Full Press Release Details
Celcuity Reports Second Quarter 2020 Financial
and Recent Business Highlights
Presented data for first CELsignia
Pathway Activity Test for ovarian cancer at AACR Annual Meeting
- Expect to announce new clinical trial collaborations with
pharmaceutical companies and
trial sponsors by the end of 2020
- Cash burn rate steady -
- Cash and Cash Equivalents of $15.4 million as of June 30, 2020,
which is expected to support operations through 2021 -
- Conference Call on Monday, August 10th at 4:30pm (ET)
Minnesota August 10, 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 second quarter ended June 30,
2020 and summarized recent business progress.
the second quarter, we continued to advance development of
additional CELsignia Pathway Activity tests. In June, we presented
results from studies of our first CELsignia Pathway Activity Test
for ovarian cancer at the American Association for Cancer Research
(AACR) Annual Meeting. Our CELsignia test for ovarian cancer
identifies a subset of ovarian cancer patients whose tumors have
abnormal c-Met signaling coincident with abnormal HER2
signaling, said Brian Sullivan, Chairman and Chief Executive
Officer of Celcuity. Celcuity's 3rd generation
diagnostic platform, CELsignia, identifies the dysregulated
signaling activity driving a patient's cancer.
also continued to make progress advancing additional new tests and
additional collaborations during the quarter. Our goal is to
develop new CELsignia tests that identify RAS pathway driven
cancers undetectable with molecular tests so that more cancer
patients can receive the targeted therapy best suited to treat
their tumors. Our collaboration discussions with pharmaceutical
companies progressed despite the headwinds COVID-19 presents. We
remain confident we will finalize additional collaborations before
year-end. Finally, although our FACT-1 and FACT-2 trials remain
somewhat impacted by COVID-19 related delays, we continue to expect
interim results from these trials in the second half of
Recent Highlights and Upcoming Milestones
CELsignia tests in two different tumor types announced during past
trial collaborations amongst several major pharmaceutical companies
advancing towards close this year.
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
Second Quarter 2020 Financials
otherwise stated, all comparisons are for the second quarter ended
June 30, 2020, compared to the second quarter ended June 30,
operating expenses were $2.21 million for the second quarter of
2020, compared to $1.84 million for the second quarter of 2019.
Operating expenses for the first six months of 2020 were $4.52
million, compared to $3.81 million for the first six months of
and development (R&D) expenses were $1.77 million for the
second quarter of 2020, compared to $1.47 million for the second
quarter of 2019. R&D expenses for the first six months of 2020
were $3.61 million, compared to $3.06 million for the first six
months of 2019. The approximately $0.55 million increase during the
first half of fiscal year 2020, compared to first half of fiscal
year 2019, resulted primarily from a $0.52 million increase in
compensation related expenses, including approximately $0.36
million of non-cash stock-based compensation expense. In addition,
other research and development expenses increased $0.03 million due
to clinical validation and laboratory studies, and operational and
business development activities.
and administrative (G&A) expenses were $0.45 million for the
second quarter of 2020, compared to $0.37 million for the second
quarter of 2019. G&A expenses for the first six months of 2020
were $0.91 million, compared to $0.75 million for the first six
months of 2019. The approximately $0.16 million increase during
fiscal year 2020, compared to fiscal year 2019, was attributable to
non-cash stock-based compensation expense.
loss for the second quarter of 2020 was $2.20 million, or $0.21 per
share, compared to a net loss of $1.72 million, or $0.17 per share,
for the second quarter of 2019. Net loss for the first six months
of 2020 was $4.45 million, or $0.43 per share, compared to $3.57
million, or $0.35 per share, for the first six months of 2019.
Non-GAAP adjusted net loss for the second quarter of 2020 was $1.78
million, or $0.17 per share, compared to non-GAAP adjusted net loss
of $1.53 million, or $0.15 per share, for the second quarter of
2019. Non-GAAP adjusted net loss for the first six months of 2020
was $3.56 million, or $0.34 per share, compared to non-GAAP
adjusted net loss of $3.19 million, or $0.31 per share, for the
first six 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 second quarter of 2020
was $1.56 million, compared to $1.23 million for the second quarter
30, 2020, Celcuity had cash and cash equivalents of $15.4 million,
compared to cash and cash equivalents of $18.7 million at December
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