Full Press Release Details
Reports Third Quarter 2021 Financial Results and Provides Corporate Update
launch of DetermaIO as first and only immunotherapy response prediction clinical test that comprehensively assesses the tumor microenvironment
and consistently outperforms PD-L1 IHC and other biomarkers
data in Triple Negative Breast Cancer published in a peer reviewed journal and confirmed in a randomized clinical trial study presented
at ESMO; Evidence in fourth tumor type suggests pan-cancer utility
test volume grows 65% year over year
transplant IP issued supporting the planned launch of TheraSure Transplant Monitor LDT testing in the U.S. and Europe
Call to be held today at 4:30pm ET/ 1:30 pm PDT
Calif., November 9, 2021 -- Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics and monitoring company with the mission to
improve patient outcomes by providing clear insights that inform critical decisions in the diagnosis, treatment, and monitoring of cancer,
reports financial results for the third quarter 2021 ended September 30, 2021, along with a corporate update.
recently announced clinical launch of our DetermaIO test, via an early access program (EAP), is an important milestone to inform
immunotherapy decisions which strengthens Oncocyte's differentiated position in precision diagnostics," said Ron Andrews,
Chief Executive Officer and President of Oncocyte. "We believe that the combination of DetermaIO with our comprehensive genomic
profiling test DetermaTx , expected to be launched late in the first quarter of 2022 upon completion of the DetermaIO EAP program,
will offer the most complete precision diagnostic solution to inform cancer treatment decisions for the 1.8 million patients diagnosed
with cancer in the United States each year and allows us to enter a total available market of $5 billion. This combined offering is further
differentiated by its ability to deliver comprehensive treatment decision information while conserving the limited tumor tissue sample
available for testing, with industry leading turnaround time. We are very encouraged with the response to our recently announced early
access program for DetermaIO, we have begun onboarding the accounts, and are excited to receive our first clinical patient samples in
the coming weeks. Our clinical studies have now reported results for over 1,000 patients, validated DetermaIO in four different tumor
types, and shown consistent outperformance of the current tests being used to select patients for treatment."
Andrews continued, "We've continued our progress with DetermaRx and, despite significant disruptions in early-stage
lung cancer surgeries over the summer due to the surge of the COVID-19 Delta variant, we generated 65% year over year growth in test
volume. We also continue to deliver on our two metrics used to measure test adoption during the current market environment: new hospital
onboards increased by42 facilities, growing 24% quarter over quarter, and our ordering physicians grew by 66 doctors or 22% quarter over
quarter. We have now established a solid install base that is poised to grow our sample volume and revenue once early-stage lung cancer
surgeries return to pre-pandemic levels."
the issuance of our IP in blood-based monitoring for transplant rejection, we now have a clear path to launching our own LDT test into
the large transplant rejection market in the U.S. and Europe. Oncocyte expects to complete 2021 with solid momentum toward our goal of
building a compelling and powerful portfolio of molecular diagnostic tests. As a complement to this progress, our recent appointment
of Gisela Paulsen as Chief Operating Officer brings additional world-class talent to the experienced leadership team at Oncocyte and
comes on board at an important time as we expand our operations to support the anticipated growth ahead."
Quarter and Recent Highlights Include:
Quarter 2021 Financial Results
September 30, 2021, Oncocyte had cash, cash equivalents and marketable securities of $44.3 million, as compared to $7.8 million on December
currently derives its revenues from the sale of its lung cancer test, DetermaRx, which was commercially launched in early 2020 and pharma
services generated by its wholly owned subsidiary, Insight Genetics, which was acquired on January 31, 2020. During the first quarter
of 2021, after accumulating additional history of cash receipts and other factors considered by management for Medicare Advantage-covered
DetermaRx tests, including the recently published Medicare rate, the Company transitioned to the accrual basis for tests covered by Medicare
Advantage insurance plans. Oncocyte will continue to recognize revenues for commercial and other payors on a cash basis until we have
reimbursement contracts with those payors. At that point, those contracts will also progress to the accrual basis for DetermaRx tests.
Until that time, for all payors other than Medicare and Medicare Advantage, Oncocyte expects to recognize revenue for DetermaRx tests
performed on a cash basis.
for the three months ended September 30, 2021, were approximately $1.0 million, generated from three sources: DetermaRx tests, pharma
services, and licensing revenues. This compares to revenues of $555,000 for the three months ended September 30, 2020, a year over year
growth rate of 77%. DetermaRx samples received this quarter grew 3% compared to last quarter, primarily due to the impact of the Delta
Variant on surgical volumes in key sales regions of the United States and 65% versus Q3 2020 .
of revenues for the third quarter 2021 were approximately $1.9 million, which includes approximately $1.0 million in non-cash amortization
expenses from the Razor Genomics and Insight Genetics acquisitions. The cost of our Razor asset amortization, which is a non-cash amortization
expense over the remaining life of the Razor patent, will be included in cost of revenues each quarter. Cost of revenues also include
testing services we perform for our pharma customers.
and development expenses for the third quarter of 2021 were $3.1 million as compared to $2.6 million for the same period in 2020, an
increase of $0.5 million, representing the increased investment in clinical studies to support the commercialization of the portfolio
of tests in the pipeline.
and administrative expenses for the third quarter of 2021 were $5.5 million, as compared to $5.0 million for the same period in 2020,
an increase of approximately $0.5 million.
and marketing expenses for the three months ended September 30, 2021 were $2.9 million, as compared to $1.6 million for the same period
in 2020. The increase was primarily due to personnel and related expenses resulting from the ramp up in sales and marketing activities
for DetermaRx, as well as market development investments in preparation for the launch of new products later this year.
losses, as reported, for the third quarter of 2021 were $13.6 million, as compared to $6.2 million for the third quarter of 2020. Operating
losses, on an adjusted basis, were $9.3 million, an increase of $3.2 million from $6.1 million as compared to the third quarter of 2020.
has provided a reconciliation between GAAP and non-GAAP operating losses in the financial tables, included with this earnings release,
which it believes is helpful in understanding its ongoing operations.
the third quarter ended September 30, 2021, Oncocyte reported a net loss of $13.8 million, or ($0.15) per share, as compared to $6.8
million, or ($0.10) per share, for the third quarter ended September 30, 2020.
used in operations was approximately $11.0 million for the third quarter of 2021.
The Company will host a conference call today, November 9th at 4:30 pm EDT / 1:30 pm PDT to discuss the results along with
recent corporate developments. The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number
is 201-493-6779. For all callers, please refer to Conference ID: 13722620. To access the live webcast, go to the investor relations section
on the Company's website, or by clicking here http://public.viavid.com/index.php?id=146378. The webcast replay will be available
on the Oncocyte website for 90 days following the completion of the call.
Oncocyte is a precision diagnostics and monitoring company with the mission to improve patient outcomes by providing clear insights
that inform critical decisions in the diagnosis, treatment, and monitoring of cancer. The Company, through its proprietary tests and
pharmaceutical services business, aims to help save lives by accelerating the diagnosis of cancer and advancing cancer care. The Company's
tests are designed to help provide clarity and confidence to physicians and their patients at every stage. DetermaRx identifies
early-stage lung cancer patients who are at high risk for cancer recurrence and who may benefit from adjuvant chemotherapy. DetermaIO ,
a gene expression test currently used as a research-use only tool, assesses the tumor microenvironment to predict response to immunotherapies.
The Company's pipeline of tests in development also includes DetermaTx , which will assess mutational status of a tumor,
blood-based monitoring test DetermaCNITM, and long-term recurrence monitoring test DetermaMx . In addition, Oncocyte's
pharmaceutical services provide companies that are developing new cancer treatments a full suite of molecular testing services to support
the drug development process.
DetermaIOTM, DetermaTxTM, DetermaCNITM, DetermaMxTM and TheraSureTM are
trademarks of Oncocyte Corporation.
Forward Looking Statements
you that this press release contains 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 launch of DetermaTX late in the first quarter Q1 of 2022; the expectation
that the combination of DetermaIO and DetermaTX will offer the most complete precision diagnostic solution to inform cancer treatment
decisions for the 1.8 million patients diagnosed with cancer in the United States, allow Oncocyte to enter a total available market of
$5 billion and deliver comprehensive treatment decision information while conserving the limited samples available for testing, and with
industry leading turnaround time; the expected receipt of Oncocyte's first clinical patient samples for the DetermaIO early access
program in the coming weeks; the expectation that the DetermaRx install base is poised to grow Oncocyte's sample volume and revenue
once early-stage lung cancer surgeries return to pre-pandemic levels; the expected launch of Oncocyte's own LDT test (TheraSure
Transplant Monitor) into the large transplant rejection market in the U.S. and Europe; the expectation that Oncocyte will complete 2021
with solid momentum toward its goal of building a compelling and powerful portfolio of molecular diagnostic tests; the anticipation of
growth ahead; the planned enrollment of more than 1,000 patients at 25 sites across the U.S. beginning in Q4 2021, for the first Real-World
Evidence registry intended to evaluate biomarker adoption and precision medicine in creating personalized treatment options for early-stage
lung cancer patients; and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management.