What changed in this filing

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Item 8. Financial Statements and Supplementary Data

2024-03-27 compared with 2023-03-23 · 279 added, 320 removed, 627 unchanged (49% of the section changed)

42 unchanged sentences

Cash and cash equivalents

Deferred transaction costs

Payroll tax receivable

Prepaid assets

Other current assets

Total current assets

2 unchanged sentences

$ 191,219,398

$ 175,697,097

Liabilities and Stockholders’ Equity:

5 unchanged sentences

Total current liabilities

Finance lease liabilities

Operating lease liabilities

5 unchanged sentences

2,500,000 shares authorized;

1,120,873 and 0 shares issued and outstanding as of December 31, 2022 and December 31, 2021

854,134 and 1,120,873 shares issued and outstanding as of December 31, 2023 and 2022, respectively

Common stock, $ 0.001 par value:

65,000,000 and 25,000,000 shares authorized;

21,667,250 and 14,918,887 shares issued and outstanding as of December 31, 2022 and December 31, 2021, respectively

65,000,000 shares authorized as of December 31, 2023 and 2022, respectively;

25,506,012 and 21,667,250 shares issued and outstanding as of December 31, 2023 and 2022, respectively

Additional paid-in capital

5 unchanged sentences

$ 191,219,398

$ 175,697,097

accompanying notes to the financial statements

13 unchanged sentences

Interest income

Loss on sale of fixed assets

Other income (expense), net

( 1,249,351 )

Net loss before income taxes

9 unchanged sentences

Preferred Stock

Additional Paid-In

Balance at December 31, 2021

$ 124,622,405

$ ( 55,926,847 )

Stock-based compensation

Employee stock purchases

Exercise of common stock warrants

Exercise of common stock options, net of shares withheld for exercise price

Issuance of common stock upon closing of follow-on offerings, net of underwriting discounts and offering costs

Issuance of common stock in an at-the-market (“ATM”) offering

Issuance costs associated with ATM offering

Issuance of common stock warrants, note payable

Issuance of common stock, licensing agreement

Issuance of common and preferred stock upon closing of private placement offering

Issuance costs associated with private placement offering

( 4,316,534 )

Issuance of common stock in an ATM offering

Issuance costs associated with an ATM offering

( 40,370,040 )

Balance at December 31, 2022

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$ ( 96,296,887 )

$ 133,771,467

$ 230,045,566

$ ( 96,296,887 )

$ 133,771,467

Stock-based compensation

Conversion of preferred to common stock

Employee stock purchases

Exercise of common stock options, net of shares withheld for exercise price

Issuance of common and preferred stock upon closing of private placement offering

Exercise of common stock warrants

Issuance costs associated with private placement offering

( 4,316,534 )

Issuance of common stock in an ATM offering

Issuance costs associated with an ATM offering

Issuance of pre-funded warrants

Issuance costs associated with pre-funded warrants

( 63,779,116 )

7 unchanged sentences

$ 139,769,322

See accompanying notes to the financial statements

accompanying notes to the financial statements

of Cash Flows

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Stock-based compensation

Issuance of common stock, licensing agreement

Amortization of debt issuance costs and discount

Non-cash operating lease, net

Loss on sale of fixed assets

Change in accrued interest income

Changes in operating assets and liabilities:

Payroll tax receivable

Prepaid assets and deposits

Other current assets

( 3,438,018 )

( 5,526,381 )

Accounts payable

4 unchanged sentences

Cash flows from investing activities:

Proceeds from maturities of investments

Purchases of investments

( 314,525,084 )

( 143,873,026 )

Purchases of property and equipment

Proceeds from sale of property and equipment

Net cash used for investing activities

( 5,008,207 )

( 144,031,794 )

Cash flows from financing activities:

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Proceeds from employee stock purchases

Proceeds from follow-on offering, net of underwriting discounts and offering costs

Proceeds from an ATM offering, net of commission fees and offering costs

Proceeds from note payable, net of debt issuance and discount costs

Proceeds from a private placement offering, net of discounts and offering costs

Proceeds from note payable, net of debt issuance and discount costs

Proceeds from an ATM offering, net of commission fees and offering costs

Proceeds from pre-funded warrants, net of offering costs

Payments for secondary registration statement costs

Payments for debt issuance costs

Payments for finance leases

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Deferred financing costs and offering and registration statement costs included in accounts payable

Issuance of common stock warrants and final fee recognized as discount to note payable

Property and equipment included in accounts payable

accompanying notes to the financial statements

TO FINANCIAL STATEMENTS

Inc., a Delaware corporation (the “Company”), is a clinical-stage biotechnology company focused on development of targeted

therapies for multiple solid tumor indications.

The Company’s lead therapeutic candidate is gedatolisib, a potent pan-PI3K and

mTOR inhibitor.

Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational

therapies that target PI3K or mTOR alone or together.

A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with

fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients.

Its CELsignia

companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to

benefit from already approved targeted therapies.

The Company was co-founded in 2012 by Brian F.

Inc., a Delaware corporation (the “Company”), is a clinical-stage biotechnology company pursuing development for oncology.

The Company’s lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTOR inhibitor.

Its mechanism of action and pharmacokinetic

properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together.

A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients

with HR+/HER2- advanced breast cancer is currently enrolling patients.

A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib

in combination with darolutamide in patients with metastatic castration resistant prostate cancer, was initiated in the first quarter

of 2024 and is currently enrolling patients.

The Company’s CELsignia companion diagnostic platform is uniquely able to analyze

live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies.

was co-founded in 2012 by Brian F.

Sullivan and Dr.

is based in Minnesota.

The Company has not generated any revenues to date.

Placement Offering

December 9, 2022, the Company completed the closing (funding) of its private placement offering with certain institutional and other

accredited investors for the sale of Company common stock, preferred stock that may be convertible into common stock and warrants

exercisable for common stock for $ 100

million in the aggregate, before deducting placement agent fees and other offering expenses of $ 4.3

The closing followed dosage of the first patient in Celcuity’s Phase 3 clinical trial, VIKTORIA-1.

Laing and is based in Minnesota.

The Company has not generated any revenues

Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements

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and Cash Equivalents

Company maintains its accounts at one financial institution.

Company maintains its accounts at two financial institutions.

At times throughout the year, the Company’s cash balances may exceed

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immaterial as of December 31, 2023.

At December 31, 2022 and December 31, 2021, the Company had $ 144,015,954 and $ 0 , respectively, of

short-term investments.

At December 31, 2023 and December 31, 2022, the Company had $ 149,919,974 and $ 144,015,954 , respectively,

of short-term investments.

and Equipment

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useful lives of property and equipment are as follows for the major classes of assets:

of Estimated Useful Lives of Property and Equipment

Schedule of Estimated Useful Lives of Property and Equipment

Asset Description

Estimated Lives

Furniture and Equipment

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Transaction Costs

transaction costs for the year ended December 31, 2022, primarily consist of legal fees that were capitalized as incurred and will be

offset against the proceeds from future ATM offerings.

The deferred transaction costs will be reviewed periodically to assess the probability

that future securities will be offered.

transaction costs in 2022 primarily consist of legal fees that are capitalized as incurred and will be offset against the proceeds

from future ATM offerings.

The deferred transaction costs will be reviewed periodically to assess the probability that future

securities will be offered.

In the event that no future offering will occur, any deferred transaction costs will be expensed.

Total costs incurred, but not accounted for as a reduction in equity, were $ 33,195 and $ 22,144 as of December 31, 2022 and 2021, respectively.

costs incurred, but not accounted for as a reduction in equity, were $ 0

and $ 33,195 as

of December 31, 2023 and 2022, respectively.

Comprehensive

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expenses incurred.

As the current VIKTORIA-1 Phase 3 trial ramps up site activation and patient enrollment, the Company’s

estimated expenses in future periods and actual services performed may vary from these estimates, and these estimates may become

more significant.

Changes in these estimates that result in material changes to the Company’s prepaid assets or accrued

expenses could materially affect the Company’s results of operations.

As the current VIKTORIA-1 Phase 3 and CELC-G-201 Phase 1b/2 trials ramp up site activation and patient

enrollment, the Company’s estimated expenses in future periods and actual services performed may vary from these estimates,

and these estimates may become more significant.

Changes in these estimates that result in material changes to the Company’s

prepaid assets or accrued expenses could materially affect the Company’s results of operations.

Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions.

Adopted Accounting Pronouncements

May 2021, the FASB issued Accounting Standards Update (ASU) No.

2021-04, Issuer’s Accounting for Certain Modifications or

Exchanges of Freestanding Equity-Classified Written Call Options, which provides guidance on how an issuer should account for

modifications made to equity-classified written call options.

The guidance in the ASU requires the issuer to treat the modification

of an equity-classified warrant that does not cause the warrant to become liability-classified as an exchange of the original

warrant for a new warrant.

The issuer should measure the effect of a modification as the difference between the fair value of the

modified warrant and the fair value of that warrant immediately before modification.

The standard is effective for all entities for

all fiscal years beginning after December 15, 2021.

The Company adopted this accounting standard effective January 1, 2022, and

based on the standard, determined that the Representative’s Warrant amendment was equity-classified, treated as a deemed

dividend within Additional Paid-in Capital, and the estimated incremental fair value of the modification for the

Representative’s Warrant at the date of amendment was $ 271,988 .

on the Company’s cash and cash equivalents and short-term investments on hand at December 31, 2023 of $ 30,662,774 and $ 149,919,974 ,

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common shares outstanding during the period.

For all periods presented, the common shares underlying the preferred stock, options, and

warrants have been excluded from the calculation because their effect would be anti-dilutive.

Therefore, the weighted-average shares

outstanding used to calculate both basic and diluted loss per common share are the same.

the years ended December 31, 2022 and 2021, potentially dilutive securities excluded from the computations of diluted

weighted-average shares outstanding were preferred stock on an as-if-converted to common stock basis of 11,208,730 and zero shares

of common stock, respectively, options to purchase 1,976,586

and 1,315,321

shares of common stock, respectively, warrants to purchase 7,266,102

shares of common stock, respectively, and 3,273

shares of restricted common stock, respectively.

For all periods presented, the common shares underlying the preferred stock, options, warrants,

and restricted stock have been excluded from the calculation because their effect would be anti-dilutive.

Therefore, the weighted-average

shares outstanding used to calculate both basic and diluted loss per common share are the same.

following table summarizes the potentially-dilutive shares excluded from the diluted weighted-average shares outstanding:

Schedule of Potentially-Dilutive Shares Excluded from the Diluted Weighted-Average Shares Outstanding

Potentially-dilutive shares excluded from diluted weighted-average shares outstanding:

Preferred stock on an as-if-converted to common stock

Options to purchase common stock

Warrants to purchase common stock

Restricted common stock

warrant shares of 5,747,787 are included in the computation of basic and diluted net loss per share for the year ended December 31, 2023,

as the pre-funded warrants are issuable for nominal consideration.

accordance with ASU 2021-04, for purposes of calculating basic and diluted net loss per share for the year ended December 31, 2022, the

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December 31, 2022.

following table summarizes the Company’s held-to-maturity investment securities at amortized cost as of December 31, 2022:

of Investments

following table summarizes the Company’s held-to-maturity investment securities at amortized cost as of December 31, 2023 and 2022:

Schedule of Investment

Amortized Cost, as Adjusted

1 unchanged sentence

Gross Unrealized Holding Losses

Estimated Fair Value

December 31, 2023

2 unchanged sentences

Gross Unrealized Holding Losses

Estimated Fair Value

Treasury Bills

$ 149,919,974

$ 149,950,969

$ 149,919,974

$ 149,950,969

Amortized Cost, as Adjusted

Gross Unrealized Holding Gains

Gross Unrealized Holding Losses

December 31, 2022

Amortized Cost, as Adjusted

Gross Unrealized Holding Gains

Gross Unrealized Holding Losses

Governmental Agency Securities

2 unchanged sentences

$ 144,087,110

Company had no investments as of December 31, 2021.

fair value of the Company’s held-to-maturity debt securities are determined based upon inputs, other than the quoted

prices in active markets, that are observable either directly or indirectly and are classified as level 2 fair value instruments.

Payroll Tax Receivable

payroll tax receivable is the result of the Company’s utilization of research and development tax credits as authorized by the

The balance at December 31, 2022 was $ 203,665 and December 31, 2021 was $ 298,764 .

Prepaid Assets

assets consisted of the following at December 31:

of Prepaid Assets

Directors & officers’ insurance

fair value of the Company’s held-to-maturity debt securities are determined based upon inputs, other than the quoted prices in

active markets, that are observable either directly or indirectly, and are classified as level 2 fair value instruments.

Other Current Assets

current assets consisted of the following at December 31:

Schedule of Other Current Assets

Prepaid clinical trial

Miscellaneous receivable

Prepaid directors & officers’ insurance

Prepaid research & development

Clinical trial

Property and Equipment

and equipment consisted of the following at December 31:

of Property and Equipment

Leasehold improvements

Summary of Property and Equipment

Furniture and equipment

Leasehold improvements

Property and equipment, Gross

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expenses consisted of the following at December 31:

of Accrued Expenses

Schedule of Accrued Expenses

Clinical trial costs

Accrued compensation

Employee stock purchase plan

Clinical trial costs

and Finance Leases

Company leases its corporate space in Minneapolis, Minnesota.

In September 2017, the Company entered into a non-cancelable operating

lease agreement for building space.

The new lease commenced, and the Company moved to the facility in May 2018, in conjunction with the

termination of its then existing lease.

Rent expense is recorded on a straight-line basis over the lease term.

In July 2020 the Company

signed an amendment to extend this lease through April 30, 2022.

The lease amendment provides for monthly rent, real estate taxes and

operating expenses.

As a result of the lease amendment, the Company recorded an incremental $ 197,211 in the operating right-of-use (“ROU”)

asset and lease liability.

In July 2021, the Company signed the second amendment to extend this lease through April 30, 2023.

This amendment

provides for monthly rent, real estate taxes and operating expenses.

The Company recorded an incremental $ 193,517 in the operating right-of-use

(“ROU”) asset and lease liability pertaining to this amendment.

In July 2022, the Company signed the third amendment to extend

this lease through April 30, 2024.

The Company leases its corporate space in Minneapolis, Minnesota, with

an operating lease in place through April 30, 2026.

The lease provides for monthly rent, real estate taxes, and operating expenses.

expense is recorded on a straight-line basis over the lease term.

In March 2023, the Company signed the fourth amendment to extend this

lease through April 30, 2026.

This amendment provides for monthly rent, real estate taxes and operating expenses.

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The lease contains a bargain purchase option at the end of the lease.

The finance lease

expired in May 2023 and the equipment was acquired for the bargain purchase option price.

an implicit rate is not provided, the Company uses its incremental borrowing rate based on the information available at the lease commencement

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balance sheet information consisted of the following at December 31, 2023:

of Supplemental Balance Sheet Information Related to Leases

Schedule of Supplemental Balance Sheet Information Related to Leases

Operating Lease

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Long term portion

Finance Lease

Furniture and equipment

Accumulated depreciation

Net book value of property and equipment under finance lease

Finance lease liability

short term portion

Long term portion

analysis under lease agreements consisted of the following as of December 31, 2023:

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Operating Leases

Finance Leases

Total minimum lease payments

Present value discount

Less amount representing services

Present value of net minimum lease payments

Weighted Average

Remaining Lease Term

Discount Rate

Operating lease

Finance lease

costs for the years ended December 31:

of Lease Costs

Lease costs for the period ended December 31:

Schedule of Lease Costs

Operating lease cost

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Variable lease cost

Total lease cost

cash flow information related to leases for the years ended December 31:

of Supplemental Cash Flow Information Related to Leases

cash flow information related to leases period ended December 31:

Schedule of Supplemental Cash Flow Information Related to Leases

Cash paid for amounts included in operating and finance leases:

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Research Studies

Company enters into contracts in the normal course of business to conduct research and development programs internally and through third

parties that include, among others, arrangements with vendors, consultants, CMO’s, and CRO’s.

The Company currently has four

Phase 2 clinical trial agreements in place to evaluate targeted therapies selected with one of our CELsignia tests.

Timing of milestone

payments related to the Phase 2 clinical trials are uncertain and the contracts generally provide for termination following a certain

period after notice, therefore the Company believes that non-cancelable obligations under the agreements are not material.

also has a license agreement in place with Pfizer to research, develop, manufacture and commercialize gedatolisib.

In conjunction with

the license agreement, the Company continued a Phase 1b study – B2151009 related to gedatolisib.

These patients subsequently transitioned

to an Expanded Access study – CELC-G-001.

Contracts related to the Phase 1B study and the Expanded Access study, are generally

based on time and material.

In addition, contracts related to the Company’s Phase 3 clinical study (VIKTORIA-1) are generally cancelable

with reasonable notice within 120 days and the Company’s obligations under these contracts are primarily based on services performed

through termination dates plus certain cancelation charges, if any, as defined in each of the respective agreements.

In addition, these

agreements may, from time to time, be subjected to amendments as a result of any change orders executed by the parties.

As of December

31, 2022, the Company had only one material non-cancelable contractual commitment with respect to these arrangements, which totaled approximately

$ 2.3 million.

Company enters into contracts in the normal course of business to conduct research and development programs internally and through

third parties that include, among others, arrangements with vendors, consultants, CMO’s, and CRO’s.

currently has three Phase 2 clinical trial agreements in place to evaluate targeted therapies selected with one of our CELsignia

Timing of milestone payments related to the Phase 2 clinical trials are uncertain and the contracts generally provide for

termination following a certain period after notice, therefore the Company believes that non-cancelable obligations under the

agreements are not material.

The Company also has a license agreement in place with Pfizer to research, develop, manufacture and

commercialize gedatolisib.

In conjunction with the license agreement, the Company continued a Phase 1b study – B2151009

related to gedatolisib.

These patients subsequently transitioned to an Expanded Access study – CELC-G-001.

Contracts related

to the Phase 1B study and the Expanded Access study, are generally based on time and material.

In addition, contracts related to the

Company’s Phase 3 clinical study (VIKTORIA-1) and Phase 1b/2 clinical study (CELC-G-201) are generally cancelable with reasonable notice within 120 days and the

Company’s obligations under these contracts are primarily based on services performed through termination dates plus certain

cancelation charges, if any, as defined in each of the respective agreements.

In addition, these agreements may, from time to time,

be subjected to amendments as a result of any change orders executed by the parties.

As of December 31, 2023, the Company had two

material non-cancelable contractual commitment with respect to these arrangements, which totaled approximately $ 2.1

Stockholders’ Equity

December 31, 2021, the Company’s authorized capital stock consisted of 25,000,000 shares of $ .001 par value common stock, of which

14,918,887 shares were outstanding, and 2,500,000 shares of $ .001 par value preferred stock, of which 0 were outstanding.

authorized number of shares of common stock was increased to 30,000,000 shares on May 12, 2022 and to 65,000,000 shares on September

On May 16, 2022, the Company designated 1,850,000 shares of the authorized preferred stock as Series A Convertible Preferred

Stock (“Series A Preferred Stock”).

The Series A Preferred Stock is non-voting, and each share is convertible at the option

of the holder, subject to certain limitations, into 10 shares of common stock.

Holders of Series A Preferred Stock are entitled to receive

dividends, on an as-if-converted-to-common stock basis, when, as and if, and in the same form as, dividends are actually paid on the

common stock.

In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, or in the event of

a Deemed Liquidation Event (as defined in the Certificate of Designations of Preferences, Rights and Limitations of Series A Convertible

Preferred Stock), the holders of Series A Preferred Stock are entitled to be paid from assets of the Company available for distribution

to its stockholders, before any payment is made to the holders of common stock by reason of their ownership thereof, an amount per share

equal to the greater of (i) the original issue price ($ 5.75 on an as-converted-to-common stock basis), plus all accrued and unpaid dividends

and (ii) the amount that the holder would have been entitled to receive at such time if the Series A Preferred Stock were converted into

common stock.

The Company may not, without the consent of holders of a majority of the outstanding shares of Series A Preferred Stock,

amend its charter in a manner that adversely affects the powers, preferences or rights of the Series A Preferred Stock or issue or obligate

itself to issue shares of any additional class or series of capital stock unless the same ranks junior to the Series A Preferred Stock

with respect to the distribution of assets on the liquidation, dissolution or winding up of the Company and the payment of dividends.

December 31, 2022, the Company’s authorized capital stock consisted of 65,000,000 shares of common stock, of which 21,667,250 shares

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1,120,873 shares were outstanding.

May 16, 2022, the Company designated 1,850,000 shares of the authorized preferred stock as Series A Convertible Preferred Stock (“Series

A Preferred Stock”).

The Series A Preferred Stock is non-voting, and each share is convertible at the option of the holder, subject

to certain limitations, into 10 shares of common stock.

Holders of Series A Preferred Stock are entitled to receive dividends, on an

as-if-converted-to-common stock basis, when, as and if, and in the same form as, dividends are actually paid on the common stock.

the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, or in the event of a Deemed Liquidation

Event (as defined in the Certificate of Designations of Preferences, Rights and Limitations of Series A Convertible Preferred Stock),

the holders of Series A Preferred Stock are entitled to be paid from assets of the Company available for distribution to its stockholders,

before any payment is made to the holders of common stock by reason of their ownership thereof, an amount per share equal to the greater

of (i) the original issue price ($ 5.75 on an as-converted-to-common stock basis), plus all accrued and unpaid dividends and (ii) the

amount that the holder would have been entitled to receive at such time if the Series A Preferred Stock were converted into common stock.

The Company may not, without the consent of holders of a majority of the outstanding shares of Series A Preferred Stock, amend its charter

in a manner that adversely affects the powers, preferences or rights of the Series A Preferred Stock or issue or obligate itself to issue

shares of any additional class or series of capital stock unless the same ranks junior to the Series A Preferred Stock with respect to

the distribution of assets on the liquidation, dissolution or winding up of the Company and the payment of dividends.

March 31, 2023, one of the Company’s preferred shareholders elected to convert 25,000 shares of Series A Convertible Preferred

Stock into 250,000 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022.

The cost basis of

the shares transferred is $ 5.75 .

June 29, 2023, one of the Company’s preferred shareholders elected to convert 10,000 shares of Series A Convertible Preferred Stock

into 100,000 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022.

The cost basis of the shares

transferred is $ 5.75 .

September 21, 2023, one of the Company’s preferred shareholders elected to convert 25,000 shares of Series A Convertible Preferred

Stock into 250,000 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022.

The cost basis of

the shares transferred is $ 5.75 .

October 16, 2023, one of the Company’s preferred shareholders elected to convert 181,739 shares of Series A Convertible Preferred

Stock into 1,817,390 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022.

The cost basis

of the shares transferred is $ 5.75 .

December 12, 2023, one of the Company’s preferred shareholders elected to convert 25,000 shares of Series A Convertible Preferred

Stock into 250,000 shares of Common Stock, in accordance with the Securities Purchase Agreement dated May 15, 2022.

The cost basis of

the shares transferred is $ 5.75 .

December 31, 2023, the Company’s authorized capital stock consisted of 65,000,000 shares of common stock, of which 25,506,012 shares

were outstanding, and 2,500,000 shares of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock, of which

854,134 shares were outstanding.

As of December 31, 2023, no dividends have been declared on the Company’s capital stock.

and Issuance of Stock

February 4, 2022, the Company entered into an Open Market Sale Agreement SM with Jefferies LLC, as agent (“Jefferies”),

pursuant to which the Company may offer and sell, from time to time, through Jefferies, shares of common stock having an aggregate offering

price of up to $ 50,000,000 .

The Company will pay Jefferies a commission equal to 3.0 % of the aggregate gross proceeds from each sale

of such shares.

On October 12, 2022, pursuant to the above agreement, the Company sold 500,000 shares of common stock in a single transaction

at a price of $ 10.35 per share, generating gross proceeds of $ 5.2 million before deducting commissions and other offering expenses of

$ 0.4 million.

December 9, 2022, the Company issued 6,182,574 shares of common stock, 1,120,873 shares of Series A Preferred Stock and warrants exercisable

8 unchanged sentences

approximately $ 100 million before deducting placement agent fees and other offering expenses of $ 4.3 million.

February 4, 2022, the Company entered into an Open Market Sale Agreement SM with Jefferies LLC, as agent (“Jefferies”),

pursuant to which the Company may offer and sell, from time to time, through Jefferies, shares of common stock having an aggregate offering

price of up to $ 50,000,000 .

The Company will pay Jefferies a commission equal to 3.0 % of the aggregate gross proceeds from each sale

of such shares.

On October 12, 2022, pursuant to the above agreement, the Company sold 500,000 shares of common stock in a single transaction

at a price of $ 10.35 per share, generating gross proceeds of $ 5.2 million before deducting commissions and other offering expenses of

$ 0.4 million.

February 26, 2021, the Company completed a follow-on offering in which it sold 1,971,100 shares of common stock (including 257,100 shares

of common stock in connection with the full exercise of the underwriters’ option to purchase additional shares) at a public offering

price of $ 14.00 per share.

The offering generated gross proceeds of approximately $ 27.6 million before deducting underwriting discounts

and other offering expenses of approximately $ 1.8 million.

April 8, 2021, in conjunction with entering into a license agreement with Pfizer to research, develop, manufacture and commercialize

gedatolisib, the Company issued to Pfizer 349,406 shares of the Company’s common stock at a price of $ 14.31 per share, for an aggregate

price of $ 5.0 million.

July 1, 2021, the Company completed a follow-on offering in which it sold 2,250,000 shares of common stock at a public offering price

of $ 25.00 per share.

The offering generated gross proceeds of approximately $ 56.3 million before deducting underwriting discounts and

other offering expenses of approximately $ 3.5 million.

At December 31, 2022:

December 1, 2023, pursuant to an Open Market Sale Agreement SM with Jefferies LLC, as agent, the Company sold 1,034,500 shares

of common stock in a single transaction at a price of $ 14.50 per share, generating gross proceeds of $ 15 million before deducting commissions

and other offering expenses of $ 0.6 million.

October 18, 2023, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain

investors (the “Investors”) pursuant to which the Company agreed to sell to the Investors in a private placement pre-funded

warrants to purchase up to 5,747,787 shares of the Company’s common stock, par value $ 0.001 per share.

Each Warrant to purchase

one share has a purchase price of $ 8.699 per share, and an exercise price of $ 0.001 per share for the Common Stock issuable upon exercise

of the Warrant.

closing of the Private Placement occurred on October 20, 2023, and resulted in gross proceeds to the Company of approximately $ 50 million,

before deducting offering expenses of approximately $ 0.1 million.

Warrant is immediately exercisable and will not expire.

Under the terms of the Warrants, the Company may not effect the exercise of any

such Warrant, and a holder will not be entitled to exercise any portion of any Warrant, if, upon giving effect to such exercise, the

aggregate number of shares of Common Stock beneficially owned by the holder (together with its affiliates, other persons acting or who

could be deemed to be acting as a group together with the holder or any of the holder’s affiliates, and any other persons whose

beneficial ownership of Common Stock would or could be aggregated with the holder’s or any of the holder’s affiliates for

purposes of Section 13(d) or Section 16 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) would exceed

4.99% of the number of shares of Common Stock outstanding immediately after giving effect to the exercise, as such percentage ownership

is calculated in accordance with Section 13(d) of the Exchange Act and the applicable regulations of the Securities and Exchange Commission

(the “Maximum Percentage”).

A holder may reset the Maximum Percentage to a higher percentage (not to exceed 19.99%), effective

61 days after written notice to the Company, or a lower percentage, effective immediately upon written notice to the Company.

increase or decrease will apply only to that holder and not to any other holder of Warrants.

Securities Purchase Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing,

indemnification obligations of the Company, other obligations of the parties and termination provisions.

Schedule of Warrants

December 31, 2023:

Expiration Date

# of Warrants Outstanding

# of Warrants

Exercise Price

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securities purchase agreement - issued to institutional and other accredited investors

private placement offering - issued to investors

Total Warrants Outstanding

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institutional and other accredited investors to purchase 6,956,450 shares of the Company’s common stock at a price of $ 8.05 .

warrants may be exercised at any time or from time to time on or after the date of issuance and on or before the earlier of (i) 5:00 p.m.

warrants may be exercised at any time or from time to time on or after the date of issuance and on or before the earlier of (i) 5:00

(New York City time) on December 9, 2027 or (ii) seventy-five (75) days after the Company publicly announces (x) whether the progression-free

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impact will be recorded as a deemed dividend, classified within Additional Paid-in Capital.

April 8, 2021, in connection with entering into a loan and security agreement with Innovatus Life Sciences Lending Fund I, LP, the Company

issued a warrant to Innovatus to purchase 26,042 shares of the Company’s common stock at an exercise price of $ 14.40 per share.

This warrant is equity classified and the $ 289,839 fair value of the warrant was reflected as additional debt discount.

December 31, 2023 and 2022, the Company had warrants to purchase 13,011,520 and 7,266,102 shares of common stock outstanding, at a weighted

average exercise price of $ 4.53 and $ 8.12 , respectively.

A total of 0 and 1,975 warrants were exercised in the years ended December 31,

A total of 2,369 and zero warrants were exercised in the years ended December

31, 2023 and 2022, respectively.

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a one-time, 500,000 increase each year for a total of 1,000,000 increase, to the number of shares reserved for issuance under the 2017

The 2017 Plan provides for options, restricted stock awards, stock appreciation rights, restricted stock units, performance awards

and stock bonuses.

The exercise price of each option granted under the 2017 Plan is not less than 100% of the fair market value of one

share on the date of grant.

The maximum permitted term of options granted under the 2017 Plan is ten years.

The 2017 Plan is generally

administered by the compensation committee of the Company’s board, which has the authority to interpret the 2017 Plan, grant awards

and make all other determinations necessary for the administration of the 2017 Plan.

At the Annual Meeting held on May 11, 2023, the stockholders approved a one-time, 1,500,000 increase to the number of shares reserved

for issuance under the 2017 Plan.

The 2017 Plan provides for options, restricted stock awards, stock appreciation rights, restricted

stock units, performance awards and stock bonuses.

The exercise price of each option granted under the 2017 Plan is not less than 100%

of the fair market value of one share on the date of grant.

The maximum permitted term of options granted under the 2017 Plan is ten

The 2017 Plan is generally administered by the compensation committee of the Company’s board, which has the authority to

interpret the 2017 Plan, grant awards and make all other determinations necessary for the administration of the 2017 Plan.

following table summarizes the activity for all stock options outstanding for the years ended December 31:

Schedule of Stock Options Activity

Weighted Average Exercise Price

Weighted Average

Exercise Price

Weighted Average

Exercise Price

Options outstanding at beginning of year

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Schedule of Stock Options Outstanding and Exercisable

Options Outstanding

Options Exercisable

Options Outstanding

Weighted Average Remaining Contractual Life

Weighted Average Exercise Price

Aggregate Intrinsic Value

Options Exercisable

Weighted Average Exercise Price

Aggregate Intrinsic Value

Weighted Average

Contractual Life

Exercise Price

Company recognized stock-based compensation expense for stock options of $ 4,716,475 and $ 4,415,415 for the years ended December 31, 2023

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price on the Nasdaq Capital Market on May 17,2022.

The effect of this modification on stock-based compensation was $ 517,000 for the year

ended December 31, 2022.

The effect of this modification on stock-based compensation over the remaining service period will be approximately

In December 2021, the Company modified the exercise price on 311,000 stock option awards to $ 13.44 , the closing market price

on the Nasdaq Capital Market on December 15, 2021.

No director or officer awards were modified.

The effect on stock-based compensation

was $ 92,000 and $ 53,000 for the years ended December 31, 2022 and 2021, respectively.

The effect on stock-based compensation over the

remaining service period will be approximately $ 173,000 .

In May 2020, the Company modified the exercise price on 203,750 stock option

awards to $ 5.10 , the closing market price on the Nasdaq Capital Market on May 14, 2020.

The effect of this modification on stock-based compensation was $ 134,000 and $ 517,000

for the years ended December 31, 2023 and 2022, respectively.

The effect of this modification on stock-based compensation over the remaining

service period will be approximately $ 163,000 .

In December 2021, the Company modified the exercise price on 311,000 stock option awards

to $ 13.44 , the closing market price on the Nasdaq Capital Market on December 15, 2021.

No director or officer awards were modified.

The effect on stock-based compensation was $ 38,000 and $ 46,000 for the years ended December 31, 2022 and 2021, respectively.

on stock-based compensation over the remaining service period will be approximately $ 20,000 .

effect on stock-based compensation was $ 65,000 and $ 92,000 for the years ended December 31, 2023 and 2022, respectively.

The effect on

stock-based compensation over the remaining service period will be approximately $ 98,000 .

In May 2020, the Company modified the exercise

price on 203,750 stock option awards to $ 5.10 , the closing market price on the Nasdaq Capital Market on May 14, 2020.

No director or

officer awards were modified.

The effect on stock-based compensation was $ 19,000 and $ 38,000 for the years ended December 31, 2023 and

2022, respectively.

The effect on stock-based compensation over the remaining service period is not material.

Black-Scholes option-pricing model was used to estimate the fair value of equity-based awards with the following weighted-average assumptions

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3.41 % - 4.86 %

0.63 % - 1.39 %

Expected volatility

76.2 % - 79.6 %

76.6 % - 76.9 %

Expected life (years)

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with the agreements would also be cancelled.

Company had 3,273 and 2,964 shares of restricted stock outstanding for the years ended December 31, 2022 and 2021, respectively, and

3,214 and 15,686 shares of restricted stock vested during the years ended December 31, 2022 and 2021, respectively.

The Company recognized

stock-based compensation expense for restricted stock of $ 41,431 and $ 80,150 for the years ended December 31, 2022 and 2021, respectively.

Company had 1,958 and 3,273 shares of restricted stock outstanding at December 31, 2023 and 2022, respectively, and 3,273 and 3,214 shares

of restricted stock vested during the years ended December 31, 2023 and 2022, respectively.

The Company recognized stock-based compensation

expense for restricted stock of $ 18,499 and $ 41,431 for the years ended December 31, 2023 and 2022, respectively.

total remaining shares available for grant under the Company’s 2017 Plan as of December 31, 2023 was 1,019,149 .

unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized as follows:

unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized at December 31:

Schedule of Unrecognized Compensation Cost

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The number of shares reserved for issuance was automatically increased by 108,337 and

shares on January 1, 2022 and 2021, respectively and will increase automatically on each subsequent January 1 by the number of shares

equal to 0.5% of the total outstanding number of shares of Company common stock as of the immediately preceding December 31 .

74,595 shares on January 1, 2023 and 2022, respectively and will increase automatically on each subsequent January 1 by the number of

shares equal to 0.5% of the total outstanding number of shares of Company common stock as of the immediately preceding December 31.

the Company’s board may reduce the amount of the increase in any particular year.

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stock equal to 2.5% of the principal amount of the relevant Term Loan funded divided by the exercise price, which will be based on the

lower of (i) $14.40 per share or (ii) the volume weighted price per share of the Company’s stock for the five-trading day period

ending on the last trading day immediately preceding the funding date of the Term B or Term C Loan, as applicable.

The warrants may be

exercised on a cashless basis and are immediately exercisable through the tenth anniversary of the applicable funding date.

In connection

with the first tranche of the Term Loans, the Company issued a warrant to Innovatus to purchase 26,042 shares of the Company’s

common stock at an exercise price of $ 14.40 per share.

The Company evaluated the warrant under ASC 470, debt, and recognized an additional

debt discount of approximately $ 0.3 million based on the relative fair value of the base instruments and warrants.

The Company calculated

the fair value of the warrant using the Black-Scholes model.

In connection with the funding of the first tranche of the Term Loans, a

final fee of approximately $ 0.7 million was recorded as additional principal as a debt discount, and a facility fee of approximately

$ 0.1 million was recorded as additional debt discount.

The Company is also required to maintain a minimum cash balance in agreement with

the term loans’ default terms.

lower of (i) $14.40 per share or (ii) the volume weighted

price per share of the Company’s stock for the five-trading day period ending on the last trading day immediately preceding the

funding date of the Term B or Term C Loan, as applicable.

The warrants may be exercised on a cashless basis and are immediately exercisable

through the tenth anniversary of the applicable funding date.

In connection with the first tranche of the Term Loans, the Company issued

a warrant to Innovatus to purchase 26,042 shares of the Company’s common stock at an exercise price of $ 14.40 per share.

evaluated the warrant under ASC 470, debt, and recognized an additional debt discount of approximately $ 0.3 million based on the relative

fair value of the base instruments and warrants.

The Company calculated the fair value of the warrant using the Black-Scholes model.

In connection with the funding of the first tranche of the Term Loans, a final fee of approximately

$ 0.7 million was recorded as additional principal as a debt discount, and a facility fee of approximately $ 0.1 million was recorded as

additional debt discount.

The Company is also required to maintain a minimum cash balance in agreement with the term loans’ default

August 9, 2022, the Company amended the Loan Agreement.

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Schedule of Long Term Debt Future Principal Payments

Years Ending December 31,

License Agreement

April 8, 2021 the Company entered into a license agreement with Pfizer to research, develop, manufacture and commercialize gedatolisib,

a potent, well-tolerated, reversible dual inhibitor that targets PI3K and mTOR, for the treatment, diagnosis and prevention of all diseases.

The Company paid Pfizer $ 5.0 million in upfront fees and issued to Pfizer $ 5.0 million of shares of the Company’s common stock

pursuant to an Equity Grant Agreement.

The upfront payment and the issuance of shares were expensed to research & development in

full for the three months ending June 30, 2021.

Company is also required to make milestone payments to Pfizer upon achievement of certain development and commercial milestone events,

up to an aggregate of $ 335.0 million.

Additionally, the Company will pay Pfizer tiered royalties on sales of gedatolisib at percentages

ranging from the low to mid-teens, which may be subject to deductions for expiration of valid claims, amounts due under third-party licenses

and generic competition.

Unless earlier terminated, the license agreement will expire upon the expiration of all royalty obligations.

The royalty period will expire on a country-by-country basis upon the later of (a) 12 years following the date of first commercial sale

of such product in such country, (b) the expiration of all regulatory or data exclusivity in such country for such product or (c) the

date upon which the manufacture, use, sale, offer for sale or importation of such product in such country would no longer infringe, but

for the license granted in the license agreement, a valid claim of a licensed patent right.

Company has the right to terminate the license agreement for convenience upon 90 days’ prior written notice.

Pfizer may not terminate

the agreement for convenience.

Either the Company or Pfizer may terminate the license agreement if the other party is in material breach

and such breach is not cured within the specified cure period.

In addition, either the Company or Pfizer may terminate the license agreement

in the event of specified insolvency events involving the other party.

the conversion of Celcuity LLC to Celcuity Inc.

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Income tax benefits

December 22, 2017 H.R.

1, commonly referred to as the Tax Cuts and Jobs Act, (the “Tax Act”) was enacted.

As part of Tax

Act, for tax years beginning on or after January 1, 2022, Congress requires taxpayers to capitalize research and experimental expenditures

that qualify as section 174 costs and recover them over 5 years for domestic expenditures, and 15 years for expenditures attributed for

foreign research .

Inflation Reduction Act of 2022 (the “IRA”) was signed into law on August 16, 2022.

Among other things, the IRA contained

three key changes for corporations—a corporate minimum tax, a one percent excise tax on certain stock buybacks and certain clean

energy incentives and initiatives.

The enactment of the IRA did not result in any material impact to the Company’s income tax provision.

August 9, 2022, President Biden signed the CHIPS and Science Act of 2022 into law, which provides certain financial incentives with the

intention of increasing American semi-conductor research, development and production and promoting domestic scientific and technological

The enactment of the CHIPS did not result in any material impact to the Company’s income tax provision.

income taxes reflect the net effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting

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The tax effects of temporary differences and carryforwards

that give rise to significant portions of the deferred tax assets are as follows:

that give rise to significant portions of the deferred tax assets are at December 31:

Schedule of Deferred Tax Assets and Liabilities

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years prior to 2020, the Company is no longer subject to U.S.

federal or state income tax examinations.

The Company’s policy is

to recognize interest and penalties related to uncertain tax positions as a component of general and administrative expenses.

federal or state income tax examinations and remains open for the unutilized

tax attributes as of December 31, 2023, carried forward from these years.

The Company’s policy is to recognize interest and penalties

related to uncertain tax positions as a component of general and administrative expenses.

Subsequent Event

March 13, 2023, the Company signed an amendment to extend

its operating lease for a period of two

The commencement of the extended period is May 1, 2024 and will terminate on April

This amendment provides for monthly rent, real estate taxes and operating expenses.

In March 2024, an investor exercised 1,739,080 warrants at an exercise

price of $ 8.05 , which generated approximately $ 14 million in cash.

The warrants were issued pursuant to a private placement that closed

and was funded on December 9, 2022.

Changes in and Disagreements With Accountants on Accounting and Financial Disclosures

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 8. Financial Statements and Supplementary Data