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Celcuity Reports First Quarter 2019 Financial Results

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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 first quarter ended March 31, 2019.

Unless otherwise stated, all comparisons are for the first quarter ended
March 31, 2019, compared to the first quarter ended March 31, 2018.

Celcuity reported a net loss of $1.85 million, or $0.18 per share, for
the first quarter of 2019, compared to a net loss of $1.97 million, or
$0.19 per share, for the first quarter of 2018. Non-GAAP adjusted net
loss was $1.66 million, or $0.16 per share, for the first quarter of
2019, compared to non-GAAP adjusted net loss of $1.63 million, or $0.16
per share, for the first quarter of 2018. Non-GAAP adjusted net loss
excludes stock-based compensation expense. Because this item has 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 first quarter of 2019 was
$1.59 million. At March 31, 2019, Celcuity had cash, cash equivalents
and investments of $23.4 million, compared to cash, cash equivalents and
investments of $30.0 million at March 31, 2018.

"To accelerate enrollment in the FACT 1 trial, we began the process of
adding new clinical sites in late 2018," 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. During the first quarter of 2019, we met our
goal of getting 16 new clinical sites to begin the activities required
to participate in the FACT 1 trial. These sites are now at various
stages of obtaining Institutional Review Board (IRB) and other related
approvals. These approval-related activities are expected to take
between three to nine months, depending on a site's internal processes.
The addition of these sites would more than double the current number of
activated sites enrolling patients for this trial. We expect interim
results will be available from this trial in late 2019 and final results
approximately nine months later.

"The FACT 2 clinical trial was activated as planned in early April and
will evaluate Puma Biotechnology Inc.'s targeted therapy, Nerlynx®, in
patients our CELx HSF test selects. We expect interim results from this
trial in late 2019 or early 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."

Mr. Sullivan added, "We continued to advance development of new tests in
breast cancer and two additional tissue types. Our goal is to complete
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. The tests for two new tumor types would further
increase the opportunities for us to provide companion diagnostics that
we believe will enable pharmaceutical companies to obtain new drug
indications for the cancer sub-types our tests diagnose.

"We also continued progress towards finalizing a clinical collaboration
with a pharmaceutical company to study breast cancer patients identified
by our CELx MP test with hyperactive and co-activated HER family and
c-Met signaling activity."

Operating Expenses
Total operating expenses were $1.97
million for the first quarter of 2019, compared to $2.08 million for the
first quarter of 2018.

Research and Development Expenses:
Research and development
(R&D) expenses were $1.59 million for the first quarter of 2019,
compared to $1.55 million for the first quarter of 2018. The
approximately $0.05 million increase resulted primarily from legal
expenses related to patent costs and operational and business
development activities.

General and Administrative Expenses:
General and
administrative (G&A) expenses were $0.38 million for the first quarter
of 2019, compared to $0.53 million for the first quarter of 2018. The
approximately $0.15 million decrease primarily resulted from non-cash
stock-based compensation.

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
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 FACT 1 clinical trial with NSABP Foundation and
Genentech, the outcome of our FACT 2 clinical trial with Puma
Biotechnology, Inc. 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 site approval
activities and the timing of such activities, 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, 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.

Celcuity Inc
Condensed Balance Sheets
 
  March 31,   December 31,
2019   2018
(unaudited)
Assets
Current Assets:
Cash and cash equivalents $ 14,724,166 $ 15,944,609
Investments 8,699,944 8,952,907
Deposits 22,009 22,009
Deferred transaction costs 28,743 28,743
Prepaid assets   287,765   269,940
Total current assets 23,762,627 25,218,208
 
Property and equipment, net 862,185 813,613
Operating lease right-of-use assets 315,688 -
   
Total Assets $ 24,940,500 $ 26,031,821
 
Liabilities and Stockholders' Equity:
Current Liabilities:
Accounts payable $ 208,919 $ 119,811
Finance lease liabilities 5,740 5,730
Operating lease liabilities 182,302 -
Accrued expenses   485,194   536,791
Total current liabilities 882,155 662,332
 
Finance lease liabilities 18,440 19,878
Operating lease liabilities 176,600 -
   
Total Liabilities   1,077,195   682,210
Total Stockholders' Equity   23,863,305   25,349,611
Total Liabilities and Stockholders' Equity $ 24,940,500 $ 26,031,821
 
Celcuity Inc.
Condensed Statements of Operations
(unaudited)
   
Three Months Ended March 31,
2019 2018
Operating expenses:
Research and development $ 1,590,958 $ 1,545,668
General and administrative   383,545     530,640  
Total operating expenses   1,974,503     2,076,308  
Loss from operations   (1,974,503 )   (2,076,308 )
 
Other income (expense)
Interest expense (43 ) -
Interest income   128,638     108,361  
Other income (expense), net   128,595     108,361  
Net loss before income taxes   (1,845,908 )   (1,967,947 )
Income tax benefits - -
Net loss $ (1,845,908 ) $ (1,967,947 )
Net loss per share, basic and diluted $ (0.18 ) $ (0.19 )
 
Weighted average common shares outstanding, basic and diluted 10,198,461 10,096,008
 

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 the cash
position of the Company, 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 issuers. 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.

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
(Unaudited)
   
Three Months Ended
March 31,
2019 2018
 
GAAP net loss $ (1,845,908 ) $ (1,967,947 )
Adjustments:
Stock-based compensation
Research and development 100,257 161,670 (1)
General and administrative   84,388     174,810   (2)
Non-GAAP adjusted net loss $ (1,661,263 ) $ (1,631,467 )
 
 
GAAP net loss per share - basic and diluted $ (0.18 ) $ (0.19 )
Adjustment to net loss (as detailed above)   0.02     0.03  
Non-GAAP adjusted net loss per share $ (0.16 ) $ (0.16 )
 
Weighted average common shares outstanding, basic and diluted 10,198,461 10,096,008
 

(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.

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