Item 9A. Controls and Procedures
ITEM
9A. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure
controls and procedures as of December 31, 2025. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e)
and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), means controls and other procedures
of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits
under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and
forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required
to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s
management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required
disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable
assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of
possible controls and procedures.
Based
on the evaluation of our disclosure controls and procedures as of December 31, 2025, our Chief Executive Officer and Chief Financial
Officer concluded that, as of such date, our disclosure controls and procedures were effective.
Management
Report on Internal Control over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined
in Rule 13a-15(f) under the Securities Exchange Act of 1934. Management has assessed the effectiveness of our internal control over financial
reporting as of December 31, 2025 based on criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission
(“COSO – 2013”) in Internal Control-Integrated Framework. Based on this assessment, our Chief Executive Officer and
Chief Financial Officer concluded that our system of internal control over financial reporting was effective as of such date.
This
Annual Report does not include an attestation report of our registered public accounting firm regarding internal control over financial
reporting. Management’s report was not subject to attestation by our registered public accounting firm pursuant to our designation
as a small reporting company or SRC and Non-Accelerated filer.
Changes
in Internal Control over Financial Reporting
There
were no changes to our system of internal control over financial reporting during the three months ended December 31, 2025 that have
materially affected, or are reasonably likely to materially affect, our system of internal controls over financial reporting.
ITEM
9B. Other Information
Trading
Plans
On
December 8, 2025 , Oncology Diagnostic & Drug Development Consulting LLC, an entity controlled by Richard E. Buller , adopted a 10b5-1
plan for the sale of up to 12,000 shares of Celcuity Inc. common stock beginning March 18, 2026 through December 23, 2026 .
During
the three months ended December 31, 2025, none of our other directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted
or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined
in Item 408 of Regulation S-K.
ITEM
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not
applicable.
91
PART
III
ITEM
10. Directors, Executive Officers and Corporate Governance
Information
regarding our executive officers is included in Part I, Item 1 of this Annual Report under the caption “Information About Our Executive
Officers.”
Our
board of directors has adopted a Code of Ethical Business Conduct that applies to our directors, officers and employees. In addition,
our CEO, CFO and other senior financial officers of the company are subject to a Code of Ethical Business Conduct for Senior Financial
Officers. These codes are available on the corporate governance section of our website (which is a subsection of the investor relations
section of our website) at the following address: www.celcuity.com. We intend to disclose on our website any amendments or waivers to
these codes that are required to be disclosed by SEC or Nasdaq rules.
Additional
information required by this Item 10 will be contained in our definitive proxy statement for our 2026 Annual Meeting of Stockholders
(the “Definitive Proxy Statement”) under the captions “Corporate Governance” and “Meetings and Committees
of the Board of Directors” and is incorporated herein by reference.
ITEM
11. Executive Compensation
The
information required by this Item 11 will be contained in the Definitive Proxy Statement under the captions “Corporate Governance,”
“Executive Compensation” and “Director Compensation” and is incorporated herein by reference.
ITEM
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The
information required by this Item 12 will be contained in the Definitive Proxy Statement under the captions “Beneficial Ownership
of Common Stock” and “Securities Authorized for Issuance under Equity Compensation Plans” and is incorporated herein
by reference.
ITEM
13. Certain Relationships and Related Transactions, and Director Independence
The
information required by this Item 13 will be contained in the Definitive Proxy Statement under the captions “Corporate Governance”
and “Certain Relationships and Related Transactions” and is incorporated herein by reference.
ITEM
14. Principal Accountant Fees and Services
The
information required by this Item 14 will be contained in the Definitive Proxy Statement under the caption “Proposal No. 2, Ratification
of Appointment of Independent Registered Public Accounting Firm” and is incorporated herein by reference.
PART
IV
ITEM
15. Exhibits and Financial Statement Schedules
FINANCIAL
STATEMENTS
Item
Page
Report of Independent Registered Public Accounting Firm
65
Balance Sheets – December 31, 2025 and 2024
66
Statements of Operations – Years ended December 31, 2025 and 2024
67
Statements of Changes in Stockholders’ Equity – Years ended December 31, 2025 and 2024
68
Statements of Cash Flows – Years ended December 31, 2025 and 2024
69
Notes to Financial Statements
70
FINANCIAL
STATEMENT SCHEDULES
None.
EXHIBITS
See
Exhibit Index immediately following the signature page hereto, which is incorporated herein by reference.
ITEM
16. Form 10-K Summary
None.
92
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
Dated:
March 26, 2026
CELCUITY
INC.
By
/s/
Brian F. Sullivan
Brian
F. Sullivan
Chairman
and Chief Executive Officer
(Principal
Executive Officer)
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
Each
person whose signature appears below constitutes and appoints Brian F. Sullivan and Vicky Hahne as the undersigned’s true and lawful
attorneys-in fact and agents, each acting alone, with full power of substitution and resubstitution, for the undersigned and in the undersigned’s
name, place and stead, in any and all amendments to this Annual Report on Form 10-K and to file the same, with all exhibits thereto,
and other documents in connection therewith, with the Securities and Exchange Commission, granted unto said attorneys-in-fact and agents,
each acting alone, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and
about the premises, as fully to all intents and purposes as the undersigned might or could do in person, hereby ratifying and confirming
all said attorneys-in-fact and agents, each acting alone, or his or her substitute or substitutes, may lawfully do or cause to be done
by virtue thereof.
Signature
Title
Date
/s/
Brian F. Sullivan
Chairman
and Chief Executive Officer
March 26, 2026
Brian
F. Sullivan
(Principal
Executive Officer)
/s/
Vicky Hahne
Chief
Financial Officer
March 26, 2026
Vicky
Hahne
(Principal
Financial and Accounting Officer)
/s/
Lance G. Laing
Chief
Science Officer, Vice President and Secretary, and
March 26, 2026
Lance
G. Laing
Director
/s/
Richard E. Buller
Director
March 26, 2026
Richard
E. Buller
/s/
Dave F. Dalvey
Director
March 26, 2026
Dave
F. Dalvey
/s/
Leo T. Furcht
Director
March 26, 2026
Leo
T. Furcht
/s/
Polly A. Murphy
Director
March 26, 2026
Polly
A. Murphy
/s/
Richard J. Nigon
Director
March 26, 2026
Richard
J. Nigon
/s/
Charles R. Romp
Director
March 26, 2026
Charles
R. Romp
93
EXHIBIT
INDEX
CELCUITY
INC.
FORM
10-K
Exhibit
No.
Description
2.1
Form of Plan of Conversion (incorporated by reference to Exhibit 2.1 to the Company’s Registration Statement on Form S-1/A filed with the SEC on September 12, 2017).
3.1
Certificate of Incorporation of the Company, as amended, including the Certificate of Designations of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on October 9, 2024).
3.2
Bylaws of the Company (incorporated by reference to Exhibit 3.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 13, 2017).
4.1
Specimen Certificate representing shares of common stock of Celcuity Inc. (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1/A filed with the SEC on September 12, 2017).
4.2*
Description of Registered Securities.
4.3
Form of Warrant to Purchase Units of Membership Interest issued by Celcuity LLC to Cedar Point Capital, LLC, as placement agent of membership units and unsecured convertible promissory notes of Celcuity LLC (incorporated by reference to Exhibit 10.9 to the Company’s Registration Statement on Form S-1 filed with the SEC on August 23, 2017).
4.4
Form of Warrant issued by Celcuity Inc. to Innovatus Life Sciences Lending Fund I, LP in connection with the Loan and Security Agreement dated April 8, 2021 (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the SEC on April 8, 2021).
4.5
Equity Grant Agreement, dated April 7, 2021, between the Company and Pfizer Inc. (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on April 8, 2021).
4.6
Form of Pre-Funded Warrant to Purchase Common Stock issued by Celcuity Inc. in connection with the Securities Purchase Agreement, dated October 18, 2023 (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on October 23, 2023).
4.7
Form of Amendment to Placement Agent’s Warrants, dated February 13, 2024 (incorporated by reference to Exhibit 4.3 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 15, 2024).
4.8
Form of Amendment to Warrants to Purchase Shares of Common Stock, dated February 13, 2024 (incorporated by reference to Exhibit 4.5 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 15, 2024).
94
4.9
Form of Warrant to Purchase Stock issued by Celcuity Inc. in connection with the Amended and Restated Loan Agreement, dated May 30, 2024 (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 30, 2024).
4.10
Form of Pre-Funded Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on July 31, 2025).
4.11
Indenture, dated as of August 1, 2025, between Celcuity Inc. and U.S. Bank Trust Company, National Association, as trustee (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on August 1, 2025).
4.12
First Supplemental Indenture, dated as of August 1, 2025, between Celcuity Inc. and U.S. Bank Trust Company, National Association, as trustee (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the SEC on August 1, 2025).
4.13
Form of Certificate Representing the 2.750% Convertible Senior Notes due 2031 (included as Exhibit A in Exhibit 4.12 above).
4.14
Form of Warrant to Purchase Stock issued by Celcuity Inc. in connection with the Third Amendment to Amended and Restated Loan and Security Agreement, dated September 9, 2025 (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on September 10, 2025).
10.1+
Celcuity Inc. 2017 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.1 to the Company’s Registration Statement on Form S-1/A filed with the SEC on September 12, 2017).
10.2+
Celcuity Inc. Amended and Restated 2017 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 16, 2025).
10.3+
Amendment to the Celcuity Inc. Amended and Restated 2017 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 12, 2023).
10.4+
Form of Stock Option Agreement pursuant to Celcuity Inc. 2017 Stock Incentive Plan (incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-1/A filed with the SEC on September 12, 2017).
10.5+
Form of Restricted Stock Agreement pursuant to Celcuity Inc. 2017 Stock Incentive Plan (incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form S-1/A filed with the SEC on September 12, 2017).
10.6+
Form of Restricted Stock Unit Agreement pursuant to Celcuity Inc. 2017 Stock Incentive Plan (incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1/A filed with the SEC on September 12, 2017).
10.7+
Form of Stock Appreciation Rights Agreement pursuant to Celcuity Inc. 2017 Stock Incentive Plan (incorporated by reference to Exhibit 10.6 to the Company’s Registration Statement on Form S-1/A filed with the SEC on September 12, 2017).
10.8+
Celcuity LLC 2012 Equity Incentive Plan, adopted August 10, 2012, as amended by First Amendment to the Celcuity LLC 2012 Equity Incentive Plan, adopted November 12, 2015 (incorporated by reference to Exhibit 10.7 to the Company’s Registration Statement on Form S-1 filed with the SEC on August 23, 2017).
10.9+
Form of Unit Option Agreement pursuant to the Celcuity LLC 2012 Equity Incentive Plan (incorporated by reference to Exhibit 10.8 to the Company’s Registration Statement on Form S-1 filed with the SEC on August 23, 2017).
95
10.10
Commercial Lease, dated September 28, 2017, between West Glen Development I, LLC and Celcuity, LLC (incorporated by reference to Exhibit 10.11 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 13, 2017).
10.11
Commercial Lease, First Amendment to Lease, dated July 28, 2020, between West Glen Development I, LLC and the Company (incorporated by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 10, 2020).
10.12
Commercial Lease, Second Amendment to Lease, dated July 19, 2021, between West Glen Development I, LLC and the Company (incorporated by reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 11, 2021).
10.13
Commercial Lease, Third Amendment to Lease, dated July 27, 2022, by and between West Glen Development I, LLC and the Company (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on July 29, 2022).
10.14
Commercial Lease, Fourth Amendment to Lease, dated March 13, 2023, by and between West Glen Development I, LLC and the Company (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on March 15, 2023).
10.15
Clinical Trial Agreement, dated May 8, 2017, by and between NSABP Foundation, Inc. and Celcuity LLC (incorporated by reference to Exhibit 10.13 to the Company’s Registration Statement on Form S-1 filed with the SEC on August 23, 2017).
10.16
Amendment No. 1, Clinical Trial Agreement for FB-12 Phase II Study, by and between NSABP Foundation, Inc and the Company, dated October 15, 2020 (incorporated by reference Exhibit 10.15 to the Company’s Annual Report on Form 10-K filed with the SEC on February 16, 2021).
10.17+
Confidentiality, Assignment of Inventions and Non-Competition Agreement, dated November 15, 2011, between Celcuity LLC and Brian F. Sullivan (incorporated by reference to Exhibit 10.14 to the Company’s Registration Statement on Form S-1 filed with the SEC on August 23, 2017).
10.18+
Confidentiality, Assignment of Inventions and Non-Competition Agreement, dated November 15, 2011, between Celcuity LLC and Lance G. Laing (incorporated by reference to Exhibit 10.15 to the Company’s Registration Statement on Form S-1 filed with the SEC on August 23, 2017).
10.19+
Confidentiality, Non-Compete, and Proprietary Rights Agreement, dated May 17, 2017, between Celcuity LLC and Vicky Hahne (incorporated by reference to Exhibit 10.16 to the Company’s Registration Statement on Form S-1 filed with the SEC on August 23, 2017).
10.20
Form of Indemnification Agreement between the Company and each of its officers and directors (incorporated by reference to Exhibit 10.17 to the Company’s Registration Statement on Form S-1/A filed with the SEC on September 12, 2017).
10.21†
License Agreement, dated April 8, 2021, by and between the Company and Pfizer Inc. (incorporated by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 11, 2021).
10.22†
Amendment No. 1 to License Agreement, dated May 6, 2021, by and between the Company and Pfizer Inc. (incorporated by reference to Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 11, 2021).
10.23
Open Market Sale Agreement SM , dated February 4, 2022, by and between the Company and Jefferies LLC (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed with the SEC on February 4, 2022).
10.24
Securities Purchase Agreement, dated May 15, 2022, by and among the Company and the Investors named therein (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 18, 2022).
96
10.25
Registration Rights Agreement, dated May 15, 2022, by and among the Company and the Investors named therein (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on May 18, 2022).
10.26
Loan and Security Agreement, dated as of April 8, 2021, by and between the Company and Innovatus Life Sciences Lending Fund I, LP (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 11, 2021).
10.27
First Amendment to Loan and Security Agreement, dated August 9, 2022, by and among the Company and Innovatus Life Sciences Lending Fund I, LP (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on August 11, 2022).
10.28
Securities Purchase Agreement, dated October 18, 2023, by and among the Company and the Investors named therein (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on October 23, 2023).
10.29
Registration Rights Agreement, dated October 18, 2023, by and among the Company and the Investors named therein (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on October 23, 2023).
10.30
Second Amendment to Loan and Security Agreement, dated March 29, 2024, by and among the Company and Innovatus Life Sciences Lending Fund I, LP (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on March 29, 2024).
10.31+
Amendment to the Celcuity Inc. Amended and Restated 2017 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 13, 2024).
10.32+
Amendment to Form of Stock Option Agreement pursuant to Celcuity Inc. Amended and Restated 2017 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 15, 2024).
10.33+
Form of Non-Qualified Stock Option Transfer Agreement pursuant to Celcuity Inc. Amended and Restated 2017 Stock Incentive Plan (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 15, 2024).
10.34†
Amended and Restated Loan and Security Agreement, dated May 30, 2024, by and among the Company, Innovatus Life Sciences Lending Fund I, LP, as collateral agent, and the Lenders named therein (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 30, 2024).
10.35+
Celcuity Inc. Change in Control and Severance Plan and Summary Plan Description (incorporated by reference to Exhibit 10.35 to the Company’s Annual Report on Form 10-K filed with the SEC on March 31, 2025).
10.36+
Form of Stock Option Agreement (Performance-Based) pursuant to Celcuity Inc. Amended and Restated 2017 Stock Incentive Plan (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 15, 2025).
10.37
First Amendment to Amended and Restated Loan and Security Agreement, dated May 13, 2025, by and among the Company, Innovatus Life Sciences Lending Fund I, LP, as collateral agent, the Lenders named therein and Oxford Finance LLC (incorporated by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 15, 2025).
10.38
Second Amendment to Amended and Restated Loan and Security Agreement, dated July 28, 2025, by and among the Company, Innovatus Life Sciences Lending Fund I, LP, as collateral agent, the Lenders named therein and Oxford Finance LLC (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on July 29, 2025).
97
10.39†
Third Amendment to Amended and Restated Loan and Security Agreement, dated September 9, 2025, by and among the Company, Oxford Finance LLC, as collateral agent, the Lenders named therein and Innovatus Life Sciences Lending Fund I, LP (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on September 10, 2025).
10.40+*
Form of Restricted Stock Unit Agreement pursuant to Celcuity Inc. 2017 Stock Incentive Plan.
19*
Celcuity Inc. Policy to Prohibit Insider Trading.
23.1*
Consent of Boulay PLLP.
24.1*
Power of Attorney (included on the signature page).
31.1*
Certification of principal executive officer required by Rule 13a-14(a).
31.2*
Certification of principal financial officer required by Rule 13a-14(a).
32.1**
Section 1350 Certification of principal executive officer.
32.2**
Section 1350 Certification of principal financial officer.
97
Celcuity Inc. Policy for the Recoupment of Erroneously Awarded Compensation (incorporated by reference to Exhibit 97 to the Company’s Annual Report on Form 10-K filed with the SEC on March 27, 2024).
101
The following information from the Annual Report on Form 10-K of the Company for the year ended December 31, 2025, formatted, in Inline XBRL: (i) the Balance Sheets, (ii) the Statements of Operations, (iii) the Statements of Changes in Stockholders’ Equity, (iv) the Statements of Cash Flows, (v) the Notes to Financial Statements, and (vi) the information under Part II, Item 9B “Other Information.”
104
Cover Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101).
*
Filed herewith.
**
Furnished herewith.
+
Management contract or compensatory plan.
†
Certain portions have been omitted from this exhibit.
98