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8-K - CURRENT REPORT - Celcuity Inc. | celc_8k.htm |
Exhibit 99.1
Celcuity Reports First Quarter 2020 Financial
Results
and Recent Business Highlights
-
Significant progress made in
development of new, highly precise diagnostics using proprietary
CELsignia platform –
- Expect to announce new clinical trial collaborations with
pharmaceutical companies and
trial sponsors by the end of 2020 –
- Expects to complete development of a CELsignia RAS test for
breast and ovarian cancer patients by the end of 2020
–
- Potential impact of the COVID-19 pandemic on clinical sites
expected to push announcement of interim data from the FACT-1 and
FACT-2 trials into the second half of 2021 –
- Conference Call on Thursday, May 7th
at 4:30pm (ET)
-
Minneapolis,
Minnesota—May 7, 2020—Celcuity Inc. (Nasdaq: CELC), a
clinical stage biotechnology company translating discoveries of new
cancer sub-types into pioneering diagnostics and expanded
therapeutic options for cancer patients, announced financial
results for the first quarter ended March 31, 2020 and provided a
corporate update.
“During
the first quarter, we made significant progress developing a new
dynamic signaling test using our proprietary CELsignia platform
that is intended to diagnose cancers driven by dysregulated RAS
signaling. We expect to complete development of a CELsignia RAS
test for breast and ovarian cancer patients by the end of 2020. Our
current tests have the potential to diagnose oncogenic signaling
activity undetectable by molecular tests in up to one in three
HER2-negative breast cancer patients,” said Brian Sullivan,
Chairman and Chief Executive Officer of Celcuity.
“Dysregulation
of RAS signaling, which includes the RAF/ERK and PI3K/AKT pathways,
is estimated to drive 30%-40% of all cancers. Our CELsignia
platform is uniquely suited to untangling the complexity of
dysregulated RAS signaling tumors and identifying the targeted
therapy combination capable of treating it. If our efforts to
develop a RAS dynamic signaling test are successful, the percentage
of cancer patients who could benefit from a CELsignia test would
increase significantly.
“We
continue to advance our discussions with pharmaceutical companies
for a number of potential clinical trial collaborations. While we
still expect to close several collaborations this year, the
clinical sponsors and pharmaceutical companies we hope to work with
have been affected to varying degrees by the COVID-19 pandemic.
These events may delay finalizing some of these potential
collaborations past year end 2020. Our potential collaboration
partners include many of the country’s leading cancer
research centers, as well as several global pharmaceutical
companies. The goal of these collaborations is to evaluate the
efficacy of targeted therapies in breast cancer patients identified
by CELsignia tests.
“In
light of recent developments relating to the COVID-19 global
pandemic, the focus of healthcare providers and hospitals on
fighting the virus, and consistent with the FDA’s updated
industry guidance for conducting clinical trials issued on March
18, 2020, we are experiencing delays in the enrollment of patients
in our ongoing clinical trials. As a result, we now expect interim
results from the FACT-1 and FACT-2 trials to be delayed until the
second half of 2021 and final results approximately nine months
later. We will continue to evaluate the situation and provide
updates as appropriate,” concluded Sullivan.
First Quarter 2020 Financials
Unless
otherwise stated, all comparisons are for the first quarter ended
March 31, 2020, compared to the first quarter ended March 31,
2019.
Total
operating expenses were $2.31 million for the first quarter of
2020, compared to $1.97 million for the first quarter of
2019.
Research
and development (R&D) expenses were $1.85 million for the first
quarter of 2020, compared to $1.59 million for the first quarter of
2019. The approximately $0.26 million increase during fiscal year
2020, compared to fiscal year 2019, resulted primarily from a $0.25
million increase in compensation related expenses, including
approximately $0.19 million of non-cash stock-based compensation.
In addition, other research and development expenses increased
$0.01 million due to clinical validation and laboratory studies,
and operational and business development activities.
General
and administrative (G&A) expenses were $0.46 million for the
first quarter of 2020, compared to $0.38 million for the first
quarter of 2019. The approximately $0.08 million increase during
fiscal year 2020, compared to fiscal year 2019, was attributable to
non-cash stock-based compensation.
1
Net
loss for the first quarter of 2020 was $2.25 million, or $0.22 per
share, compared to a net loss of $1.85 million, or $0.18 per share,
for the first quarter of 2019. Non-GAAP adjusted net loss for the
first quarter of 2020 was $1.78 million, or $0.17 per share,
compared to non-GAAP adjusted net loss of $1.66 million, or $0.16
per share, for the first quarter 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 first quarter of 2020 was
$1.83 million, compared to $1.59 million for the first quarter of
2019.
At
March 31, 2020, Celcuity had cash and cash equivalents of $16.9
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.
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 proprietary CELsignia diagnostic platform 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.
We are 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 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,
collaboration with pharmaceutical companies and the outcomes of
such collaboration, 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,
expectations regarding the impact that the COVID-19 pandemic and
related economic effects will have on our business and results of
operations, 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, the unknown impact
of the COVID-19 pandemic on our 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 release, except as required by
law.
Contacts:
Celcuity
Inc.
Brian
Sullivan, bsullivan@celcuity.com
Vicky
Hahne, vhahne@celcuity.com
763-392-0123
LifeSci
Advisors, LLC
Jeremy
Feffer,
Jeremy@LifeSciAdvisors.com
(212) 915-2568
2
Celcuity Inc.
|
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Condensed Balance Sheets
|
||
|
||
|
March
31,
2020
|
December
31,
2019
|
|
(unaudited)
|
|
Assets
|
|
|
Current Assets:
|
|
|
Cash
and cash equivalents
|
$16,854,359
|
$18,735,002
|
Deposits
|
22,009
|
22,009
|
Deferred
transaction costs
|
34,870
|
28,743
|
Payroll
tax receivable
|
190,000
|
190,000
|
Prepaid
assets
|
337,251
|
274,600
|
Total current assets
|
17,438,489
|
19,250,354
|
|
|
|
Property
and equipment, net
|
795,676
|
833,463
|
Operating
lease right-of-use assets
|
158,666
|
196,983
|
Total Assets
|
$18,392,831
|
$20,280,800
|
|
|
|
Liabilities and Stockholders' Equity:
|
|
|
Current Liabilities:
|
|
|
Accounts
payable
|
$68,104
|
$142,773
|
Finance
lease liabilities
|
5,780
|
5,769
|
Operating
lease liabilities
|
176,600
|
178,466
|
Accrued
expenses
|
614,462
|
584,319
|
Total current liabilities
|
864,946
|
911,327
|
Finance
lease liabilities
|
12,660
|
14,109
|
Operating
lease liabilities
|
-
|
57,793
|
Total Liabilities
|
877,606
|
983,229
|
Total Stockholders' Equity
|
17,515,225
|
19,297,571
|
Total Liabilities and Stockholders' Equity
|
$18,392,831
|
$20,280,800
|
|
|
|
3
Celcuity Inc.
|
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Condensed Statements of Operations
|
||
(unaudited)
|
||
|
|
|
|
Three
Months Ended March 31,
|
|
|
2020
|
2019
|
|
|
|
Operating expenses:
|
|
|
Research
and development
|
$1,847,414
|
$1,590,958
|
General
and administrative
|
463,399
|
383,545
|
Total
operating expenses
|
2,310,813
|
1,974,503
|
Loss
from operations
|
(2,310,813)
|
(1,974,503)
|
Other
income (expense)
|
|
|
Interest
expense
|
(33)
|
(43)
|
Interest
income
|
63,851
|
128,638
|
Other
income (expense), net
|
63,818
|
128,595
|
Net loss before income taxes
|
(2,246,995)
|
(1,845,908)
|
Income
tax benefits
|
-
|
-
|
Net loss
|
$(2,246,995)
|
$(1,845,908)
|
|
|
|
Net
loss per share, basic and diluted
|
$(0.22)
|
$(0.18)
|
|
|
|
Weighted
average common shares outstanding, basic and diluted
|
10,253,988
|
10,198,461
|
4
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.
5
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 EndedMarch 31,
|
|
|
2020
|
2019
|
|
|
|
GAAP
net loss
|
$(2,246,995)
|
$(1,845,908)
|
Adjustments:
|
|
|
Stock-based
compensation
|
|
|
Research
and development
|
293,116
|
100,257(1)
|
General
and administrative
|
171,533
|
84,388(2)
|
Non-GAAP
adjusted net loss
|
$(1,782,346)
|
$(1,661,263)
|
|
|
|
|
|
|
GAAP
net loss per share - basic and diluted
|
$(0.22)
|
$(0.18)
|
Adjustment
to net loss (as detailed above)
|
0.05
|
0.02
|
Non-GAAP
adjusted net loss per share
|
$(0.17)
|
$(0.16)
|
|
|
|
Weighted
average common shares outstanding, basic and diluted
|
10,253,988
|
10,198,461
|
|
|
|
(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.
6