Full Press Release Details
Celcuity Reports Third Quarter Fiscal
2017 Financial Results
Minneapolis, Minnesota-November 13, 2017-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 third quarter ended September 30, 2017.
Unless otherwise stated, all comparisons are for the third quarter
and nine months ended September 30, 2017, compared to the third quarter and nine months ended September 30, 2016.
Celcuity reported a net loss of $1.8 million, or $0.26 per share,
for the third quarter of 2017, compared to a net loss of $0.9 million, or $0.13 per share, for the third quarter of 2016. Net loss
for the first nine months of 2017 was $4.5 million, or $0.69 per share, compared to $2.4 million, or $0.38 per share, for the first
nine months of 2016.
Non-GAAP adjusted net loss was $1.4 million, or $0.20 per share,
for the third quarter of 2017, compared to non-GAAP adjusted net loss of $0.8 million, or $0.12 per share, for the third quarter
of 2016. Non-GAAP adjusted net loss for the first nine months of 2017 was $3.5 million, or $0.53 per share, compared to non-GAAP
adjusted net loss of $2.3 million, or $0.37 per share, for the first nine months of 2016. Non-GAAP adjusted net loss excludes stock-based
compensation expense and non-cash interest expenses, each of which have no impact on the cash position of the Company. 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 third quarter
of 2017 was $1.6 million. Net cash used in operating activities for the first nine months of 2017 was $3.8 million. At September
30, 2017, Celcuity had cash, cash equivalents and investments of $32.5 million, compared to cash, cash equivalents, and investments
of $5.9 million at December 31, 2016.
Chief Executive Officer, Brian Sullivan, commented,
"During the third quarter of 2017, we completed our initial public offering and received aggregate net proceeds of
$23.3 million. We expect this funding, along with our previous cash-on-hand, will enable us to continue our efforts to
discover new cancer sub-types, to develop additional CELx Signaling Function tests, and to support our efforts to collaborate
with pharmaceutical companies. Activities related to the clinical trial we are fielding in collaboration with the NSABP
Foundation and Genentech were also initiated in the third quarter. 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.
During the third quarter, we also entered into a lease for 16,000 square feet of office and laboratory space that we will
move into during the second quarter of 2018. This new space will replace our current space and enable us to expand our
R&D programs and related operational processes."
Operating expenses were $1.5 million for the third quarter of
2017, compared to $0.9 million for the third quarter of 2016. Operating expenses for the first nine months of 2017 were $4.1 million,
compared to $2.4 million for the first nine months of 2016.
Research and Development Expenses:
Research and development (R&D) expenses were $1.4 million
for the third quarter of 2017, compared to $0.8 million for the third quarter of 2016. R&D expenses for the first nine months
of 2017 were $3.6 million, compared to $2.2 million for the first nine months of 2016. The approximately $1.4 million increase
during the first nine months of 2017, compared to the first nine months of 2016, resulted primarily from increased expenses associated
with development of the CELx platform, verification studies associated with new CELx tests under development, legal expenses related
to pending patents, start-up clinical trial costs, and business development activities, as well as other employee-related expenses,
including approximately $0.3 million of stock-based compensation.
General and Administrative Expenses:
General and administrative (G&A) expenses were $0.2 million
for the third quarter of 2017, compared to $0.1 million for the third quarter of 2016. G&A expenses for the first nine months
of 2017 were $0.6 million, compared to $0.2 million for the first nine months of 2016. The approximately $0.4 million increase
during the first nine months of 2017 compared to the first nine months of 2016 resulted primarily from increases in professional
accounting and audit fees, director and officer insurance and employee-related expenses, including approximately $0.1 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 1-800-459-5346 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 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
Condensed Balance Sheets
| September 30, 2017 | December 31, 2016 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 32,304,145 | $ | 5,856,348 | ||||
| Investments | 245,000 | - | ||||||
| Restricted cash | 50,000 | 50,000 | ||||||
| Deposits | 27,726 | 5,717 | ||||||
| Prepaid assets | 247,429 | - | ||||||
| Total current assets | 32,874,300 | 5,912,065 | ||||||
| Property and equipment, net | 272,245 | 144,912 | ||||||
| Total Assets | $ | 33,146,545 | $ | 6,056,977 | ||||
| Liabilities and Stockholders' Equity: | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 34,861 | $ | 331,534 | ||||
| Accrued expenses | 301,586 | 113,825 | ||||||
| Total current liabilities | 336,447 | 445,359 | ||||||
| Total Liabilities | 336,447 | 445,359 | ||||||
| Total Stockholders' Equity | 32,810,098 | 5,611,618 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 33,146,545 | $ | 6,056,977 |
CONDENSED STATEMENTS OF OPERATIONS
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 1,364,728 | $ | 812,803 | $ | 3,577,357 | $ | 2,224,859 | ||||||||
| General and administrative | 164,665 | 64,738 | 551,555 | 196,155 | ||||||||||||
| Total operating expenses | 1,529,393 | 877,541 | 4,128,912 | 2,421,014 | ||||||||||||
| Loss from operations | (1,529,393 | ) | (877,541 | ) | (4,128,912 | ) | (2,421,014 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest expense | (264,905 | ) | - | (451,664 | ) | - | ||||||||||
| Interest income | 30,322 | 9,021 | 53,034 | 13,040 | ||||||||||||
| Other income (expense), net | (234,583 | ) | 9,021 | (398,630 | ) | 13,040 | ||||||||||
| Net loss before income taxes | (1,763,976 | ) | (868,520 | ) | (4,527,542 | ) | (2,407,974 | ) | ||||||||
| Income tax benefit | - | - | - | - | ||||||||||||
| Net loss | $ | (1,763,976 | ) | $ | (868,520 | ) | $ | (4,527,542 | ) | $ | (2,407,974 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.26 | ) | $ | (0.13 | ) | $ | (0.69 | ) | $ | (0.38 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 6,846,827 | 6,440,139 | 6,577,191 | 6,268,471 |
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 and
non-cash interest expenses from net loss and net loss per share. Management excludes these items because they do 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.
Reconciliation of GAAP Net Loss to Non-GAAP
Adjusted Net Loss and
GAAP Net Loss Per Share to Non-GAAP Adjusted
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||||
| GAAP net loss | $ | (1,763,976 | ) | $ | (868,520 | ) | $ | (4,527,542 | ) | $ | (2,407,974 | ) | |||||
| Adjustments: | |||||||||||||||||
| Stock-based compensation: | |||||||||||||||||
| Research and development | 126,600 | 73,275 | 420,789 | 109,576 | (1) | ||||||||||||
| General and administrative | 11,682 | - | 140,308 | - | (2) | ||||||||||||
| Non-cash interest expense | 264,905 | - | 451,664 | - | (3) | ||||||||||||
| Non-GAAP adjusted net loss | $ | (1,360,789 | ) | $ | (795,245 | ) | $ | (3,514,781 | ) | $ | (2,298,398 | ) | |||||
| GAAP net loss per share - basic and diluted | $ | (0.26 | ) | $ | (0.13 | ) | $ | (0.69 | ) | $ | (0.38 | ) | |||||
| Adjustment to net loss (as detailed above) | 0.06 | 0.01 | 0.16 | 0.01 | |||||||||||||
| Non-GAAP adjusted net loss per share | $ | (0.20 | ) | $ | (0.12 | ) | $ | (0.53 | ) | $ | (0.37 | ) | |||||
| Weighted average common shares outstanding, basic and diluted | 6,846,827 | 6,440,139 | 6,577,191 | 6,268,471 |