Full Press Release Details
Celcuity Reports Fourth Quarter and Full Year 2019 Financial
Minnesota March 12, 2020 Celcuity Inc. (Nasdaq: CELC),
a functional cellular analysis company that is developing companion
diagnostic tests designed to expand the eligible patient
populations for targeted therapies, announced financial results for
the fourth quarter and year ended December 31, 2019.
otherwise stated, all comparisons are for the fourth quarter and
year ended December 31, 2019, compared to the fourth quarter and
year ended December 31, 2018.
reported a net loss of $1.81 million, or $0.18 per share, for the
fourth quarter of 2019, compared to a net loss of $1.83 million, or
$0.18 per share, for the fourth quarter of 2018. Net loss for
fiscal year 2019 was $7.36 million, or $0.72 per share, compared to
$7.48 million, or $0.74 per share, for fiscal year 2018. Non-GAAP
adjusted net loss was $1.45 million, or $0.14 per share, for the
fourth quarter of 2019, compared to non-GAAP adjusted net loss of
$1.57 million, or $0.15 per share, for the fourth quarter of 2018.
Non-GAAP adjusted net loss for fiscal year 2019 was $6.32 million,
or $0.62 per share, compared to non-GAAP adjusted net loss of $6.31
million, or $0.62 per share, for fiscal year 2018. 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
cash used in operating activities for the fourth quarter of 2019
was $1.70 million. At December 31, 2019, Celcuity had cash and cash
equivalents of $18.7 million, compared to cash, cash equivalents
and investments of $24.9 million at December 31, 2018.
progress advancing our CELsignia (previously known as CELx)
platform in the fourth quarter of 2019. In December, we presented
results from pre-clinical studies for our new CELsignia PI3K Test
at the San Antonio Breast Cancer Symposium, said Brian
Sullivan, Chairman and Chief Executive Officer of Celcuity.
The studies we presented demonstrate how the measurement of
PI3K-involved signaling initiated by G-protein-couple receptors
(GPCRs) using our CELsignia platform may provide a more sensitive
and specific method than PIK3-mutational status to identify
patients most likely to benefit from PI3K inhibitors. We have
already begun discussions with leading cancer centers to design
clinical trials that would evaluate PI3K targeted therapies in
HER2-negative breast cancer patients the CELsignia PI3K Test
is our third CELsignia test for breast cancer. Each of our three
tests offers a potential opportunity for pharmaceutical companies
to expand the number of patients eligible for their targeted
therapies. The patients diagnosed by our CELsignia tests are
patients current molecular tests cannot identify. Celcuity now has
the potential to identify dysregulated signaling activity
undiagnosable by molecular tests in up to one in three
HER2-negative breast cancer patients.
are also continuing our efforts to develop additional tests for
breast cancer patients. The development of our fourth test for
breast cancer also advanced during the quarter. We hope to complete
the pre-clinical studies for this new test in 2020.
long-term goal at Celcuity is to offer CELsignia tests for a range
of solid tumor types, in addition to our current ones for breast
cancer. Our breast cancer research has given us valuable insights
into another cancer that uniquely afflicts women ovarian
cancer. We are pleased to announce that, we will report
pre-clinical study results for our first CELsignia test for ovarian
cancer at the 2020 Annual Meeting of the American Association for
Cancer Research. This new test will identify a new sub-group of
ovarian cancer patients with tumors that have undiagnosed
hyperactive oncogenic signaling activity. Nearly 15,000 women a
year die from ovarian cancer, a disease that has less than a 50%
five-year survival rate and a limited range of targeted therapy
options. There is thus a significant unmet need for additional
therapeutic options for ovarian cancer patients. As a companion
diagnostic, our CELsignia test for ovarian cancer will be intended
to help pharmaceutical companies obtain new drug indications and
expand treatment options for this challenging tumor type. We would
expect to initiate discussions with pharmaceutical companies about
collaborating on clinical trials later in 2020.
efforts to finalize several clinical trial collaborations with
pharmaceutical companies and clinical sponsors continued to
progress. Our goal is to evaluate the efficacy of targeted
therapies in breast cancer patients identified by our CELsignia
tests. We remain very confident that we will close several
collaborations this year. Since the collaborations we are pursuing
involve Celcuity, the clinical sponsor, and in some cases two
pharmaceutical companies, significant time is required to finalize
the related agreements between the three or four
conjunction with our efforts to collaborate with pharmaceutical
companies to field clinical trials, we have expanded our Scientific
Advisory Board, or SAB. We are pleased to announce that several
nationally recognized medical oncologists have joined our SAB over
the past few months. Our new SAB members include: Ben Park, MD,
PhD, co-leader of the Breast Cancer Research Program and Director
of Precision Oncology at Vanderbilt University Medical Center;
Filip Janku, MD, PhD, Medical Director of the Clinical and
Translational Research Center at MD Anderson Cancer Center; and
Bora Lim, MD, Assistant Professor, MD Anderson Cancer Center. We
are excited about the opportunities to gain their insights as well
as to potentially collaborate with them on future clinical
has largely completed the addition of new clinical sites to the
FACT 1 trial. We now have 27 activated sites participating. The
FACT 1 trial is evaluating the safety and efficacy of