Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology
company pursuing development of targeted therapies for oncology,
today announced financial results for the fourth quarter and full
year ended December 31, 2023 and other recent business
developments.
“In 2023, we made significant progress advancing development of
gedatolisib while strengthening our balance sheet and adding to our
leadership team,” said Brian Sullivan, CEO and Co-Founder of
Celcuity. “Our Phase 3 VIKTORIA-1 trial remains on track to report
topline data from the PI3KCA wild type patient sub-group in the
second half of this year. We were also excited to begin development
of gedatolisib for patients with metastatic castration resistant
prostate cancer this past year. Enrollment has begun in our Phase
1b/2 trial evaluating gedatolisib in combination with darolutamide,
and we look forward to sharing preliminary data from this trial in
the first half of 2025.”
Fourth Quarter 2023 Business Highlights and Other Recent
Developments
- The VIKTORIA-1 Phase 3 trial remains on track to provide
topline data for the PIK3CA wild type patient sub-group in the
second half of 2024 and for the PIK3CA mutant patient sub-group in
the first half of 2025.
- VIKTORIA-1 is evaluating gedatolisib in combination with
fulvestrant with and without palbociclib in adults with HR+, HER2-
advanced breast cancer who have received prior treatment with a
CDK4/6 inhibitor.
- The Phase 3 VIKTORIA-1 clinical trial is enrolling patients at
approximately 220 sites in 23 countries in North and South America,
Europe, and Asia.
- The Phase 1b/2 clinical trial evaluating gedatolisib in
combination with darolutamide for the treatment of metastatic
castration resistant prostate cancer (mCRPC) was initiated in the
fourth quarter of 2023. In February 2024, the first patient was
dosed.
- The trial is expected to enroll up to 54 patients with mCRPC
whose disease progressed after treatment with an androgen receptor
signaling inhibitor.
- In December 2023, Celcuity presented data from nonclinical
studies evaluating gedatolisib and other PI3K/AKT/mTOR (PAM)
inhibitors in breast cancer cell lines during a poster session at
the 2023 San Antonio Breast Cancer Symposium (SABCS). In a panel of
breast cancer cell lines, gedatolisib was found to be more
cytotoxic and at least 300-fold more potent, on average, compared
to the single node PAM inhibitors.
- In February 2024, Eldon Mayer was
appointed Chief Commercial Officer. His 30 years of
biopharmaceutical commercial experience includes senior leadership
roles at several companies where he led the launch of their first
drug.
Fourth Quarter and Full Year 2023 Financial
Results
Unless otherwise stated, all comparisons are for the fourth
quarter and full year ended December 31, 2023, compared to the
fourth quarter and full year ended December 31, 2022.
Total operating expenses were $19.7 million for the fourth
quarter of 2023, compared to $11.6 million for the fourth quarter
of 2022. Operating expenses for the full year 2023 were $66.2
million, compared to $39.4 million for the full year 2022.
Research and development (R&D) expenses were $18.1 million
for the fourth quarter of 2023, compared to $10.6 million for the
prior-year period. Of the approximately $7.5 million increase in
R&D expenses, $6.8 million primarily related to activities
supporting the VIKTORIA-1 Phase 3 trial and the initiation of the
CELC-G-201 Phase 1b/2 clinical trial, and $0.7 million was related
to increased employee and consulting expenses.
R&D expenses for the full year 2023 were $60.6 million,
compared to $35.3 million for the prior year. Of the approximately
$25.3 million increase in R&D expenses, $22.9 million was
related to activities supporting the VIKTORIA-1 Phase 3 trial and
the initiation of the CELC-G-201 Phase 1b/2 clinical trial. The
remaining $2.4 million increase in R&D expenses was related to
increased employee and consulting expenses.
General and administrative (G&A) expenses were $1.6 million
for the fourth quarter of 2023, compared to $1.0 million for the
prior-year period. Employee-related expenses accounted for $0.5
million of the increase. The remaining increase resulted from
professional fees and other expenses associated with compliance
related activities that support financing and clinical
operations.
G&A expenses for the full year 2023 were $5.6 million,
compared to $4.1 million for the prior year. Of the approximately
$1.5 million increase in G&A expenses, $1.1 million was related
to increased employee-related expenses, and $0.4 million was
related to professional fees and other expenses associated with
compliance related activities that support financing and clinical
operations.
Net loss for the fourth quarter of 2023 was $18.8 million, or
$0.65 loss per share, compared to a net loss of $11.6 million, or
$0.69 loss per share, for the fourth quarter of 2022. Net loss for
the full year 2023 was $63.8 million, or $2.69 loss per share,
compared to a net loss of $40.4 million, or $2.64 loss per share,
in 2022. Non-GAAP adjusted net loss for the fourth quarter of 2023
was $17.6 million, or $0.61 loss per share, compared to non-GAAP
adjusted net loss of $10.3 million, or $0.61 loss per share, for
the fourth quarter of 2022. Non-GAAP adjusted net loss for the full
year 2023 was $57.8 million, or $2.44 loss per share, compared to
non-GAAP adjusted net loss of $35.0 million, or $2.27 loss per
share, for 2022. Non-GAAP adjusted net loss excludes stock-based
compensation expense, non-cash interest expense, and non-cash
interest income. Because these items have 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
2023 was $18.5 million, compared to $9.5 million for the fourth
quarter of 2022. Net cash used in operating activities for the full
year 2023 was $53.8 million, compared to $36.0 million for the full
year 2022.
In October of 2023, Celcuity closed a private placement of
equity that resulted in gross proceeds of approximately $50
million. In December 2023, Celcuity closed on an additional $15
million of gross proceeds through its at-the-market offering. The
Company expects to use the net proceeds to advance the clinical
development of gedatolisib and for general corporate purposes.
At December 31, 2023, Celcuity reported cash, cash equivalents
and short-term investments of $180.6 million. We expect cash, cash
equivalents, investments and available funds under our debt
facility to provide adequate capital to fund current operational
activities into the first half of 2026.
Webcast and Conference Call Information
The Celcuity management team will host a webcast/conference call
at 4:30 p.m. ET today to discuss the fourth quarter and full year
2023 financial results and provide a corporate update. To
participate in the teleconference, domestic callers should dial
1-888-886-7786 or 1-416-764-8658. A live webcast presentation can
also be accessed using this weblink:
https://viavid.webcasts.com/starthere.jsp?ei=1655995&tp_key=04c7a07803.
A replay of the webcast will be available on the Celcuity website
following the live event.
About Celcuity
Celcuity is a clinical-stage biotechnology company focused on
development of targeted therapies for treatment of multiple solid
tumor indications. The company's lead therapeutic candidate is
gedatolisib, a potent, pan-PI3K and mTOR inhibitor. Its mechanism
of action and pharmacokinetic properties are highly differentiated
from other currently approved and investigational therapies that
target PI3K or mTOR alone or together. A Phase 3 clinical trial,
VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant
with or without palbociclib in patients with HR+/HER2- advanced
breast cancer is currently enrolling patients. More detailed
information about the VIKTORIA-1 study can be found at
ClinicalTrials.gov. A Phase 1b/2 clinical trial, CELC-G-201,
evaluating gedatolisib in combination with darolutamide in patients
with metastatic castration resistant prostate cancer, is enrolling
patients. The company's CELsignia companion diagnostic platform is
uniquely able to analyze live patient tumor cells to identify new
groups of cancer patients likely to benefit from already approved
targeted therapies. Further information about Celcuity can be
found at www.celcuity.com. Follow us
on LinkedIn and Twitter.
Forward-Looking Statements
This press release contains statements that constitute
"forward-looking statements" including, but not limited to, the
design of our clinical trials; the timing of initiating and
enrolling patients in, and receiving results and data from, our
clinical trials; the costs and expected results from any ongoing or
planned clinical trials; the market opportunity for gedatolisib;
our strategy, marketing and commercialization plans; other
expectations with respect to Celcuity's lead product candidate,
gedatolisib, and its CELsignia platform; our anticipated use of
cash; and the strength of our balance sheet. 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 are
subject to numerous risks, uncertainties, and conditions, many of
which are beyond the control of Celcuity. These include, but are
not limited to, unforeseen delays in our clinical trials, our
ability to obtain and maintain regulatory approvals to
commercialize our products, and the market acceptance of such
products, the development of therapies and tools competitive with
our products, and those risks set forth in the Risk Factors section
in Celcuity's Annual Report on Form 10-K for the year ended
December 31, 2023 to be filed with the Securities and Exchange
Commission on March 27, 2024. 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.
View source version of release on GlobeNewswire.com
Contacts:
Celcuity Inc. Brian Sullivan,
bsullivan@celcuity.com Vicky Hahne,
vhahne@celcuity.com (763) 392-0123
ICR Westwicke Maria Yonkoski,
maria.yonkoski@westwicke.com (203) 682-7167
|
Celcuity Inc. |
Balance Sheets |
|
|
December 31, 2023 |
|
December 31, 2022 |
|
|
|
|
Assets |
|
|
|
Current
Assets: |
|
|
|
Cash and cash equivalents |
$ |
30,662,774 |
|
|
$ |
24,571,557 |
|
Investments |
|
149,919,974 |
|
|
|
144,015,954 |
|
Other current assets |
|
10,007,849 |
|
|
|
6,603,026 |
|
Total current
assets |
|
190,590,597 |
|
|
|
175,190,537 |
|
|
|
|
|
Property and equipment,
net |
|
228,782 |
|
|
|
260,294 |
|
Operating lease right-of-use
assets |
|
400,019 |
|
|
|
246,266 |
|
Total
Assets |
$ |
191,219,398 |
|
|
$ |
175,697,097 |
|
|
|
|
|
Liabilities and
Stockholders' Equity: |
|
|
|
Current
Liabilities: |
|
|
|
Accounts payable |
$ |
5,076,699 |
|
|
$ |
2,627,076 |
|
Finance lease liabilities |
|
- |
|
|
|
2,449 |
|
Operating lease liabilities |
|
184,950 |
|
|
|
191,749 |
|
Accrued expenses |
|
8,927,094 |
|
|
|
4,060,280 |
|
Total current
liabilities |
|
14,188,743 |
|
|
|
6,881,554 |
|
Operating lease
liabilities |
|
225,922 |
|
|
|
61,002 |
|
Note payable, non-current |
|
37,035,411 |
|
|
|
34,983,074 |
|
Total
Liabilities |
|
51,450,076 |
|
|
|
41,925,630 |
|
Total Stockholders'
Equity |
|
139,769,322 |
|
|
|
133,771,467 |
|
Total Liabilities and
Stockholders' Equity |
$ |
191,219,398 |
|
|
$ |
175,697,097 |
|
|
Celcuity Inc. |
Statements of Operations |
|
|
Three Months Ended December 31, |
|
Years Ended December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
18,081,194 |
|
|
$ |
10,604,043 |
|
|
$ |
60,594,005 |
|
|
$ |
35,289,548 |
|
General and administrative |
|
1,648,079 |
|
|
|
1,035,161 |
|
|
|
5,636,326 |
|
|
|
4,101,543 |
|
Total operating expenses |
|
19,729,273 |
|
|
|
11,639,204 |
|
|
|
66,230,331 |
|
|
|
39,391,091 |
|
Loss from operations |
|
(19,729,273 |
) |
|
|
(11,639,204 |
) |
|
|
(66,230,331 |
) |
|
|
(39,391,091 |
) |
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
Interest expense |
|
(1,397,247 |
) |
|
|
(678,003 |
) |
|
|
(5,326,387 |
) |
|
|
(2,106,111 |
) |
Interest income |
|
2,278,048 |
|
|
|
735,863 |
|
|
|
7,777,602 |
|
|
|
1,127,162 |
|
Other income (expense),
net |
|
880,801 |
|
|
|
57,860 |
|
|
|
2,451,215 |
|
|
|
(978,949 |
) |
Net loss before income
taxes |
|
(18,848,472 |
) |
|
|
(11,581,344 |
) |
|
|
(63,779,116 |
) |
|
|
(40,370,040 |
) |
Income tax benefits |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net loss |
$ |
(18,848,472 |
) |
|
$ |
(11,581,344 |
) |
|
$ |
(63,779,116 |
) |
|
$ |
(40,370,040 |
) |
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.65 |
) |
|
$ |
(0.69 |
) |
|
$ |
(2.69 |
) |
|
$ |
(2.64 |
) |
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
28,900,075 |
|
|
|
16,872,018 |
|
|
|
23,679,472 |
|
|
|
15,418,543 |
|
|
|
|
|
|
|
|
|
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, non-cash interest
expense, and non-cash interest income from net loss and net loss
per share. Management excludes these items because they do 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 |
|
|
Three Months Ended December 31, |
|
Years Ended December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
GAAP net loss |
$ |
(18,848,472 |
) |
|
$ |
(11,581,344 |
) |
|
$ |
(63,779,116 |
) |
|
$ |
(40,370,040 |
) |
Adjustments: |
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
Research and development (1) |
|
745,629 |
|
|
|
625,583 |
|
|
|
2,700,318 |
|
|
|
2,563,291 |
|
General and administrative (2) |
|
496,904 |
|
|
|
513,838 |
|
|
|
2,201,116 |
|
|
|
2,074,914 |
|
Non-cash interest expense
(3) |
|
528,637 |
|
|
|
254,884 |
|
|
|
2,052,336 |
|
|
|
850,831 |
|
Non-cash interest income
(4) |
|
(554,126 |
) |
|
|
(142,928 |
) |
|
|
(993,457 |
) |
|
|
(142,928 |
) |
Non-GAAP adjusted net
loss |
$ |
(17,631,428 |
) |
|
$ |
(10,329,967 |
) |
|
$ |
(57,818,803 |
) |
|
$ |
(35,023,932 |
) |
|
|
|
|
|
|
|
|
GAAP net loss per share -
basic and diluted |
$ |
(0.65 |
) |
|
$ |
(0.69 |
) |
|
$ |
(2.69 |
) |
|
$ |
(2.64 |
) |
Adjustment to net loss (as
detailed above) |
|
0.04 |
|
|
|
0.08 |
|
|
|
0.25 |
|
|
|
0.35 |
|
Warrant modification
adjustment (5) |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
0.02 |
|
Non-GAAP adjusted net
loss per share |
$ |
(0.61 |
) |
|
$ |
(0.61 |
) |
|
$ |
(2.44 |
) |
|
$ |
(2.27 |
) |
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
28,900,075 |
|
|
|
16,872,018 |
|
|
|
23,679,472 |
|
|
|
15,418,543 |
|
(1) |
To reflect a non-cash charge to operating expense for Research and
Development stock-based compensation. |
(2) |
To reflect a non-cash charge to operating expense for General and
Administrative stock-based compensation. |
(3) |
To reflect a non-cash charge to other expense for amortization of
debt issuance and discount costs |
|
and PIK interest related to the issuance of a note payable. |
(4) |
To reflect a non-cash adjustment to other income for accretion on
investments. |
(5) |
To reflect an adjustment to basic and diluted net loss per share
related to a warrant modification. |
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