Oncocyte Corp. (Nasdaq: OCX), a diagnostics technology company,
today published the following letter to shareholders in conjunction
with its fourth quarter results:
Fellow Shareholders,
Our dynamic team is making swift progress toward delivering a
regulated organ transplant rejection monitoring test kit to the
market next year. To be clear, this test kit is the assay that we
expect can generate future material and self-sustaining revenue
within a few years. In 2024, we began to drive commercial awareness
of our tests and capture market share in the estimated $1
billion total addressable transplant rejection testing
market.
We are proud of our ability to stay nimble and move quickly
relative to our industry. In 2025, we expect to announce a series
of catalysts that build upon our momentum. We expect to announce
progress with our multi-center clinical trial of the clinical test
kit, commercial expansion of sales of our GraftAssureTM
research-use-only (RUO) test kit, and favorable data that further
solidify our global credibility in the transplant community. In
addition, we expect to deepen our relationships with our existing
strategic partners and announce new relationships with additional
strategic partners. Meanwhile, our pipeline of commercial contracts
continues to strengthen, with leading transplant centers
progressing through the stages of assay validation.
Since our November 2024 update, our confidence in the transplant
opportunity has grown in line with the enthusiasm we see among
leading transplant centers to participate in our clinical trial as
part of our FDA submission. With the clinical trial agreement
process already underway, we are eager to name these globally
recognized and well-respected institutions in the coming weeks.
We expect that our clinical trial will be conducted at several
leading U.S. transplant centers and a leading transplant research
institution in Europe, reinforcing the global credibility of our
approach. We are sincerely impressed by the demand that we see
among transplant centers to become part of our clinical trial.
Their strong interest has exceeded our expectations, underscoring
the need for localized and reliable testing solutions.
To recap the significance of this trial, in January 2023, when
we first decided to commercialize our transplant intellectual
property (IP) by designing a kitted test, we essentially planted a
flag that said we would put our assay through the approval
processes of the FDA and its EU equivalent. This decision was
significant because in the U.S., we estimate that most complex
molecular diagnostics tests are run without FDA authorization and
are instead performed in siloed, centralized labs. Moreover, these
North American lab tests are not easily accessible to hospitals in
the rest of the world. Regulatory authorization is a key step
toward achieving our mission to democratize access to these
important tests. With regulatory authorization, we anticipate
selling test kits to hospital labs, thereby empowering hospitals to
run the tests themselves to expediently deliver actionable
results.
It is our belief that if we do the hard work of designing a lab
test in kitted form, and achieving regulatory authorization, we
will not only democratize access to these tests – thus bringing
care closer to the patient and helping hospitals to operate more
sustainably – but also create a rapidly growing, high-margin,
recurring business model.
On December 5, 2024, we had our first meeting with the FDA. We
were pleased with the collaborative nature of the discussion and
our reviewers’ feedback. As we continue to develop our kitted
product technology alongside our clinical trial, we are targeting
submission to the FDA by the end of this year, followed by FDA
authorization in 2026.
Additionally, our research-use-only version of the transplant
assay, which has been in the field since July, has generated
invaluable feedback from leading transplant center labs, allowing
us to refine the product for an enhanced user experience. These
collaborations continue to build momentum, increasing awareness
within the transplant community and reinforcing the potential for
clinical use of digital PCR technology for transplant rejection
testing.
Executive summary
Oncocyte is at a pivotal stage in commercializing what we expect
to be an industry-transforming organ transplant rejection
monitoring test. We aim to deliver proven, more affordable, faster
tests that can be run at local labs.
Specifically, we are developing a kitted test that quantifies a
molecular biomarker known as donor-derived cell-free DNA
(dd-cfDNA). Our scientists in Germany and the U.S. have played a
critical role over the past decade in developing the science that
helped establish dd-cfDNA as a trusted biomarker1 of transplant
rejection, and we are now commercializing that technology using a
market disruptive approach.
Our goal is to enable transplant centers to use our kits to
capture the potential patient benefit of a rapid response time and
the business benefit of generating laboratory revenue by running
the test. In addition to designing a laboratory test in kitted
form, our assay uses a digital-PCR workflow that we believe offers
distinct advantages over assays run on Next-Generation Sequencing
(NGS) technology.
We expect meaningful revenue in transplant rejection testing
after we have reached the clinical in-vitro diagnostic (IVD2) stage
of our kitted product development. In the meantime, we believe that
customers who are now adopting GraftAssure test kits for research
use are motivated in part by the eventual opportunity to use our
IVD kits to measure this biomarker in their own labs.
We also can run our clinical-use assay, VitaGraftTM, at our
clinical lab in Nashville, Tenn. We received Medicare reimbursement
for the test run at our lab in August 2023.
Looking back: 2024 Highlights
Successfully launched the research version of our kitted
transplant assay in July 2024: Bringing research centers
online with our GraftAssure RUO assay was a key part of our
land-and-expand strategy to drive commercial adoption of our tests.
This also was an important step toward capturing market share in an
estimated $1 billion global total addressable market for
transplant rejection testing. In 2H 2024, we signed leading
transplant centers in the U.S. and Germany, as well as the UK,
Switzerland, Austria, and Southeast Asia. Within six months of
launch, transplant centers representing about 9% of German
transplant volumes and about 2% of U.S. transplant volumes had
signed on to use GraftAssure RUO in its early launch phase.
Achieved claims expansion for transplant rejection
monitoring: In January 2025, we announced that Medicare
coverage for our assay expanded following a study showing that
monitoring with Oncocyte’s assay significantly reduces time to
rejection diagnosis in patients with newly developed donor-specific
antibodies (DSA). The Molecular Diagnostics program (MolDX)
confirmed the use of VitaGraft Kidney to monitor patients with
newly developed donor-specific antibodies (dnDSA+) for
antibody-mediated rejection (AMR). This achievement followed the
publication of a groundbreaking study demonstrating
VitaGraft Kidney’s ability to detect AMR in dnDSA+ patients up to
11 months earlier than the current standard of care. Early
detection of transplant rejection is growing in significance as
novel therapeutic treatments show promising early results in
treating antibody mediated rejection. Indeed, leveraging our
clinical assay in our laboratories to support data generation is a
key lever in our strategy that increases the market potential for
our kitted product.
Attracted a key strategic partner and investor:
In April 2024, we welcomed Bio-Rad Laboratories (NYSE: BIO) as a
strategic investor and partner. Bio-Rad subsequently invested in
Oncocyte two additional times. Bio-Rad now is a top shareholder,
holding approximately 9.66% of Oncocyte’s outstanding shares as of
today. In addition to its equity investments, Bio-Rad has pledged
to provide valuable financial support for the upcoming clinical
trial and further commercialization assistance, underscoring the
depth of its strategic partnership with Oncocyte.
Advanced the science of transplant and oncology, with
favorable data published in:
- The New England Journal of Medicine
- Transplant International
- Clinical Cancer Research
- Nephrology Dialysis Transplantation
- Acta Neuropathologica Communications
Completed a productive first meeting with the
FDA: As noted above, one of our most significant
milestones was our pre-submission meeting with the FDA on December
5, 2024. At that meeting, we received valuable feedback regarding
their expectations for marketing authorization of our kitted
clinical tests. The FDA clarified that we may proceed using the de
novo pathway rather than a 510(k) submission. We view this as a
meaningful accomplishment — it establishes a new device category
for our kitted test and reinforces the uniqueness and potentially
large clinical value of our technology. We are in continuous
dialogue with the FDA with the next meeting scheduled in the coming
months.
Fully funded our clinical assay development and
streamlined our capital structure: From January 2023 until
March 2025, we raised $57 million in equity from new and existing
investors. This includes the $29 million from our February 2025
registered direct offering and concurring private placement, in
which our five largest shareholders, including Bio-Rad, led the
funding round. We expect the offering proceeds to fully fund the
development of our transplant assay program through FDA
authorization. Also in 2024, we redeemed all remaining shares of
our Series A Redeemable Convertible Preferred Stock – positioning
us favorably with a streamlined capital structure ahead of a growth
inflection point.
Strengthened our team: In June 2024, in
preparation for the next several years of sustained, rapid growth,
we welcomed Andrea James as Chief Financial Officer. She
has a proven track record of guiding financial strategy through
multiple phases of growth, raising and stewarding capital, and
building relationships with high quality institutional investors.
In January 2025, we appointed Dr. Paul Billings as Consulting Chief
Medical Officer. Dr. Billings is a recognized pioneer in genomics
and precision medicine with over 40 years of experience spanning
academia, government, and the biotechnology industry, including as
Chief Medical Officer at Natera, Inc., during the commercialization
phase of its blood test for kidney transplant rejection as well as
its cancer blood test that can identify minimal residual disease.
He also has been an advisor or a physician leader with Laboratory
Corporation of America Holdings, Quest Diagnostics, Life
Technologies Corp, Johnson & Johnson, and Thermo Fisher
Scientific, contributing to transformative advances in molecular
medicine. Dr. Billings has substantial experience in
commercializing novel assays in precision medicine. He will provide
key regulatory and reimbursement support and assist with business
development efforts and strategic partnerships.Looking
Ahead
We believe that our market opportunity is promising, and that we
must continue to focus and execute. As the market shifts away from
centralized testing, our easy-to-use technology positions us to
potentially lead the transition to decentralized, in-lab
diagnostics.
Also, with favorable data expected later this year regarding our
transplant assay, we anticipate further validation of our assay's
performance, which we believe will be instrumental in driving
adoption and securing payer support.
Our three major goals this year:
- Finalizing the clinical assay design: We are
locking in ease-of-use improvements based on feedback from some of
the most scientifically advanced labs in the world, which have been
using GraftAssure kits for research since last year and will be
among our expected initial clinical customers.
- Kicking off, conducting, and concluding our clinical
trial: We are finalizing the necessary protocols with the
FDA, and ensuring that our clinical trial partners are positioned
to deliver robust, high-quality data.
- For further context, we are designing a prospective,
observational, single-arm, multicenter clinical trial to validate
our clinical kitted transplant assay, which we intend to name
GraftAssureDx. Our study will analyze samples from healthy
transplant recipients as well as from those with transplant organ
rejection, ensuring statistically robust validation of dd-cfDNA
thresholds. The study also will allow for repeat testing across
multiple clinical sites. Our key objectives include confirming
predefined dd-cfDNA thresholds for detecting transplant rejection,
evaluating the test’s sensitivity, specificity, positive predictive
value (PPV), and negative predictive value (NPV) compared to
existing methods, and conducting a repeatability study across a
smaller number of sites to ensure test consistency. We expect to
successfully determine non-inferiority to existing commercial
rejection biomarkers, with expected results meeting or exceeding
the sensitivity and specificity benchmarks observed in previous
studies, and then submit this data to the FDA. We are planning a
second FDA pre-submission meeting to confirm the endpoints with the
agency.
- Spring loading 2H 2026 revenue: We remain on
track to meet the commitment that we made to investors in August
2024 to have at least 20 transplant centers signed up for our assay
by the end of 2025. We estimate that transplant centers that become
customers of our kitted clinical assay each represent a potential
annual high-margin revenue stream of several hundred thousand
dollars to $2 million of clinical-use tests, depending on
the size of the center.
Beyond the above immediate regulatory and product development
objectives, we are preparing for a broader industry shift in
transplant care. By 2028, we expect localized, real-time monitoring
to become the standard of care, and we believe that we are
well-positioned to capture an outsized share of this evolving and
growing market.
The enthusiasm we have seen from transplant centers, patient
advocates, and industry partners reinforces our belief that we are
building something transformative. We remain confident that the
next few years will define the future of transplant diagnostics and
solidify our leadership in this space.
--The Oncocyte Management Team
Q4 2024 Financial Overview
- Relative to our strategic objective of commercializing our
transplant tests, we consider ourselves to be “pre-revenue.” Our
reported revenues of $1.5 million in Q4 2024 and $1.9 million for
the full year were largely derived from pharma services performed
at our clinical laboratory in Nashville. We see this revenue as a
testament to our team’s ability to achieve the on-time delivery of
clear, scientifically sound and accurate data sets to our
clients.
- A gross profit of $595,000 in Q4 2024, representing a 40% gross
margin, reflected the cost of materials to perform services at our
Nashville laboratory, and the relatively fixed costs of operating
that lab, including labor, infrastructure expenses such as the
depreciation of laboratory equipment, allocated rent costs,
leasehold improvements, and allocated information technology costs.
Full year gross profit of $740,000 reflected a 39% gross
margin.
- In Q4 2024, operating expenses of $34.2 million included $41.9
million in non-cash impairment losses offset by a $13.7 million
non-cash gain due the change in fair value of our contingent
consideration, as well as $499,000 in non-cash stock-based
compensation expenses and $522,000 in non-cash depreciation and
amortization expenses. Excluding these non-cash items in the
current and prior periods, our Q4 2024 operating expenses decreased
approximately 12% sequentially and increased 21% year over year.
- Research and development expenses of $2.3 million declined both
sequentially and year over year, reflecting a decrease of 20% and
11%, respectively, largely due to timing regarding laboratory
expenses.
- Sales and marketing expenses of $1.2 million reflected added
costs as we commercialize our research-use-only transplant test
kits.
- General and administrative expenses of $2.6 million were flat
sequentially, reflecting cost discipline as we focus on investing
in research and development on IVD product development, and sales
and marketing of GraftAssure.
- The $41.9 million intangible asset impairment charge we
recorded in Q4 2024 reflects our decision to maintain a low rate of
investment in our oncology assets as we focus on commercializing
transplant. Specifically, we recorded a charge of $35.1 million for
DetermaCNI and $6.8 million for DetermaIO. Offsetting that charge
in the quarter was a gain of $13.7 million recorded relative to the
decline in our contingent consideration liabilities. This liability
is tied to our expected future contingency payments to shareholders
of companies we had acquired in the past. The liability decline was
similarly related to DetermaIO and DetermaCNI, and was partially
offset by our increased contingent consideration liability in
transplant due to our increased revenue expectations for transplant
in the nearer term. The net decrease in our contingent
consideration liability was recorded as a gain to operating income,
partially offsetting the intangible asset impairment relating to
those same assets.
- On a full-year basis, we believe that the underlying trend in
operating expenses highlights our cost discipline. GAAP operating
expenses grew from $25.5 million in 2023 to $61.8 million in 2024,
with most of the change driven by a $37.8 million change in
non-cash impairment losses and contingent consideration fair
values. Excluding those non-cash items, GAAP R&D, Sales and
Marketing and General and Administrative expenses grew just
$716,000 year over year, or 3% -- even while accomplishing all the
achievements listed above.
- General and administrative expenses declined about $978,000
year over year, or 9%, mainly due to cost cutting as well as 2023
severance payments that did not repeat.
- Research and development expenses grew from $9.3 million in
2023 to $9.8 million in 2024, a $545,000 increase, or 6%, as we
continued progress on our assay. Incremental expenses included
software development costs of $450,000 related to our clinical
kitted product development.
- Sales and marketing expenses reflect intentional investments in
commercialization, growing from $2.8 million in 2023 to $3.9
million in 2024, an increase of about $1.1 million. This included
growth in salaries and commission as we signed new top-transplant
centers, travel expenses related to signing our European pilot
sites, and equipment leasing expenses related to instruments
installed at research-use-only assay pilot sites.
- Our Q4 2024 loss from continuing operations was $33.5 million,
or $1.93 per share.
- Our Q4 2024 Non-GAAP loss from operations was $4.4 million and
excludes certain non-cash items. Please refer to the table below,
“Reconciliation of Non-GAAP Financial Measure,” for additional
information.
- Our Q4 2024 per share results reflect 17.4 million weighted
average shares outstanding.
- Including the shares issued as part of our February 2025
offering and private placement, we currently have 28.6 million
shares outstanding.
- Oncocyte’s cash, cash equivalents, and restricted cash balance
at the end of the fourth quarter was approximately $10.3 million.
- We are pleased that our fourth quarter outgoing cash flow from
operations (net cash used in operating activities) of $5.4 million,
combined with capital expenditures of $0.2 million, came in
favorably to our targeted spend $6 million, which was partially a
result of operational efficiency and partly a result of working
capital management.
- Please note that our ending year cash balance of $10.3 million
excludes the $29.1 million in gross financing cash flow from our
registered direct offering and private placement in February
2025.
Footnotes(1) MolDX,
a program that identifies and establishes coverage and U.S.
government reimbursement for molecular diagnostic tests, cited our
publications twice when it established the LCD (Local Coverage
Determination) for Medicare and Medicaid reimbursement coverage for
cell free DNA testing. Source:
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=38671&ver=4(2) The
kitted version of our assay must be cleared by regulatory bodies in
the U.S., Europe and elsewhere as an in-vitro diagnostic (IVD) to
be used in clinical decision making.
Webcast and Conference Call
InformationLive Zoom Call and Webcast on Monday,
March 24, 2025, at 2:00 p.m. PT / 5:00 p.m. ET.
Those interested may access the live Zoom call by registering
here: Oncocyte Q4 2024 Earnings Webinar. Once registered, a
confirmation email will be sent with instructions.
A replay of the Zoom call will be available on the company’s
website shortly after the call.
About OncocyteOncocyte is a diagnostics
technology 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/. For 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 StatementsAny 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, future expansion
and growth, the Company’s land-and-expand strategy to drive
commercial adoption of its tests and capture market share, plans to
have transplant centers running GraftAssure tests through the end
of 2025, projected revenue path, IVD strategy, assumptions
regarding regulatory approvals, authorizations and clearances,
timing and planned regulatory submissions, the ongoing global
launch of GraftAssure with the support of Bio-Rad Laboratories, our
ability to continue to access capital, 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 Ramson PCG Advisory (646)
863-6893 jramson@pcgadvisory.com
ONCOCYTE CORPORATIONCONSOLIDATED
BALANCE SHEETS(In thousands, except per share
data)
|
|
December 31, |
|
|
|
2024 |
|
|
|
2023 |
|
ASSETS |
|
|
|
|
CURRENT ASSETS |
|
|
|
|
Cash and cash equivalents |
|
$ |
8,636 |
|
|
$ |
9,432 |
|
Accounts receivable, net of allowance for credit losses of $16 and
$5, respectively |
|
|
1,613 |
|
|
|
484 |
|
Inventories |
|
|
410 |
|
|
|
— |
|
Deferred financing costs |
|
|
279 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
821 |
|
|
|
643 |
|
Assets held for sale |
|
|
— |
|
|
|
139 |
|
Total current assets |
|
|
11,759 |
|
|
|
10,698 |
|
NONCURRENT ASSETS |
|
|
|
|
Right-of-use and financing lease assets, net |
|
|
2,757 |
|
|
|
1,637 |
|
Machinery and equipment, net, and construction in progress |
|
|
3,567 |
|
|
|
3,799 |
|
Intangible assets, net |
|
|
14,607 |
|
|
|
56,595 |
|
Restricted cash |
|
|
1,700 |
|
|
|
1,700 |
|
Other noncurrent assets |
|
|
691 |
|
|
|
463 |
|
TOTAL ASSETS |
|
$ |
35,081 |
|
|
$ |
74,892 |
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ (DEFICIT)
EQUITY |
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
Accounts payable |
|
$ |
2,279 |
|
|
$ |
953 |
|
Accrued compensation |
|
|
1,939 |
|
|
|
1,649 |
|
Accrued royalties |
|
|
1,116 |
|
|
|
1,116 |
|
Accrued expenses and other current liabilities |
|
|
418 |
|
|
|
452 |
|
Right-of-use and financing lease liabilities, current |
|
|
1,295 |
|
|
|
665 |
|
Current liabilities of discontinued operations |
|
|
— |
|
|
|
45 |
|
Contingent consideration liabilities, current |
|
|
228 |
|
|
|
2,314 |
|
Total current liabilities |
|
|
7,275 |
|
|
|
7,194 |
|
NONCURRENT LIABILITIES |
|
|
|
|
Right-of-use and financing lease liabilities, noncurrent |
|
|
2,369 |
|
|
|
2,204 |
|
Contingent consideration liabilities, noncurrent |
|
|
37,711 |
|
|
|
39,900 |
|
TOTAL LIABILITIES |
|
|
47,355 |
|
|
|
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
December 31, 2023; aggregate liquidation preference of $5,296
as of December 31, 2023 |
|
|
— |
|
|
|
5,126 |
|
|
|
|
|
|
SHAREHOLDERS’ (DEFICIT) EQUITY |
|
|
|
|
Preferred stock, no par value, 5,000 shares authorized; no shares
issued and outstanding |
|
|
— |
|
|
|
— |
|
Common stock, no par value, 230,000 shares authorized; 17,453 and
8,261 shares issued and outstanding at December 31, 2024 and
2023, respectively |
|
|
338,244 |
|
|
|
310,295 |
|
Accumulated other comprehensive income |
|
|
21 |
|
|
|
49 |
|
Accumulated deficit |
|
|
(350,539 |
) |
|
|
(289,876 |
) |
Total shareholders’ (deficit) equity |
|
|
(12,274 |
) |
|
|
20,468 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ (DEFICIT) EQUITY |
|
$ |
35,081 |
|
|
$ |
74,892 |
|
ONCOCYTE CORPORATIONUNAUDITED
CONSOLIDATED STATEMENTS OF OPERATIONS(In
thousands, except per share data)
|
|
Three Months EndedDecember 31, |
|
Years EndedDecember 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Net revenue |
|
$ |
1,486 |
|
|
$ |
314 |
|
|
$ |
1,881 |
|
|
$ |
1,503 |
|
|
|
|
|
|
|
|
|
|
Cost of revenues |
|
|
869 |
|
|
|
409 |
|
|
|
1,053 |
|
|
|
1,002 |
|
Cost of revenues – amortization of acquired intangibles |
|
|
22 |
|
|
|
22 |
|
|
|
88 |
|
|
|
88 |
|
Gross profit |
|
|
595 |
|
|
|
(117 |
) |
|
|
740 |
|
|
|
413 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
2,257 |
|
|
|
2,547 |
|
|
|
9,839 |
|
|
|
9,294 |
|
Sales and marketing |
|
|
1,202 |
|
|
|
582 |
|
|
|
3,944 |
|
|
|
2,795 |
|
General and administrative |
|
|
2,559 |
|
|
|
1,752 |
|
|
|
10,204 |
|
|
|
11,182 |
|
Change in fair value of contingent consideration |
|
|
(13,696 |
) |
|
|
11,185 |
|
|
|
(4,275 |
) |
|
|
(5,762 |
) |
Impairment losses |
|
|
41,900 |
|
|
|
(4 |
) |
|
|
41,900 |
|
|
|
6,757 |
|
Impairment loss on held for sale assets |
|
|
— |
|
|
|
— |
|
|
|
169 |
|
|
|
1,283 |
|
Total operating expenses |
|
|
34,222 |
|
|
|
16,062 |
|
|
|
61,781 |
|
|
|
25,549 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(33,627 |
) |
|
|
(16,179 |
) |
|
|
(61,041 |
) |
|
|
(25,136 |
) |
|
|
|
|
|
|
|
|
|
Other (expenses) income: |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(30 |
) |
|
|
(13 |
) |
|
|
(84 |
) |
|
|
(52 |
) |
Loss on marketable equity securities |
|
|
— |
|
|
|
(69 |
) |
|
|
— |
|
|
|
(61 |
) |
Other income, net |
|
|
146 |
|
|
|
269 |
|
|
|
462 |
|
|
|
394 |
|
Total other income, net |
|
|
116 |
|
|
|
187 |
|
|
|
378 |
|
|
|
281 |
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations |
|
|
(33,511 |
) |
|
|
(15,992 |
) |
|
|
(60,663 |
) |
|
|
(24,855 |
) |
|
|
|
|
|
|
|
|
|
Loss from discontinued operations |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(2,926 |
) |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(33,511 |
) |
|
$ |
(15,992 |
) |
|
$ |
(60,663 |
) |
|
$ |
(27,781 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
Net loss from continuing operations - basic and diluted |
|
$ |
(33,511 |
) |
|
$ |
(16,190 |
) |
|
$ |
(60,926 |
) |
|
$ |
(25,797 |
) |
Net loss from discontinued operations - basic and diluted |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(2,926 |
) |
Net loss attributable to common stockholders - basic and
diluted |
|
$ |
(33,511 |
) |
|
$ |
(16,190 |
) |
|
$ |
(60,926 |
) |
|
$ |
(28,723 |
) |
|
|
|
|
|
|
|
|
|
Net loss from continuing operations per share - basic and
diluted |
|
$ |
(1.93 |
) |
|
$ |
(1.96 |
) |
|
$ |
(4.66 |
) |
|
$ |
(3.37 |
) |
Net loss from discontinued operations per share - basic and
diluted |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(0.38 |
) |
Net loss attributable to common stockholders per share - basic and
diluted |
|
$ |
(1.93 |
) |
|
$ |
(1.96 |
) |
|
$ |
(4.66 |
) |
|
$ |
(3.75 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding - basic and diluted |
|
|
17,382 |
|
|
|
8,261 |
|
|
|
13,071 |
|
|
|
7,651 |
|
ONCOCYTE CORPORATIONUNAUDITED
CONSOLIDATED STATEMENTS OF CASH FLOWS(In
thousands)
|
|
Three Months EndedDecember 31, |
|
Years EndedDecember 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(33,511 |
) |
|
$ |
(15,992 |
) |
|
$ |
(60,663 |
) |
|
$ |
(27,781 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization expense |
|
|
541 |
|
|
|
303 |
|
|
|
1,476 |
|
|
|
1,592 |
|
Amortization of intangible assets |
|
|
22 |
|
|
|
22 |
|
|
|
88 |
|
|
|
88 |
|
Stock-based compensation |
|
|
499 |
|
|
|
484 |
|
|
|
1,753 |
|
|
|
2,760 |
|
Equity compensation for bonus awards and consulting services |
|
|
50 |
|
|
|
19 |
|
|
|
160 |
|
|
|
127 |
|
Loss on marketable equity securities |
|
|
— |
|
|
|
69 |
|
|
|
— |
|
|
|
61 |
|
Change in fair value of contingent consideration |
|
|
(13,696 |
) |
|
|
11,185 |
|
|
|
(4,275 |
) |
|
|
(5,762 |
) |
Impairment losses |
|
|
41,900 |
|
|
|
(4 |
) |
|
|
41,900 |
|
|
|
6,757 |
|
Loss on disposal of discontinued operations |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,521 |
|
Impairment loss on held for sale assets |
|
|
— |
|
|
|
— |
|
|
|
169 |
|
|
|
1,283 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(1,404 |
) |
|
|
(21 |
) |
|
|
(1,129 |
) |
|
|
109 |
|
Inventories |
|
|
(178 |
) |
|
|
— |
|
|
|
(410 |
) |
|
|
— |
|
Prepaid expenses and other assets |
|
|
(113 |
) |
|
|
139 |
|
|
|
(458 |
) |
|
|
784 |
|
Accounts payable and accrued liabilities |
|
|
704 |
|
|
|
(564 |
) |
|
|
967 |
|
|
|
(4,757 |
) |
Lease assets and liabilities |
|
|
(168 |
) |
|
|
(64 |
) |
|
|
(291 |
) |
|
|
(107 |
) |
Net cash used in operating activities |
|
|
(5,354 |
) |
|
|
(4,424 |
) |
|
|
(20,713 |
) |
|
|
(23,325 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from sale of marketable equity securities |
|
|
— |
|
|
|
367 |
|
|
|
— |
|
|
|
367 |
|
Proceeds from sale of equipment |
|
|
4 |
|
|
|
— |
|
|
|
4 |
|
|
|
354 |
|
Construction in progress and purchases of furniture and
equipment |
|
|
(214 |
) |
|
|
(264 |
) |
|
|
(516 |
) |
|
|
(281 |
) |
Cash sold in discontinued operations |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,372 |
) |
Net cash used in investing activities |
|
|
(210 |
) |
|
|
103 |
|
|
|
(512 |
) |
|
|
(932 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from sale of common shares |
|
|
10,205 |
|
|
|
— |
|
|
|
26,012 |
|
|
|
13,848 |
|
Financing costs to issue common shares |
|
|
(836 |
) |
|
|
— |
|
|
|
(1,374 |
) |
|
|
(427 |
) |
Proceeds from sale of common shares under at-the-market
transactions |
|
|
1,784 |
|
|
|
— |
|
|
|
1,802 |
|
|
|
— |
|
Financing costs for at-the-market sales |
|
|
(234 |
) |
|
|
— |
|
|
|
(421 |
) |
|
|
— |
|
Redemption of Series A redeemable convertible preferred shares |
|
|
— |
|
|
|
— |
|
|
|
(5,389 |
) |
|
|
(1,118 |
) |
Repayment of financing lease obligations |
|
|
(82 |
) |
|
|
(30 |
) |
|
|
(201 |
) |
|
|
(117 |
) |
Net provided by financing activities |
|
|
10,837 |
|
|
|
(30 |
) |
|
|
20,429 |
|
|
|
12,186 |
|
|
|
|
|
|
|
|
|
|
NET CHANGE IN CASH, CASH EQUIVALENTS (INCLUDES DISCONTINUED
OPERATIONS) AND RESTRICTED CASH |
|
|
5,273 |
|
|
|
(4,351 |
) |
|
|
(796 |
) |
|
|
(12,071 |
) |
|
|
|
|
|
|
|
|
|
CASH, CASH EQUIVALENTS (INCLUDES DISCONTINUED OPERATIONS)
AND RESTRICTED CASH, BEGINNING |
|
|
5,063 |
|
|
|
15,483 |
|
|
|
11,132 |
|
|
|
23,203 |
|
CASH, CASH EQUIVALENTS AND RESTRICTED CASH,
ENDING |
|
$ |
10,336 |
|
|
$ |
11,132 |
|
|
$ |
10,336 |
|
|
$ |
11,132 |
|
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 that disclosing the
adjusted amounts is helpful in assessing our ongoing performance,
providing insight into the Company’s core operating performance by
excluding certain non-cash, and / or intangible items that may
obscure the underlying trends in the business. These non-GAAP
financial measures, when viewed in a reconciliation to respective
GAAP measures, provide an additional way of viewing the Company’s
results of operations and factors and trends affecting the
Company’s business. These non-GAAP financial measures should be
considered as a supplement to, and not as a substitute for, or
superior to, the respective financial results presented in
accordance with GAAP.
The following is a reconciliation of the non-GAAP measure to the
most directly comparable GAAP measure:
|
|
Three Months EndedDecember 31, |
|
Years EndedDecember 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
|
(In thousands) |
Consolidated GAAP loss from operations |
|
$ |
(33,627 |
) |
|
$ |
(16,179 |
) |
|
$ |
(61,041 |
) |
|
$ |
(25,136 |
) |
Stock-based compensation |
|
|
499 |
|
|
|
484 |
|
|
|
1,753 |
|
|
|
2,742 |
|
Depreciation and amortization expenses |
|
|
563 |
|
|
|
325 |
|
|
|
1,564 |
|
|
|
1,680 |
|
Change in fair value of contingent consideration |
|
|
(13,696 |
) |
|
|
11,185 |
|
|
|
(4,275 |
) |
|
|
(5,762 |
) |
Impairment losses |
|
|
41,900 |
|
|
|
(4 |
) |
|
|
41,900 |
|
|
|
6,757 |
|
Impairment loss on held for sale assets |
|
|
— |
|
|
|
— |
|
|
|
169 |
|
|
|
1,283 |
|
Consolidated Non-GAAP loss from operations, as
adjusted |
|
$ |
(4,361 |
) |
|
$ |
(4,189 |
) |
|
$ |
(19,930 |
) |
|
$ |
(18,436 |
) |
Grafico Azioni Oncocyte (NASDAQ:OCX)
Storico
Da Feb 2025 a Mar 2025
Grafico Azioni Oncocyte (NASDAQ:OCX)
Storico
Da Mar 2024 a Mar 2025