CELC 8-K
Celcuity Inc. (CELC)
8-K
2021-02-16
For: 2021-02-16
View Original
Added on
April 11, 2026
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
February 16, 2021
(Exact name of Registrant as Specified in its Charter)
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(State or Other Jurisdiction
of Incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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(Address of Principal Executive Offices and Zip Code)
(763 )
392-0767
(Registrant’s telephone number, including area
code)
Not Applicable
(Former Name or Former Address, if Changed Since Last
Report)
Check
the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
Securities
registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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The
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Indicate
by check mark whether the registrant is an emerging growth company
as defined in as defined in Rule 405 of the Securities Act of 1933
(§ 230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§ 240.12b-2 of this
chapter).
Emerging
growth company ☒
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☒
Item
2.02.
Results
of Operations and Financial Condition.
On
February 16, 2021, Celcuity Inc. (the “Company”) issued a press
release regarding the Company’s financial results for the
fourth quarter and fiscal year ended December 31, 2020. A copy of
the Company’s press release is furnished as Exhibit 99.1 to
this report and is incorporated herein by reference.
The
information in this Item 2.02, including the accompanying exhibit,
is being furnished and shall not be deemed “filed” for
the purposes of Section 18 of the Securities Exchange Act of
1934, as amended (the “Exchange Act”), or otherwise
subject to the liabilities of that Section. The information in this
Item 2.02 shall not be incorporated by reference into any filing
pursuant to the Securities Act of 1933, as amended, or the Exchange
Act, regardless of any general incorporation language in such
filing.
Item 9.01.
Financial
Statements and Exhibits.
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(d)
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Exhibits
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Exhibit
Number
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Description
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Press
release dated February 16, 2021
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104
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Cover
Page Interactive Data File (embedded within the Inline XBRL
document)
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
Date:
February 16, 2021
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CELCUITY INC.
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By:
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/s/
Brian F. Sullivan
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Brian
F. Sullivan
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Chairman
and Chief Executive Officer
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Exhibit 99.1
Celcuity Reports Fourth Quarter and Full Year 2020 Financial
Results
and Recent Business Highlights
- Announced a clinical trial collaboration in December with
Massachusetts General Hospital, UCLA, and Vanderbilt and Puma
Biotechnology to conduct a Phase II clinical trial.
- In January, announced a clinical trial collaboration with Sarah
Cannon Research Institute and Pfizer Inc. to conduct a Phase II
clinical trial.
- Additional clinical trial collaborations with major
pharmaceutical companies are expected to be announced in the first
half of 2021.
MINNEAPOLIS, MN - February 16, 2021 - Celcuity Inc.
(NASDAQ:CELC), a clinical stage biotechnology company translating
discoveries of new cancer sub-types into 3rd generation
diagnostics and expanded therapeutic options for cancer patients,
announced financial results for the fourth quarter and year ended
December 31, 2020 and summarized recent business
progress.
"We
built momentum in our business over the past few months, signing
additional clinical trial agreements to collaborate with several
major cancer research centers and pharmaceutical companies while
advancing additional new CELsignia tests. In December, we announced
a collaboration with Massachusetts General Hospital, UCLA,
Vanderbilt, and Puma Biotechnology for a Phase II trial to evaluate
the safety and efficacy of Puma’s drug, Nerlynx, and
AstraZeneca’s drug, Faslodex,” said Brian Sullivan,
Chairman and Chief Executive Officer of Celcuity.
“Last
month, we announced another clinical trial collaboration, our
fourth one, with Sarah Cannon Research Institute and Pfizer, Inc.,
for a Phase II trial that will evaluate the efficacy and safety of
two Pfizer targeted therapies, VIZIMPRO®, a pan-HER
inhibitor, and XALKORI®, a c-Met
inhibitor. Both of these recent collaborations aim to address a
significant unmet need for new treatment options for metastatic
HER2- breast cancer patients whose disease progressed on prior
therapies.
“Additional
collaboration discussions with pharmaceutical companies also
progressed despite the headwinds from COVID-19. We remain confident
we will finalize new clinical trial collaborations in the first
half of 2021. Finally, although our FACT-1 and FACT-2 trials were
somewhat impacted by COVID-19 related delays in recent months, we
still expect interim results from these trials in the latter half
of 2021 or early 2022."
Recent Highlights and Upcoming Milestones
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Announced two new
clinical trial collaborations in past two months.
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Expect to announce
additional clinical trial collaborations in the first half of
2021.
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Continue to develop
CELsignia RAS test for breast and ovarian cancers, and plan to
report data on these new tests in the first half of
2021.
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Interim results
from the FACT-1 and FACT-2 trials are expected in late 2021 or
early 2022.
Fourth Quarter and Fiscal Year 2020 Financial Results
Unless
otherwise stated, all comparisons are for the fourth quarter and
full year ended December 31, 2020, compared with the fourth quarter
and full year ended December 31, 2019.
Total
operating expenses were $2.55 million for the fourth quarter of
2020, compared to $1.90 million for the fourth quarter of 2019.
Operating expenses for the fiscal year 2020 were $9.56 million,
compared to $7.81 million for the fiscal year 2019.
Research
and development (R&D) expenses were $2.11 million for the
fourth quarter of 2020, compared to $1.50 million for the fourth
quarter of 2019. R&D expenses for fiscal year 2020 were $7.68
million, compared to $6.27 million for fiscal year 2019. The
approximately $1.41 million increase during fiscal year 2020,
compared to fiscal year 2019, resulted primarily from a $1.15
million increase in compensation related expenses, including
approximately $0.49 million of non-cash stock-based compensation
expense. In addition, other research and development expenses
increased $0.26 million due to clinical validation and laboratory
studies, and operational and business development
activities.
General
and administrative (G&A) expenses were $0.44 million for the
fourth quarter of 2020, compared to $0.40 million for the fourth
quarter of 2019. G&A expenses for fiscal year 2020 were $1.87
million, compared to $1.53 million for fiscal year 2019. The
approximately $0.34 million increase during fiscal year 2020,
compared to fiscal year 2019, resulted primarily from a $0.28
million increase in compensation related expenses, including
approximately $0.24 million of non-cash stock-based compensation.
In addition, other general and administrative expenses increased
$0.06 million primarily due to professional fees associated with
being a public company.
Net
loss for the fourth quarter of 2020 was $2.55 million, or $0.25 per
share, compared to a net loss of $1.81 million, or $0.18 per share,
for the fourth quarter of 2019. Net loss for fiscal year 2020 was
$9.47 million, or $0.92 per share, compared to $7.36 million, or
$0.72 per share, for fiscal year 2019. Non-GAAP adjusted net loss
for the fourth quarter of 2020 was $2.12 million, or $0.21 per
share, compared to non-GAAP adjusted net loss of $1.45 million, or
$0.14 per share, for the fourth quarter of 2019. Non-GAAP adjusted
net loss for fiscal year 2020 was $7.71 million, or $0.75 per
share, compared to non-GAAP adjusted net loss of $6.32 million, or
$0.62 per share, for fiscal year 2019. Non-GAAP adjusted net loss
excludes stock-based compensation expense. Because this item has no
impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss
better enables Celcuity to focus on cash used in operations.
For a reconciliation of financial measures calculated in accordance
with generally accepted accounting principles in the United States
(GAAP) to non-GAAP financial measures, please see the financial
tables at the end of this press release.
Net
cash used in operating activities for the fourth quarter of 2020
was $2.11 million, compared to $1.70 million for the fourth quarter
of 2019.
At
December 31, 2020, Celcuity had cash and cash equivalents of $11.6
million, compared to cash and cash equivalents of $18.7 million at
December 31, 2019.
Conference Call
Management
will host a conference call at 4:30 PM Eastern Time today to
discuss the results. Anyone interested in participating should dial
1-866-831-8616 and use
passcode 92066. Participants are asked to dial in 5 to 10
minutes prior to the start of the call.
About Celcuity
Celcuity
is a clinical stage biotechnology company translating discoveries
of new cancer sub-types into pioneering companion diagnostics and
expanded therapeutic options for cancer patients. Celcuity's
3rd
generation diagnostic platform, CELsignia, analyzes living tumor
cells to untangle the complexity of the cellular activity driving a
patient's cancer. This allows Celcuity to discover new cancer
sub-types molecular diagnostics cannot detect. Celcuity is driven
to improve outcomes for patients and to transform how
pharmaceutical companies define the patient populations for their
targeted therapies. 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 press release
include, without limitation, expectations with respect to new
clinical trial collaborations and the timing or outcomes of such
collaborations, commercializing diagnostic tests, the use of cash,
the discovery of additional cancer sub-types, the development of
additional CELsignia tests, the uses and breadth of application of
CELsignia tests, the outcome of the FACT-1, FACT-2, FACT-3, and
FACT-4 clinical trials, clinical trial patient enrollment and
timing of results, anticipated benefits that Celcuity's tests may
provide to pharmaceutical companies and to the clinical outcomes of
cancer patients, and expectations regarding the impact that the
COVID-19 pandemic and related economic effects will have on
Celcuity's business and results of operations. Forward-looking
statements are subject to numerous conditions, many of which are
beyond the control of Celcuity, which include, but are not limited
to, the unknown impact of the COVID-19 pandemic on Celcuity's
business and those other risks set forth in the Risk Factors
section in Celcuity's Annual Report on Form 10-K for the year ended
December 31, 2020 filed with the Securities and Exchange Commission
on February 16, 2021. 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
press release, except as required by law.
Contacts:
Celcuity
Inc.
Brian
Sullivan, [email protected]
Vicky
Hahne, [email protected]
763-392-0123
Westwicke
ICR
Mike
Cavanaugh
(617)
877-9641
Celcuity Inc.
Balance Sheets
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December 31,
2020
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December 31,
2019
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Assets
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Current Assets:
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Cash
and cash equivalents
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$11,637,911
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$18,735,002
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Deposits
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22,009
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22,009
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Deferred
transaction costs
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28,743
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Payroll
tax receivable
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190,000
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190,000
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Prepaid
assets
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317,040
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274,600
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Total current assets
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12,166,960
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19,250,354
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Property
and equipment, net
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558,876
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833,463
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Operating
lease right-of-use assets
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230,911
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196,983
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Total Assets
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$12,956,747
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$20,280,800
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Liabilities and Stockholders' Equity:
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Current Liabilities:
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Accounts
payable
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$217,377
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$142,773
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Finance
lease liabilities
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5,810
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5,769
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Operating
lease liabilities
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187,518
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178,466
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Accrued
expenses
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774,612
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584,319
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Total current liabilities
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1,185,317
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911,327
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Finance
lease liabilities
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8,299
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14,109
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Operating
lease liabilities
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60,861
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57,793
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Total Liabilities
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1,254,477
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983,229
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Total Stockholders' Equity
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11,702,270
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19,297,571
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Total Liabilities and Stockholders' Equity
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$12,956,747
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$20,280,800
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Celcuity Inc.
Statements of Operations
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Three Months Ended
December 31, |
Years Ended
December 31,
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2020
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2019
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2020
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2019
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Operating expenses:
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Research
and development
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$2,107,272
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$1,497,023
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$7,683,522
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$6,269,308
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General
and administrative
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444,064
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400,742
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1,872,642
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1,535,993
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Total
operating expenses
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2,551,336
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1,897,765
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9,556,164
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7,805,301
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Loss
from operations
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(2,551,336)
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(1,897,765)
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(9,556,164)
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(7,805,301)
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Other
income (expense)
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Interest
expense
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(26)
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(36)
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(120)
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(159)
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Interest
income
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469
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88,776
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82,109
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446,096
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Other
income, net
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443
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88,740
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81,989
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445,937
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Net loss before income taxes
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(2,550,893)
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(1,809,025)
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(9,474,175)
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(7,359,364)
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Income
tax benefits
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-
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-
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-
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Net loss
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$(2,550,893)
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$(1,809,025)
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$(9,474,175)
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$(7,359,364)
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Net
loss per share, basic and diluted
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$(0.25)
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$(0.18)
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$(0.92)
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$(0.72)
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Weighted
average common shares outstanding, basic and diluted
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10,279,535
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10,251,555
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10,266,884
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10,226,041
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Cautionary Statement Regarding Non-GAAP Financial
Measures
This press 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 net loss and net
loss per share. Management excludes this item because it does not
impact Celcuity’s cash position, 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. As a result,
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. Therefore, non-GAAP adjusted
net loss and non-GAAP adjusted net loss per share may not be
comparable to similarly titled measures presented by other
companies. 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.
Celcuity Inc.
Reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss
and
GAAP Net Loss Per Share to Non-GAAP Adjusted Net Loss Per
Share
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Three Months Ended
December 31,
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Years Ended
December 31,
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2020
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2019
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2020
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2019
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GAAP
net loss
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$(2,550,893)
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$(1,809,025)
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$(9,474,175)
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$(7,359,364)
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Adjustments:
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Stock-based
compensation
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Research and development (1)
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241,996
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202,403
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1,055,094
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567,305
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General and administrative (2)
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185,094
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158,452
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708,785
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473,684
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Non-GAAP
adjusted net loss
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$(2,123,803)
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$(1,448,170)
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$(7,710,296)
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$(6,318,375)
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GAAP
net loss per share - basic and diluted
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$(0.25)
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$(0.18)
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$(0.92)
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$(0.72)
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Adjustment
to net loss (as detailed above)
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0.04
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0.04
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0.17
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0.10
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Non-GAAP
adjusted net loss per share
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$(0.21)
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$(0.14)
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$(0.75)
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$(0.62)
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Weighted
average common shares outstanding, basic and diluted
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10,279,535
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10,251,555
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10,266,884
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10,226,041
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(1) Reflects a non-cash charge to operating expense for Research
and Development stock-based compensation.
(2) Reflects a non-cash charge to operating expense for General and
Administrative stock-based compensation.