Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology
company pursuing development of targeted therapies for oncology,
today reported financial results for the third quarter ended
September 30, 2023 and provided other recent corporate updates.
“Despite the important role the PI3K/mTOR pathway plays in tumor
types such as breast and prostate cancer, the available therapies
that target this pathway have only reported limited improvements in
outcomes for patients. Development of an optimized PI3K/mTOR
inhibitor, like gedatolisib, thus represents, we believe, one of
the most important opportunities to improve the standard of care in
these cancers. With our Phase 3 program in HR+/HER2- advanced
breast cancer, and our newly initiated Phase 1b/2 program in
metastatic castration resistance prostate cancer, we are hoping to
eventually impact over 200,000 patients globally,” said Brian
Sullivan, CEO and Co-Founder of Celcuity. “The equity financing we
recently closed further supports these programs and extends our
cash runway into mid-2026.”
Third Quarter 2023 Business Highlights and Other Recent
Developments
- The VIKTORIA-1 Phase 3 trial remains on track to provide
initial data and analysis of the PIK3CA wild type patient sub-group
in the second half of 2024 and data for the PIK3CA mutated patient
sub-group in the first half of 2025.
- The Phase 3 VIKTORIA-1 clinical trial is now recruiting
patients at nearly 220 sites in 23 countries in North and South
America, Europe, and Asia.
- VIKTORIA-1 is evaluating gedatolisib in combination with
fulvestrant, an endocrine therapy, with and without palbociclib, a
CDK4/6 inhibitor, in adults with HR+, HER2- advanced breast
cancer.
- The CELC-G-201 Phase 1b/2 clinical trial evaluating gedatolisib
in combination with Nubeqa® (darolutamide) for the treatment of
metastatic castration resistant prostate cancer (mCRPC) is on track
to activate trial sites in the first quarter of 2024 and to report
initial data in the first half of 2025.
- The U.S. Food and Drug Administration (FDA) cleared an
Investigational New Drug (IND) submission that enables Celcuity to
proceed with a trial to evaluate gedatolisib in combination with
darolutamide in August 2023.
- We entered into a clinical trial collaboration and supply
agreement with Bayer AG in August 2023 to provide Nubeqa®
(darolutamide) at no cost.
- The Phase 1b/2 trial will enroll up to 54 patients with mCRPC
whose disease progressed after treatment with an androgen receptor
inhibitor.
- Celcuity closed a private placement of equity that resulted in
net proceeds of approximately $50 million in October 2023.
Third Quarter 2023 Financial Results
Unless otherwise stated, all comparisons are for the third
quarter ended September 30, 2023, compared to the third quarter
ended September 30, 2022.
Total operating expenses were $18.9 million for the third
quarter of 2023, compared to $10.6 million for the third quarter of
2022. Research and development (R&D) expenses were $17.5
million for the third quarter of 2023, compared to $9.6 million for
the third quarter of 2022. Of the approximately $7.9 million
increase in R&D expenses, $7.5 million was due to an increase
in expenses related to the VIKTORIA-1 Phase 3 clinical trial, and
$0.4 million was related to increased employee-related
expenses.
General and administrative expenses were $1.4 million for the
third quarter of 2023, compared to $1.0 million for the third
quarter of 2022. Employee-related expenses accounted for $0.3
million of the increase. The remaining $0.1 million increase
resulted from professional fees and other expenses associated with
being a public company.
Net loss for the third quarter of 2023 was $18.4 million, or
$0.83 loss per share, compared to a net loss of $10.9 million, or
$0.75 loss per share, for the third quarter of 2022. Non-GAAP
adjusted net loss for the third quarter of 2023 was $17.3 million,
or $0.78 loss per share, compared to non-GAAP adjusted net loss for
the third quarter of 2022 of $9.5 million, or $0.63 loss per share.
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 third quarter of
2023 was $12.7 million, compared to $9.3 million for the third
quarter of 2022. At September 30, 2023, Celcuity reported cash,
cash equivalents and short-term investments of $133.9 million.
Webcast and Conference Call Information
The Celcuity management team will host a webcast/conference call
at 8:00 a.m. ET today to discuss the third quarter financial
results and provide a corporate update. To participate in the
teleconference, domestic callers should dial 1-877-407-0784
or1-201-689-8560. A live webcast presentation can also be accessed
using this weblink:
https://viavid.webcasts.com/starthere.jsp?ei=1639042&tp_key=7d2827005c.
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 expected
to be initiated in the first quarter of 2024. 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 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
adequacy of Celcuity’s cash on hand to fund research and
development expenses and other general corporate expenses, the
timing of initiating and enrolling patients in, and receiving
results from, clinical trials, such as Celcuity's Phase 3
VIKTORIA-1 clinical trial and Phase 1b/2 CELC-G-201 clinical trial,
the costs and expected results from any ongoing or planned clinical
trials, the impact on gedatolisib and Celcuity of preliminary
clinical trial results, any potential benefits resulting from
Breakthrough Therapy designation for gedatolisib, and other
expectations with respect to Celcuity's lead product candidate,
gedatolisib and its CELsignia platform. 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, those risks set forth in the Risk Factors section
in Celcuity's Annual Report on Form 10-K for the year ended
December 31, 2022, filed with the Securities and Exchange
Commission on March 23, 2023, as may be updated by our quarterly
reports on Form 10-Q. 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. |
Condensed Balance Sheets |
|
|
September 30, 2023 |
|
December 31, 2022 |
|
(unaudited) |
|
|
Assets |
|
|
|
Current
Assets: |
|
|
|
Cash and cash equivalents |
$ |
25,759,887 |
|
$ |
24,571,557 |
Investments |
|
108,180,417 |
|
|
144,015,954 |
Other current assets |
|
7,771,131 |
|
|
6,603,026 |
Total current
assets |
|
141,711,435 |
|
|
175,190,537 |
|
|
|
|
Property and equipment,
net |
|
223,378 |
|
|
260,294 |
Operating lease right-of-use
assets |
|
449,368 |
|
|
246,266 |
Total
Assets |
$ |
142,384,181 |
|
$ |
175,697,097 |
|
|
|
|
Liabilities and
Stockholders' Equity: |
|
|
|
Current
Liabilities: |
|
|
|
Accounts payable |
$ |
5,634,806 |
|
$ |
2,627,076 |
Finance lease liabilities |
|
- |
|
|
2,449 |
Operating lease liabilities |
|
188,100 |
|
|
191,749 |
Accrued expenses |
|
6,887,136 |
|
|
4,060,280 |
Total current
liabilities |
|
12,710,042 |
|
|
6,881,554 |
Operating lease
liabilities |
|
270,925 |
|
|
61,002 |
Note payable, non-current |
|
36,506,774 |
|
|
34,983,074 |
Total
Liabilities |
|
49,487,741 |
|
|
41,925,630 |
Total Stockholders'
Equity |
|
92,896,440 |
|
|
133,771,467 |
Total Liabilities and
Stockholders' Equity |
$ |
142,384,181 |
|
$ |
175,697,097 |
|
|
|
|
Celcuity Inc. |
Condensed Statements of Operations |
(unaudited) |
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
17,488,236 |
|
|
$ |
9,621,505 |
|
|
$ |
42,512,811 |
|
|
$ |
24,685,505 |
|
General and administrative |
|
1,409,801 |
|
|
|
1,022,050 |
|
|
|
3,988,248 |
|
|
|
3,066,382 |
|
Total operating expenses |
|
18,898,037 |
|
|
|
10,643,555 |
|
|
|
46,501,059 |
|
|
|
27,751,887 |
|
Loss from operations |
|
(18,898,037 |
) |
|
|
(10,643,555 |
) |
|
|
(46,501,059 |
) |
|
|
(27,751,887 |
) |
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
Interest expense |
|
(1,372,132 |
) |
|
|
(537,661 |
) |
|
|
(3,929,140 |
) |
|
|
(1,428,108 |
) |
Interest income |
|
1,865,629 |
|
|
|
287,495 |
|
|
|
5,499,555 |
|
|
|
391,301 |
|
Other income (expense),
net |
|
493,497 |
|
|
|
(250,166 |
) |
|
|
1,570,415 |
|
|
|
(1,036,807 |
) |
Net loss before income
taxes |
|
(18,404,540 |
) |
|
|
(10,893,721 |
) |
|
|
(44,930,644 |
) |
|
|
(28,788,694 |
) |
Income tax benefits |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net loss |
$ |
(18,404,540 |
) |
|
$ |
(10,893,721 |
) |
|
$ |
(44,930,644 |
) |
|
$ |
(28,788,694 |
) |
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.83 |
) |
|
$ |
(0.75 |
) |
|
$ |
(2.05 |
) |
|
$ |
(1.95 |
) |
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
22,117,626 |
|
|
|
14,938,224 |
|
|
|
21,920,147 |
|
|
|
14,928,727 |
|
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 and non-cash interest
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 September 30, |
|
|
|
Nine Months Ended September 30, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss |
|
$ |
(18,404,540 |
) |
|
$ |
(10,893,721 |
) |
|
$ |
(44,930,644 |
) |
|
$ |
(28,788,694 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (1) |
|
|
660,706 |
|
|
|
676,524 |
|
|
|
1,954,689 |
|
|
|
1,937,707 |
|
General and administrative (2) |
|
|
447,931 |
|
|
|
546,530 |
|
|
|
1,704,213 |
|
|
|
1,561,077 |
|
Non-cash interest expense
(3) |
|
|
520,794 |
|
|
|
210,409 |
|
|
|
1,523,699 |
|
|
|
595,947 |
|
Non-cash interest income
(4) |
|
|
(480,520 |
) |
|
|
- |
|
|
|
(439,331 |
) |
|
|
- |
|
Non-GAAP adjusted net
loss |
|
$ |
(17,255,629 |
) |
|
$ |
(9,460,258 |
) |
|
$ |
(40,187,374 |
) |
|
$ |
(24,693,964 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per share -
basic and diluted |
|
$ |
(0.83 |
) |
|
$ |
(0.75 |
) |
|
$ |
(2.05 |
) |
|
$ |
(1.95 |
) |
Adjustment to net loss (as
detailed above) |
|
|
0.05 |
|
|
|
0.10 |
|
|
|
0.22 |
|
|
|
0.27 |
|
Warrant modification
adjustment (5) |
|
|
- |
|
|
|
0.02 |
|
|
|
- |
|
|
|
0.02 |
|
Non-GAAP adjusted net
loss per share |
|
$ |
(0.78 |
) |
|
$ |
(0.63 |
) |
|
$ |
(1.83 |
) |
|
$ |
(1.66 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
|
22,117,626 |
|
|
|
14,938,224 |
|
|
|
21,920,147 |
|
|
|
14,928,727 |
|
(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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