Exhibit 99.1
Celcuity Reports Second Quarter 2020 Financial
Results
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)
-
Minneapolis,
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.
“During
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.
“We
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
2021.”
Recent Highlights and Upcoming Milestones
-
Data for two new
CELsignia tests in two different tumor types announced during past
nine months.
-
Multiple clinical
trial collaborations amongst several major pharmaceutical companies
advancing towards close this year.
-
Expect to complete
development of a CELsignia RAS test for breast cancer patients by
the end of 2020.
-
Interim results
from the FACT-1 and FACT-2 trials are expected in the second half
of 2021
1
Second Quarter 2020 Financials
Unless
otherwise stated, all comparisons are for the second quarter ended
June 30, 2020, compared to the second quarter ended June 30,
2019.
Total
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
2019.
Research
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.
General
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.
Net
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.
Net
cash used in operating activities for the second quarter of 2020
was $1.56 million, compared to $1.23 million for the second quarter
of 2019.
At June
30, 2020, Celcuity had cash and cash equivalents of $15.4 million,
compared to cash and cash equivalents of $18.7 million at December
31, 2019.
Conference Call
Management
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
call.
2
About Celcuity
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 3rd
generation diagnostic platform,
CELsignia, analyzes living tumor cells to untangle the complexity
of the cellular activity driving a patient’s cancer. This
allows Celcuity to discover new cancer sub-types molecular
diagnostics cannot detect. Celcuity is driven to improve outcomes
for patients and to transform how pharmaceutical companies define
the patient populations for their targeted therapies. 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 press release
include, without limitation, expectations with respect to new
clinical trial collaborations and the timing or outcomes of such
collaborations, 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, the outcome of the FACT 1 and FACT 2 clinical
trials, 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
expectations regarding the impact that the COVID-19 pandemic and
related economic effects will have on Celcuity’s business and
results of operations. Forward-looking statements are subject to
numerous conditions, many of which are beyond the control of
Celcuity, which include, but are not limited to, the unknown impact
of the COVID-19 pandemic on Celcuity’s business and those
other risks set forth in the Risk Factors section in
Celcuity’s Annual Report on Form 10-K for the year ended
December 31, 2019 filed with the Securities and Exchange Commission
on March 13, 2020. 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
press release, except as required by law.
Contacts:
Celcuity
Inc.
Brian
Sullivan, [email protected]
Vicky
Hahne, [email protected]
763-392-0123
LifeSci
Advisors, LLC
Jeremy
Feffer,
(212) 915-2568
3
Celcuity Inc.
Condensed Balance Sheets
|
|
June 30,
2020
|
December 31,
2019
|
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
Current Assets:
|
|
|
|
Cash
and cash equivalents
|
$15,430,559
|
$18,735,002
|
|
Deposits
|
22,009
|
22,009
|
|
Deferred
transaction costs
|
-
|
28,743
|
|
Payroll
tax receivable
|
190,000
|
190,000
|
|
Prepaid
assets
|
232,648
|
274,600
|
|
Total current assets
|
15,875,216
|
19,250,354
|
|
|
|
|
|
Property
and equipment, net
|
706,219
|
833,463
|
|
Operating
lease right-of-use assets
|
121,015
|
196,983
|
|
Total Assets
|
$16,702,450
|
$20,280,800
|
|
|
|
|
|
Liabilities and Stockholders' Equity:
|
|
|
|
Current Liabilities:
|
|
|
|
Accounts
payable
|
$81,048
|
$142,773
|
|
Finance
lease liabilities
|
5,789
|
5,769
|
|
Operating
lease liabilities
|
131,538
|
178,466
|
|
Accrued
expenses
|
610,508
|
584,319
|
|
Total current liabilities
|
828,883
|
911,327
|
|
Finance
lease liabilities
|
11,209
|
14,109
|
|
Operating
lease liabilities
|
-
|
57,793
|
|
Total Liabilities
|
840,092
|
983,229
|
|
Total Stockholders' Equity
|
15,862,358
|
19,297,571
|
|
Total Liabilities and Stockholders' Equity
|
$16,702,450
|
$20,280,800
|
|
|
|
|
4
Celcuity Inc.
Condensed Statements of Operations
(unaudited)
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||
|
|
2020
|
2019
|
2020
|
2019
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
$1,766,227
|
$1,469,731
|
$3,613,641
|
$3,060,689
|
|
General
and administrative
|
447,714
|
371,988
|
911,113
|
755,533
|
|
Total
operating expenses
|
2,213,941
|
1,841,719
|
4,524,754
|
3,816,222
|
|
Loss
from operations
|
(2,213,941)
|
(1,841,719)
|
(4,524,754)
|
(3,816,222)
|
|
|
|
|
|
|
|
Other
income (expense)
|
|
|
|
|
|
Interest
expense
|
(31)
|
(41)
|
(64)
|
(85)
|
|
Interest
income
|
11,983
|
121,583
|
75,834
|
250,221
|
|
Other
income, net
|
11,952
|
121,542
|
75,770
|
250,136
|
|
Net loss before income taxes
|
(2,201,989)
|
(1,720,177)
|
(4,448,984)
|
(3,566,086)
|
|
Income
tax benefits
|
-
|
-
|
-
|
-
|
|
Net loss
|
$(2,201,989)
|
$(1,720,177)
|
$(4,448,984)
|
$(3,566,086)
|
|
|
|
|
|
|
|
Net
loss per share, basic and diluted
|
$(0.21)
|
$(0.17)
|
$(0.43)
|
$(0.35)
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding, basic and diluted
|
10,260,234
|
10,213,455
|
10,257,111
|
10,206,000
|
5
Cautionary Statement Regarding Non-GAAP Financial
Measures
This press 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 Ended June 30,
|
Six Months Ended June 30,
|
||
|
|
2020
|
2019
|
2020
|
2019
|
|
|
|
|
|
|
|
GAAP
net loss
|
$(2,201,989)
|
$(1,720,177)
|
$(4,448,984)
|
$(3,566,086)
|
|
Adjustments:
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
|
|
Research
and development
|
265,446
|
101,303
|
558,562
|
201,560(1)
|
|
General
and administrative
|
157,747
|
90,943
|
329,280
|
175,331(2)
|
|
Non-GAAP
adjusted net loss
|
$(1,778,796)
|
$(1,527,931)
|
$(3,561,142)
|
$(3,189,195)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP
net loss per share - basic and diluted
|
$(0.21)
|
$(0.17)
|
$(0.43)
|
$(0.35)
|
|
Adjustment
to net loss (as detailed above)
|
0.04
|
0.02
|
0.09
|
0.04
|
|
Non-GAAP
adjusted net loss per share
|
$(0.17)
|
$(0.15)
|
$(0.34)
|
$(0.31)
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding, basic and diluted
|
10,260,234
|
10,213,455
|
10,257,111
|
10,206,000
|
(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