Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics
company, today reported financial results for the quarter ended
March 31, 2024.
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, 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.
“In 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.”
“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 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.”
2024 First Quarter Financial
Results
Net 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.
Total 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.
Research 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 DetermaIO™, VitaGraft™ and DetermaCNI™.
Sales 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.
General 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.
Loss 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.
For 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.
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 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 OncocyteOncocyte 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:
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 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 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:Jeff RamsonPCG Advisory(646)
863-6893jramson@pcgadvisory.com
- Tables Follow -
ONCOCYTE
CORPORATIONCONDENSED CONSOLIDATED BALANCE
SHEETS(In 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 |
|
|
|
|
|
|
ONCOCYTE
CORPORATIONUNAUDITED CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS(In 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 |
|
|
|
|
|
|
Oncocyte
CorporationReconciliation of Non-GAAP Financial
MeasureConsolidated Adjusted Loss from
Operations
Note: 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 GAAP measure:
|
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 |
) |
|
|
|
|
|
|
Oncocyte (NASDAQ:OCX)
과거 데이터 주식 차트
부터 10월(10) 2024 으로 11월(11) 2024
Oncocyte (NASDAQ:OCX)
과거 데이터 주식 차트
부터 11월(11) 2023 으로 11월(11) 2024