Exhibit 99.1
Celcuity Reports Fourth Quarter and Full Year 2019 Financial
Results
Minneapolis,
Minnesota—March 12, 2020—Celcuity Inc. (Nasdaq: CELC),
a functional cellular analysis company that is developing companion
diagnostic tests designed to expand the eligible patient
populations for targeted therapies, announced financial results for
the fourth quarter and year ended December 31, 2019.
Unless
otherwise stated, all comparisons are for the fourth quarter and
year ended December 31, 2019, compared to the fourth quarter and
year ended December 31, 2018.
Celcuity
reported a net loss of $1.81 million, or $0.18 per share, for the
fourth quarter of 2019, compared to a net loss of $1.83 million, or
$0.18 per share, for the fourth quarter of 2018. Net loss for
fiscal year 2019 was $7.36 million, or $0.72 per share, compared to
$7.48 million, or $0.74 per share, for fiscal year 2018. Non-GAAP
adjusted net loss was $1.45 million, or $0.14 per share, for the
fourth quarter of 2019, compared to non-GAAP adjusted net loss of
$1.57 million, or $0.15 per share, for the fourth quarter of 2018.
Non-GAAP adjusted net loss for fiscal year 2019 was $6.32 million,
or $0.62 per share, compared to non-GAAP adjusted net loss of $6.31
million, or $0.62 per share, for fiscal year 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.
Net
cash used in operating activities for the fourth quarter of 2019
was $1.70 million. At December 31, 2019, Celcuity had cash and cash
equivalents of $18.7 million, compared to cash, cash equivalents
and investments of $24.9 million at December 31, 2018.
“We made significant
progress advancing our CELsignia (previously known as CELx)
platform in the fourth quarter of 2019. In December, we presented
results from pre-clinical studies for our new CELsignia PI3K Test
at the San Antonio Breast Cancer Symposium,” said Brian
Sullivan, Chairman and Chief Executive Officer of Celcuity.
“The studies we presented demonstrate how the measurement of
PI3K-involved signaling initiated by G-protein-couple receptors
(GPCRs) using our CELsignia platform may provide a more sensitive
and specific method than PIK3-mutational status to identify
patients most likely to benefit from PI3K inhibitors. We have
already begun discussions with leading cancer centers to design
clinical trials that would evaluate PI3K targeted therapies in
HER2-negative breast cancer patients the CELsignia PI3K Test
identifies.
“This
is our third CELsignia test for breast cancer. Each of our three
tests offers a potential opportunity for pharmaceutical companies
to expand the number of patients eligible for their targeted
therapies. The patients diagnosed by our CELsignia tests are
patients current molecular tests cannot identify. Celcuity now has
the potential to identify dysregulated signaling activity
undiagnosable by molecular tests in up to one in three
HER2-negative breast cancer patients.
1
“We
are also continuing our efforts to develop additional tests for
breast cancer patients. The development of our fourth test for
breast cancer also advanced during the quarter. We hope to complete
the pre-clinical studies for this new test in 2020.
“Our
long-term goal at Celcuity is to offer CELsignia tests for a range
of solid tumor types, in addition to our current ones for breast
cancer. Our breast cancer research has given us valuable insights
into another cancer that uniquely afflicts women – ovarian
cancer. We are pleased to announce that, we will report
pre-clinical study results for our first CELsignia test for ovarian
cancer at the 2020 Annual Meeting of the American Association for
Cancer Research. This new test will identify a new sub-group of
ovarian cancer patients with tumors that have undiagnosed
hyperactive oncogenic signaling activity. Nearly 15,000 women a
year die from ovarian cancer, a disease that has less than a 50%
five-year survival rate and a limited range of targeted therapy
options. There is thus a significant unmet need for additional
therapeutic options for ovarian cancer patients. As a companion
diagnostic, our CELsignia test for ovarian cancer will be intended
to help pharmaceutical companies obtain new drug indications and
expand treatment options for this challenging tumor type. We would
expect to initiate discussions with pharmaceutical companies about
collaborating on clinical trials later in 2020.
“Our
efforts to finalize several clinical trial collaborations with
pharmaceutical companies and clinical sponsors continued to
progress. Our goal is to evaluate the efficacy of targeted
therapies in breast cancer patients identified by our CELsignia
tests. We remain very confident that we will close several
collaborations this year. 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.
“In
conjunction with our efforts to collaborate with pharmaceutical
companies to field clinical trials, we have expanded our Scientific
Advisory Board, or SAB. We are pleased to announce that several
nationally recognized medical oncologists have joined our SAB over
the past few months. Our new SAB members include: Ben Park, MD,
PhD, co-leader of the Breast Cancer Research Program and Director
of Precision Oncology at Vanderbilt University Medical Center;
Filip Janku, MD, PhD, Medical Director of the Clinical and
Translational Research Center at MD Anderson Cancer Center; and
Bora Lim, MD, Assistant Professor, MD Anderson Cancer Center. We
are excited about the opportunities to gain their insights as well
as to potentially collaborate with them on future clinical
trials.
“NSABP
has largely completed the addition of new clinical sites to the
FACT 1 trial. We now have 27 activated sites participating. The
FACT 1 trial is evaluating the safety and efficacy of
Genentech’s anti-HER2 targeted therapies, Herceptin® and
Perjeta®, and chemotherapy, in early stage breast cancer
patients selected with Celcuity’s CELsignia HSF Test. We
expected that these new sites would immediately increase the
enrollment rate for the trial. To date, however, these new sites
have not yet impacted enrollment rate as we expected. Given the
slower than expected enrollment from these sites, we now expect
interim results will be available from this trial in
early-to-mid-2021 and final results approximately nine months
later.
“The
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 CELsignia HSF Test is progressing. We expect
interim results from this trial in mid-2021 and final results
approximately 9-12 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.”
2
Operating Expenses
Total
operating expenses were $1.90 million for the fourth quarter of
2019, compared to $1.95 million for the fourth quarter of 2018.
Operating expenses for the fiscal year 2019 were $7.81 million,
compared to $7.93 million for the fiscal year 2018.
Research and Development Expenses:
Research
and development (R&D) expenses were $1.50 million for the
fourth quarter of 2019, compared to $1.63 million for the fourth
quarter of 2018. R&D expenses for fiscal year 2019 were $6.27
million, compared to $6.33 million for fiscal year 2018. The
approximately $0.06 million decrease during fiscal year 2019,
compared to fiscal year 2018, resulted primarily from a $0.31
million decrease in compensation expense, primarily in payroll
taxes resulting from utilization of research and development tax
credits as authorized by the Path Act and a decrease of $0.16
million in non-cash stock-based compensation. This decrease was
offset by a $0.41 million increase in 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 $0.40 million for the
fourth quarter of 2019, compared to $0.32 million for the fourth
quarter of 2018. G&A expenses for fiscal year 2019 were $1.54
million, compared to $1.61 million for fiscal year 2018. The
approximately $0.07 million decrease during fiscal year 2019,
compared to fiscal year 2018, primarily resulted from a decrease in
professional fees associated with being a public
company.
Conference Call
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.”
About Celcuity
We are a functional cellular analysis company that is developing
companion diagnostic tests designed to expand the eligible patient
populations for targeted therapies by discovering new cancer
sub-types molecular-based approaches cannot detect. Our
proprietary CELsignia diagnostic platform is currently the only
commercially ready technology that we are aware of that uses a
patient’s living tumor cells to identify the cellular
activity that may be driving a patient’s cancer. 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 CELsignia tests,
the uses and breadth of application of CELsignia tests, whether
alone or in collaboration with other tests, collaboration with
pharmaceutical companies and the outcomes of such collaboration,
the outcome of the FACT 1 clinical trial with NSABP Foundation and
Genentech, the outcome of the FACT 2 clinical trial with
Puma Biotechnology and the West Cancer Center, the outcome of the clinical trial Puma
Biotechnology and NSABP Foundation are
fielding and for which Celcuity is providing services, clinical
trial site approval activities and the timing of such activities,
clinical trial patient enrollment and timing of results,
anticipated benefits that Celcuity’s 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 Celcuity’s
Annual Report on Form 10-K for the year ended December 31, 2018
filed with the Securities and Exchange Commission on March 1, 2019.
Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
Celcuity undertakes no obligation to update these statements for
revisions or changes after the date of this release, except as
required by law.
Contacts:
Celcuity
Inc.
Brian
Sullivan, bsullivan@celcuity.com
Vicky
Hahne, vhahne@celcuity.com
763-392-0123
3
Celcuity Inc.
Balance Sheets
|
|
December 31,
2019
|
December 31,
2018
|
|
|
|
|
|
Assets
|
|
|
|
Current Assets:
|
|
|
|
Cash
and cash equivalents
|
$18,735,002
|
$15,944,609
|
|
Investments
|
-
|
8,952,907
|
|
Deposits
|
22,009
|
22,009
|
|
Deferred
transaction costs
|
28,743
|
28,743
|
|
Payroll
tax receivable
|
190,000
|
-
|
|
Prepaid
assets
|
274,600
|
269,940
|
|
Total current assets
|
19,250,354
|
25,218,208
|
|
|
|
|
|
Property
and equipment, net
|
833,463
|
813,613
|
|
Operating
lease right-of-use assets
|
196,983
|
-
|
|
Total Assets
|
$20,280,800
|
$26,031,821
|
|
|
|
|
|
Liabilities and Stockholders' Equity:
|
|
|
|
Current Liabilities:
|
|
|
|
Accounts
payable
|
$142,773
|
$119,811
|
|
Finance
lease liabilities
|
5,769
|
5,730
|
|
Operating
lease liabilities
|
178,466
|
-
|
|
Accrued
expenses
|
584,319
|
536,791
|
|
Total current liabilities
|
911,327
|
662,332
|
|
Finance
lease liabilities
|
14,109
|
19,878
|
|
Operating
lease liabilities
|
57,793
|
-
|
|
Total Liabilities
|
983,229
|
682,210
|
|
Total Stockholders' Equity
|
19,297,571
|
25,349,611
|
|
Total Liabilities and Stockholders' Equity
|
$20,280,800
|
$26,031,821
|
4
Celcuity Inc.
Statements of Operations
|
|
Three Months Ended December 31,
|
Years Ended December 31,
|
||
|
|
2019
|
2018
|
2019
|
2018
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
$1,497,023
|
$1,634,746
|
$6,269,308
|
$6,325,995
|
|
General
and administrative
|
400,742
|
316,460
|
1,535,993
|
1,606,543
|
|
Total
operating expenses
|
1,897,765
|
1,951,206
|
7,805,301
|
7,932,538
|
|
Loss
from operations
|
(1,897,765)
|
(1,951,206)
|
(7,805,301)
|
(7,932,538)
|
|
|
|
|
|
|
|
Other
income (expense)
|
|
|
|
|
|
Interest
expense
|
(36)
|
(46)
|
(159)
|
(111)
|
|
Interest
income
|
88,776
|
122,951
|
446,096
|
448,834
|
|
Gain
on sale of fixed assets
|
-
|
3,000
|
-
|
3,000
|
|
Other
income (expense), net
|
88,740
|
125,905
|
445,937
|
451,723
|
|
Net loss before income taxes
|
(1,809,025)
|
(1,825,301)
|
(7,359,364)
|
(7,480,815)
|
|
Income
tax benefits
|
-
|
-
|
-
|
-
|
|
Net loss
|
$(1,809,025)
|
$(1,825,301)
|
$(7,359,364)
|
$(7,480,815)
|
|
|
|
|
|
|
|
Net
loss per share, basic and diluted
|
$(0.18)
|
$(0.18)
|
$(0.72)
|
$(0.74)
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding, basic and diluted
|
10,251,555
|
10,162,690
|
10,226,041
|
10,124,544
|
5
Cautionary Statement Regarding Non-GAAP Financial
Measures
This news release contains references to non-GAAP adjusted net loss
and non-GAAP adjusted net loss per share. Management believes these
non-GAAP financial measures are useful supplemental measures for
planning, monitoring, and evaluating operational performance as
they exclude stock-based compensation expense from net loss and net
loss per share. Management excludes this item because it does not
impact Celcuity’s cash position, which management believes
better enables Celcuity to focus on cash used in operations.
However, non-GAAP adjusted net loss and non-GAAP adjusted net loss
per share are not recognized measures under GAAP and do not have a
standardized meaning prescribed by GAAP. Therefore, non-GAAP
adjusted net loss and non-GAAP adjusted net loss per share may not
be comparable to similar measures presented by other companies.
Investors are cautioned that non-GAAP adjusted net loss and
non-GAAP adjusted net loss per share should not be construed as
alternatives to net loss, net loss per share or other statements of
operations data (which are determined in accordance with GAAP) as
an indicator of Celcuity’s performance or as a measure of
liquidity and cash flows. Management’s method of calculating
non-GAAP adjusted net loss and non-GAAP adjusted net loss per share
may differ materially from the method used by other companies and
accordingly, may not be comparable to similarly titled measures
used by other companies.
6
Celcuity Inc.
Reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss
and
GAAP Net Loss Per Share to Non-GAAP Adjusted Net Loss Per
Share
|
|
Three Months EndedDecember 31,
|
Years EndedDecember 31,
|
||
|
|
2019
|
2018
|
2019
|
2018
|
|
|
|
|
|
|
|
GAAP
net loss
|
$(1,809,025)
|
$(1,825,301)
|
$(7,359,364)
|
$(7,480,815)
|
|
Adjustments:
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
|
|
Research
and development
|
202,403
|
172,183
|
567,305
|
727,216(1)
|
|
General
and administrative
|
158,452
|
83,394
|
473,684
|
441,400(2)
|
|
Non-GAAP
adjusted net loss
|
$(1,448,170)
|
$(1,569,724)
|
$(6,318,375)
|
$(6,312,199)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP
net loss per share - basic and diluted
|
$(0.18)
|
$(0.18)
|
$(0.72)
|
$(0.74)
|
|
Adjustment
to net loss (as detailed above)
|
0.04
|
0.03
|
0.10
|
0.12
|
|
Non-GAAP
adjusted net loss per share
|
$(0.14)
|
$(0.15)
|
$(0.62)
|
$(0.62)
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding, basic and diluted
|
10,251,555
|
10,162,690
|
10,226,041
|
10,124,544
|
(1)
To
reflect a non-cash charge to operating expense for Research and
Development stock-based compensation.
(2)
To
reflect a non-cash charge to operating expense for General and
Administrative stock-based compensation.
7