Full Press Release Details
REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS
Call on Wednesday, May 15, 2024 at 1:30 p.m. PT / 4:30 p.m. ET
Calif., May 15, 2024 (GLOBE NEWSWIRE) -- Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, today reported financial
results for the quarter ended March 31, 2024.
| Announced global commercialization partnership with Bio-Rad Laboratories, Inc. | ||
| On track to ship research use only (RUO) GraftAssure TM transplant monitoring test kits to initial customers in Asia, the U.S., and the EU in 2Q 2024. IVD kits are under development for FDA submission. | ||
| Raised $15.8 million in gross proceeds from equity private placement; as part of the financing, Bio-Rad purchased 8.99% of Oncocyte; new and existing investors invested as well. | ||
| Reduced cash burn to $3.9 million, reflecting capital-efficient business model. |
the first quarter of 2024, Oncocyte made significant progress toward commercializing its innovative blood-based diagnostic tests. That
progress was bolstered by a $15.8 million equity private placement and a global strategic partnership with Bio-Rad Laboratories,"
said Josh Riggs, Oncocyte's CEO. "We believe that the collaboration with Bio-Rad is pivotal for the upcoming launch of our
GraftAssure RUO transplant rejection diagnostic test kit and central to our mission of developing and providing accessible point of care
diagnostics and continuous innovation in transplant rejection monitoring."
Bio-Rad partnership validates the efficacy and market opportunity of our proprietary assays and enables us to rapidly enter the growing
transplant monitoring market at key academic centers with GraftAssure RUO. It also lays the groundwork for broader commercial expansion.
Together with Bio-Rad, we are developing regulated products including VitaGraft TM Kidney IVD, and preparing for clinical
adoption. Additionally, our technology has been selected to support multiple Phase 2 clinical studies by pharmaceutical companies that
are developing therapeutics to treat and manage anti-body mediated rejection. These therapeutic studies may unlock valuable new commercial
on the momentum of these achievements, we are preparing to ship to several initial commercial customers in the U.S., the EU, and Asia
in Q2. We are encouraged by prospective customers' positive response to GraftAssure's superior affordability, turn-around-time,
and ease of use. We are well-positioned to achieve numerous critical commercial and regulatory milestones throughout 2024 and into 2025.
We also are continuing to advance the development of our oncology diagnostics pipeline products, DetermaIO and DetermaCNI. Lastly, in
Q1 2024, our cash burn stayed low at $3.9 million , reflecting our cost-control measures and financial discipline. We continue to
meet our goal of maintaining a low average quarterly burn rate below $5 million."
First Quarter Financial Results
revenue for the three months ended March 31, 2024 was $176,000, a decrease of 41% compared to the same period in 2023, due to decreased
revenue from our Pharma Services business.
cost of revenues for the three months ended March 31, 2024 was $274,000, a decrease of 5% compared to the same period in 2023. Total
cost of revenues included $252,000 from the cost of diagnostic tests and testing services we performed for Pharma Services customers,
with the remaining cost from noncash amortization expense.
and development expense for the three months ended March 31, 2024 was $2.2 million, an increase of 2% compared to the same period in
2023. The increase was driven by continued focused investment in developing kitted versions of assays including
DetermaIOTM, VitaGraft and DetermaCNITM.
and marketing expense for the three months ended March 31, 2024 was $846,000, an increase of 22% compared to the same period in 2023.
The increase was primarily driven by a continued ramp in sales, marketing and commercialization activities related to the commercial
launch of GraftAssure.
and administrative expense for the three months ended March 31, 2024 was $2.7 million, a decrease of 22% compared to the same period
in 2023. The decrease was primarily due to decreased stock-based compensation, personnel expenses, professional fees, and facilities
and insurance expenses.
from operations for the three months ended March 31, 2024 was $9.3 million, compared to income from operations of $5.9 million during
the same period in 2023. The increased loss from operations was primarily due to the unrealized noncash change in fair value of contingent
consideration. The 2024 loss from operations included a loss of $3.3 million from the change in fair value of contingent consideration,
compared to a gain of $18.3 million in 2023. Excluding the change in fair value of contingent consideration, the 2024 loss from operations
decreased 52% compared to 2023.
Oncocyte's complete financial results for the first quarter ended March 31, 2024, see the Company's quarterly Form 10-Q to
be filed with the Securities and Exchange Commission on May 15, 2024.
and Conference Call Information
will host a conference call to discuss first quarter 2024 financial results after market close on Wednesday, May 15, 2024 at 1:30 p.m.
Pacific Time / 4:30 p.m. Eastern Time. The conference call may be accessed live via telephone by dialing toll free (800) 715-9871 for
both domestic and 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.
is a precision diagnostics company. The Company's tests are designed to help provide clarity and confidence to physicians and their
patients. VitaGraft is a clinical blood-based solid organ transplantation monitoring test. GraftAssure is a research use
only (RUO) blood-based solid organ transplantation monitoring test. DetermaIO is a gene expression test that assesses the tumor
microenvironment to predict response to immunotherapies. DetermaCNI is a blood-based monitoring tool for monitoring therapeutic
efficacy in cancer patients. For more information about Oncocyte, please visit https://oncocyte.com/. More information about our
products, please visit the following web pages:
GraftAssure , DetermaIO , and DetermaCNI are trademarks of Oncocyte Corporation.
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 anticipated launch of the Company's
GraftAssure RUO transplant rejection diagnostic test and the Company's rapid entry into the transplant monitoring market at key
academic centers, the expectation that the Company and Bio-Rad will successfully develop regulated products, including VitaGraft Kidney
IVD, the Company's high-margin and low-complexity business model, anticipated shipments to commercial customers in Q2, the belief
that the Company is well positioned to meet numerous critical commercial and regulatory milestones throughout 2024 and into 2025, 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, 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.
CONSOLIDATED BALANCE SHEETS
thousands, except per share data)
| March 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 5,578 | $ | 9,432 | ||||
| Accounts receivable, net of allowance for credit losses of $2 and $5, respectively | 161 | 484 | ||||||
| Prepaid expenses and other current assets | 735 | 643 | ||||||
| Assets held for sale | 61 | 139 | ||||||
| Total current assets | 6,535 | 10,698 | ||||||
| NONCURRENT ASSETS | ||||||||
| Right-of-use and financing lease assets, net | 2,199 | 1,637 | ||||||
| Machinery and equipment, net, and construction in progress | 3,528 | 3,799 | ||||||
| Intangible assets, net | 56,573 | 56,595 | ||||||
| Restricted cash | 1,700 | 1,700 | ||||||
| Other noncurrent assets | 438 | 463 | ||||||
| TOTAL ASSETS | $ | 70,973 | $ | 74,892 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable | $ | 908 | $ | 953 | ||||
| Accrued compensation | 2,427 | 1,649 | ||||||
| Accrued royalties | 1,116 | 1,116 | ||||||
| Accrued expenses and other current liabilities | 741 | 452 | ||||||
| Accrued severance from acquisition | 2,314 | 2,314 | ||||||
| Right-of-use liabilities, current | 821 | 665 | ||||||
| Current liabilities of discontinued operations | - | 45 | ||||||
| Total current liabilities | 8,327 | 7,194 | ||||||
| NONCURRENT LIABILITIES | ||||||||
| Right-of-use liabilities, noncurrent | 2,514 | 2,204 | ||||||
| Contingent consideration liabilities | 43,212 | 39,900 | ||||||
| TOTAL LIABILITIES | 54,053 | 49,298 | ||||||
| Commitments and contingencies | ||||||||
| Series A Redeemable Convertible Preferred Stock, no par value; stated value $1,000 per share; 5 shares issued and outstanding at March 31, 2024 and December 31, 2023; aggregate liquidation preference of $5,376 and $5,296 as of March 31, 2024 and December 31, 2023, respectively | 5,332 | 5,126 | ||||||
| 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; 8,273 and 8,261 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 310,553 | 310,295 | ||||||
| Accumulated other comprehensive income | 40 | 49 | ||||||
| Accumulated deficit | (299,005 | ) | (289,876 | ) | ||||
| Total shareholders' equity | 11,588 | 20,468 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 70,973 | $ | 74,892 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
thousands, except per share data)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| Net revenue | $ | 176 | $ | 297 | ||||
| Cost of revenues | 252 | 265 | ||||||
| Cost of revenues - amortization of acquired intangibles | 22 | 22 | ||||||
| Gross (loss) profit | (98 | ) | 10 | |||||
| Operating expenses: | ||||||||
| Research and development | 2,169 | 2,127 | ||||||
| Sales and marketing | 846 | 695 | ||||||
| General and administrative | 2,673 | 3,412 | ||||||
| Change in fair value of contingent consideration | 3,312 | (18,307 | ) | |||||
| Impairment loss | - | 4,950 | ||||||
| Impairment loss on held for sale assets | 169 | 1,283 | ||||||
| Total operating expenses (credits) | 9,169 | (5,840 | ) | |||||
| (Loss) income from operations | (9,267 | ) | 5,850 | |||||
| Other (expenses) income: | ||||||||
| Interest expense | (15 | ) | (11 | ) | ||||
| Unrealized gain on marketable equity securities | - | 121 | ||||||
| Other income (expenses), net | 153 | (1 | ) | |||||
| Total other income | 138 | 109 | ||||||
| (Loss) income before income taxes | (9,129 | ) | 5,959 | |||||
| Income taxes | - | - | ||||||
| (Loss) income from continuing operations | (9,129 | ) | 5,959 | |||||
| Loss from discontinued operations | - | (2,926 | ) | |||||
| Net (loss) income | $ | (9,129 | ) | $ | 3,033 | |||
| Net (loss) income per share: | ||||||||
| Net (loss) income from continuing operations - basic and diluted | $ | (9,335 | ) | $ | 4,899 | |||
| Net loss from discontinued operations - basic and diluted | $ | - | $ | (2,502 | ) | |||
| Net (loss) income attributable to common stockholders - basic and diluted | $ | (9,335 | ) | $ | 2,397 | |||
| Net (loss) income from continuing operations per share - basic and diluted | $ | (1.13 | ) | $ | 0.82 | |||
| Net loss from discontinued operations per share - basic and diluted | $ | - | $ | (0.42 | ) | |||
| Net (loss) income attributable to common stockholders per share - basic and diluted | $ | (1.13 | ) | $ | 0.40 | |||
| Weighted average shares outstanding - basic | 8,264 | 5,958 | ||||||
| Weighted average shares outstanding - diluted | 8,264 | 5,963 |
of Non-GAAP Financial Measure
Adjusted Loss from Operations
In addition to financial results determined in accordance with U.S. generally accepted accounting principles ("GAAP"), this
press release also includes a non-GAAP financial measure (as defined under SEC Regulation G). We believe the adjusted amounts are more
representative of our ongoing performance. The following is a reconciliation of the non-GAAP measure to the most directly comparable
| Three Months Ended | ||||||||||||
| March 31, | December 31, | March 31, | ||||||||||
| 2024 | 2023 | 2023 | ||||||||||
| (unaudited) | (unaudited) | (unaudited) | ||||||||||
| Consolidated GAAP (loss) income from operations | $ | (9,267 | ) | $ | (16,179 | ) | $ | 5,850 | ||||
| Stock-based compensation | 418 | 484 | 816 | |||||||||
| Severance charge | - | 2 | 14 | |||||||||
| Depreciation and amortization expense | 335 | 325 | 472 | |||||||||
| Change in fair value of contingent consideration | 3,312 | 11,185 | (18,307 | ) | ||||||||
| Impairment losses | - | (4 | ) | 4,950 | ||||||||
| Impairment loss on held for sale assets | 169 | - | 1,283 | |||||||||
| Consolidated Non-GAAP loss from operations, as adjusted | $ | (5,033 | ) | $ | (4,187 | ) | $ | (4,922 | ) |