Item 8. Financial Statements and Supplementary Data
ITEM 8. Financial Statements and Supplementary Data
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To
the Board of Directors and
Stockholders of Celcuity Inc.
Opinion
on the Financial Statements
We
have audited the accompanying balance sheets of Celcuity Inc. (the Company) as of December 31, 2024 and 2023, and the related statements
of operations, changes in stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31,
2024, and the related notes (collectively referred to as the financial statements). In our opinion, the financial statements present
fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations
and its cash flows for each of the years in the two-year period ended December 31, 2024, in conformity with accounting principles generally
accepted in the United States of America.
Basis
for Opinion
These
financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent
with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities
and Exchange Commission and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits,
we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits
provide a reasonable basis for our opinion.
Critical
Audit Matters
Critical
audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required
to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements
and (2) involved our especially challenging, subjective, or complex judgments. We determined that there were no critical audit matters.
/s/ Boulay
LLP
We
have served as the Company’s auditor since 2017.
Minneapolis,
Minnesota
March 31, 2025
PCAOB
ID: 542
48
Celcuity Inc.
Balance Sheets
December 31, 2024
December 31, 2023
Assets
Current Assets:
Cash and cash equivalents
$ 22,514,823
$ 30,662,774
Investments
212,588,960
149,919,974
Other current assets
9,467,247
10,007,849
Total current assets
244,571,030
190,590,597
Property and equipment, net
336,515
228,782
Operating lease right-of-use assets
215,502
400,019
Total Assets
$ 245,123,047
$ 191,219,398
Liabilities and Stockholders’ Equity:
Current Liabilities:
Accounts payable
$ 9,366,007
$ 5,076,699
Operating lease liabilities
171,952
184,950
Accrued expenses
22,184,948
8,927,094
Total current liabilities
31,722,907
14,188,743
Operating lease liabilities
53,969
225,922
Note payable, non-current
97,727,136
37,035,411
Total Liabilities
129,504,012
51,450,076
Commitments and Contingencies (Note 9)
-
-
Stockholders’ Equity:
Preferred stock, $ 0.001 par value: 2,500,000 shares authorized; 317,577 and 854,134 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively
318
854
Common stock, $ 0.001 par
value: 95,000,000 and 65,000,000 shares
authorized as of December 31, 2024 and December 31, 2023, respectively; 37,143,242 and 25,506,012
shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively
37,143
25,506
Additional paid-in capital
387,436,682
299,818,965
Accumulated deficit
( 271,855,108 )
( 160,076,003 )
Total Stockholders’ Equity
115,619,035
139,769,322
Total Liabilities and Stockholders’ Equity
$ 245,123,047
$ 191,219,398
See accompanying notes to the financial statements
49
Celcuity Inc.
Statements of Operations
2024
2023
Twelve Months Ended December 31,
2024
2023
Operating expenses:
Research and development
$ 104,203,230
$ 60,594,005
General and administrative
9,063,721
5,636,326
Total operating expenses
113,266,951
66,230,331
Loss from operations
( 113,266,951 )
( 66,230,331 )
Other (expense) income
Interest expense
( 10,280,445 )
( 5,326,387 )
Interest income
11,768,291
7,777,602
Other income, net
1,487,846
2,451,215
Net loss before income taxes
( 111,779,105 )
( 63,779,116 )
Income tax benefits
-
-
Net loss
$ ( 111,779,105 )
$ ( 63,779,116 )
Net loss per share, basic and diluted
$ ( 2.83 )
$ ( 2.69 )
Weighted average common shares outstanding, basic and diluted
39,449,393
23,679,472
See accompanying notes to the financial statements
50
Celcuity Inc.
Statements of Changes in Stockholders’ Equity
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Common Stock
Preferred Stock
Additional
Paid-In
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balance at December 31, 2022
21,667,250
$ 21,667
1,120,873
$ 1,121
$ 230,045,566
$ ( 96,296,887 )
$ 133,771,467
Stock-based compensation
1,958
2
-
-
4,901,432
-
4,901,434
Conversion of preferred to common stock
2,667,390
2,668
( 266,739 )
( 267 )
( 2,401 )
-
-
Employee stock purchases
33,850
33
-
-
202,812
-
202,845
Exercise of common stock options, net of shares withheld for exercise price
98,695
99
-
-
388,423
-
388,522
Exercise of common stock warrants
2,369
2
-
-
22,503
-
22,505
Issuance costs associated with private placement offering
-
-
-
-
( 7,486 )
-
( 7,486 )
Issuance of common stock in an ATM offering
1,034,500
1,035
-
-
14,999,216
-
15,000,251
Issuance costs associated with an ATM offering
-
-
-
-
( 614,205 )
-
( 614,205 )
Issuance of pre-funded warrants
-
-
-
-
50,000,000
-
50,000,000
Issuance costs associated with pre-funded warrants
-
-
-
-
( 116,895 )
-
( 116,895 )
Net loss
-
-
-
-
( 63,779,116 )
( 63,779,116 )
Balance at December 31, 2023
25,506,012
$ 25,506
854,134
$ 854
$ 299,818,965
$ ( 160,076,003 )
$ 139,769,322
Balance
25,506,012
$ 25,506
854,134
$ 854
$ 299,818,965
$ ( 160,076,003 )
$ 139,769,322
Stock-based compensation
1,429
1
-
-
6,988,340
-
6,988,341
Conversion of preferred to common stock
5,365,570
5,367
( 536,557 )
( 536 )
( 4,831 )
-
-
Employee stock purchases
33,215
33
-
-
275,568
-
275,601
Exercise of common stock options, net of shares withheld for exercise price
103,245
104
-
-
769,463
-
769,567
Exercise of common stock warrants, net of shares withheld for exercise price
1,827,357
1,826
-
-
14,733,991
-
14,735,817
Issuance of common stock in an ATM offering
435,414
435
-
-
7,641,765
-
7,642,200
Issuance costs associated with an ATM offering
-
-
-
-
( 263,727 )
-
( 263,727 )
Issuance of common stock upon closing of follow-on offering, net of underwriting discounts and offering costs
3,871,000
3,871
-
-
56,248,237
-
56,252,108
Issuance of common stock warrants, note payable
-
-
-
-
1,228,911
-
1,228,911
Net loss
-
-
-
-
-
( 111,779,105 )
( 111,779,105 )
Balance at December 31, 2024
37,143,242
$ 37,143
317,577
$ 318
$ 387,436,682
$ ( 271,855,108 )
$ 115,619,035
Balance
37,143,242
$ 37,143
317,577
$ 318
$ 387,436,682
$ ( 271,855,108 )
$ 115,619,035
See accompanying notes to the financial statements
51
Celcuity Inc.
Statements of Cash Flows
2024
2023
Twelve Months Ended December 31,
2024
2023
Cash flows from operating activities:
Net loss
$ ( 111,779,105 )
$ ( 63,779,116 )
Adjustments to reconcile net loss to net cash used for operations:
Depreciation
129,947
142,772
Stock-based compensation
6,988,341
4,901,434
Amortization of debt issuance costs and discount
1,330,652
241,752
Payment-in-Kind interest
1,363,708
1,810,584
Non-cash operating lease, net
( 434 )
4,368
Change in accrued interest income
150,421
( 993,457 )
Changes in operating assets and liabilities:
Other current assets
775,981
( 3,438,018 )
Accounts payable
4,315,892
2,430,614
Accrued expenses
13,257,854
4,866,814
Net cash used for operating activities
( 83,466,743 )
( 53,812,253 )
Cash flows from investing activities:
Proceeds from maturities of investments
642,345,545
309,614,521
Purchases of investments
( 705,164,950 )
( 314,525,084 )
Purchases of property and equipment
( 249,878 )
( 97,644 )
Net cash used for investing activities
( 63,069,283 )
( 5,008,207 )
Cash flows from financing activities:
Proceeds from exercise of common stock warrants
14,735,817
22,505
Proceeds from exercise of employee stock options
769,571
388,522
Proceeds from employee stock purchases
275,601
202,845
Proceeds from follow-on offering, net of underwriting discounts and offering costs
56,252,108
-
Proceeds from note payable, net of debt issuance costs and discount of $ 2,437,644
59,226,276
-
Proceeds from an ATM offering, net of issuance costs
7,356,107
14,431,186
Proceeds from pre-funded warrants, net of offering costs
-
49,917,589
Payments for secondary registration statement costs
( 227,405 )
( 45,805 )
Payments for debt issuance costs
-
( 2,716 )
Payments for finance leases
-
( 2,449 )
Net cash provided by financing activities
138,388,075
64,911,677
Net change in cash and cash equivalents
( 8,147,951 )
6,091,217
Cash and cash equivalents:
Beginning of period
30,662,774
24,571,557
End of period
$ 22,514,823
$ 30,662,774
Supplemental disclosure of cash flow information:
Interest paid
$ 7,586,084
$ 3,274,051
Supplemental disclosures of non-cash investing and financing activities:
Deferred financing costs and offering and registration statement costs included in accounts payable
$ 42,028
$ 56,414
Property and equipment included in accounts payable
$ 1,417
$ 13,615
Common stock warrants issued with the note payable transaction
$ 1,228,911
$ -
See accompanying notes to the financial statements
52
CELCUITY INC.
NOTES TO FINANCIAL STATEMENTS
1. Organization
Nature of Business
Celcuity Inc., a Delaware corporation (the “Company”) is a
clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications.
The Company’s lead therapeutic candidate is gedatolisib, a potent, well-tolerated, small molecule reversible inhibitor, administered
intravenously, that selectively targets all Class I isoforms of phosphatidylinositol-3-kinase (“PI3K”) and the two mechanistic
targets of rapamycin (“mTOR”) sub-complexes, mTORC1 and mTORC2. Gedatolisib’s mechanism of action and pharmacokinetic
properties are 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. Site selection and activation activities for a Phase 3 clinical trial,
VIKTORIA-2, evaluating gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2-
advanced breast cancer has commenced. The first patient is expected to be dosed in the second quarter of 2025. A Phase 1b/2 clinical trial,
CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer,
is currently underway. The Company was co-founded in 2012 by Brian F. Sullivan and Dr. Lance G. Laing and is based in Minnesota. The Company
has not generated any revenues to date.
2. Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements
Basis of Presentation
The accompanying financial statements
have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and pursuant
to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Operating results for the year ended December
31, 2024 are not necessarily indicative of results to be expected for any future year.
Accounting Estimates
Management uses estimates and assumptions in preparing these
financial statements in accordance with U.S. GAAP. Those estimates and assumptions affect the reported amounts of assets and liabilities,
the disclosure of contingent assets and liabilities, and the reported revenues and expenses. Actual results could differ from those estimates
and the difference could be material. Significant items subject to such estimates and assumptions include the valuation of stock-based
compensation and prepaid or accrued clinical trial costs.
Cash and Cash Equivalents
The Company maintains its accounts at two financial institutions.
At times throughout the year, the Company’s cash balances may exceed amounts insured by the Federal Deposit Insurance Corporation.
At December 31, 2024 and December 31, 2023, the Company had $ 22,514,823 and $ 30,662,774 , respectively, in business checking accounts and
money market funds that are considered cash equivalents and not insured by the Federal Deposit Insurance Corporation.
Investments
The Company maintains its investments in U.S. governmental agency
securities and U.S. treasury bills and has classified them as held-to-maturity at the time of purchase. Held-to-maturity purchases are
those securities in which the Company has the ability and intent to hold until maturity. Held-to-maturity securities are recorded at amortized
cost, adjusted for the amortization or accretion of premiums and discounts. Premiums and discounts are amortized or accreted over the
life of the related held-to-maturity security using a straight-line method. The difference between the carrying value, which is based
on cost, and the aggregate fair value of the held-to-maturity securities, was immaterial as of December 31, 2024. At December 31, 2024
and December 31, 2023, the Company had $ 212,588,960 and $ 149,919,974 , respectively, of short-term investments.
53
Property and Equipment
Property and equipment are stated at cost. Depreciation is provided
over estimated useful lives using the straight-line method. Maintenance and repairs are expensed as incurred; major improvements and betterments
are capitalized.
Estimated useful lives of property and equipment are as follows for the
major classes of assets:
Schedule of Estimated Useful Lives of Property and Equipment
Estimated
Asset Description
Lives
Furniture and Equipment
4 - 5
Leasehold Improvements
2 - 3
Long-Lived Assets
Long-lived assets, such as property and equipment, are reviewed for impairment
whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If circumstances require
a long-lived asset or asset group be tested for possible impairment, the Company first compares undiscounted cash flows expected to be
generated by that asset or asset group to its carrying value. If the carrying value of the long-lived asset or asset group is not recoverable
on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying value exceeds its fair value. Fair value
is determined through various valuation techniques including discounted cash flow models, quoted market values, and third-party independent
appraisals, as considered necessary.
Deferred Transaction Costs
Deferred transaction costs primarily consist of legal fees that are capitalized
as incurred and will be offset against the proceeds from future equity financing arrangements. 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 $ 235,379 and
$ 0 as of December 31, 2024 and 2023, respectively.
Debt Issuance Costs
The Company recognizes debt issuance costs as deferred costs, which are
capitalized and amortized over the term of the related debt using the effective interest method. These costs primarily consist of fees,
commissions, legal, and other costs directly attributable to securing debt financing. Debt issuance costs are reported as a direct reduction
of the carrying amount of the related debt on the balance sheets. Amortization of these costs is recorded as interest expense in the statements
of operations over the life of the debt instrument.
Comprehensive Loss
Comprehensive loss includes net loss as well as other changes in stockholders’
equity that result from transactions and economic events other than those with stockholders. For all periods presented, there was no difference
between net loss and comprehensive loss.
Risks and Uncertainties
The Company is subject to risks common to companies in the development
stage including, but not limited to, dependency on the clinical and commercial success of its initial drug product, gedatolisib, the ability
to obtain regulatory approval for gedatolisib, the need for substantial additional financing to achieve its goals, uncertainty of broad
adoption of its approved products, if any, by physicians and consumers, and significant competition.
Fair Value of Financial Instruments
The Company’s accounting for fair value measurements of
assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring or nonrecurring basis
adheres to the Financial Accounting Standards Board (“FASB”) fair value hierarchy that prioritizes the inputs to valuation
techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical
assets or liabilities (Level 1 measurements) and the lowest priority to measurements involving significant unobservable inputs (Level
3 measurements). The three levels of the fair value hierarchy are as follows:
● Level
1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the Company at the measurement
date.
● Level
2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly,
for substantially the full term of the asset or liability.
● Level
3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available,
thereby allowing for situations in which there is little, if any, market activity for the asset or liability at measurement date.
54
The level in the fair value hierarchy within which a fair value
measurement in its entirety falls, is based on the lowest level input that is significant to the fair value measurement in its entirety.
The carrying values of cash equivalents, accounts payable, accrued
expenses and other financial working capital items approximate fair value at December 31, 2024 and December 31, 2023, due to the short
maturity nature of these items.
Income Taxes
The Company accounts for income taxes using the asset and liability method,
as required by the accounting standard for income taxes. Under this method, deferred tax assets and liabilities are recognized for the
future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities
and their respective tax bases, as well as net operating loss and tax credit carryforwards. Deferred taxes are measured using enacted
tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.
The effect on deferred taxes of a change in tax rates is recognized in results of operations in the period that includes the enactment
date. The effects of any future changes in tax laws or rates have not been considered. The Company regularly reviews deferred tax assets
to assess their potential realization and establish a valuation allowance for portions of such assets to reduce the carrying value if
the Company does not consider it to be more likely than not that the deferred tax assets will be realized.
The Company recognizes the impact of an uncertain tax position in its financial
statements if, in management’s judgment, the position is more-likely-than-not sustainable upon audit based on the position’s
technical merits. This involves the identification of potential uncertain tax positions, the evaluation of applicable tax laws and an
assessment of whether a liability for an uncertain tax position is necessary.
Stock-Based Compensation
The Company’s stock-based compensation consists of stock
options and restricted stock issued to certain employees and non-employees of the Company and the Company’s 2017 Employee Stock
Purchase Plan. The Company recognizes compensation expense based on an estimated grant date fair value using the Black-Scholes option-pricing
method for equity-based awards and the Monte Carlo simulation model for performance-based awards. If the factors change and different
assumptions are used, the Company’s stock-based compensation expense could be materially different in the future. The Company recognizes
stock-based compensation expense for these options on a straight-line basis over the requisite service period. The Company has elected
to account for forfeitures as they occur.
Research and Development
Research and development costs are expensed as incurred. Research and development
costs amounted to $ 104,203,230 for the year ended December 31, 2024 and $ 60,594,005 for the year ended December 31, 2023.
Clinical Trial Costs
The Company relies on third parties to conduct
certain aspects of clinical studies and to formulate and manufacture our drug product. While there are alternative vendors that can
perform these functions, any disruption or delay by the Company’s current third parties in carrying out their contractual
duties could delay the clinical trials. The Company records prepaid assets or accrued expenses for prepaid or estimated clinical
trial costs conducted by third-party service providers, which includes the conduct of preclinical studies and clinical trials. These
costs can be a significant component of the Company’s research and development expenses. The Company primarily relies on a
compilation of progress reports from third-party service providers, including the respective invoicing, to record actual expenses,
along with determining changes to prepaid assets and accrued liabilities. To date, the Company believes utilization of third-party
reports most accurately reflects expenses incurred. With the ongoing VIKTORIA-1 Phase 3 trial and the CELC-G-201 Phase 1b/2 trial,
and the commencement of the VIKTORIA-2 Phase 3 clinical trial site activation and patient enrollment anticipated in Q2 2025 ,
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 and financial position.
Segment Data
In November 2023, the FASB issued ASU 2023-07: Improvements to Reportable
Segment Disclosures. This ASU, which amends Topic 280: Segment Reporting, improves disclosure requirements for reportable segments
and enhances disclosures for companies with single reportable segments. The Company has a single reportable segment based on the nature
of its operations. The nature of business and the accounting policies of the segment are the same as described throughout Notes 1 and
2. The Company’s Chief Operating Decision Maker (“CODM”) is its executive team. The CODM assesses the reportable segment’s performance
and allocates resources for the reportable segment based on net income and total assets, which are the same amounts in all material respects
as those reported on the statements of operations and balance sheets. The Company adopted the standard on January 1, 2024. The adoption
did not have a material impact on the Company’s financial statements.
55
3. Liquidity
Based on the Company’s cash and cash equivalents and short-term investments
on hand at December 31, 2024 of $ 22,514,823 and $ 212,588,960 , respectively, the Company believes that its cash and short-term investments
will be sufficient to fund the Company’s current operating plan through at least the next 12 months from the issuance date of this
Annual Report.
4. Net Loss Per Common Share
Basic and diluted net loss per common share is determined by dividing net
loss attributable to common stockholders by the weighted-average common shares outstanding during the period. 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.
The 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
2024
2023
December 31,
2024
2023
Potentially-dilutive shares excluded from diluted weighted-average shares outstanding:
Preferred stock on an as-if-converted to common stock
3,175,770
8,541,340
Options to purchase common stock
4,306,977
2,815,392
Warrants to purchase common stock
5,521,152
7,263,733
Restricted common stock
1,079
1,958
Total
13,004,978
18,622,423
Anti-dilutive securities excluded from
diluted weighted- average shares outstanding
13,004,978
18,622,423
Pre-funded warrant shares of 5,747,787 are included in the computation
of basic and diluted net loss per share for the years ended December 31, 2024 and 2023, as the pre-funded warrants are issuable for nominal
consideration.
5. Investments
The following table summarizes the Company’s held-to-maturity investment
securities at amortized cost as of December 31, 2024 and 2023:
Schedule of Investment
Amortized Cost, as Adjusted
Gross Unrealized Holding Gains
Gross Unrealized Holding Losses
Estimated Fair Value
December 31, 2024
Amortized Cost, as Adjusted
Gross Unrealized Holding Gains
Gross Unrealized Holding Losses
Estimated Fair Value
U.S. Treasury Bills
$ 212,588,960
$ 82,251
$ -
$ 212,671,211
Total
$ 212,588,960
$ 82,251
$ -
$ 212,671,211
Amortized Cost, as Adjusted
Gross Unrealized Holding Gains
Gross Unrealized Holding Losses
Estimated Fair Value
December 31, 2023
Amortized Cost, as Adjusted
Gross Unrealized Holding Gains
Gross Unrealized Holding Losses
Estimated Fair Value
U.S. Treasury Bills
$ 149,919,974
$ 30,995
$ -
$ 149,950,969
Total
$ 149,919,974
$ 30,995
$ -
$ 149,950,969
The fair value of the Company’s held-to-maturity debt securities
is 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.
56
6. Other Current Assets
Other current assets consisted of the following at
December 31:
Schedule of Other Current Assets
2024
2023
Current:
Prepaid clinical trial costs
$ 6,768,668
$ 8,763,150
Miscellaneous receivable
1,600,621
805,882
Directors & officers’ insurance
256,629
157,453
Other
841,329
281,364
Total
$ 9,467,247
$ 10,007,849
7. Property and Equipment
Property and equipment consisted of the following
at December 31:
Summary of Property and Equipment
2024
2023
Furniture and equipment
$ 2,025,875
$ 1,788,195
Leasehold improvements
302,577
302,577
Property and equipment, Gross
2,328,452
2,090,772
Less: Accumulated depreciation
( 1,991,937 )
( 1,861,990 )
Total
$ 336,515
$ 228,782
Depreciation expense
was $ 129,947 and $ 142,772 for the years ended December 31, 2024 and 2023, respectively.
8. Accrued Expenses
Accrued expenses consisted of the following at December
31:
Schedule of Accrued Expenses
2024
2023
Clinical trial costs
$ 16,708,499
$ 6,464,772
Accrued compensation
3,987,786
1,763,316
Other
1,384,803
641,512
Employee stock purchase plan
103,860
57,494
Total
$ 22,184,948
$ 8,927,094
57
9. Commitments
Operating and Finance Leases
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. Rent 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.
In May 2018, the Company entered into a non-cancelable finance
lease agreement for office equipment with a five-year term. The underlying assets are included in furniture and equipment. 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.
When an implicit rate is not provided, the Company uses its
incremental borrowing rate based on the information available at the lease commencement date in determining the present value of the lease
payments.
Supplemental balance sheet information consisted of the following at December
31, 2024:
Schedule of Supplemental Balance Sheet Information Related to Leases
Operating Lease
Right-of-use assets
$ 215,502
Operating lease liability
$ 225,921
Less: short term portion
( 171,952 )
Long term portion
$ 53,969
Maturity analysis under lease agreements consisted of the following as
of December 31, 2024:
Schedule of Maturity Analysis Under Lease Agreements
Operating Leases
2025
$ 220,389
2026
74,170
Total minimum lease payments
294,559
Less: Present value discount
( 68,638 )
Present value of net minimum lease payments
$ 225,921
Weighted Average
Remaining Lease Term
Discount Rate
Operating lease
1.3 years
10.5 %
Lease costs for the period ended December 31:
Schedule of Lease Costs
2024
2023
Operating lease cost
$ 213,104
$ 212,238
Finance lease cost:
Amortization
-
2,411
Interest
-
4
Variable lease cost
111,246
101,957
Lease costs
$ 324,350
$ 316,610
Supplemental cash flow information related to leases for the period ended December 31:
Schedule of Supplemental Cash Flow Information Related to Leases
2024
2023
Cash paid for amounts included in operating and finance leases:
Operating cash outflow from operating leases
$ 324,783
$ 308,914
Operating cash outflow from finance leases
-
4
Financing cash outflow from finance leases
-
2,449
Total cash paid for amounts
included in operating and finance leases
$ 324,783
$ 311,367
58
Clinical Research Studies
The 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,
CMOs, and CROs. The Company has a license agreement in place with Pfizer to research, develop, manufacture and commercialize gedatolisib.
In conjunction with the license agreement, the Company completed a Phase 1b clinical trial – B2151009 related to gedatolisib. These
patients subsequently transitioned to an Expanded Access study – CELC-G-001. Contracts related to the Expanded Access study are
generally based on time and material. In addition, contracts related to the Company’s Phase 3 clinical studies (VIKTORIA-1 and VIKTORIA-2)
and the Phase 1b/2 clinical trial (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, 2024, the Company had five material non-cancelable contractual
commitments with respect to these arrangements, which totaled approximately $ 9.7 million.
10. Stockholders’ Equity
Capital Stock
At December 31, 2023, the Company’s authorized
capital stock consisted of 65,000,000 shares of $ .001 par value common stock, of which 25,506,012 shares were outstanding, and 2,500,000
shares of $ .001 par value preferred stock, of which 854,134 shares were outstanding.
In 2024, several of the Company’s preferred
shareholders elected to convert 536,557 shares of Series A Convertible Preferred Stock into 5,365,570 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 per share.
In 2024, several of the Company’s investors
exercised 1,827,357 common stock warrants at exercise prices ranging between $ 8.05 and $ 9.50 per share, which generated approximately
$ 14.7 million in cash. The 1,827,357 common stock warrants were net of shares withheld for exercise price.
At December 31, 2024, the Company’s
authorized capital stock consisted of 95,000,000 shares of common stock, of which 37,143,242 shares were outstanding, and 2,500,000 shares
of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock, of which 317,577 shares were outstanding. As of
December 31, 2024, no dividends have been declared on the Company’s capital stock.
Sale and Issuance of Stock
On April 22, 2024, pursuant to an Open Market Sale
Agreement SM with Jefferies LLC, as agent, the Company sold 285,714 shares of common stock in a single transaction at a price
of $ 17.50 per share, generating gross proceeds of $ 5.0 million.
On May 8, 2024, pursuant to an Open Market
Sale Agreement with Jefferies LLC, as agent, the Company sold 149,700 shares of common stock in a single transaction at a price of $ 17.65
per share, generating gross proceeds of $ 2.6 million.
Commissions and other offering expenses related to the Open Market Sale
Agreement transactions in April and May 2024 were $ 0.3 million.
59
On May 30, 2024, the Company entered into an underwriting
agreement with Leerink Partners LLC, TD Securities (USA) LLC and Stifel, Nicolaus & Company, Incorporated as representatives of the
several underwriters relating to the issuance and sale of 3,871,000 shares of common stock, at a price to the public of $ 15.50 , generating
gross proceeds of approximately $ 60.0 million. The offering closed on May 31, 2024 and resulted in net proceeds to the Company of approximately
$ 56.3 million after deducting underwriting discounts and other offering expenses payable by the Company. The Company intends to use the
net proceeds from the offering for working capital and general corporate purposes, which may include capital expenditures, research and
development expenditures, clinical trial expenditures, expansion of business development activities and other general corporate purposes.
Pre-Funded Warrants
On 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 had 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.
The closing of the Private
Placement occurred on October 20, 2023, and resulted in gross proceeds to the Company of approximately $ 50.0 million, before deducting
offering expenses of approximately $ 0.1 million.
Each 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 SEC (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. Any such increase or decrease will apply only to that holder and
not to any other holder of Warrants.
The 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.
Warrants
Schedule of Warrants
At December 31, 2024:
Issue Date
Expiration
Date
# of Warrants
Outstanding
Exercise
Price
Offering
1/21/2016
1/14/2026
33,719
$ 7.56
private placement offering - issued to placement agent
5/2/2016
5/2/2026
21,530
$ 7.56
private placement offering - issued to placement agent
4/28/2017
4/28/2027
33,250
$ 8.42
private placement offering - issued to placement agent
5/17/2017
5/17/2027
15,365
$ 8.42
private placement offering - issued to placement agent
9/22/2017
9/19/2025
70,000
$ 10.45
IPO - issued to underwriter
4/8/2021
4/8/2031
26,042
$ 14.40
debt financing - issued to lender
5/30/2024
5/30/2034
84,227
$ 14.84
debt financing – issued to lender
5/30/2024
5/30/2034
19,649
$ 14.84
debt financing – issued to lender
12/9/2022
see below
5,217,370
$ 8.05
securities purchase agreement - issued to institutional and other accredited investors
10/18/2023
see above
5,747,787
$ 0.001
private placement offering - issued to investors
Total Warrants Outstanding
11,268,939
60
At December 31, 2024 and 2023, the Company had warrants
to purchase 11,268,939
and 13,011,520
shares of common stock outstanding, at a weighted average exercise price of $ 4.04
and $ 4.53 ,
respectively. A total of 1,842,913
and 2,369
warrants were exercised in the years ended December 31, 2024 and 2023, respectively. There were 3,544
warrants that expired in 2024.
11. Stock-Based Compensation
2012 Equity Incentive Plan
The 2012 Equity Incentive Plan, as amended, was adopted by the Company’s
board and approved by the members of Celcuity LLC on August 10, 2012. The Company reserved a maximum of 625,000 shares of common stock
for issuance under the 2012 Equity Incentive Plan. The 2012 Equity Incentive Plan provides for options, restricted stock awards, performance
stock awards or stock bonuses. The exercise price of each option granted under the 2012 Equity Incentive 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 2012 Equity Incentive
Plan is ten years. The Company’s board administers the 2012 Equity Incentive Plan and determines the provisions of incentive awards,
including eligible recipients, number of shares subject to an incentive award, exercise price, vesting schedule, duration of an incentive
award and other restrictions an incentive award may be subject to. The 2012 Equity Incentive Plan was frozen on September 6, 2017 and
new awards are issued under the terms of the 2017 Amended and Restated Stock Incentive Plan.
2017 Stock Incentive Plan
The 2017 Amended and Restated Stock Incentive Plan (the “2017 Plan”)
was adopted by the Company’s board on September 6, 2017, became effective following the corporate conversion on September 15, 2017,
and was approved by stockholders at the Company’s annual stockholder meeting on May 10, 2018. The 2017 Plan was amended and approved
by stockholders at the Company’s annual stockholder meeting on May 14, 2020. The Company initially reserved a maximum of 750,000
shares of common stock for issuance under the 2017 Plan. The number of shares reserved for issuance was automatically increased by 255,060
and 216,673 shares on January 1, 2024 and 2023, respectively, and will increase automatically on January 1 of each of 2025 through 2027
by the number of shares equal to 1.0% of the aggregate number of outstanding shares of Company common stock as of the immediately preceding
December 31. However, the Company’s board may reduce the amount of the increase in any particular year. At each of the Annual Meetings
held on May 12, 2021 and May 12, 2022, the stockholders approved a 500,000 increase for a total of 1,000,000 increase, to the number of
shares reserved for issuance under the 2017 Plan. At each of the Annual Meetings held on May 11, 2023 and May 9, 2024, the stockholders
approved 1,500,000 increases for a total increase of 3,000,000 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 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.
The following table summarizes the activity for all stock options outstanding
for the years ended December 31:
Schedule of Stock Options Activity
2024
2023
Shares
Weighted Average Exercise Price
Shares
Weighted Average Exercise Price
Options outstanding at beginning of year
2,815,392
$ 7.95
1,976,586
$ 6.34
Granted
1,716,729
16.14
1,003,298
10.69
Exercised
( 103,245 )
7.45
( 98,695 )
3.94
Forfeited
( 121,899 )
11.57
( 65,797 )
7.45
Balance at December 31:
4,306,977
$ 11.13
2,815,392
$ 7.95
Options exercisable at December 31:
2,011,474
$ 7.35
1,524,731
$ 6.44
Weighted Average Grant Date Fair Value for options granted during the year:
$ 11.22
$ 7.48
61
The
following table summarizes additional information about stock options outstanding and exercisable at December 31, 2024:
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
4,306,977
7.96
$ 11.13
$ 13,914,458
2,011,474
$ 7.35
$ 11,781,660
The Company recognized stock-based compensation expense for stock options
of $ 6,626,402 and $ 4,716,475 for the years ended December 31, 2024 and 2023, respectively. In May 2022, the Company modified the exercise
price on 776,324 stock option awards to $ 5.50 , the closing market price on the Nasdaq Capital Market on May 17,2022. The effect of this
modification on stock-based compensation was $ 106,000 and $ 134,000 for the years ended December 31, 2024 and 2023, respectively. The effect
of this modification on stock-based compensation over the remaining service period will be approximately $ 57,000 . 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 $ 63,000 and $ 65,000 for the
years ended December 31, 2024 and 2023, respectively. The effect on stock-based compensation over the remaining service period will be
approximately $ 35,000 . 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 $ 696 and $ 19,000 for the years ended December 31, 2024 and 2023, respectively. There is no effect on stock-based compensation remaining.
The Black-Scholes option-pricing model was used to estimate the
fair value of equity-based awards and the Monte Carlo simulation model was used to estimate the fair value of the performance-based awards,
with the following weighted-average assumptions for the years ended December 31:
Schedule
of Assumptions for Fair Value of Equity-based Awards
2024
2023
Risk-free interest rate
3.48 % - 4.71 %
3.41 % - 4.86 %
Expected volatility
71.2 % - 76.20 %
77.1 % - 79.8 %
Expected life (years)
5.25 to 10.00
5.25 to 6.08
Expected dividend yield
0 %
0 %
The inputs for the Black-Scholes valuation model and the Monte Carlo simulation
model require management’s significant assumptions. Prior to the Company’s initial public offering, the price per share of
common stock was determined by the Company’s board based on recent prices of common stock sold in private offerings. Subsequent
to the initial public offering, the price per share of common stock is determined by using the closing market price on the Nasdaq Capital
Market on the grant date. The risk-free interest rates are based on the rate for U.S. Treasury securities at the date of grant with maturity
dates approximately equal to the expected life at the grant date. The expected life is based on the simplified method for the time-based
awards and the life of the option for the performance-based awards, in accordance with the SEC Staff Accounting Bulletin Nos. 107 and
110. The expected volatility is estimated based on historical volatility information of peer companies that are publicly available in
combination with the Company’s calculated volatility since being publicly traded for the time-based awards. For the performance-based
awards, the Company’s full historical volatility was used to value the options.
All assumptions used to calculate the grant date fair value of non-employee
options are generally consistent with the assumptions used for options granted to employees. In the event the Company terminates any of
its consulting agreements, the unvested options issued in connection with the agreements would also be cancelled.
The Company had 1,079 and 1,958 shares of restricted stock outstanding
at December 31, 2024 and 2023, respectively, and 2,308 and 3,273 shares of restricted stock vested during the years ended December 31,
2024 and 2023, respectively. The Company recognized stock-based compensation expense for restricted stock of $ 22,220 and $ 18,499 for the
years ended December 31, 2024 and 2023, respectively.
The total remaining shares available for grant under the Company’s
2017 Plan as of December 31, 2024 was 1,177,450 .
62
Total unrecognized compensation cost related to stock options and restricted
stock is estimated to be recognized at December 31:
Schedule
of Unrecognized Compensation Cost
2025
$ 7,776,307
2026
6,307,024
2027
5,165,880
2028
1,964,136
Total estimated compensation cost to be recognized
$ 21,213,347
2017 Employee Stock Purchase Plan
The Company’s 2017 Employee Stock Purchase Plan (the “ESPP”)
was adopted by the Company’s board on September 6, 2017 and approved by stockholders at the Company’s annual stockholder meeting
on May 10, 2018. The Company initially reserved a total of 100,000 shares for issuance under the ESPP. The number of shares reserved for
issuance was automatically increased by 127,530 and 108,337 shares on January 1, 2024 and 2023, 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. However, the Company’s board may reduce the amount of the increase in any particular year.
The total remaining shares available for issuance under the employee stock purchase plan as of December 31, 2024 is 360,950 .
The ESPP provides participating employees with an opportunity to purchase
shares of the Company’s common stock at a discount through payroll deductions. The ESPP is available to all employees unless they
are employed for less than 20 hours per week or own 5% or more of the total combined voting power or value of the Company’s common
stock. The ESPP is administered using overlapping 24 month offering periods, referred to as an Offering Period. Each Offering Period has
four six-month purchase periods. A new Offering Period and purchase period begin every six months on May 1 and November 1 of each year.
Participating employees may purchase common stock, on a voluntary after tax-basis, at a price equal to 85% of the fair market value of
a share of common stock on either the offering date or the purchase date, whichever is lower. If the purchase date has a lower price,
the employee will automatically be placed in the Offering Period beginning immediately after the purchase date. The Company recognized
stock-based compensation expense related to the ESPP of $ 339,719 and $ 166,460 for the years ended December 31, 2024 and 2023, respectively.
The Company recognized total stock-based compensation
expense as follows for the years ended December 31:
Schedule
of Stock-based Compensation Expenses
Years Ended
December 31:
2024
2023
Stock-based compensation expense in operating expenses:
Research and development
$ 4,404,518
$ 2,700,318
General and administrative
2,583,823
2,201,116
Total
$ 6,988,341
$ 4,901,434
Stock-based compensation expense
$ 6,988,341
$ 4,901,434
12. Debt
On May 30, 2024, the Company entered into an Amended
and Restated Loan and Security Agreement (the “A&R Loan Agreement”) with Innovatus Life Sciences Lending Fund I, LP, a
Delaware limited partnership (“Innovatus”), as collateral agent, and the Lenders including Innovatus in its capacity as a
Lender and Oxford Finance LLC (“Oxford”), pursuant to which Innovatus and Oxford, as Lenders, have agreed to make certain
term loans (“Term Loans”) to the Company in the aggregate principal amount of up to $ 180 million. The A&R Loan Agreement
amends and restates, in its entirety, that certain Loan and Security Agreement, dated April 8, 2021, as amended, between the Company and
Innovatus, as collateral agent, and the Lenders named therein (the “Prior Loan Agreement”).
63
Funding of the first $ 100 million under the A&R
Loan Agreement occurred on May 30, 2024, including tranche payments of $ 16.8 million (the “Term A Loan”) and $ 21.5 million
(the “Term B Loan”) reflecting repayment of the principal amount of loans under the Prior Loan Agreement plus accrued payment-in-kind
interest, in addition to $ 61.7 million of new borrowings (the “Term C Loan”). The Company will be eligible to draw on a fourth
tranche of $ 30 million (the “Term D Loan”) and fifth tranche of $ 50 million (the “Term E Loan”), in each case
upon achievement of certain clinical trial milestones and satisfaction of certain financial covenants determined on a pro forma as-funded
basis. The Lenders may, in their sole discretion upon the Company’s request, make additional term loans to the Company of $ 45 million
(the “Term F Loan”). Funding of these additional tranches is also subject to other customary conditions and limits on when
the Company can request funding for such tranches. Costs associated with the new borrowings was approximately $ 2.4 million.
Pursuant to the A&R Loan Agreement, the Company
is entitled to make interest-only payments for thirty-six months, or up to forty-eight months if certain conditions are met. The Term
Loans will mature on May 1, 2029 and will bear interest at a rate equal to the sum of (a) the greater of (i) the Prime Rate (as defined
in the A&R Loan Agreement) or (ii) 7.75%, plus (b) 2.85%, provided that 1.0% of such interest will be payable in-kind by adding an
amount equal to such 1.0% of the outstanding principal amount to the then outstanding principal balance on a monthly basis through May
31, 2027. The A&R Loan Agreement is secured by all assets of the Company. Proceeds will be used for working capital purposes and to
fund the Company’s general business requirements, including the Phase 3 VIKTORIA-2 clinical trial. The A&R Loan Agreement contains
customary representations and warranties and covenants, subject to customary carve-outs, and includes financial covenants related to liquidity
and other financial measures. Innovatus has the right, at its election and until August 9, 2025, to convert up to 20 % of the outstanding
principal of the Term A Loan into shares of the Company’s common stock at a price per share of $ 10.00 (the “Conversion Right”).
Innovatus will continue to have the right to exercise a previously disclosed warrant granted to it under the Prior Loan Agreement to purchase
26,042 shares of common stock at a price per share of $ 14.40 through April 8, 2031.
The A&R Loan Agreement contains a Final Fee, which
is equal to 4.5 % of the initial funding of the agreement and is due on the earliest to occur of (a) the Maturity Date, (b) the acceleration
of any Term Loan, and (c) the prepayment of the Term Loans. There is also a contingent non-utilization fee for both the Term D and Term
E loans. If the Company achieves the Term D Milestone and (i) fails to draw the full amount of the Term D Loan during the Term D Draw
Period and (ii) fails to notify Collateral Agent, at any time before the date that is four weeks after the Company’s achievement
of the Term D Milestone, of the Company’s intent not to draw the full amount of the Term D Loan, a non-utilization fee of $ 900,000 ,
with respect to the Term D Loan shall become due and payable on the earliest of (i) the termination of the Term D Draw Period, (ii) the
Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans. If the Company achieves the
Term E Milestone and (i) fails to draw the full amount of the Term E Loan during the Term E Draw Period and (ii) fails to notify Collateral
Agent, at any time before the date that is four weeks after the Company’s achievement of the Term E Milestone, of the Company’s
intent not to draw the full amount of the Term E Loan, a non-utilization fee of $ 1,500,000 , with respect to the Term E Loan shall become
due and payable on the earliest of (i) the termination of the Term E Draw Period, (ii) the Maturity Date, (iii) the acceleration of any
Term Loan, and (iv) the prepayment in whole of the Term Loans. After the 18-month anniversary of the Effective Date, the Company shall
have the option to prepay all, but not less than all, of the Term Loans advanced by the Lenders under the A&R Loan Agreement, provided
the Company (i) provides written notice to Collateral Agent of its election to prepay the Term Loans at least seven Business Days prior
to such prepayment, and (ii) pays to Lenders on the date of such prepayment, payable to each Lender in accordance with its respective
Pro Rata Share, an amount equal to the sum of (A) all outstanding principal of the Term Loans plus accrued and unpaid interest thereon
through the prepayment date, (B) the Final Fee, (C) the Prepayment Fee, plus (D) all other outstanding Obligations that are due and payable,
including, without limitation, Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts. At May 30,
2024, the Company recognized the Final Fee of $ 4.5 million as additional debt principal and a corresponding debt discount to be amortized
over the life of the loan.
In connection with the funding of each of the Term
C Loan, the Term D Loan, the Term E Loan and the Term F Loan, the Company agreed to issue to Innovatus and Oxford warrants to purchase
that number of shares of the Company’s common stock equal to 2.5 % of the principal amount of the applicable Term Loan divided by
the exercise price, which shall, with respect to the Term C Loan, be equal to the lower of (i) the volume weighted average closing price
of the Company’s common stock for the five-trading day period ending on the last trading day immediately preceding the execution
of the A&R Loan Agreement or (ii) the closing price on the last trading day immediately preceding the execution of the A&R Loan
Agreement. Accordingly, on May 30, 2024, the Company issued 103,876 warrants with an exercise price of $ 14.84 per share. The relative
fair value of the warrants was approximately $ 1.2 million. For the additional Term Loans, the exercise price will be based on the lower
of (i) the exercise price for the Warrants issued pursuant to the Term C Loan or (ii) the volume weighted average closing price of the
Company’s common stock for the five-trading day period ending on the last trading day immediately preceding the applicable Term
Loan funding. The Warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary of the applicable funding
date. The number of shares of common stock for which each Warrant is exercisable and the associated exercise price are subject to certain
proportional adjustments as set forth in such Warrant.
64
The Company evaluated the change of terms under ASC
470-50, “Debt – Modification and Extinguishment”, and concluded the change in terms did not result in significant and
consequential changes to the economic substance of the debt and thus resulted in a modification of the debt and not an extinguishment
of the debt.
Long-term debt consisted of the following at December 31, 2024 and 2023:
Schedule
of Long-term Debt
2024
2023
Note payable
$ 100,000,000
$ 35,000,000
Add: Final fee
4,500,000
-
Add: PIK interest (added to principal)
593,288
2,565,660
Less: unamortized debt issuance costs
( 1,613,734 )
( 480,810 )
Less: unamortized debt discount
( 5,752,418 )
( 49,439 )
Total long-term debt
$ 97,727,136
$ 37,035,411
Future principal payments, including the incurred PIK interest and Final
Fee, are as follows:
Schedule
of Long Term Debt Future Principal Payments
Years Ending December 31,
2027
$ 30,615,349
2028
52,483,455
2029
21,994,484
Total
$ 105,093,288
13. Income Taxes
Following the conversion of Celcuity
LLC to Celcuity Inc. on September 15, 2017, Celcuity Inc. began filing federal and state returns where required. No income tax benefit
was recorded for the years 2024 and 2023, due to net losses and recognition of a valuation allowance. The following table presents a reconciliation
of the tax expense computed at the statutory federal rate and the Company’s tax expense for the years ended December 31:
Schedule of Effective Income Tax Rate Reconciliation
2024
2023
Tax benefit at statutory federal rate
$ ( 23,474,000 )
$ ( 13,394,000 )
State income tax benefit, net of federal tax effect
( 95,000 )
( 82,000 )
Change in valuation allowance on deferred tax assets
24,081,000
13,542,000
Research & Development Credits
( 1,236,000 )
( 550,000 )
Other permanent items
724,000
484,000
Income tax benefits
$ -
$ -
65
Deferred income taxes reflect the net effects of temporary differences
between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.
The Company’s deferred tax assets relate primarily to its net operating loss carryforwards and other balance sheet basis differences.
In accordance with ASC 740, “Income Taxes,” the Company recorded a valuation allowance to fully offset the net deferred tax
asset, because it is more likely than not that the Company will not realize future benefits associated with these deferred tax assets
at December 31, 2024. The tax effects of temporary differences and carryforwards that give rise to significant portions of the deferred
tax assets are at December 31:
Schedule of Deferred Tax Assets and Liabilities
2024
2023
Deferred tax assets (liabilities):
Accrued expenses
$ 459,000
$ 207,000
Share-based compensation
2,861,000
2,141,000
Property and equipment
420,000
393,000
Right-of-use assets
( 45,000 )
( 85,000 )
Lease liability
48,000
87,000
IRC 174 Expenditures
30,133,000
13,900,000
Start-up expenditures
12,998,000
11,029,000
Net operating losses and tax credits
13,340,000
8,461,000
Valuation allowance
( 60,214,000 )
( 36,133,000 )
Net deferred tax assets
$ -
$ -
At December 31, 2024, the Company had federal and
state net operating loss carryforwards of approximately $ 43.2 million and $ 0.8 million, respectively. The federal and state net operating
loss carryforwards for 2017 will begin to expire in the year ending December 31, 2037. The federal net operating loss carryforwards starting
in 2018 have no expiration. These deferred tax assets were subject to a full valuation allowance as of December 31, 2024 and December
31, 2023.
At December 31, 2024, the Company had federal and
state research and development tax credit carryforwards resulting in deferred tax assets of approximately $ 2.9 million and $ 1.6 million,
respectively. The federal and state credit carryforwards will begin to expire in the years ending December 31, 2038 and December 31, 2033,
respectively. These deferred tax assets were subject to a full valuation allowance as of December 31, 2024 and December 31, 2023.
Under the provisions of Section 382 of the Internal
Revenue Code of 1986, certain substantial changes in the Company’s ownership, including a sale of the Company, or significant changes
in ownership due to sales of equity, may limit in the future the amount of net operating loss carryforwards available to offset future
taxable income.
The Company recognizes uncertain tax positions in
accordance with ASC 740 on the basis of evaluating whether it is more-likely-than not that the tax positions will be sustained upon examination
by tax authorities. For those tax positions that meet the more-likely-than not recognition threshold, we recognize the largest amount
of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement. As of December 31, 2024, and 2023, the Company
has no significant uncertain tax positions. There are no unrecognized tax benefits included on the balance sheet that would, if recognized,
impact the effective tax rate. The Company does not anticipate there will be a significant change in unrecognized tax benefits within
the next 12 months.
Prior to the conversion, Celcuity was a limited liability
company and therefore was taxed as a partnership for income tax purposes. Accordingly, no benefit for income taxes was recorded prior
to the conversion.
For years prior to 2021, the Company is no longer
subject to U.S. federal or state income tax examinations and remains open for the unutilized tax attributes as of December 31, 2024, 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.
14.
Subsequent Event
In
January 2025, the Board of Directors approved a repricing of certain outstanding stock options previously granted to employees. As of
the repricing date, the exercise prices of these options were reduced to $ 11.92 per share, from their previous exercise prices ranging
from $ 12.80 to $ 18.73 per share. This adjustment was made in response to the decline in the company’s stock price, with the intent
of retaining and motivating key employees. As a result of this repricing, approximately 837,000 stock options held by 44 employees were
affected. The repriced options will continue to vest according to their original schedule.
In
March 2025, an investor exercised 695,650 warrants at an exercise price of $ 8.05 , which generated approximately $ 5.6 million in cash.
The warrants were issued pursuant to a private placement that closed and was funded on December 9, 2022.
66
ITEM 9. Changes in and Disagreements With Accountants on Accounting
and Financial Disclosure
None.