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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): July 28, 2025
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
7.01 |
Regulation
FD Disclosure. |
On
July 28, 2025, Celcuity Inc. (the “Company”) issued a press release announcing topline results from its PIK3CA wild-type
cohort of Phase 3 VIKTORIA-1 clinical trial. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated
herein by reference.
The
information in this Item 7.01, including the accompanying exhibit, is being furnished and shall not be deemed “filed” for
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 7.01 shall not be incorporated 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.
On
July 28, 2025, the Company announced positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical
trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant in adults with hormone receptor (HR)-positive,
human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA wild-type, locally advanced or metastatic breast cancer, following
progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor.
In
the trial, gedatolisib in combination with palbociclib and fulvestrant (the “gedatolisib triplet”) demonstrated
a statistically significant and clinically meaningful improvement in progression free survival (“PFS”) among patients, reducing
the risk of disease progression or death by 76% compared to fulvestrant (based on a hazard ratio [HR] of 0.24, 95% confidence interval
[CI] 0.17-0.35; p<0.0001). The median PFS (“mPFS”), as assessed by blinded independent central review (“BICR”),
was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months.
Gedatolisib in combination with fulvestrant
(“gedatolisib doublet”) also demonstrated a statistically significant and clinically meaningful improvement in PFS among
patients, reducing the risk of disease progression or death by 67% compared to fulvestrant (based on a HR of 0.33, 95% CI 0.24-0.48;
p<0.0001). The mPFS, as assessed by BICR, was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental
improvement of 5.4 months.
The
topline efficacy data from the VIKTORIA-1 PIK3CA wild-type cohort established several new milestones in the history of drug development
for HR+/HER2- advanced breast cancer (“ABC”):
| |
● |
The
hazard ratios for the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase 3 trial
for patients with HR+/HER2- ABC. |
| |
|
|
| |
● |
The
7.3- and 5.4-months incremental improvements in mPFS for the gedatolisib triplet and gedatolisib doublet over fulvestrant, respectively,
are higher than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving at least their second
line of therapy. |
| |
|
|
| |
● |
Gedatolisib
is the first inhibitor targeting the PI3K/AKT/mTOR pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/PIK3CA
wild-type ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor. |
Treatment
discontinuation due to a treatment-related adverse event for the gedatolisib triplet and gedatolisib doublet was lower than was observed
in Arm D of the Phase 1b trial in patients with ABC, and lower than observed in any Phase 3 trials for currently approved drug combinations
in HR+/HER2- ABC. Additionally, the gedatolisib triplet and gedatolisib doublet were better tolerated than was observed in the Phase
1b trial in patients with ABC, including lower rates of hyperglycemia and stomatitis.
Full
data from the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial will be presented at an upcoming medical conference later
this year. The Company expects to submit a New Drug Application for gedatolisib to the U.S. Food and Drug Administration in the fourth
quarter of 2025. Topline data for the VIKTORIA-1 PIK3CA mutation cohort is expected by the end of 2025.
Forward-Looking
Statements
This
Current Report on Form 8-K (including the exhibit thereto) contains statements that constitute “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic
benefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of topline clinical trial data; the ability
of our data to support the filing of an NDA with the FDA; our expectations regarding the timing of and our ability to obtain FDA approval
to commercialize gedatolisib; and other expectations with respect to gedatolisib. Words such as, but not limited to, “look forward
to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “confidence,”
“encouraged,” “potential,” “plan,” “targets,” “likely,” “may,”
“will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking
statements. The forward-looking statements included in this report are based on management’s current expectations and beliefs which
are subject to a number of risks, uncertainties and factors, including that our topline results are based on a preliminary analysis of
key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial;
unforeseen delays in our planned NDA for gedatolisib; and our ability to obtain and maintain regulatory approvals to commercialize gedatolisib.
In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended
December 31, 2024, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as such risks may be updated in our subsequent
filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements,
and we undertake no obligation to revise or update this report to reflect events or circumstances after the date hereof.
| Item
9.01 |
Financial
Statements and Exhibits. |
| 99.1 |
|
Press release dated July 28, 2025 |
| 104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
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:
July 28, 2025
| |
CELCUITY
INC. |
| |
|
|
| |
By: |
/s/
Brian F. Sullivan |
| |
|
Brian
F. Sullivan |
| |
|
Chief
Executive Officer |
