Full Press Release Details
Celcuity Reports Fourth Quarter and Full Year 2020 Financial
and Recent Business Highlights
- Announced a clinical trial collaboration in December with
Massachusetts General Hospital, UCLA, and Vanderbilt and Puma
Biotechnology to conduct a Phase II clinical trial.
- In January, announced a clinical trial collaboration with Sarah
Cannon Research Institute and Pfizer Inc. to conduct a Phase II
- Additional clinical trial collaborations with major
pharmaceutical companies are expected to be announced in the first
MINNEAPOLIS, MN - February 16, 2021 - Celcuity Inc.
(NASDAQ:CELC), a clinical stage biotechnology company translating
discoveries of new cancer sub-types into 3rd generation
diagnostics and expanded therapeutic options for cancer patients,
announced financial results for the fourth quarter and year ended
December 31, 2020 and summarized recent business
built momentum in our business over the past few months, signing
additional clinical trial agreements to collaborate with several
major cancer research centers and pharmaceutical companies while
advancing additional new CELsignia tests. In December, we announced
a collaboration with Massachusetts General Hospital, UCLA,
Vanderbilt, and Puma Biotechnology for a Phase II trial to evaluate
the safety and efficacy of Puma's drug, Nerlynx, and
AstraZeneca's drug, Faslodex, said Brian Sullivan,
Chairman and Chief Executive Officer of Celcuity.
month, we announced another clinical trial collaboration, our
fourth one, with Sarah Cannon Research Institute and Pfizer, Inc.,
for a Phase II trial that will evaluate the efficacy and safety of
two Pfizer targeted therapies, VIZIMPRO , a pan-HER
inhibitor, and XALKORI , a c-Met
inhibitor. Both of these recent collaborations aim to address a
significant unmet need for new treatment options for metastatic
HER2- breast cancer patients whose disease progressed on prior
collaboration discussions with pharmaceutical companies also
progressed despite the headwinds from COVID-19. We remain confident
we will finalize new clinical trial collaborations in the first
half of 2021. Finally, although our FACT-1 and FACT-2 trials were
somewhat impacted by COVID-19 related delays in recent months, we
still expect interim results from these trials in the latter half
of 2021 or early 2022."
Recent Highlights and Upcoming Milestones
clinical trial collaborations in past two months.
additional clinical trial collaborations in the first half of
CELsignia RAS test for breast and ovarian cancers, and plan to
report data on these new tests in the first half of
from the FACT-1 and FACT-2 trials are expected in late 2021 or
Fourth Quarter and Fiscal Year 2020 Financial Results
otherwise stated, all comparisons are for the fourth quarter and
full year ended December 31, 2020, compared with the fourth quarter
and full year ended December 31, 2019.
operating expenses were $2.55 million for the fourth quarter of
2020, compared to $1.90 million for the fourth quarter of 2019.
Operating expenses for the fiscal year 2020 were $9.56 million,
compared to $7.81 million for the fiscal year 2019.
and development (R&D) expenses were $2.11 million for the
fourth quarter of 2020, compared to $1.50 million for the fourth
quarter of 2019. R&D expenses for fiscal year 2020 were $7.68
million, compared to $6.27 million for fiscal year 2019. The
approximately $1.41 million increase during fiscal year 2020,
compared to fiscal year 2019, resulted primarily from a $1.15
million increase in compensation related expenses, including
approximately $0.49 million of non-cash stock-based compensation
expense. In addition, other research and development expenses
increased $0.26 million due to clinical validation and laboratory
studies, and operational and business development
and administrative (G&A) expenses were $0.44 million for the
fourth quarter of 2020, compared to $0.40 million for the fourth
quarter of 2019. G&A expenses for fiscal year 2020 were $1.87
million, compared to $1.53 million for fiscal year 2019. The
approximately $0.34 million increase during fiscal year 2020,
compared to fiscal year 2019, resulted primarily from a $0.28
million increase in compensation related expenses, including
approximately $0.24 million of non-cash stock-based compensation.
In addition, other general and administrative expenses increased
$0.06 million primarily due to professional fees associated with
being a public company.
loss for the fourth quarter of 2020 was $2.55 million, or $0.25 per
share, compared to a net loss of $1.81 million, or $0.18 per share,
for the fourth quarter of 2019. Net loss for fiscal year 2020 was
$9.47 million, or $0.92 per share, compared to $7.36 million, or
$0.72 per share, for fiscal year 2019. Non-GAAP adjusted net loss
for the fourth quarter of 2020 was $2.12 million, or $0.21 per
share, compared to non-GAAP adjusted net loss of $1.45 million, or
$0.14 per share, for the fourth quarter of 2019. Non-GAAP adjusted
net loss for fiscal year 2020 was $7.71 million, or $0.75 per
share, compared to non-GAAP adjusted net loss of $6.32 million, or
$0.62 per share, for fiscal year 2019. Non-GAAP adjusted net loss
excludes stock-based compensation expense. Because this item has no
impact on Celcuity's cash position, management believes non-GAAP adjusted net loss
better enables Celcuity to focus on cash used in operations.
For a reconciliation of financial measures calculated in accordance
with generally accepted accounting principles in the United States
(GAAP) to non-GAAP financial measures, please see the financial
tables at the end of this press release.
cash used in operating activities for the fourth quarter of 2020
was $2.11 million, compared to $1.70 million for the fourth quarter
December 31, 2020, Celcuity had cash and cash equivalents of $11.6
million, compared to cash and cash equivalents of $18.7 million at
will host a conference call at 4:30 PM Eastern Time today to
discuss the results. Anyone interested in participating should dial
1-866-831-8616 and use