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Oncocyte Reports First Quarter 2023 Financial Results

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Oncocyte Corporation reported financial results for Q1 2023, including a capital raise of $13.86 million and progress in developing kitted versions of their diagnostic tests. Consolidated revenues decreased by 50% compared to Q1 2022. R&D expenses decreased by $2.3 million, and G&A expenses decreased by $2.0 million. Sales and Marketing expenses decreased by $2.0 million due to the sale of Razor Genomics. A conference call to discuss the results will be held on May 11, 2023.
Positive
  • Oncocyte completed an equity capital raise of $13.86 million to strengthen their balance sheet and support their product portfolio.
  • The company is making rapid progress in getting kitted versions of their tests to market.
  • Consolidated operating income for Q1 2023 was $2.9 million, a change of $12.3 million compared to the same period last year.
  • R&D expenses decreased by $2.3 million, and G&A expenses decreased by $2.0 million.
  • Sales and Marketing expenses decreased by $2.0 million due to the sale of Razor Genomics.
Negative
  • Consolidated revenues for Q1 2023 decreased by 50% compared to Q1 2022.
  • The decrease in revenues is primarily due to the decrease in DetermaRx revenue.
  • Net consolidated operating income for Q1 2023 was a loss of $9.4 million in the prior year.
  • Sales and Marketing expenses decreased by $2.0 million due to the decrease in product development and commercialization efforts of DetermaRx.

Nearing Manufacturing Start Up of First Kitted Product

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.

First Quarter 2023 and Recent Highlights:

  • Completed an equity capital raise of $13.86 million from the sale and issuance of common stock to strengthen the balance sheet and further support the Company’s product portfolio.
  • Implemented additional cost cutting initiatives to accelerate our transition to a capital-light business model based on commercializing kitted product versions of our novel diagnostic tests.
  • Published a peer-reviewed article in Clinical Cancer Research on the results of a study applying DetermaIO™ to samples collected from the randomized Phase II AtezoTRIBE clinical trial in metastatic colorectal cancer.
  • Presented five abstracts at the Annual Meeting of the American Association for Cancer Research.
    • Four explored the tumor microenvironment and its potential implications for therapeutic response, leveraging the expertise and technology behind DetermaIO.
    • One abstract highlighted exciting study results applying DetermaCNI to metastatic pancreatic cancer.
  • Completed 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.”

First Quarter 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, a change 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 to be filed with the Securities and Exchange Commission on May 12, 2023.

Webcast and 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.

About Oncocyte

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-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 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) 
      
  March 31,  December 31, 
   2023   2022  
  (unaudited)   
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  
      



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 
     

 


Oncocyte Corporation      
       
Reconciliation of Non-GAAP Financial Measure      
Adjusted Income (Loss) 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)
       

Investor Contact
Jesse Arno
(949) 409-6770
jarno@oncocyte.com


Consolidated revenues for Q1 2023 were approximately $0.7 million, a 50% decrease compared to Q1 2022. Net consolidated operating income was $2.9 million, compared to a loss of $9.4 million in the prior year.

The equity capital raise of $13.86 million was to strengthen Oncocyte's balance sheet and support their product portfolio.

Oncocyte is making rapid progress in getting kitted versions of their tests to market.

Sales and Marketing expenses decreased by $2.0 million due to the decrease in product development and commercialization efforts of DetermaRx.

The conference call will be held on May 11, 2023.
Oncocyte Corporation

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In-Vitro Diagnostic Substance Manufacturing
Manufacturing
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Health Technology, Medical Specialties, Manufacturing, In-Vitro Diagnostic Substance Manufacturing
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Irvine

About OCX

oncocyte is focused on the discovery, development, and commercialization of non-invasive, liquid biopsy diagnostics to facilitate clinical decision making in the early detection of cancer. the company's pipeline is focused on molecular tests for areas of high unmet need - lung, breast, and bladder cancers - where the current standard of diagnostic care is often ambiguous, costly, and involves invasive surgical procedures. oncocyte's diagnostics are developed based on a proprietary set of biomarkers that have been shown to differentiate benign from malignant nodules or masses. for more information, visit www.oncocyte.com.