Full Press Release Details
Celcuity Reports Third Quarter 2020 Financial
and Recent Business Highlights
- New clinical trial collaborations with pharmaceutical companies
- Cash burn rate steady -
- Cash and cash equivalents of $13.7 million as of September 30,
2020, which is expected to support operations through 2021
- Conference Call on Monday, November 9th at 4:30pm (ET)
Minnesota November 9, 2020 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 third quarter ended September
30, 2020 and summarized recent business progress.
the third quarter, we continued to advance our collaboration
discussions with pharmaceutical companies. We expect to close
several pharmaceutical company collaborations over the next few
months, said Brian Sullivan, Chairman and Chief Executive
Officer of Celcuity. Each collaboration will evaluate
different drug combinations in HER2-negative metastatic breast
cancer patients selected with our CELsignia Multipathway Activity
test. The collaborations we expect to close first will evaluate
patients with either hyperactive HER2 signaling tumors or those
with hyperactive c-Met and HER2 signaling tumors. Our discussions
with pharmaceutical companies to evaluate PI3K inhibitors in breast
or ovarian cancer patients with hyperactive PI3K signaling are also
progressing. These discussions are at an earlier stage than those
involving patients with hyperactive HER2 or c-Met signaling. We are
also very excited about the clinical investigators we expect to
partner with to field these trials. They are amongst the most
respected oncology researchers and thought leaders in the
continued to make progress advancing additional new tests during
the quarter. Our goal is to develop new CELsignia tests that
identify RAS pathway driven cancers undetectable with molecular
tests in breast and ovarian cancer. Dysregulated signaling
involving RAS network nodes is responsible for a significant
percentage of all cancers, which has led many pharmaceutical
companies to sponsor research in this area.
CELsignia platform also provides unique insights into the relative
potency and efficacy of the different therapies targeting RAS
nodes. This enables us to determine the relative superiority of the
different RAS-node approved and investigational targeted therapies,
which will help guide our collaboration activities.
we continue to expect interim results from our FACT-1 and FACT-2
trials in the second half of 2021. However, as you would expect, we
are monitoring the recent increase in COVD-19 related
hospitalizations for potential impact on enrollment activities for
Recent Highlights and Upcoming Milestones
trial collaborations amongst several major pharmaceutical companies
advancing towards close.
CELsignia tests in two different tumor types announced during past
development of a CELsignia RAS test for breast cancer patients by
from the FACT-1 and FACT-2 trials are expected in the second half
Third Quarter 2020 Financials
operating expenses were $2.48 million for the third quarter of
2020, compared to $2.09 million for the third quarter of 2019.
Operating expenses for the first nine months of 2020 were $7.0
million, compared to $5.91 million for the first nine months of
and development (R&D) expenses were $1.96 million for the third
quarter of 2020, compared to $1.71 million for the third quarter of
2019. R&D expenses for the first nine months of 2020 were $5.57
million, compared to $4.77 million for the first nine months of
2019. The approximately $0.80 million increase during the first
nine months of fiscal year 2020, compared to the first nine months
of fiscal year 2019, resulted primarily from a $0.71 million
increase in compensation related expenses, including approximately
$0.45 million of non-cash stock-based compensation expense. In
addition, other research and development expenses increased $0.09
million due to clinical validation and laboratory studies, and
operational and business development activities.
and administrative (G&A) expenses were $0.52 million for the
third quarter of 2020, compared to $0.38 million for the third
quarter of 2019. G&A expenses for the first nine months of 2020
were $1.43 million, compared to $1.13 million for the first nine
months of 2019. The approximately $0.30 million increase during
fiscal year 2020, compared to fiscal year 2019, resulted primarily
from a $0.24 million increase in compensation related expenses,
including approximately $0.21 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 third quarter of 2020 was $2.47 million, or $0.24 per
share, compared to a net loss of $1.98 million, or $0.19 per share,
for the third quarter of 2019. Net loss for the first nine months
of 2020 was $6.92 million, or $0.67 per share, compared to $5.55
million, or $0.54 per share, for the first nine months of 2019.
Non-GAAP adjusted net loss for the third quarter of 2020 was $2.03
million, or $0.20 per share, compared to non-GAAP adjusted net loss
of $1.68 million, or $0.16 per share, for the third quarter of
2019. Non-GAAP adjusted net loss for the first nine months of 2020
was $5.59 million, or $0.54 per share, compared to non-GAAP
adjusted net loss of $4.87 million, or $0.47 per share, for the
first nine months of 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 third quarter of 2020 was