Full Press Release Details
Celcuity Reports First Quarter 2020 Financial
and Recent Business Highlights
Significant progress made in
development of new, highly precise diagnostics using proprietary
- Expect to announce new clinical trial collaborations with
pharmaceutical companies and
trial sponsors by the end of 2020
- Expects to complete development of a CELsignia RAS test for
breast and ovarian cancer patients by the end of 2020
- Potential impact of the COVID-19 pandemic on clinical sites
expected to push announcement of interim data from the FACT-1 and
FACT-2 trials into the second half of 2021
- Conference Call on Thursday, May 7th
Minnesota May 7, 2020 Celcuity Inc. (Nasdaq: CELC), a
clinical stage biotechnology company translating discoveries of new
cancer sub-types into pioneering diagnostics and expanded
therapeutic options for cancer patients, announced financial
results for the first quarter ended March 31, 2020 and provided a
the first quarter, we made significant progress developing a new
dynamic signaling test using our proprietary CELsignia platform
that is intended to diagnose cancers driven by dysregulated RAS
signaling. We expect to complete development of a CELsignia RAS
test for breast and ovarian cancer patients by the end of 2020. Our
current tests have the potential to diagnose oncogenic signaling
activity undetectable by molecular tests in up to one in three
HER2-negative breast cancer patients, said Brian Sullivan,
Chairman and Chief Executive Officer of Celcuity.
of RAS signaling, which includes the RAF/ERK and PI3K/AKT pathways,
is estimated to drive 30%-40% of all cancers. Our CELsignia
platform is uniquely suited to untangling the complexity of
dysregulated RAS signaling tumors and identifying the targeted
therapy combination capable of treating it. If our efforts to
develop a RAS dynamic signaling test are successful, the percentage
of cancer patients who could benefit from a CELsignia test would
increase significantly.
continue to advance our discussions with pharmaceutical companies
for a number of potential clinical trial collaborations. While we
still expect to close several collaborations this year, the
clinical sponsors and pharmaceutical companies we hope to work with
have been affected to varying degrees by the COVID-19 pandemic.
These events may delay finalizing some of these potential
collaborations past year end 2020. Our potential collaboration
partners include many of the country's leading cancer
research centers, as well as several global pharmaceutical
companies. The goal of these collaborations is to evaluate the
efficacy of targeted therapies in breast cancer patients identified
light of recent developments relating to the COVID-19 global
pandemic, the focus of healthcare providers and hospitals on
fighting the virus, and consistent with the FDA's updated
industry guidance for conducting clinical trials issued on March
18, 2020, we are experiencing delays in the enrollment of patients
in our ongoing clinical trials. As a result, we now expect interim
results from the FACT-1 and FACT-2 trials to be delayed until the
second half of 2021 and final results approximately nine months
later. We will continue to evaluate the situation and provide
updates as appropriate, concluded Sullivan.
First Quarter 2020 Financials
otherwise stated, all comparisons are for the first quarter ended
March 31, 2020, compared to the first quarter ended March 31,
operating expenses were $2.31 million for the first quarter of
2020, compared to $1.97 million for the first quarter of
and development (R&D) expenses were $1.85 million for the first
quarter of 2020, compared to $1.59 million for the first quarter of
2019. The approximately $0.26 million increase during fiscal year
2020, compared to fiscal year 2019, resulted primarily from a $0.25
million increase in compensation related expenses, including
approximately $0.19 million of non-cash stock-based compensation.
In addition, other research and development expenses increased
$0.01 million due to clinical validation and laboratory studies,
and operational and business development activities.
and administrative (G&A) expenses were $0.46 million for the
first quarter of 2020, compared to $0.38 million for the first
quarter of 2019. The approximately $0.08 million increase during
fiscal year 2020, compared to fiscal year 2019, was attributable to
non-cash stock-based compensation.
loss for the first quarter of 2020 was $2.25 million, or $0.22 per
share, compared to a net loss of $1.85 million, or $0.18 per share,
for the first quarter of 2019. Non-GAAP adjusted net loss for the
first quarter of 2020 was $1.78 million, or $0.17 per share,
compared to non-GAAP adjusted net loss of $1.66 million, or $0.16
per share, for the first quarter 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 first quarter of 2020 was
$1.83 million, compared to $1.59 million for the first quarter of
March 31, 2020, Celcuity had cash and cash equivalents of $16.9
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
1-866-342-8588 and use passcode 52638. Participants are asked to
dial in 5 to 10 minutes prior to the start of the
Celcuity is a clinical stage biotechnology company translating
discoveries of new cancer sub-types into pioneering companion
diagnostics and expanded therapeutic options for cancer patients.
Celcuity's proprietary CELsignia diagnostic platform analyzes