Recent Highlights
- Announced global commercialization partnership with Bio-Rad Laboratories, Inc.
- On track to ship research use only (RUO) GraftAssure™ transplant monitoring test kits to initial customers in
Asia , theU.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% ofOncocyte ; new and existing investors invested as well. - Reduced cash burn to
$3.9 million , reflecting capital-efficient business model.
“In the first quarter of 2024,
“The 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™ 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 applications.”
“Building on the momentum of these achievements, we are preparing to ship to several initial commercial customers in the
2024 First Quarter Financial Results
Net revenue for the three months ended
Total cost of revenues for the three months ended
Research and development expense for the three months ended
The increase was driven by continued focused investment in developing kitted versions of assays including DetermaIO™, VitaGraft™ and DetermaCNI™.
Sales and marketing expense for the three months ended
General and administrative expense for the three months ended
Loss from operations for the three months ended
For Oncocyte’s complete financial results for the first quarter ended
Webcast and Conference Call Information
Oncocyte 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
About Oncocyte
VitaGraft Kidney™ - https://oncocyte.com/vitagraft-kidney/
VitaGraft Liver™ - https://oncocyte.com/vitagraft-liver/
GraftAssure™ - https://oncocyte.com/graftassure/
DetermaIO™ - https://oncocyte.com/determa-io/
DetermaCNI™ - https://oncocyte.com/determa-cni/
VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of
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 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.
CONTACT:
PCG Advisory
(646) 863-6893
jramson@pcgadvisory.com
- Tables Follow -
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
2024 | 2023 | |||||||
(Unaudited) | ||||||||
ASSETS | ||||||||
CURRENT ASSETS | ||||||||
Cash and cash equivalents | $ | 5,578 | $ | 9,432 | ||||
Accounts receivable, net of allowance for credit losses of | 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 | 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 | 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 | ||||
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three Months Ended | ||||||||
| ||||||||
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 | ||||||
Reconciliation of Non-GAAP Financial Measure
Consolidated Adjusted Loss from Operations
Note: In addition to financial results determined in accordance with
Three Months Ended | |||||||||||
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 | ) | ||
Source:
2024 GlobeNewswire, Inc., source