended | ||||||
|---|---|---|---|---|---|---|
| March 31, | ||||||
| 2023 | 2022 | |||||
| Net revenue | $ | 297 | $ | 380 | ||
| Cost of revenues | 265 | 105 | ||||
| Cost of revenues – amortization of acquired intangibles | 22 | 28 | ||||
| Gross margin | 10 | 247 | ||||
| Operating expenses: | ||||||
| Research and development | 2,127 | 2,007 | ||||
| Sales and marketing | 695 | 266 | ||||
| General and administrative | 3,412 | 5,647 | ||||
| Change in fair value of contingent consideration | (18,307 | ) | (4,656 | ) | ||
| Impairment loss from intangible assets | 4,950 | - | ||||
| Loss on disposal and held for sale assets | 1,335 | - | ||||
| Total operating (income) expenses | (5,788 | ) | 3,264 | |||
| Income (loss) from operations | 5,798 | (3,017 | ) | |||
| OTHER INCOME (EXPENSES), NET | ||||||
| Interest expense, net | (10 | ) | (30 | ) | ||
| Unrealized gain (loss) on marketable equity securities | 121 | (330 | ) | |||
| Other income (expenses), net | 50 | (36 | ) | |||
| Total other income (expenses), net | 161 | (396 | ) | |||
| INCOME (LOSS) BEFORE INCOME TAXES | 5,959 | (3,413 | ) | |||
| Income (loss) from continuing operations | 5,959 | (3,413 | ) | |||
| Loss from discontinuing operations | (2,926 | ) | (6,878 | ) | ||
| NET INCOME (LOSS) | 3,033 | (10,291 | ) | |||
| NET INCOME (LOSS) FROM CONTINUING OPERATIONS ATTRIBUTABLE TO COMMON STOCKHOLDERS: BASIC | 4,899 | (3,413 | ) | |||
| NET LOSS FROM DISCONTINUED OPERATIONS ATTRIBUTABLE TO COMMON STOCKHOLDERS: BASIC | (2,502 | ) | (6,878 | ) | ||
| NET INCOME (LOSS) ATTRIBUTABLE TO COMMON STOCKHOLDERS: BASIC | 2,397 | (10,291 | ) | |||
| NET INCOME (LOSS) FROM CONTINUING OPERATIONS ATTRIBUTABLE TO COMMON STOCKHOLDERS: DILUTED | 4,900 | (3,413 | ) | |||
| NET LOSS FROM DISCONTINUED OPERATIONS ATTRIBUTABLE TO COMMON STOCKHOLDERS: DILUTED | (2,502 | ) | (6,878 | ) | ||
| NET INCOME (LOSS) ATTRIBUTABLE TO COMMON STOCKHOLDERS: DILUTED | 2,398 | (10,291 | ) | |||
| Net income (loss) from continuing operations attributable to common stockholders per share - basic | $ | 0.04 | $ | (0.04 | ) | |
| Net loss from discontinued operations attributable to common stockholders per share - basic | $ | (0.02 | ) | $ | (0.07 | ) |
| Net income (loss) attributable to common stockholders per share - basic | $ | 0.02 | $ | (0.11 | ) | |
| Net income (loss) from continuing operations attributable to common stockholders per share - diluted | $ | 0.04 | $ | (0.04 | ) | |
| Net loss from discontinued operations attributable to common stockholders per share - diluted | $ | (0.02 | ) | $ | (0.07 | ) |
| Net income (loss) attributable to common stockholders per share - diluted | $ | 0.02 | $ | (0.11 | ) | |
| Weighted average shares outstanding: basic | 119,150 | 92,243 | ||||
| Weighted average shares outstanding: diluted | 119,253 | 92,243 |
OncocyteCorporation
Reconciliationof Non-GAAP Financial Measure
AdjustedLoss from Operations
(Amounts in Thousands)
| For the Three Months Ended | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| March 31, | December 31, | March 31, | |||||||
| 2023 | 2022 | 2022 | |||||||
| (unaudited) | (unaudited) | (unaudited) | |||||||
| GAAP income (loss) from operations - as reported | $ | 2,872 | $ | (44,664 | ) | (9,895 | ) | ||
| Stock-based compensation expense | 834 | 2,619 | 2,010 | ||||||
| Change in fair value of contingent consideration | (18,307 | ) | (13,862 | ) | (4,656 | ) | |||
| Severance charge | 14 | 1,640 | - | ||||||
| Depreciation and amortization expense | 472 | 1,278 | 1,216 | ||||||
| Loss on disposal and held for sale assets | 1,335 | - | - | ||||||
| Impairment loss | 4,950 | 44,550 | - | ||||||
| Non-GAAP loss from operations, as adjusted | $ | (7,830 | ) | $ | (8,439 | ) | $ | (11,325 | ) |