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Celcuity Reports Second Quarter 2018 Financial Results Minneapolis, Minnesota

Key Takeaway: Celcuity Reports Second Quarter 2018 Minneapolis, Minnesota-August 9, 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 c

Full Press Release Details

Celcuity Reports Second Quarter 2018
Minneapolis, Minnesota-August 9, 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 second quarter ended June 30, 2018.
Unless otherwise stated, all comparisons are for the second
quarter ended June 30, 2018, compared to the second quarter ended June 30, 2017.
Celcuity reported a net loss of $1.8 million, or $0.18 per share,
for the second quarter of 2018, compared to a net loss of $1.8 million, or $0.28 per share, for the second quarter of 2017. Net
loss for the first six months of 2018 was $3.8 million, or $0.37 per share, compared to $2.8 million, or $0.43 per share, for the
first six months of 2017. Non-GAAP adjusted net loss was $1.5 million, or $0.15 per share, for the second quarter of 2018, compared
to non-GAAP adjusted net loss of $1.3 million, or $0.20 per share, for the second quarter of 2017. Non-GAAP adjusted net loss for
the first six months of 2018 was $3.2 million, or $0.31 per share, compared to $2.2 million, or $0.33 per share, for the first
six months of 2017. Non-GAAP adjusted net loss excludes stock-based compensation expense and non-cash interest expense. 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 second quarter
of 2018 was $1.4 million. Net cash used in operating activities for the first six months of 2018 was $2.8 million. At June 30,
2018, Celcuity had cash, cash equivalents and investments of $28.5 million, compared to cash, cash equivalents and investments
of $31.4 million at December 31, 2017.
"During the second quarter, our R&D teams continued
to advance the development of new CELx Signaling Function tests for breast cancer and two new tissue types," said Chairman
and Chief Executive Officer, Brian Sullivan. "In breast cancer, we are evaluating new signaling pathways to add to our current
CELx MP Signaling Function test for breast cancer. This test currently analyzes HER1, HER2, HER3, and c-Met signaling activity
and diagnoses untreated cell signaling dysfunction in approximately 25% of HER2-negative breast cancer patients. We believe there
is an opportunity to increase the total percentage of HER2-negative breast cancer patients diagnosed with untreated signaling dysfunction
"To develop CELx tests in new tumor types, we are advancing
our cell microenvironment technology and furthering our capability to assess different types of signaling dysfunction. As we have
demonstrated in breast cancer, we are working to provide functional analysis of multiple signaling pathways for these other tissue
"Each signaling pathway test creates opportunities
for Celcuity to collaborate with multiple pharmaceutical companies. We intend to work with these companies to facilitate
approvals of their targeted therapeutics to treat the new patient sub-groups our CELx tests identify. We are currently in
various stages of discussions with several pharmaceutical companies. We expect any resulting collaborations to involve, as a
first step, clinical trials that evaluate the efficacy of our collaboration partners' therapy or therapies in breast
cancer patients who have either hyperactive HER2 signaling tumors or hyperactive and co-activated HER family and c-Met
"The clinical trial we are fielding in collaboration with
Genentech and the NSABP Foundation is continuing to progress. The institutional review board (IRB) approvals at our sites are proceeding
as we previously disclosed, and we continue to expect to receive interim results from this trial in mid-2019. The clinical trial
that Puma Biotechnology and the NSABP Foundation are fielding is also progressing as previously disclosed. This clinical trial
is 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. For this trial, Celcuity will
analyze tissue sent us so that Puma can compare the tissue's HER2 signaling status with the patient's response to therapy."
Total operating expenses were $1.9 million for the second quarter
of 2018, compared to $1.6 million for the second quarter of 2017. Operating expenses for the first six months of 2018 were $4.0
million, compared to $2.6 million for the first six months of 2017.
Research and Development Expenses:
Research and development (R&D) expenses were $1.5 million
for the second quarter of 2018, compared to $1.3 million for the second quarter of 2017. R&D expenses for the first six months
of 2018 were $3.1 million, compared to $2.2 million for the first six months of 2017. The approximately $0.9 million increase during
the first half of fiscal year 2018, compared to the first half of fiscal year 2017, resulted primarily from a $0.4 million increase
in compensation related expenses to support development of our CELx platform. In addition, other research and development expenses
increased $0.5 million due to clinical validation studies and laboratory supplies to support the CELx platform and operational
and business development activities.
General and Administrative Expenses:
General and administrative (G&A) expenses were $0.4 million
for the second quarter of 2018, compared to $0.3 million for the second quarter of 2017. G&A expenses for the first six months
of 2018 were $0.9 million, compared to $0.4 million for the first six months of 2017. The approximately $0.5 million increase during
first half of 2018, compared to the first half of 2017, primarily resulted from a $0.2 million increase in compensation related
expenses. Other G&A expenses increased $0.3 million due to 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 1-877-876-9176 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 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 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
Condensed Balance Sheets
June 30, 2018 December 31, 2017
(unaudited)
Assets
Current Assets:
Cash and cash equivalents $ 3,172,782 $ 2,639,789
Investments 18,385,920 21,556,857
Restricted cash 50,000 50,000
Deposits 27,726 27,726
Prepaid assets 154,002 209,708
Total current assets 21,790,430 24,484,080
Property and equipment, net 730,449 280,056
Long term investments 6,948,606 7,205,374
Total Assets $ 29,469,485 $ 31,969,510
Liabilities and Stockholders' Equity:
Current Liabilities:
Accounts payable $ 149,401 $ 71,913
Capital lease obligations 5,706 -
Accrued expenses 807,783 506,140
Total current liabilities 962,890 578,053
Capital lease obligations 23,226 -
Total Liabilities 986,116 578,053
Total Stockholders' Equity 28,483,369 31,391,457
Total Liabilities and Stockholders' Equity $ 29,469,485 $ 31,969,510
Condensed Statements of Operations
Three Months Ended June 30, Six Months Ended June 30,
2018 2017 2018 2017
Operating expenses:
Research and development $ 1,546,537 $ 1,303,886 $ 3,092,205 $ 2,212,629
General and administrative 382,646 301,820 913,286 386,963
Total operating expenses 1,929,183 1,605,706 4,005,491 2,599,592
Loss from operations (1,929,183 ) (1,605,706 ) (4,005,491 ) (2,599,592 )
Other income (expense)
Interest expense - (186,659 ) - (186,686 )
Interest income 112,722 16,150 221,084 22,712
Other income (expense), net 112,722 (170,509 ) 221,084 (163,974 )
Net loss before income taxes (1,816,461 ) (1,776,215 ) (3,784,407 ) (2,763,566 )
Income tax benefits - - - -
Net loss $ (1,816,461 ) $ (1,776,215 ) $ (3,784,407 ) $ (2,763,566 )
Net loss per share, basic and diluted $ (0.18 ) $ (0.28 ) $ (0.37 ) $ (0.43 )
Weighted average common shares outstanding, basic and diluted 10,110,558 6,440,139 10,103,323 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
Last updated: Aug 9, 2018