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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): February 11, 2026
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
5.02 |
Departure
of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
On
February 11, 2026, the Board of Directors (the “Board”) of Celcuity Inc. (the “Company”), upon the recommendation
of the Nominating and Corporate Governance Committee of the Board, voted to increase the size of the Board from seven members to eight
members and to appoint Charles (Chip) R. Romp as a new director to fill the resulting vacancy, effective immediately, for a term extending
through the date of the Company’s 2026 Annual Meeting of Stockholders (the “2026 Annual Meeting”) and the election
of his successor, or his earlier death, resignation or removal. The Board determined that Mr. Romp qualifies as an independent director
pursuant to the listing standards of The Nasdaq Stock Market LLC and the rules of the U.S. Securities and Exchange Commission (the “SEC”).
The Board has not appointed Mr. Romp to serve on any committees of the Board as of the date hereof.
Mr.
Romp will receive compensation for his service in accordance with the Company’s non-employee director compensation program, which
currently provides for an annual cash retainer of $50,000, payable quarterly, and an annual equity award with a fair market value of
$100,000, payable in the form of restricted stock, stock options, or a combination of both, at the director’s election.
Upon
appointment to the Board, the Company granted Mr. Romp a pro-rated annual grant of 215 shares of restricted stock under the Company’s
2017 Stock Incentive Plan, which will vest as to all shares upon the earlier of (i) the 2026 Annual Meeting or (ii) April 30, 2026.
There
are no arrangements or understandings between Mr. Romp and any other persons pursuant to which Mr. Romp was selected as a director of
the Company. There are no relationships or related transactions between Mr. Romp or any member of his immediate family and the Company
that would be required to be reported under Item 404(a) of Regulation S-K.
| Item
7.01 |
Regulation
FD Disclosure. |
On
February 12, 2026, the Company issued a press release announcing the Mr. Romp’s appointment to the Board. A copy of this 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.
| Item
9.01 |
Financial
Statements and Exhibits. |
| 99.1 |
Press release dated February 12, 2026 |
| 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:
February 12, 2026
| |
CELCUITY
INC. |
| |
|
| |
By: |
/s/
Brian F. Sullivan |
| |
|
Brian
F. Sullivan |
| |
|
Chief
Executive Officer |
Exhibit
99.1

Celcuity
Appoints Charles Romp to its Board of Directors
MINNEAPOLIS,
February 12, 2026 — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies
for oncology, today announced the appointment of Charles (Chip) R. Romp to its Board of Directors. Mr. Romp brings over 25 years of experience
in the pharmaceutical industry to Celcuity, including leadership of sales teams and commercial organizations in the oncology setting.
“Chip
brings a wealth of oncology-related commercial expertise to our Board,” said Brian Sullivan, Chief Executive Officer and co-founder
of Celcuity. “Chip’s deep experience commercializing significant oncology drugs will provide valuable insight to Celcuity
as we advance our programs and prepare for the potential approval and launch of gedatolisib later this year.”
Mr.
Romp is currently Chief Executive Officer of Secura Bio, an integrated, commercial-stage pharmaceutical company dedicated to the worldwide
development and commercialization of oncology therapies. Mr. Romp previously served as Executive Vice President, Commercial U.S., at
Seagen, Inc., where he was a member of the Executive Committee and oversaw the company’s entire commercial organization before
its sale to Pfizer. He joined Seagen in 2010 as one of its first commercial employees, where he managed the growth and expansion of ADCETRIS®
(brentuximab vedotin), PADCEV® (enfortumab vedotin-ejfv), TUKYSA® (tucatinib), and TIVDAK® (tisotumab vedotin-tftv). Prior
to Seagen, Mr. Romp held several senior sales leadership positions at Genentech, Inc, where he was responsible for both oncology and
immunology products, including AVASTIN® (bevacizumab), RITUXAN® (rituximab), and XOLAIR® (omalizumab). Mr. Romp received
a Bachelor of Arts from the University of Florida and an MBA from Saint Leo University in Florida.
“Gedatolisib
has tremendous potential to enhance outcomes for women with breast cancer, which gives Celcuity a very significant opportunity to build
an important franchise in oncology,” said Mr. Romp. “I am very excited to join the Board at this important moment in Celcuity’s
history and work with Brian and the Board to share my experience commercializing a number of pathbreaking oncology therapeutics.”
About
Celcuity
Celcuity
is a clinical-stage biotechnology company pursuing the development of targeted therapies for the treatment of multiple solid tumor indications.
The company’s lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades
the PI3K/AKT/mTOR (“PAM”) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently
approved and investigational therapies that target PI3Kα, AKT, or mTORC1 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
(“ABC”), has completed enrollment, and the company has reported detailed results for the PIK3CA wild-type cohort.
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- ABC, is currently enrolling patients. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with
darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. More detailed information about Celcuity’s
active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about
Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.
Forward-Looking
Statements
This
press release 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 clinical trial data; the ability of our data to support the filing of a new drug
application (“NDA”) with the U.S. Food and Drug Administration (the “FDA”); our expectations regarding the timing
of and our ability to obtain FDA approval under the Real-Time Oncology Review program and 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 press release are based on management’s current expectations and beliefs which are subject to a number of risks, uncertainties
and factors, including that our clinical results are based on an ongoing analysis of key efficacy and safety data and our interpretation
of such data may change; unforeseen delays in the review of our 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, 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 press release to reflect events or circumstances after the date hereof.
Contacts:
Celcuity
Inc.
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
(763)
392-0123
Jodi Sievers,
jsievers@celcuity.com
(415) 494-9924