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Celcuity Reports First Quarter 2018 Financial Results Minneapolis, Minnesota

Key Takeaway: Celcuity Reports First Quarter 2018 Financial Minneapolis, Minnesota-May 14, 2018-Celcuity Inc. (Nasdaq: CELC), a functional cellular analysis company that is discovering new cancer subtypes and commercializing diagnostic tests designed to significantly improve clinical outcom

Full Press Release Details

Celcuity Reports First Quarter 2018 Financial
Minneapolis, Minnesota-May 14, 2018-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, 2018.
Unless otherwise stated, all comparisons are for the first quarter
ended March 31, 2018, compared to the first quarter ended March 31, 2017.
Celcuity reported a net loss of $2.0 million, or $0.19 per share,
for the first quarter of 2018, compared to a net loss of $1.0 million, or $0.15 per share, for the first quarter of 2017. Non-GAAP
adjusted net loss was $1.6 million, or $0.16 per share, for the first quarter of 2018, compared to non-GAAP adjusted net loss of
$0.9 million, or $0.14 per share, for the first quarter of 2017. 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 2018 was $1.4 million. At March 31, 2018, Celcuity had cash, cash equivalents and investments of $30.0 million, compared to
cash, cash equivalents, and investments of $4.9 million at March 31, 2017.
"We are excited to announce that we completed development
of our second CELx test for breast cancer during the first quarter of 2018," said Chairman and Chief Executive Officer, Brian
Sullivan. "This new test evaluates independent c-Met pathway signaling activity and its involvement with HER family signaling
in HER2-negative breast cancer tumor cells. We intend to combine this c-Met signaling function test with our current HER2 signaling
function test to create the CELx Multi-Pathway (MP) Test. With this next generation CELx test, we plan to provide
an analysis of HER1, HER2, HER3, and c-MET signaling activity with a single patient tumor specimen."
Mr. Sullivan added, "Our internal studies show that approximately
15%-20% of HER2-negative breast cancer patients have abnormal c-Met signaling activity that is co-activated with abnormal HER1
signaling. These studies suggest that this sub-group of HER2-negative breast cancer patients may best respond to treatment with
a combination of HER family and c-Met inhibitors.
"We demonstrated the role of abnormal c-Met signaling
as a cancer driver in breast cancer in a mouse xenograft study performed at the University of Minnesota. A breast cancer cell line
determined by the CELx MP test to have normal HER2 signaling, abnormal HER1 signaling, and abnormal c-Met signaling was studied.
Mice were randomly assigned to either a control group or a treatment group that received either the pan-HER inhibitor, neratinib,
the c-Met inhibitor, tepotinib, or the combination of neratinib and tepotinib. Tumor volumes in the mouse arm receiving both neratinib
and tepotinib shrank significantly more than the tumors in the study arms that received neratinib or tepotinib alone.
"Celcuity will seek collaborations with pharmaceutical
companies to field clinical trials that evaluate the efficacy of combining HER family inhibitors and c-Met inhibitors in breast
cancer patients who have abnormal c-Met and abnormal HER1 pathway activity. The FDA has approved two c-Met inhibitors and six HER-family
inhibitors for cancer treatment. Additional c-Met and HER-family inhibitors are being evaluated in on-going clinical trials. Several
pharmaceutical companies possess both a c-Met and a HER family inhibitor.
"We are also excited about the quality of sites for
the clinical trial we are fielding in collaboration with the NSABP Foundation and Genentech. We believe that we will get
interim results from this trial in the first or second quarter of 2019, instead of the end of 2018 as originally anticipated.
The longer timeline is primarily due to more sites opting to rely on their internal institutional review board
(IRB) instead of the central IRB that has already approved our clinical trial protocol. We originally
anticipated that approximately 80% of the expected sites would utilize the central IRB, and we now believe that number is
approximately 25% of sites. The internal IRB process typically takes several months, which will cause the bulk of our sites
to begin enrolling patients later than originally projected. Final results are still expected approximately six months
following interim results."
Operating expenses were $2.1 million for the first quarter of
2018, compared to $1.0 million for the first quarter of 2017.
Research and Development Expenses:
Research and development (R&D) expenses were $1.5 million
for the first quarter of 2018, compared to $0.9 million for the first quarter of 2017. The increase primarily resulted from a $0.35
million increase in compensation related expenses, including approximately $0.07 million of non-cash stock-based compensation,
to support development of our CELx platform. In addition, other research and development expenses increased $0.25 million due to
validation studies to support the CELx platform, legal expenses related to patent costs, start-up clinical trial costs, and operational
and business development activities.
General and Administrative Expenses:
General and administrative (G&A) expenses were $0.5 million
for the first quarter of 2018, compared to $0.1 million for the first quarter of 2017. The increase primarily resulted from a $0.25
million increase in compensation related expenses, including approximately $0.18 million of non-cash stock-based compensation,
professional fees associated with being a public company and director and officer insurance.
Management will host a teleconference call at 4:30 PM Eastern
Time today to discuss the results. Anyone interested in participating should dial 1-877-876-9174 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 of CELx signaling function tests, whether alone or in collaboration with other tests, collaboration
with pharmaceutical companies, the outcome of our clinical trial with NSABP Foundation and Genentech, and the participation of
clinical trial sites, including expected use of central internal review board approval of clinical trial protocol, 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 hereof. Celcuity undertakes no obligation to update these statements for revisions or changes after the date of this release,
except as required by law.
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
Celcuity Inc.
Condensed Balance Sheets
March 31, 2018 December 31, 2017
(unaudited)
Assets
Current Assets:
Cash and cash equivalents $ 2,572,658 $ 2,639,789
Investments 20,431,620 21,556,857
Restricted cash 50,000 50,000
Deposits 27,726 27,726
Prepaid assets 246,677 209,708
Total current assets 23,328,681 24,484,080
Property and equipment, net 443,578 280,056
Long term investments 6,954,523 7,205,374
Total Assets $ 30,726,782 $ 31,969,510
Liabilities and Stockholders' Equity:
Current Liabilities:
Accounts payable $ 130,044 $ 71,913
Accrued expenses 652,990 506,140
Total current liabilities 783,034 578,053
Total Liabilities 783,034 578,053
Total Stockholders' Equity 29,943,748 31,391,457
Total Liabilities and Stockholders' Equity $ 30,726,782 $ 31,969,510
Condensed Statements of Operations
Three Months Ended
March 31,
2018 2017
Operating expenses:
Research and development $ 1,545,668 $ 908,767
General and administrative 530,640 85,144
Total operating expenses 2,076,308 993,911
Loss from operations (2,076,308 ) (993,911 )
Interest income 108,361 6,561
Net loss before income taxes (1,967,947 ) (987,350 )
Income tax benefits - -
Net loss $ (1,967,947 ) $ (987,350 )
Net loss per share, basic and diluted $ (0.19 ) $ (0.15 )
Weighted average common shares outstanding, basic and diluted 10,096,008 6,440,139
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
Last updated: May 14, 2018