Full Press Release Details
Celcuity Reports Third Quarter 2018 Financial
Minneapolis, Minnesota-November 13, 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 third quarter ended September 30, 2018.
Unless otherwise stated, all comparisons are for the third quarter
ended September 30, 2018, compared to the third quarter ended September 30, 2017.
Celcuity reported a net loss of $1.9 million, or $0.18 per share,
for the third quarter of 2018, compared to a net loss of $1.8 million, or $0.26 per share, for the third quarter of 2017. Net loss
for the first nine months of 2018 was $5.7 million, or $0.56 per share, compared to $4.5 million, or $0.69 per share, for the first
nine months of 2017. Non-GAAP adjusted net loss was $1.6 million, or $0.15 per share, for the third quarter of 2018, compared to
non-GAAP adjusted net loss of $1.4 million, or $0.20 per share, for the third quarter of 2017. Non-GAAP adjusted net loss for the
first nine months of 2018 was $4.7 million, or $0.47 per share, compared to $3.5 million, or $0.54 per share, for the first nine
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 third quarter
of 2018 was $1.8 million. Net cash used in operating activities for the first nine months of 2018 was $4.6 million. At September
30, 2018, Celcuity had cash, cash equivalents and investments of $26.7 million, compared to cash, cash equivalents and investments
of $31.4 million at December 31, 2017.
"We are excited to begin implementing the clinical trial
agreement we signed in October with Puma Biotechnology and the West Cancer Center," said Chairman and Chief Executive Officer,
Brian Sullivan. "This clinical trial, which we will refer to as the Functional Analysis of live Cell signaling Transduction
2 trial, or the FACT 2 Trial, will evaluate the efficacy of Puma's pan-HER inhibitor, NERLYNX (neratinib), in early
stage triple-negative breast cancer patients who have hyperactive HER2 signaling tumors, as identified by our CELx HSF Test. The
trial is planning to enroll up to 27 patients. We expect enrollment to begin in early 2019. Based on its estimates of patient enrollment
rates, Celcuity expects to obtain interim results in 10 to 12 months after the first patient is enrolled and final results within
"We now have two clinical trials in process to evaluate
the efficacy of anti-HER2 drugs in early-stage HER2-negative breast patients selected by our CELx HSF Test. Our clinical collaborators,
the NSABP Foundation and the West Cancer Center, are amongst the most well-respected cancer research organizations in the country.
We are hopeful that these clinical trial collaborations can eventually lead to better treatment options for breast cancer patients.
"We continue 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. "We
also continue to engage in discussions with several pharmaceutical companies to 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 signaling tumors.
"The FACT 1 clinical trial we are fielding in collaboration
with Genentech and the NSABP Foundation and the clinical trial that Puma Biotechnology and the NSABP Foundation are fielding are
continuing to progress."
Total operating expenses were $2.0 million for the third quarter
of 2018, compared to $1.5 million for the third quarter of 2017. Operating expenses for the first nine months of 2018 were $6.0
million, compared to $4.1 million for the first nine months of 2017.
Research and Development Expenses:
Research and development (R&D) expenses were $1.6 million
for the third quarter of 2018, compared to $1.4 million for the third quarter of 2017. R&D expenses for the first nine months
of 2018 were $4.7 million, compared to $3.6 million for the first nine months of 2017. The approximately $1.1 million increase
during the first nine months of fiscal year 2018, compared to the first nine months of fiscal year 2017, resulted primarily from
a $0.6 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 third quarter of 2018, compared to $0.2 million for the second quarter of 2017. G&A expenses for the first nine months
of 2018 were $1.3 million, compared to $0.6 million for the first nine months of 2017. The approximately $0.7 million increase
during the first nine months of 2018, compared to the first nine months of 2017, primarily resulted from a $0.3 million increase
in compensation related expenses. Other G&A expenses increased $0.4 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 1-877-876-9177 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, the outcome of our clinical trial with Puma Biotechnology 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 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, 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
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
| Celcuity Inc |
| Condensed Balance Sheets |
| September 30, 2018 | December 31, 2017 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 3,808,774 | $ | 2,639,789 | ||||
| Investments | 18,949,924 | 21,556,857 | ||||||
| Restricted cash | - | 50,000 | ||||||
| Deposits | 22,009 | 27,726 | ||||||
| Deferred transaction costs | 27,379 | - | ||||||
| Prepaid assets | 352,321 | 209,708 | ||||||
| Total current assets | 23,160,407 | 24,484,080 | ||||||
| Property and equipment, net | 814,051 | 280,056 | ||||||
| Long term investments | 3,920,000 | 7,205,374 | ||||||
| Total Assets | $ | 27,894,458 | $ | 31,969,510 | ||||
| Liabilities and Stockholders' Equity: | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 177,686 | $ | 71,913 | ||||
| Capital lease obligations | 5,720 | - | ||||||
| Accrued expenses | 777,199 | 506,140 | ||||||
| Total current liabilities | 960,605 | 578,053 | ||||||
| Capital lease obligations | 21,315 | - | ||||||
| Total Liabilities | 981,920 | 578,053 | ||||||
| Total Stockholders' Equity | 26,912,538 | 31,391,457 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 27,894,458 | $ | 31,969,510 |
| Celcuity Inc. |
| Condensed Statements of Operations |
| (unaudited) |
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 1,599,045 | $ | 1,364,728 | $ | 4,691,250 | $ | 3,577,357 | ||||||||
| General and administrative | 376,796 | 164,665 | 1,290,082 | 551,555 | ||||||||||||
| Total operating expenses | 1,975,841 | 1,529,393 | 5,981,332 | 4,128,912 | ||||||||||||
| Loss from operations | (1,975,841 | ) | (1,529,393 | ) | (5,981,332 | ) | (4,128,912 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest expense | (65 | ) | (264,905 | ) | (65 | ) | (451,664 | ) | ||||||||
| Interest income | 104,799 | 30,322 | 325,883 | 53,034 | ||||||||||||
| Other income (expense), net | 104,734 | (234,583 | ) | 325,818 | (398,630 | ) | ||||||||||
| Net loss before income taxes | (1,871,107 | ) | (1,763,976 | ) | (5,655,514 | ) | (4,527,542 | ) | ||||||||
| Income tax benefits | - | - | - | - | ||||||||||||
| Net loss | $ | (1,871,107 | ) | $ | (1,763,976 | ) | $ | (5,655,514 | ) | $ | (4,527,542 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.18 | ) | $ | (0.26 | ) | $ | (0.56 | ) | $ | (0.69 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 10,128,606 | 6,846,827 | 10,111,843 | 6,577,191 |
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 expense from net loss and net loss per share. Management excludes these items because it does not impact the