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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): August 14, 2024
Celcuity
Inc.
(Exact
name of Registrant as Specified in its Charter)
Delaware |
|
001-38207 |
|
82-2863566 |
(State
or Other Jurisdiction
of
Incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
16305
36th Avenue North; Suite 100
Minneapolis, Minnesota 55446
(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:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, $0.001 par value per share |
|
CELC |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company 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
August 14, 2024, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for
the second quarter ended June 30, 2024. 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 referenced 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. |
(d)
Exhibits
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:
August 14, 2024
|
CELCUITY
INC. |
|
|
|
By: |
/s/
Brian F. Sullivan |
|
|
Brian
F. Sullivan |
|
|
Chief
Executive Officer |
Exhibit
99.1
Celcuity
Inc. Reports Second Quarter Financial Results and Provides Corporate Update
|
- |
Announced
plan to initiate Phase 3 VIKTORIA-2 trial evaluating gedatolisib combined with fulvestrant plus a CDK4/6 inhibitor as first-line
treatment for patients with HR+, HER2- advanced breast cancer; expect to enroll first patient in Q2 2025 |
|
|
|
|
- |
Expect
to reach enrollment target for VIKTORIA-1 PIK3CA WT cohort in Q4 2024 and report topline data for this cohort in late Q4 2024 or
Q1 2025 |
|
|
|
|
- |
Raised
$129 million in gross proceeds from equity and debt financings; extending runway of current operational activities through 2026 |
|
|
|
|
- |
Management
to host webcast and conference call today, August 14, 2024, at 4:30 p.m. ET |
MINNEAPOLIS,
August 14, 2024 — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies
for oncology, today announced financial results for the second quarter ended June 30, 2024 and other recent business developments.
“We
made significant strides advancing the clinical development of gedatolisib this quarter. Overall enrollment in VIKTORIA-1 remains robust
and on-track relative to our previous projections,” said Brian Sullivan, CEO and co-founder of Celcuity. “We also initiated
efforts to launch VIKTORIA-2, a Phase 3 study to evaluate gedatolisib as a first-line treatment option for patients with HR+, HER2- advanced
breast cancer.”
“In
our VIKTORIA-1 study, while overall enrollment is on track, the proportion of patients who have PIK3CA wild-type tumors, versus those
with PIK3CA mutations, has recently shifted lower than our original estimates. As a result, we expect to reach the enrollment target
for the PIK3CA wild-type cohort in the fourth quarter, rather than the third quarter, as we originally forecasted. In light of this,
we expect topline data for the PIK3CA WT cohort to shift to sometime between late Q4 2024 and Q1 2025.”
Second
Quarter 2024 Business Highlights and Other Recent Developments
● |
The VIKTORIA-1 Phase 3 trial
expects to provide topline data for the PIK3CA wild-type cohort in late Q4 2024 or Q1 2025 and for the PIK3CA mutant
cohort 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. |
|
○ |
Enrollment
of the PIK3CA wild-type cohort is more than 80% complete and expected to reach the enrollment target during Q4 2024. The PIK3CA wild-type
cohort represents approximately 60% of the total patients enrolled to date in VIKTORIA-1. |
● |
In May, the Company announced
its plan to initiate VIKTORIA-2, a Phase 3 study to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant
plus a CDK4/6 inhibitor, either ribociclib or palbociclib, in comparison to fulvestrant plus a CDK4/6 inhibitor as a first-line treatment
for patients with HR+/HER2- advanced breast cancer. |
|
○ |
A
safety run-in study to evaluate the safety of gedatolisib combined with ribociclib and fulvestrant will precede initiation of the
Phase 3 portion of the study. |
|
○ |
The
Phase 3 portion of the study is expected to enroll approximately 638 patients at up to 200 sites across North America, Europe, Latin
America, and Asia. |
|
○ |
First
patient enrollment is expected in the second quarter of 2025. |
● |
During
the quarter, the Company secured a combined total of $129 million in gross proceeds from equity and debt financings, which extended
the cash runway for current clinical development program activities through 2026. |
|
|
● |
The
Phase 1b/2 trial, evaluating gedatolisib in combination with darolutamide for the treatment of patients with metastatic castration
resistant prostate cancer (mCRPC), remains on track to report preliminary data in the first half of 2025. |
|
○ |
Enrollment is ongoing and
the trial is expected to enroll up to 54 patients with mCRPC whose disease progressed after treatment with an androgen receptor signaling
inhibitor. |
● |
Three manuscripts reporting clinical and nonclinical results
for gedatolisib were published recently. |
|
○ |
In
April, The Lancet Oncology published results from the dose expansion groups of its Phase 1b study evaluating gedatolisib in
combination with palbociclib and endocrine therapy in HR+/HER2- advanced breast cancer. The published manuscript is available online
and on the publications section of Celcuity’s website. |
|
○ |
In
June, npj Breast Cancer published results of nonclinical studies showing gedatolisib’s superior potency and efficacy
versus single-node PI3K/AKT/mTOR inhibitors in breast cancer models. The article is available online and on the publications section
of Celcuity’s website. |
|
○ |
In
August, Molecular Oncology published results of nonclinical studies in prostate cancer models showing gedatolisib’s
superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors. The article is available online and will soon be available
on the publications section of Celcuity’s website. |
Second
Quarter 2024 Financial Results
Unless
otherwise stated, all comparisons are for the second quarter ended June 30, 2024, compared to the second quarter ended June 30, 2023.
Total
operating expenses were $24.3 million for the second quarter of 2024, compared to $15.1 million for the second quarter of 2023.
Research
and development (R&D) expenses were $22.5 million for the second quarter of 2024, compared to $13.8 million for the prior-year period.
Of the approximately $8.7 million increase in R&D expenses, $6.6 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 $2.1 million was related to increased employee and
consulting expenses.
General
and administrative (G&A) expenses were $1.8 million for the second quarter of 2024, compared to $1.3 million for the prior-year period.
Employee and consulting related expenses accounted for $0.3 million of the increase. Professional fees and other administrative expenses
accounted for the remaining increase of approximately $0.2 million.
Net
loss for the second quarter of 2024 was $23.7 million, or $0.62 loss per share, compared to a net loss of $14.6 million, or $0.66 loss
per share, for the second quarter of 2023. Non-GAAP adjusted net loss for the second quarter of 2024 was $22.2 million, or $0.58 loss
per share, compared to non-GAAP adjusted net loss of $11.1 million, or $0.51 loss per share, for the second quarter of 2023. 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 second quarter of 2024 was $18.1 million, compared to $9.7 million for the second quarter of
2023.
At
June 30, 2024, Celcuity reported cash, cash equivalents and short-term investments of $283.1 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 2024 financial results
and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-800-717-1738 or 1-646-307-1865.
A live webcast presentation can also be accessed using this weblink: https://viavid.webcasts.com/starthere.jsp?ei=1678191&tp_key=c55c86e8c3.
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. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib
plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is expected to begin
enrolling patients in the second quarter of 2025. Celcuity is headquartered in Minneapolis. 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; revenue expectations;
our strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; 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, our ability
to access capital upon favorable terms or at all, 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.
Condensed
Balance Sheets
| |
June
30, 2024 | | |
December
31, 2023 | |
| |
(unaudited) | | |
| |
Assets | |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash and cash
equivalents | |
$ | 30,458,800 | | |
$ | 30,662,774 | |
Investments | |
| 252,609,622 | | |
| 149,919,974 | |
Other
current assets | |
| 8,862,940 | | |
| 10,007,849 | |
Total current assets | |
| 291,931,362 | | |
| 190,590,597 | |
| |
| | | |
| | |
Property and equipment, net | |
| 308,444 | | |
| 228,782 | |
Operating lease right-of-use
assets | |
| 305,179 | | |
| 400,019 | |
Total
Assets | |
$ | 292,544,985 | | |
$ | 191,219,398 | |
| |
| | | |
| | |
Liabilities and Stockholders’
Equity: | |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 6,203,132 | | |
$ | 5,076,699 | |
Operating lease liabilities | |
| 178,587 | | |
| 184,950 | |
Accrued
expenses | |
| 13,146,769 | | |
| 8,927,094 | |
Total current liabilities | |
| 19,528,488 | | |
| 14,188,743 | |
Operating lease liabilities | |
| 138,533 | | |
| 225,922 | |
Note payable, non-current | |
| 96,193,172 | | |
| 37,035,411 | |
Total
Liabilities | |
| 115,860,193 | | |
| 51,450,076 | |
Total
Stockholders’ Equity | |
| 176,684,792 | | |
| 139,769,322 | |
Total
Liabilities and Stockholders’ Equity | |
$ | 292,544,985 | | |
$ | 191,219,398 | |
Celcuity
Inc.
Condensed
Statements of Operations
(unaudited)
| |
Three
Months Ended June 30, | | |
Six
Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Research and
development | |
$ | 22,496,975 | | |
$ | 13,746,082 | | |
$ | 43,144,534 | | |
$ | 25,024,575 | |
General
and administrative | |
| 1,786,111 | | |
| 1,309,403 | | |
| 3,632,387 | | |
| 2,578,447 | |
Total operating expenses | |
| 24,283,086 | | |
| 15,055,485 | | |
| 46,776,921 | | |
| 27,603,022 | |
Loss from operations | |
| (24,283,086 | ) | |
| (15,055,485 | ) | |
| (46,776,921 | ) | |
| (27,603,022 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense) | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (2,260,583 | ) | |
| (1,314,996 | ) | |
| (3,661,295 | ) | |
| (2,557,008 | ) |
Interest
income | |
| 2,821,849 | | |
| 1,782,794 | | |
| 5,103,941 | | |
| 3,633,926 | |
Other income (expense),
net | |
| 561,266 | | |
| 467,798 | | |
| 1,442,646 | | |
| 1,076,918 | |
Net
loss before income taxes | |
| (23,721,820 | ) | |
| (14,587,687 | ) | |
| (45,334,275 | ) | |
| (26,526,104 | ) |
Income tax benefits | |
| - | | |
| - | | |
| - | | |
| - | |
Net
loss | |
$ | (23,721,820 | ) | |
$ | (14,587,687 | ) | |
$ | (45,334,275 | ) | |
$ | (26,526,104 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share, basic and diluted | |
$ | (0.62 | ) | |
$ | (0.66 | ) | |
$ | (1.26 | ) | |
$ | (1.22 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding,
basic and diluted | |
| 38,444,163 | | |
| 21,957,140 | | |
| 36,028,109 | | |
| 21,819,772 | |
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 June 30, | | |
Six
Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
GAAP net
loss | |
$ | (23,721,820 | ) | |
$ | (14,587,687 | ) | |
$ | (45,334,275 | ) | |
$ | (26,526,104 | ) |
Adjustments: | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation | |
| | | |
| | | |
| | | |
| | |
Research
and development (1) | |
| 978,037 | | |
| 639,511 | | |
| 1,810,216 | | |
| 1,293,982 | |
General
and administrative (2) | |
| 432,475 | | |
| 637,471 | | |
| 931,642 | | |
| 1,256,282 | |
Non-cash interest expense
(3) | |
| 629,579 | | |
| 507,717 | | |
| 1,160,398 | | |
| 1,002,905 | |
Non-cash
interest income (4) | |
| (484,991 | ) | |
| 1,656,623 | | |
| (638,836 | ) | |
| (41,188 | ) |
Non-GAAP
adjusted net loss | |
$ | (22,166,720 | ) | |
$ | (11,146,365 | ) | |
$ | (42,070,855 | ) | |
$ | (23,014,123 | ) |
| |
| | | |
| | | |
| | | |
| | |
GAAP net loss per share - basic and diluted | |
$ | (0.62 | ) | |
$ | (0.66 | ) | |
$ | (1.26 | ) | |
$ | (1.22 | ) |
Adjustment to net loss
(as detailed above) | |
| 0.04 | | |
| 0.15 | | |
| 0.09 | | |
| 0.17 | |
Non-GAAP
adjusted net loss per share | |
$ | (0.58 | ) | |
$ | (0.51 | ) | |
$ | (1.17 | ) | |
$ | (1.05 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding,
basic and diluted | |
| 38,444,163 | | |
| 21,957,140 | | |
| 36,028,109 | | |
| 21,819,772 | |
(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 and interest receivable on investments. |
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