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Item 9A. Controls and Procedures

2025-03-31 compared with 2024-03-27 · 335 added, 247 removed, 99 unchanged (85% of the section changed)

Controls and Procedures

of Disclosure Controls and Procedures

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, 2023.

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

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

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.

on the evaluation of our disclosure controls and procedures as of December 31, 2023, our Chief Executive Officer and Chief Financial

Officer concluded that, as of such date, our disclosure controls and procedures were effective.

Report on Internal Control over Financial Reporting

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, 2023 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.

Annual Report does not include an attestation report of our registered public accounting firm regarding internal control over financial

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.

in Internal Control over Financial Reporting

were no changes to our system of internal control over financial reporting during the three months ended December 31, 2023 and during

the subsequent time period through the filing of this Annual Report that have materially affected, or are reasonably likely to materially

affect, our system of controls over financial reporting.

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, 2024.

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.

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, 2024, 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

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

Management has assessed the effectiveness of our internal control over financial reporting as of December 31, 2024 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.

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, 2024 that have materially affected, or are reasonably likely to materially affect, our system

of internal controls over financial reporting.

Other Information

the three months ended December 31, 2023, none of our directors or officers 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.

On November 19, 2024, Brightstone Venture Capital Fund, LP (“Brightstone”)

adopted a 10b5-1 plan that provided for the sale of up to 220,000 shares of Celcuity Inc.

common stock through November 19, 2025.

plan was terminated on December 12, 2024.

On December 13, 2024,

Brightstone adopted a 10b5-1 plan that provides for the sale of up to 229,325 shares

of Celcuity Inc.

common stock through December 13, 2025.

David Dalvey is a General Partner at Brightstone.

During the three months ended December 31, 2024, 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

March 28, 2025, the Compensation Committee of the Board of Directors (the “Committee”) of the Company

adopted the Celcuity Inc.

Change in Control and Severance Plan (the “Severance Plan”).

The purpose of the Severance Plan

is to provide assurances to employees of the Company of specified benefits in the event of a Change in Control of the Company (as defined

in the Company’s equity plan) or certain terminations of employment following a Change in Control.

The Severance Plan covers all

regular full or part-time employees of the Company, including each executive officer of the Company.

The Committee is responsible for

administering the Severance Plan.

The Severance Plan may be amended or terminated at any time prior

to a Change in Control.

In the event of a

participant’s involuntary termination of employment without cause or resignation for good reason (as such terms are defined in

the Severance Plan) within the twelve-month period following a Change in Control, the Severance Plan provides for:

(i) a severance

payment in an amount ranging from three months to three years of the participant’s base salary and target cash bonus, plus

(ii) COBRA premiums for the participant and their enrolled dependents for the same time period, but no greater than eighteen months,

both payable in a lump sum.

The amount of severance provided under the Severance

three years for the Company’s chief executive officer;

two years for the Company’s other executive officers;

year for the Company’s other executives that are not executive officers;

six months for the Company’s vice presidents;

for all other participants, the greater of (i) three months or (ii) two weeks per each full year of employment, with a maximum of six

In addition, the Severance Plan provides that

in the event of a Change in Control, all outstanding equity awards held by any participant will fully vest (with performance awards vesting

at the greater of target or actual performance levels) immediately upon the effective date of such change in control.

The foregoing description of the Severance Plan

does not purport to be complete and is qualified in its entirety by reference to the full text of the Severance Plan, which is filed

as Exhibit 10.35 hereto and is incorporated herein by reference.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Not applicable.

Directors, Executive Officers and Corporate Governance

Sullivan , age 62, is our co-Founder and has served as Chairman of the Board and Chief Executive Officer since we commenced operations

Sullivan has over 30 years of experience founding and building successful, high growth technology companies.

He was Chairman

and CEO of SterilMed, a medical device reprocessing company, from 2003, when he led an investment group to acquire a majority interest,

until its sale to Ethicon Endo-Surgery Inc., a Johnson & Johnson company, for $330 million in 2011.

Previously, he was co-founder

and Chief Executive Officer of Recovery Engineering, a filtration company, which he took public and subsequently sold to Procter &

Gamble for $265 million in 1999.

Sullivan previously served on the board of directors of two publicly-held companies, Entegris, Inc.

Sullivan , age 63, is our co-Founder

and has served as Chairman of the Board and Chief Executive Officer since we commenced operations in 2012.

Sullivan has over 30 years

of experience founding and building successful, high-growth technology companies.

He was Chairman and CEO of SterilMed, a medical device

reprocessing company, from 2003, when he led an investment group to acquire a majority interest, until its sale to Ethicon Endo-Surgery

Inc., a Johnson & Johnson company, for $330 million in 2011.

Previously, he was co-founder and Chief Executive Officer of Recovery

Engineering, a filtration company, which he took public and subsequently sold to Procter & Gamble for $265 million in 1999.

previously served on the board of directors of two publicly-held companies, Entegris, Inc.

and Virtual Radiologic Inc.

Sullivan has received nine U.S.

has received nine U.S.

patents and has several pending.

He graduated magna cum laude

with distinction from Harvard College with an A.B.

He graduated magna cum laude with distinction from Harvard College with

in economics.

Among other attributes, skills, and qualifications, the board of directors

Sullivan is uniquely qualified to serve as a director based on his extensive operational and business development experience,

and his knowledge in building stockholder value, growing a company from inception and navigating significant corporate transactions and

the public company process.

Laing, Ph.D., age 62, is our co-Founder and has served as Chief Science Officer, Vice President, Secretary and Director since

we commenced operations in 2012.

Laing’s career spans more than 20 years in drug discovery research and technology development.

He received his doctorate in biophysics and biochemistry from The Johns Hopkins University and completed a National Institutes of Health

post-doctoral fellowship at Washington University Medical School.

Among other attributes, skills, and qualifications, the board of directors believes Mr.

Sullivan is uniquely

qualified to serve as a director based on his extensive operational and business development experience, and his knowledge in building

stockholder value, growing a company from inception and navigating significant corporate transactions and the public company process.

Laing, Ph.D., age 63, is our co-Founder

and has served as Chief Science Officer, Vice President, Secretary and Director since we commenced operations in 2012.

career spans more than 20 years in drug discovery research and technology development.

He received his doctorate in biophysics and biochemistry

from The Johns Hopkins University and completed a National Institutes of Health post-doctoral fellowship at Washington University Medical

He has received 24 U.S.

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patents pending.

His drug discovery research career began at Scriptgen/Anadys Pharmaceuticals (purchased by Novartis), where he worked under Professor

Peter Kim, who became President of Merck Research.

He also was Director of Chemistry and Bioapplications and Director of Detection Product

Development for two companies that each developed instruments similar to those Celcuity uses to perform the CELsignia tests.

at these two instrument companies gave him unique expertise and experience in developing a variety of patented applications for these

Most recently, he served as an executive director for an international drug discovery and development company.

attributes, skills, and qualifications, the board of directors believes Dr.

Laing is uniquely qualified to serve as a director based

on his significant research, medical and scientific expertise.

Buller, M.D., Ph.D., age 74, was appointed to Celcuity’s board of directors in December 2019.

Buller has over 15 years

of experience leading oncology clinical development and translational medicine departments at major pharmaceutical companies.

participated in the development of 15 drugs and several companion diagnostics that received U.S.

His drug discovery research career began at Scriptgen/Anadys

Pharmaceuticals (purchased by Novartis), where he worked under Professor Peter Kim, who became President of Merck Research.

Director of Chemistry and Bioapplications and Director of Detection Product Development for two companies that each developed instruments

similar to those Celcuity uses to perform the CELsignia tests.

His work at these two instrument companies gave him unique expertise and

experience in developing a variety of patented applications for these instruments.

Most recently, he served as an executive director for

an international drug discovery and development company.

Among other attributes, skills, and qualifications, the board of directors believes

Laing is uniquely qualified to serve as a director based on his significant research, medical and scientific expertise.

Buller, M.D., Ph.D., age 75, was

appointed to Celcuity’s board of directors in December 2019.

Buller has over 15 years of experience leading oncology clinical

development and translational medicine departments at major pharmaceutical companies.

He has participated in the development of 15 drugs

and several companion diagnostics that received U.S.

FDA approval.

Buller most recently

served as Head Oncology Clinical Development and Vice President of Translational Oncology at Pfizer, Inc, one of the world’s largest

pharmaceutical companies, until he retired in 2016.

He had previously served as Vice President of Translational Medicine at Exelixis,

a leading biopharmaceutical company, where he led efforts to study patients selected by molecular testing for inclusion in their phase

2 and phase 3 clinical trials.

He began his pharmaceutical company career at GlaxoSmithKline as Director of the Oncology Medicine Development

Prior to his leadership positions in drug development, he was Professor of Gynecologic Oncology at the University of Iowa, where

he led laboratory research focused on identifying genomic variants involved in ovarian cancer.

Buller most recently served as Head Oncology Clinical Development

and Vice President of Translational Oncology at Pfizer, Inc, one of the world’s largest pharmaceutical companies, until he retired

He had previously served as Vice President of Translational Medicine at Exelixis, a leading biopharmaceutical company, where

he led efforts to study patients selected by molecular testing for inclusion in their phase 2 and phase 3 clinical trials.

pharmaceutical company career at GlaxoSmithKline as Director of the Oncology Medicine Development Center.

Prior to his leadership positions

in drug development, he was Professor of Gynecologic Oncology at the University of Iowa, where he led laboratory research focused on identifying

genomic variants involved in ovarian cancer.

He received his M.D.

from the Baylor College

of Medicine, where he also received his Ph.D.

from the Baylor College of Medicine, where he also received his Ph.D.

in cell biology.

Among other attributes, skills, and qualifications, the board of directors believes Dr.

Buller is uniquely qualified

to serve as a director based on his oncology drug and diagnostic development expertise.

Dalvey , age 66, has served as a member

of Celcuity’s board of directors since February 2014.

Dalvey has more than 30 years of experience in the fields of

corporate finance and venture capital, working primarily with growth-oriented technology and life-science businesses.

He has over 10 years

of corporate finance advisory experience with two national investment banks, completing over 150 individual transactions.

the General Partner of Brightstone Venture Capital, a venture capital management company, since September 2000.

Brightstone is a

25-year old venture capital management company that has raised and managed ten venture partnerships.

Previously, he held management positions

Steichen and Company, an investment bank, from 1995 to 2000, The Food Fund LP, a venture capital firm, from 1992 to 1995 and

Wessels, Arnold & Henderson, an investment bank, from 1987 to 1992.

Dalvey served on the board of directors for Navarre Corporation

(now Speed Commerce, Inc.) from 2009 until November 2012, on the board of managers for Blue Rock Market Neutral Fund, a mutual fund

registered under the Investment Company Act of 1940 from 2000 to 2014 and on the board of directors for Digitiliti, Inc.

from July 2011

until October 2012.

Dalvey has significant operational exposure as a board director or advisor to many other public and privately

held growth businesses and has served on these companies’ audit, strategic or governance committees, including companies such as

HomeSpotter, Definity Health, AppTec Laboratories, CHF Solutions, BiteSquad, Agiliti, and Nature Vision.

Dalvey received a B.S.

Business/Management Economics from University of Minnesota.

Among other attributes, skills, and qualifications, the board of directors

Buller is uniquely qualified to serve as a director based on his oncology drug and diagnostic development expertise.

Dalvey , age 65, has served as a member of Celcuity’s board of directors since February 2014.

Dalvey has more than 30

years of experience in the fields of corporate finance and venture capital, working primarily with growth-oriented technology and life-science

He has over 10 years of corporate finance advisory experience with two national investment banks, completing over 150 individual

transactions.

He has been the General Partner of Brightstone Venture Capital, a venture capital management company, since September 2000.

Brightstone is a 25-year old venture capital management company that has raised and managed ten venture partnerships.

Previously, he

held management positions with R.J.

Steichen and Company, an investment bank, from 1995 to 2000, The Food Fund LP, a venture capital

firm, from 1992 to 1995 and Wessels, Arnold & Henderson, an investment bank, from 1987 to 1992.

Dalvey served on the board of

directors for Navarre Corporation (now Speed Commerce, Inc.) from 2009 until November 2012, on the board of managers for Blue Rock Market

Neutral Fund, a mutual fund registered under the Investment Company Act of 1940 from 2000 to 2014 and on the board of directors for Digitiliti,

from July 2011 until October 2012.

Dalvey has significant operational exposure as a board director or advisor to many other

public and privately held growth businesses and has served on these companies’ audit, strategic or governance committees, including

companies such as HomeSpotter, Definity Health, AppTec Laboratories, CHF Solutions, BiteSquad, Agiliti, and Nature Vision.

received a B.S.

in Business/Management Economics from University of Minnesota.

Among other attributes, skills, and qualifications, the

board of directors believes Mr.

Dalvey is uniquely qualified to serve as a director based on his leadership experience in operating both

public and private companies and his experience working in the investment community and with investment firms enable him to bring valuable

insight and knowledge to our board of directors.

Furcht, M.D., age 77, was appointed to Celcuity’s board of directors in May 2019.

Furcht is currently Allen-Pardee Professor

of Cancer Biology and Head of the Department of Laboratory Medicine and Pathology at the University of Minnesota and a member of the

Division of Molecular Pathology and Genomics.

He served as Chairman of the Board of Directors for University of Minnesota Physicians,

the Medical School practice plan with approximately 700 physicians, from 2004-2014.

He was also the founding Director of the Biomedical

Engineering Center from 1990-2001, where he led efforts to establish stem cell and molecular diagnostics expertise at the University

of Minnesota.

He has published more than 180 scientific papers and holds more than 30 patents in the fields of polypeptides, biomaterials,

and adult stem cells.

His business experience includes co-founding two medical technology companies, South Bay Medical, a medical device

company that was acquired by Mentor Corporation, and Diascreen, a diagnostics company, which was later acquired by Chronimed.

attributes, skills, and qualifications, the board of directors believes Dr.

Furcht is uniquely qualified to serve as a director based

on his research in tumor cell behavior and extracellular matrix proteins, Head of the University of Minnesota’s Department of Laboratory

Medicine and Pathology, and his experience in several biotechnology start-ups.

Murphy, D.V.M., Ph.D., age 59, was appointed to Celcuity’s board of directors in September 2022.

Murphy has served as

Chief Business Officer at UroGen Pharma, Inc.

since August 2020.

Dalvey is uniquely qualified to serve as a director based on his leadership experience in operating both public and private

companies and his experience working in the investment community and with investment firms, which enable him to bring valuable insight

and knowledge to our board of directors.

Furcht, M.D., age 78, was appointed

to Celcuity’s board of directors in May 2019.

Furcht is currently Allen-Pardee Professor of Cancer Biology and Head of the Department

of Laboratory Medicine and Pathology at the University of Minnesota and a member of the Division of Molecular Pathology and Genomics.

He served as Chairman of the Board of Directors for University of Minnesota Physicians, the Medical School practice plan with approximately

700 physicians, from 2004-2014.

He was also the founding Director of the Biomedical Engineering Center from 1990-2001, where he led efforts

to establish stem cell and molecular diagnostics expertise at the University of Minnesota.

He has published more than 180 scientific papers

and holds more than 30 patents in the fields of polypeptides, biomaterials, and adult stem cells.

His business experience includes co-founding

two medical technology companies, South Bay Medical, a medical device company that was acquired by Mentor Corporation, and Diascreen,

a diagnostics company, which was later acquired by Chronimed.

Among other attributes, skills, and qualifications, the board of directors

Furcht is uniquely qualified to serve as a director based on his research in tumor cell behavior and extracellular matrix

proteins, Head of the University of Minnesota’s Department of Laboratory Medicine and Pathology, and his experience in several biotechnology

Murphy, D.V.M., Ph.D., age 60, was

appointed to Celcuity’s board of directors in September 2022.

Murphy has served as Chief Business Officer at Avadel Pharmaceuticals

plc since May 2024.

Prior to that, Dr.

Murphy served in various leadership roles at Pfizer,

from September 2008 to August 2020, including as Vice President and Head of Early Commercial Development, Pfizer Oncology Business

Unit from January 2019 to August 2020, Vice President and Head of Global Marketing and Commercial Development, Pfizer Oncology Business

Unit from June 2017 to December 2018, and as Vice President and Head of Strategy and Business Development for Pfizer China from November

2013 to May 2018.

Since August 2020, Dr.

Murphy was Chief Business Officer at UroGen Pharma, Inc.

from August 2020 through May 2024 and

served in various leadership roles at Pfizer Inc.

from September 2008 to August 2020, including as Vice President and Head of Early Commercial

Development, Pfizer Oncology Business Unit from January 2019 to August 2020, Vice President and Head of Global Marketing and Commercial

Development, Pfizer Oncology Business Unit from June 2017 to December 2018, and Vice President and Head of Strategy and Business Development

for Pfizer China from November 2013 to May 2018.

Since August 2020,

Murphy as served on the board of directors of Atea Pharmaceuticals, Inc., a publicly held company.

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from Nova Southeastern University.

Among other attributes,

skills, and qualifications, the board of directors believes Dr.

Murphy is uniquely qualified to serve as a director based on her significant

medical and scientific expertise and experience in the pharmaceutical industry in business development

and commercialization.

Nigon , age 76, is currently Senior Vice President of Cedar Point Capital, LLC., a private company that raises capital for early-stage

companies, where he has served since 2007.

Among other attributes, skills, and qualifications,

the board of directors believes Dr.

Murphy is uniquely qualified to serve as a director based on her significant medical and scientific

expertise and experience in the pharmaceutical industry in business development and commercialization.

Nigon , age 77, is currently Senior

Vice President of Cedar Point Capital, LLC., a private company that raises capital for early-stage companies, where he has served since

Nigon has also been a board member for Northern Technologies International Corp.

February 2010, including its non-executive Chairman of the board of directors since November 2012.

Nigon also serves as a director

of several private companies.

Nigon previously served as a board member for Tactile Systems Technology from September 2012 to May

2022, Vascular Solutions, Inc.

from November 2000 to February 2017, when it was acquired by Teleflex, Incorporated and as a board member

for Virtual Radiologic Corporation from May 2007 until it was acquired in July 2010.

since February 2010, including its non-executive

Chairman of the board of directors since November 2012.

Nigon also serves as a director of several private companies.

previously served as a board member for Tactile Systems Technology from September 2012 to May 2022, Vascular Solutions, Inc.

from November 2000

to February 2017, when it was acquired by Teleflex, Incorporated and as a board member for Virtual Radiologic Corporation from May 2007

until it was acquired in July 2010.

From February 2001 until December 2006, Mr.

was a Director of Equity Corporate Finance for Miller Johnson Steichen Kinnard, a privately held investment firm, which was acquired

in December 2006 by Stifel Nicolaus, a brokerage and investment banking firm.

Nigon was a Director of Equity Corporate

Finance for Miller Johnson Steichen Kinnard, a privately held investment firm, which was acquired in December 2006 by Stifel Nicolaus,

a brokerage and investment banking firm.

After that acquisition, Mr.

Nigon became a Managing Director

of Private Placements of Stifel Nicolaus until May 2007.

Nigon became a Managing Director of Private Placements of Stifel

Nicolaus until May 2007.

From February 2000 to February 2001, Mr.

Nigon served as the Chief Financial

Officer of Dantis, Inc., a web hosting company.

Nigon served as the Chief Financial Officer of Dantis,

Inc., a web hosting company.

Prior to joining Dantis, Mr.

Nigon was employed by Ernst & Young LLP from 1970 to

2000, where he served as a partner from 1981 to 2000.

Nigon was employed by Ernst & Young LLP from 1970 to 2000, where he served

as a partner from 1981 to 2000.

While at Ernst & Young, Mr.

Nigon served as the Director of Ernst & Young’s

Twin Cities Entrepreneurial Services Group and was the coordinating partner on several publicly-traded companies in the consumer retailing

and manufacturing sectors.

Nigon served as the Director of Ernst & Young’s Twin Cities

Entrepreneurial Services Group and was the coordinating partner on several publicly-traded companies in the consumer retailing and manufacturing

Among other attributes, skills, and qualifications, the board of directors believes Mr.

Nigon is qualified

to serve as a director because of his extensive public accounting and auditing experience, including particular experience with emerging

growth companies.

The board of directors also believes that Mr.

Nigon will bring to the board of directors a strong background in financial

controls and reporting, financial management, financial analysis, SEC reporting requirements and mergers and acquisitions.

His strategic

planning expertise gained through his management and leadership roles at private investment firms also makes him well-suited to serve

as a member of the board of directors.

regarding our Chief Executive Officer, Brian F.

Nigon is qualified to serve as a director

because of his extensive public accounting and auditing experience, including particular experience with emerging growth companies.

board of directors also believes that Mr.

Nigon will bring to the board of directors a strong background in financial controls and reporting,

financial management, financial analysis, SEC reporting requirements and mergers and acquisitions.

His strategic planning expertise gained

through his management and leadership roles at private investment firms also makes him well-suited to serve as a member of the board of

Executive Officers

Information regarding our Chief Executive Officer,

Sullivan, and our Chief Science Officer, Lance G.

Laing, PhD., is included above under

the heading “Directors”.

Hahne , age 57, joined as our Chief Financial Officer in July 2017.

She has more than 25 years of financial leadership experience,

including the most recent 15 years in the healthcare industry.

Laing, PhD., is included above under the heading “Directors”.

Vicky Hahne , age 58, joined as our Chief Financial

Officer in July 2017.

She has more than 25 years of financial leadership experience, including the most recent 15 years in the healthcare

Prior to joining Celcuity, Ms.

Hahne served as Controller of Respiratory

Technologies Inc., a medical device manufacturer, from 2015 to 2017.

While at Respiratory Technologies, she played a key role in the

due diligence process to sell the company to Koninklijke Philips.

In 2014, she served as Controller for Ability Network Inc., a healthcare

information technology company.

Hahne served as Controller of Respiratory Technologies Inc., a medical device manufacturer, from

2015 to 2017.

While at Respiratory Technologies, she played a key role in the due diligence process to sell the company to Koninklijke

In 2014, she served as Controller for Ability Network Inc., a healthcare information technology company.

From 2007 to 2012, Ms.

Hahne served as Controller of SterilMed Inc., a medical device reprocessing company,

where she was significantly involved in the sale of the company to Johnson & Johnson.

Hahne served as Controller of SterilMed Inc., a medical device reprocessing company, where she was significantly involved in the sale

of the company to Johnson & Johnson.

Prior to these roles, Ms.

Hahne held several

senior financial positions at SimonDelivers Inc., including Chief Financial Officer.

Hahne has extensive experience in early stage,

high growth companies with responsibilities including financial controls and stewardship, financial analysis, mergers and acquisitions,

building infrastructure and systems.

She received a B.S.

degree in Finance and Accounting from Northern State University and received

her CPA certificate in 1990.

board of directors has adopted a Code of Business Conduct and Ethics that applies to our directors, officers and employees.

our CEO, CFO and other senior financial officers of the company are subject to a Code of Ethical Business Conduct for Senior Financial

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:

Hahne held several senior financial positions at SimonDelivers Inc.,

including Chief Financial Officer.

Hahne has extensive experience in early stage, high growth companies with responsibilities including

financial controls and stewardship, financial analysis, mergers and acquisitions, building infrastructure and systems.

She received a

degree in Finance and Accounting from Northern State University and received her CPA certificate in 1990.

Corporate Governance

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

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.

information required by this Item 10 will be contained in our definitive proxy statement for our 2023 Annual Meeting of Stockholders

(the “Definitive Proxy Statement”) and is incorporated herein by reference.

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 2025 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.

Executive Compensation

information required by this Item 11 will be contained in the Definitive Proxy Statement and is incorporated herein by reference.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

information required by this Item 12 will be contained in the Definitive Proxy Statement and is incorporated herein by reference.

Certain Relationships and Related Transactions, and Director Independence

information required by this Item 13 will be contained in the Definitive Proxy Statement and is incorporated herein by reference.

Principal Accounting Fees and Services

information required by this Item 14 will be contained in the Definitive Proxy Statement and is incorporated herein by reference.

Exhibits, Financial Statement Schedules.

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.

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.

Certain Relationships and Related Transactions, and Director

The information required by this Item 13 will be contained

in the Definitive Proxy Statement under the captions and “Corporate Governance” and “Certain Relationships and Related

Transactions” and is incorporated herein by reference.

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.

Exhibits and Financial Statement Schedules.

FINANCIAL STATEMENTS

Report of Independent Registered Public Accounting Firm

1 unchanged sentence

Statements of Operations – Years ended December 31, 2024 and 2023

Statements of Stockholders’ Equity – Years ended December 31, 2023 and 2022

Statements of Changes in Stockholders’ Equity – Years ended December 31, 2024 and 2023

Statements of Cash Flows – Years ended December 31, 2024 and 2023

Notes to Consolidated Financial Statements

STATEMENT SCHEDULES

Exhibit Index immediately following the signature page hereto, which is incorporated herein by reference.

FINANCIAL STATEMENT SCHEDULES

See Exhibit Index immediately following the signature

page hereto, which is incorporated herein by reference.

Form 10-K Summary

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.

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.

March 31, 2025

and Chief Executive Officer

Executive Officer)

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.

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 substitute or substitutes, may lawfully do or cause to be done by virtue

and Chief Executive Officer

Executive Officer)

Financial Officer

Financial and Accounting Officer)

Science Officer, Vice President and Secretary, and

CELCUITY INC.

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.

Chairman and Chief Executive Officer

March 31, 2025

(Principal Executive Officer)

Chief Financial Officer

March 31, 2025

(Principal Financial and Accounting Officer)

Chief Science Officer, Vice President and Secretary, and

March 31, 2025

EXHIBIT INDEX

CELCUITY INC.

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).

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 Annual Report on Form 10-K/A filed with the SEC on April 7, 2023).

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).

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).

3 unchanged sentences

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).

Form of Warrant to Purchase Shares of Common Stock issued by Celcuity Inc.

Form of Warrant to Purchase Common Stock issued by Celcuity Inc.

in connection with the conversion of 1.25% Unsecured Convertible Promissory Notes (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on September 25, 2017).

3 unchanged sentences

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 from Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the SEC on April 8, 2021).

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).

Equity Grant Agreement, dated April 8, 2021, between the Company and Pfizer Inc.

(incorporated by reference from Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on April 8, 2021).

Form of Warrant issued by Celcuity 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).

Form of Stock Purchase Warrant issued by Celcuity Inc.

in connection with the Securities Purchase Agreement, dated May 15, 2022 (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 18, 2022).

Form of Pre-Funded Warrant issued by Celcuity Inc.

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).

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).

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).

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).

Celcuity Inc.

1 unchanged sentence

Celcuity Inc.

Amended and Restated 2017 Stock Incentive Plan (incorporated by reference from Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 14, 2020).

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 15, 2020).

Amendment to the Celcuity Inc.

9 unchanged sentences

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).

Form of Incentive Plan 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).

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).

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).

Commercial Lease, First Amendment to Lease, dated July 28, 2020, between West Glen Development I, LLC and Celcuity Inc.

(incorporated by reference from Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 10, 2020).

(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).

Commercial Lease, Second Amendment to Lease, dated July 19, 2021, between West Glen Development I, LLC and Celcuity Inc.

(incorporated by reference from Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 11, 2021).

(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).

Commercial Lease, Third Amendment to Lease, dated July 27, 2022, by and between Celcuity Inc.

2 unchanged sentences

and West Glen Development I, LLC (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).

Clinical Trial Agreement, dated May 8, 2017, between NSABP Foundation, Inc.

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).

Clinical Trial Agreement, Amendment No.

1, between NSABP Foundation, Inc and Celcuity Inc., 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).

Amendment No.

1, Clinical Trial Agreement for FB-12 Phase II Study, by and between NSABP Foundation, Inc and Celcuity Inc., 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).

Confidentiality, Assignment of Inventions and Non-Competition Agreement, dated November 15, 2011, between Celcuity LLC and Brian F.

6 unchanged sentences

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).

Amendment to License Agreement, dated May 6, 2021, by and between the Company and Pfizer, Inc.

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).

Open Market Sale Agreement SM , dated February 4, 2022, by and between Celcuity Inc., 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).

Securities Purchase Agreement, dated May 15, 2022, by and among the Registrant and the Purchasers 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).

Registration Rights Agreement, dated May 15, 2022, by and among the Registrant and the Purchasers 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).

Securities Purchase Agreement, dated May 15, 2022, by and among the Registrant 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).

Registration Rights Agreement, dated May 15, 2022, by and among the Registrant 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).

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 from Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 11, 2021).

The 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).

(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).

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).

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).

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).

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).

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).

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).

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).

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).

Change in Control and Severance Plan and Summary Plan Description.

Celcuity Inc.

Policy to Prohibit Insider Trading.

Consent of Boulay PLLP.

5 unchanged sentences

Celcuity Inc.

Policy for the Recoupment of Erroneously Awarded Compensation.

statements from the Annual Report on Form 10-K of the Company for the year ended December 31, 2023, formatted, in Inline XBRL:

the Balance Sheets, (ii) the Statements of Operations, (iii) the Statements of Changes in Stockholders’ Equity, (iv) the Statements

of Cash Flows, and (v) the Notes to Financial Statements.

Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101).

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).

The following information from the Annual Report on Form 10-K of the Company for the year ended December 31, 2024, 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.”.

Cover Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101).

* Filed herewith.

3 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures