Full Press Release Details
Celcuity Reports Third Quarter 2019 Financial Results
Minnesota November 7, 2019 Celcuity Inc. (Nasdaq:
CELC), a functional cellular analysis company that is discovering
new cancer subtypes and commercializing diagnostic tests designed
to significantly improve clinical outcomes of cancer patients
treated with targeted therapies, announced financial results for
the third quarter ended September 30, 2019.
otherwise stated, all comparisons are for the third quarter ended
September 30, 2019, compared to the third quarter ended September
reported a net loss of $1.98 million, or $0.19 per share, for the
third quarter of 2019, compared to a net loss of $1.87 million, or
$0.18 per share, for the third quarter of 2018. Net loss for the
first nine months of 2019 was $5.55 million, or $0.54 per share,
compared to $5.66 million, or $0.56 per share, for the first nine
months of 2018. Non-GAAP adjusted net loss was $1.68 million, or
$0.16 per share, for the third quarter of 2019, compared to
non-GAAP adjusted net loss of $1.57 million, or $0.15 per share,
for the third quarter of 2018. Non-GAAP adjusted net loss for the
first nine months of 2019 was $4.87 million, or $0.47 per share,
compared to non-GAAP adjusted net loss of $4.74 million, or $0.47
per share, for the first nine months of 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 release.
cash used in operating activities for the third quarter of 2019 was
$1.48 million. At September 30, 2019, Celcuity had cash, cash
equivalents and investments of $20.4 million, compared to cash,
cash equivalents and investments of $24.9 million at December 31,
continued to make progress advancing development of new CELx tests
to diagnose patients with new cancer sub-types and establishing
collaborations with pharmaceutical companies. In December, we will
report pre-clinical study results for our next cell signaling
function test for breast cancer at the San Antonio Breast Cancer
Conference, said Chairman and Chief Executive Officer, Brian
new test will identify a new sub-group of HER2-negative breast
cancer patients with tumors that have currently undiagnosed
hyperactive oncogenic signaling activity. We will incorporate this
test into our CELx Multi-Pathway (MP) Signaling Function Test. With
this new sub-group, we will increase the proportion of
HER2-negative breast cancer patients our CELx Multi-Pathway (MP)
Signaling Function test can diagnose. We would expect to initiate
discussions with pharmaceutical companies about collaborating on
clinical trials beginning in the early to mid-2020. Development of
an additional test for breast cancer, which would be our fourth,
also advanced during the quarter. We hope to complete the
pre-clinical studies for this new test in 2020.
of CELx tests for two new solid tumor types also progressed during
the quarter. We expect to complete pre-clinical studies for a cell
signaling function test in a second tumor type in the first quarter
of 2020 and present the results of these studies at a cancer
research conference in the second quarter. Completion of the
pre-clinical data package for this second tumor type will further
increase our opportunities to provide companion diagnostics that we
believe will enable pharmaceutical companies to obtain new drug
indications for the cancer sub-types our tests
also continued to progress towards finalizing several clinical
trial collaborations with pharmaceutical companies and clinical
sponsors to study breast cancer patients identified by our CELx MP
test. 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 parties. We are very confident
that we will close several collaborations in the next several
efforts by NSABP to add new clinical sites to the FACT 1 trial
continued this quarter. Six new clinical sites obtained
Institutional Review Board (IRB) approval and activated the trial.
We now have 26 sites who are enrollment ready and another four
sites that are at various stages of obtaining IRB and other related
approvals. We are hopeful that most, if not all, of the four sites
that are in the midst of approval-related activities will be
enrollment ready by year-end, said Chairman and Chief
Executive Officer, Brian Sullivan. The FACT 1 trial is evaluating
the safety and efficacy of Genentech's drugs, Herceptin
and Perjeta , and chemotherapy, in early stage breast cancer
patients selected with Celcuity's CELx HSF Test.
addition of these six new sites and four pending sites would double
the number of activated sites enrolling patients for this trial
compared to the end of 2018. Since most of the new sites only began
participating recently, they have not yet had a significant impact
on the patient enrollment rate for the trial. We now expect interim
results will be available from this trial in mid-2020 and final
results approximately nine months later.
FACT 2 clinical trial that is evaluating the safety and efficacy of
Puma Biotechnology's pan-HER inhibitor, Nerlynx , and
chemotherapy, in early state breast cancer patients selected with
Celcuity's CELx HSF Test is progressing. We expect interim
results from this trial in mid-2020 and final results approximately
12 months later. The trial with NSABP and Puma Biotechnology, Inc.
to evaluate tissue samples from a Phase II study evaluating Puma
Biotechnology's pan-HER inhibitor, Nerlynx, Genentech's
HER2 antibody, Herceptin, and Bristol-Myers Squibb's EGFR
inhibitor, Erbitux , in metastatic colorectal cancer patients
also continues to progress.
operating expenses were $2.09 million for the third quarter of
2019, compared to $1.98 million for the third quarter of 2018.
Operating expenses for the first nine months of 2019 were $5.91