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Celcuity Reports Fourth Quarter and Full Year 2017 Financial Results Minneapolis, Minnesota

Key Takeaway: Celcuity Reports Fourth Quarter and Full Year 2017 Financial Results Minneapolis, Minnesota-March 15, 2018-Celcuity Inc. (Nasdaq: CELC) a functional cellular analysis company that is discovering new cancer subtypes and commercializing diagnostic tests designed to significantl

Full Press Release Details

Celcuity Reports Fourth Quarter and Full
Year 2017 Financial Results
Minneapolis, Minnesota-March 15, 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 fourth quarter and year ended December 31, 2017. Unless otherwise stated, all comparisons are for the fourth quarter
and year ended December 31, 2017, compared to the fourth quarter and year ended December 31, 2016.
Celcuity reported a net loss of $1.7 million, or $0.17 per share,
for the fourth quarter of 2017, compared to a net loss of $0.9 million, or $0.14 per share, for the fourth quarter of 2016. Net
loss for fiscal year 2017 was $6.3 million, or $0.84 per share, compared to $3.3 million, or $0.52 per share, for fiscal year 2016.
Non-GAAP adjusted net loss was $1.4 million, or $0.14 per share,
for the fourth quarter of 2017, compared to non-GAAP adjusted net loss of $0.8 million, or $0.13 per share, for the fourth quarter
of 2016. Non-GAAP adjusted net loss for fiscal year 2017 was $4.9 million, or $0.66 per share, compared to non-GAAP adjusted net
loss of $3.1 million, or $0.49 per share, for fiscal year 2016. Non-GAAP adjusted net loss excludes stock-based compensation expense
and non-cash interest expenses. Because these items have 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 fourth quarter
of 2017 was $1.1 million. Net cash used in operating activities for fiscal year 2017 was $4.9 million. At December 31, 2017, Celcuity
had cash, cash equivalents and investments of $31.4 million, compared to cash, cash equivalents, and investments of $5.9 million
at December 31, 2016.
"With the completion of our initial public offering, expansion
of our R&D team, and the initiation of our clinical collaboration with the NSABP Foundation and Genentech, Celcuity made tremendous
progress in 2017," said Chairman and Chief Executive Officer, Brian Sullivan. "With our expanded R&D team in place,
we began work on our next generation of cell signaling function tests to diagnose new cancer sub-types. Additionally, we presented
results of several pre-clinical studies at major conferences, including the American Society of Clinical Oncology Annual Meeting,
the Miami Breast Cancer Conference, and the San Antonio Breast Cancer Symposium.
Mr. Sullivan added, "During the fourth quarter, we continued
to lay the groundwork to activate the clinical trial we are fielding in collaboration with the NSABP Foundation and Genentech.
This clinical trial, Functional Analysis of live Cell signaling Transduction 1, or FACT 1, will evaluate
the efficacy of two of Genentech's HER2 drugs, Herceptin and Perjeta , in HER2-negative breast cancer patients selected
by our CELx HER2 Signaling Function test. We expect interim results from this trial in late 2018 and final results six to nine
"Our strategy is to develop diagnostics that identify
new cancer sub-types and to seek collaborations with pharmaceutical companies, which can vary in scope. Our efforts have resulted
in Celcuity recently being selected by NSABP and Puma Biotechnology 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
drug, EGFR inhibitor, Erbitux, in metastatic colorectal cancer patients. This 35-patient study is expected to be completed in late
2020. Unlike our current trial with NSABP and Genentech, Celcuity's test will be used solely to evaluate patient samples
after they have been enrolled in this trial. We expect our CELx test will provide critical insight after the trial is completed
about the patient characteristics most correlative to drug response.
"Finally, as we look ahead to the end of 2018, we anticipate
completing development of new cell signaling function tests for breast cancer and two additional tumor types. We anticipate these
new tests will create opportunities for pharmaceutical companies to obtain new drug indications to treat patients who have the
cancer sub-types our tests diagnose. We also hope to initiate an additional clinical collaboration with a pharmaceutical company
Operating expenses were $1.8 million for the fourth quarter
of 2017, compared to $0.9 million for the fourth quarter of 2016. Operating expenses for fiscal year 2017 were $6.0 million, compared
to $3.3 million for fiscal year 2016.
Research and Development Expenses:
Research and development (R&D) expenses were $1.4 million
for the fourth quarter of 2017, compared to $0.8 million for the fourth quarter of 2016. R&D expenses for fiscal year 2017
were $5.0 million, compared to $3.1 million for fiscal year 2016. The approximately $1.9 million increase during fiscal year 2017,
compared to fiscal year 2016, resulted primarily from an increase in employee-related expenses, including approximately $0.4 million
of stock-based compensation, to support development of the CELx platform. Legal expenses related to patent costs, start-up clinical
trial costs, and business development activities also contributed to the increase.
General and Administrative Expenses:
General and administrative (G&A) expenses were $0.4 million
for the fourth quarter of 2017, compared to $0.1 million for the fourth quarter of 2016. G&A expenses for fiscal year 2017
were $1.0 million, compared to $0.3 million for fiscal year 2016. The approximately $0.7 million increase during fiscal year 2017
compared to fiscal year 2016 resulted primarily from increases in expenses associated with being a public company, such as professional
accounting and audit fees and director and officer insurance, and compensation-related expenses, including approximately $0.3 million
of stock-based compensation.
Management will host a teleconference call at 4:30 PM Eastern
Time today to discuss the results. Anyone interested in participating should dial 1-888-632-3389 referencing confirmation code
"Celcuity" (23528489). 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, the anticipated benefits
to the clinical outcomes of cancer patients, expectations with respect to commercializing diagnostic tests, expectations with respect
to use of cash, the discovery of additional cancer sub-types, the development of additional CELx Signaling Function tests and planned
collaboration with pharmaceutical companies, expectations regarding the outcome of the clinical trial with NSABP Foundation and
Genentech, expectations with respect to our future collaboration with NSABP Foundation and Puma Biotechnology, anticipated
benefits that our tests may provide pharmaceutical companies 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 of Celcuity's Prospectus,
dated September 19, 2017, filed with the Securities and Exchange Commission on September 20, 2017 pursuant to Rule 424(b)(4) under
the Securities Act of 1933, as amended. 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.
Balance Sheets
December 31, 2017 December 31, 2016
Assets
Current Assets:
Cash and cash equivalents $ 2,639,789 $ 5,856,348
Investments 21,556,857 -
Restricted cash 50,000 50,000
Deposits 27,726 5,717
Prepaid assets 209,708 -
Total current assets 24,484,080 5,912,065
Property and equipment, net 280,056 144,912
Long term investments 7,205,374 -
Total Assets $ 31,969,510 $ 6,056,977
Liabilities and Stockholders' Equity:
Current Liabilities:
Accounts payable $ 71,913 $ 331,534
Accrued expenses 506,140 113,825
Total current liabilities 578,053 445,359
Total Liabilities 578,053 445,359
Total Stockholders' Equity 31,391,457 5,611,618
Total Liabilities and Stockholders' Equity $ 31,969,510 $ 6,056,977
Celcuity Inc
Statements of Operations
Three Months Ended December 31, Twelve Months Ended December 31,
2017 2016 2017 2016
Operating expenses:
Research and development $ 1,403,070 $ 839,903 $ 4,980,427 $ 3,064,762
General and administrative 420,963 67,509 972,518 263,664
Total operating expenses 1,824,033 907,412 5,952,945 3,328,426
Loss from operations (1,824,033 ) (907,412 ) (5,952,945 ) (3,328,426 )
Other income (expense)
Interest expense - - (451,664 ) -
Interest income 99,845 4,978 152,879 18,018
Other income (expense), net 99,845 4,978 (298,785 ) 18,018
Net loss before income taxes (1,724,188 ) (902,434 ) (6,251,730 ) (3,310,408 )
Income tax benefits - - - -
Net loss before income taxes $ (1,724,188 ) $ (902,434 ) $ (6,251,730 ) $ (3,310,408 )
Net loss per unit, basic and diluted $ (0.17 ) $ (0.14 ) $ (0.84 ) $ (0.52 )
Weighted average common shares outstanding, basic and diluted 10,082,177 6,440,139 7,460,640 6,313,089
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
Last updated: Mar 15, 2018