Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology
company pursuing development of targeted therapies for oncology,
today reported financial results for the second quarter ended June
30, 2023 and provided other recent corporate updates.
“Patient enrollment in the Phase 3 VIKTORIA-1 trial is
progressing in-line with our planned timeline. Nearly 200 sites are
now recruiting patients in 20 countries,” said Brian Sullivan, CEO
and Co-Founder of Celcuity. “We are also very encouraged by the
updated median PFS and DOR data we reported for gedatolisib in
combination with letrozole and palbociclib in the first-line
setting. These results continue to drive our confidence that
gedatolisib can play an important role in improving outcomes for
women with HR+/HER2- advanced breast cancer, regardless of
PIK3CA-status.”
Second 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 200 sites in 20 countries.
- 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.
- In May 2023, updated results from a
Phase 1b trial evaluating gedatolisib, in combination with
palbociclib and the aromatase inhibitor, letrozole, were presented
at the 2023 European Society for Medical Oncology (ESMO) Breast
Cancer Annual Congress, with data updated as of March 16, 2023.
- For treatment-naïve patients from Escalation Arm A and
Expansion Arm A (n=41), mPFS was 48.6 months, mDOR was 46.9 months,
and ORR was 79%.
- This data compares favorably to published data for current
first-line standard-of-care treatments for patients with HR+/HER2-
advanced breast cancer.
- In April 2023, Celcuity presented a
poster at the American Association for Cancer Research (AACR)
Annual Meeting demonstrating gedatolisib’s superior therapeutic
activity relative to the various PI3K, AKT, and mTOR inhibitors,
regardless of the cell lines’ PTEN, PI3K, or AKT mutational status
in endometrial, ovarian and cervical cancer cell lines.
- Enrollment is ongoing in the FACT-1 and FACT-2 trials for
CELsignia selected patients who have early-stage HR+/HER2- breast
cancer with interim results expected in the first half of
2024.
Second Quarter 2023 Financial Results
Unless otherwise stated, all comparisons are for the second
quarter ended June 30, 2023, compared to the second quarter ended
June 30, 2022.
Total operating expenses were $15.1 million for the second
quarter of 2023, compared to $9.6 million for the second quarter of
2022. Net cash used in operating activities for the second quarter
of 2023 was $9.7 million, compared to $11.3 million for the second
quarter of 2022.
Research and development (R&D) expenses were $13.7 million
for the second quarter of 2023, compared to $8.4 million for the
second quarter of 2022. Of the approximately $5.4 million increase
in research and development expenses, $0.5 million was related to
increased employee and consulting expenses. The remaining $4.9
million increase in research and development expenses was primarily
the result of activities supporting the VIKTORIA-1 pivotal
trial.
General and administrative (G&A) expenses were $1.3 million
for the second quarter of 2023, compared to $1.2 million for the
second quarter of 2022.
Net loss for the second quarter of 2023 was $14.6 million, or
$0.66 loss per share, compared to a net loss of $10.0 million, or
$0.67 loss per share, for the second quarter of 2022. Non-GAAP
adjusted net loss for the second quarter of 2023 was $12.8 million,
or $0.58 loss per share, compared to non-GAAP adjusted net loss for
the second quarter of 2022 of $8.3 million, or $0.55 per share.
Non-GAAP adjusted net loss excludes stock-based compensation
expense and non-cash interest expense. 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.
At June 30, 2023, Celcuity reported cash, cash equivalents and
short-term investments of $146.2 million.
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 second quarter financial
results and provide a corporate update. To participate in the
teleconference, domestic callers should dial 1-888-886-7786 and
international callers should dial 1-416-764-8658. A live webcast
presentation can also be accessed using this weblink:
https://viavid.webcasts.com/starthere.jsp?ei=1625068&tp_key=c09a941d3d.
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. 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. Celcuity is headquartered in
Minneapolis. 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
timing of initiating and enrolling patients in, and receiving
results from, clinical trials, such as Celcuity's Phase 3
VIKTORIA-1 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.
Contacts:
Celcuity Inc. Brian Sullivan,
bsullivan@celcuity.com Vicky Hahne,
vhahne@celcuity.com 763-392-0123
ICR Westwicke Robert Uhl, robert.uhl@westwicke.com
(619) 228-5886
Celcuity Inc. |
Condensed Balance Sheets |
|
|
June 30, 2023 |
|
December 31, 2022 |
|
(unaudited) |
|
|
Assets |
|
|
|
Current
Assets: |
|
|
|
Cash and cash equivalents |
$ |
32,238,702 |
|
$ |
24,571,557 |
Investments |
|
114,005,385 |
|
|
144,015,954 |
Deposits |
|
22,009 |
|
|
22,009 |
Deferred transaction costs |
|
79,088 |
|
|
33,195 |
Payroll tax receivable |
|
- |
|
|
203,665 |
Prepaid assets |
|
6,461,156 |
|
|
6,344,157 |
Total current
assets |
|
152,806,340 |
|
|
175,190,537 |
|
|
|
|
Property and equipment,
net |
|
210,858 |
|
|
260,294 |
Operating lease right-of-use
assets |
|
499,993 |
|
|
246,266 |
Total
Assets |
$ |
153,517,191 |
|
$ |
175,697,097 |
|
|
|
|
Liabilities and
Stockholders' Equity: |
|
|
|
Current
Liabilities: |
|
|
|
Accounts payable |
$ |
3,019,282 |
|
$ |
2,627,076 |
Finance lease liabilities |
|
- |
|
|
2,449 |
Operating lease liabilities |
|
191,333 |
|
|
191,749 |
Accrued expenses |
|
3,871,135 |
|
|
4,060,280 |
Total current
liabilities |
|
7,081,750 |
|
|
6,881,554 |
Operating lease
liabilities |
|
317,120 |
|
|
61,002 |
Note payable, non-current |
|
35,985,980 |
|
|
34,983,074 |
Total
Liabilities |
|
43,384,850 |
|
|
41,925,630 |
Total Stockholders'
Equity |
|
110,132,341 |
|
|
133,771,467 |
Total Liabilities and
Stockholders' Equity |
$ |
153,517,191 |
|
$ |
175,697,097 |
|
|
|
|
Celcuity Inc. |
Condensed Statements of Operations |
(unaudited) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
13,746,082 |
|
|
$ |
8,367,687 |
|
|
$ |
25,024,575 |
|
|
$ |
15,064,000 |
|
General and administrative |
|
1,309,403 |
|
|
|
1,233,040 |
|
|
|
2,578,447 |
|
|
|
2,044,332 |
|
Total operating expenses |
|
15,055,485 |
|
|
|
9,600,727 |
|
|
|
27,603,022 |
|
|
|
17,108,332 |
|
Loss from operations |
|
(15,055,485 |
) |
|
|
(9,600,727 |
) |
|
|
(27,603,022 |
) |
|
|
(17,108,332 |
) |
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
Interest expense |
|
(1,314,996 |
) |
|
|
(455,445 |
) |
|
|
(2,557,008 |
) |
|
|
(890,446 |
) |
Interest income |
|
1,782,794 |
|
|
|
95,646 |
|
|
|
3,633,926 |
|
|
|
103,805 |
|
Other income (expense),
net |
|
467,798 |
|
|
|
(359,799 |
) |
|
|
1,076,918 |
|
|
|
(786,641 |
) |
Net loss before income
taxes |
|
(14,587,687 |
) |
|
|
(9,960,526 |
) |
|
|
(26,526,104 |
) |
|
|
(17,894,973 |
) |
Income tax benefits |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net loss |
$ |
(14,587,687 |
) |
|
$ |
(9,960,526 |
) |
|
$ |
(26,526,104 |
) |
|
$ |
(17,894,973 |
) |
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.66 |
) |
|
$ |
(0.67 |
) |
|
$ |
(1.22 |
) |
|
$ |
(1.20 |
) |
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
21,957,140 |
|
|
|
14,930,538 |
|
|
|
21,819,772 |
|
|
|
14,923,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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(unaudited) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
GAAP net loss |
$ |
(14,587,687 |
) |
|
$ |
(9,960,526 |
) |
|
$ |
(26,526,104 |
) |
|
$ |
(17,894,973 |
) |
Adjustments: |
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
Research and development (1) |
|
639,511 |
|
|
|
810,664 |
|
|
|
1,293,982 |
|
|
|
1,261,183 |
|
General and administrative (2) |
|
637,471 |
|
|
|
708,795 |
|
|
|
1,256,282 |
|
|
|
1,014,547 |
|
Non-cash interest expense
(3) |
|
507,717 |
|
|
|
188,439 |
|
|
|
1,002,906 |
|
|
|
385,537 |
|
Non-GAAP adjusted net
loss |
$ |
(12,802,988 |
) |
|
$ |
(8,252,627 |
) |
|
$ |
(22,972,934 |
) |
|
$ |
(15,233,706 |
) |
|
|
|
|
|
|
|
|
GAAP net loss per share -
basic and diluted |
$ |
(0.66 |
) |
|
$ |
(0.67 |
) |
|
$ |
(1.22 |
) |
|
$ |
(1.20 |
) |
Adjustment to net loss (as
detailed above) |
|
0.08 |
|
|
|
0.12 |
|
|
|
0.17 |
|
|
|
0.18 |
|
Non-GAAP adjusted net
loss per share |
$ |
(0.58 |
) |
|
$ |
(0.55 |
) |
|
$ |
(1.05 |
) |
|
$ |
(1.02 |
) |
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
21,957,140 |
|
|
|
14,930,538 |
|
|
|
21,819,772 |
|
|
|
14,923,900 |
|
|
|
|
|
|
|
|
|
(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. |
|
|
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