Full Press Release Details
Celcuity Reports Fourth Quarter and Full
Year 2018 Financial Results
Minneapolis, Minnesota-February 26, 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 fourth quarter and year ended December 31, 2018.
Unless otherwise stated, all comparisons are for the fourth
quarter and year ended December 31, 2018, compared to the fourth quarter and year ended December 31, 2017.
Celcuity reported a net loss of $1.8 million, or $0.18 per share,
for the fourth quarter of 2018, compared to a net loss of $1.7 million, or $0.17 per share, for the fourth quarter of 2017. Net
loss for fiscal year 2018 was $7.5 million, or $0.74 per share, compared to $6.3 million, or $0.84 per share, for fiscal year 2017.
Non-GAAP adjusted net loss was $1.6 million, or $0.15 per share, for the fourth quarter of 2018, compared to non-GAAP adjusted
net loss of $1.4 million, or $0.14 per share, for the fourth quarter of 2017. Non-GAAP adjusted net loss for the fiscal year 2018
was $6.3 million, or $0.62 per share, compared to $4.9 million, or $0.66 per share, for the fiscal year 2017. Non-GAAP adjusted
net loss excludes stock-based compensation expense and non-cash interest expense. Because these items have no impact on the cash
position of the Company, management believes Non-GAAP adjusted net loss better enables Celcuity to
focus on cash used in operations. For a reconciliation of financial measures in accordance with generally accepted accounting
principles of the United States (GAAP) to non-GAAP financial measures in this release, please see the financial tables at the end
of this news release.
Net cash used in operating activities for the fourth quarter
of 2018 was $1.5 million. Net cash used in operating activities for fiscal year 2018 was $6.1 million. At December 31, 2018, Celcuity
had cash, cash equivalents and investments of $24.9 million, compared to cash, cash equivalents and investments of $31.4 million
at December 31, 2017.
"We made significant progress in 2018 and achieved many
of our critical objectives. Our first clinical trial, FACT 1, was activated in collaboration with Genentech and the NSABP Foundation.
The FACT 1 trial is evaluating the safety and efficacy of Genentech's drugs, Herceptin and Perjeta , and chemotherapy,
in breast cancer patients selected with Celcuity's CELx HSF Test. We signed a clinical trial agreement with Puma Biotechnology,
Inc. and West Cancer Center to conduct a Phase II clinical trial, known as FACT 2, to evaluate the efficacy and safety of Puma's
drug, Nerlynx , and chemotherapy, in breast cancer patients selected with Celcuity's CELx HSF Test. We were also selected
by 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.
"We completed development of our second CELx
signaling function Test for HER2-negative breast cancer. This second test identifies HER2-negative breast cancer patients who
have hyperactive and co-activated HER family and c-Met signaling activity. We also advanced development of several new CELx
signaling function tests to diagnose new cancer sub-types, including a third test for breast cancer and tests for two new
tumor tissue types. Additionally, we presented results of several pre-clinical studies at major conferences, including the
American Society of Clinical Oncology Annual Meeting, the Miami Breast Cancer Conference, and the San Antonio Breast Cancer
Mr. Sullivan added, "The FACT 1 clinical trial that is
evaluating Genentech's targeted therapies in patients our CELx HSF test selects now has 14 activated sites. While this is
consistent with our goal at the beginning of 2018, the enrollment rate of patients at these sites has been lower than NSABP's
original expectations. To offset the lower than expected enrollment rate, NSABP has agreed to activate up to 16 additional sites,
for a total of 30 sites. We expect the addition of these sites will increase Celcuity's cost for the FACT 1 trial by up to
$650,000. We now expect interim results from this trial in late 2019 and final results approximately nine months later.
"The FACT 2 clinical trial that is evaluating Puma's
targeted therapy, Nerlynx, in patients our CELx HSF test selects has received all required regulatory and Institutional Review
Board approvals and is expected to be activated later in early 2019. We expect interim results from this trial in late 2019 or
early 2020 and final results approximately 12 months later.
"As we look ahead to the remainder of 2019, we anticipate
completing development of another cell signaling function test for breast cancer that diagnoses a new sub-type of breast cancer
not currently detected with a molecular test. We also anticipate completing development of tests for two new tumor types. Each
of these new tests would increase the opportunities for us to provide companion diagnostics that enable pharmaceutical companies
to obtain new drug indications for the cancer sub-types our tests diagnose. We also hope to initiate at least one additional clinical
collaboration with a pharmaceutical company by year-end to study breast cancer patients identified by our CELx MP test with hyperactive
and co-activated HER family and c-Met signaling activity."
Total operating expenses were $2.0 million for the fourth quarter
of 2018, compared to $1.8 million for the fourth quarter of 2017. Operating expenses for fiscal year 2018 were $7.9 million, compared
to $6.0 million for fiscal year 2017.
Research and Development Expenses:
Research and development (R&D) expenses were $1.6 million
for the fourth quarter of 2018, compared to $1.4 million for the fourth quarter of 2017. R&D expenses for fiscal year 2018
were $6.3 million, compared to $5.0 million for fiscal year 2017. The approximately $1.3 million increase during fiscal year 2018,
compared to fiscal year 2017, resulted primarily from a $0.6 million increase in compensation related expenses to support development
of our CELx platform. In addition, other R&D expenses increased $0.7 million due to clinical validation and laboratory studies,
legal expenses related to patent costs and operational and business development activities.
General and Administrative Expenses:
General and administrative (G&A) expenses were $0.3 million
for the fourth quarter of 2018, compared to $0.4 million for the fourth quarter of 2017. G&A expenses for fiscal year 2018
were $1.6 million, compared to $1.0 million for fiscal year 2017. The approximately $0.6 million increase during fiscal year 2018,
compared to fiscal year 2017, primarily resulted from a $0.4 million increase in professional fees associated with being a public
company for a full year versus only one quarter in 2017, and director and officer insurance. Other G&A expenses increased $0.2
million in compensation related expenses, including non-cash stock-based compensation.
Management will host a teleconference call at 4:30 PM Eastern
Time today to discuss the results. Anyone interested in participating should dial 1-877-876-9173 referencing confirmation code
"Celcuity." Participants are asked to dial in 5 to 10 minutes prior to the start of the call and inform the operator
you would like to join the "Celcuity Conference Call."
Celcuity Inc. is a cellular analysis
company that is discovering new cancer sub-types and commercializing diagnostic tests designed to significantly improve the clinical
outcomes of cancer patients treated with targeted therapies. Celcuity's proprietary CELx diagnostic platform uses a
patient's living tumor cells to identify the specific abnormal cellular activity driving a patient's cancer and the
targeted therapy that can best treat that patient's disease. Celcuity is headquartered in Minneapolis, MN. Further information
about Celcuity can be found at www.celcuity.com.
Forward-Looking Statements
This press release contains statements
that constitute "forward-looking statements." In some cases, you can identify forward-looking statements by terminology
such as "may," "should," "expects," "plans," "anticipates," "believes,"
"estimates," "predicts," "potential," "intends" or "continue," and
other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or
other comparable terminology. Forward looking statements in this release include, without limitation, expectations with respect
to commercializing diagnostic tests, the use of cash, the discovery of additional cancer sub-types, the development of additional
CELx signaling function tests, the uses and breadth of application of CELx signaling function tests, whether alone or in collaboration
with other tests, collaboration with pharmaceutical companies and the outcomes of such collaboration, the outcome of our clinical
trial with NSABP Foundation and Genentech, the outcome of our clinical trial with Puma Biotechnology and the West Cancer
Center, the outcome of the clinical trial Puma Biotechnology and the NSABP Foundation are
fielding and of which we are providing services, clinical trial patient enrollment and timing of results, anticipated benefits
that our tests may provide to pharmaceutical companies and to the clinical outcomes of cancer patients
and plans to expand research and development and operational processes. Forward-looking statements are subject to numerous conditions,
many of which are beyond the control of Celcuity, which include, but are not limited to, those set forth in the Risk Factors section
in our Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission on March
15, 2018. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date