Item 1. Financial Statements
ITEM
1. Financial Statements
Celcuity
Inc.
Condensed
Balance Sheets
(in
thousands, except share and par value amounts)
September 30, 2025
December 31, 2024
(unaudited)
Assets
Current Assets:
Cash and cash equivalents
$ 74,252
$ 22,515
Investments
380,726
212,589
Other current assets
20,519
9,467
Total current assets
475,497
244,571
Property and equipment, net
417
336
Operating lease right-of-use assets
90
216
Total Assets
$ 476,004
$ 245,123
Liabilities and Stockholders’ Equity:
Current Liabilities:
Accounts payable
$ 11,418
$ 9,366
Operating lease liabilities
96
172
Accrued expenses
27,278
22,185
Total current liabilities
38,792
31,723
Operating lease liabilities
-
54
Note payable, non-current
125,166
97,727
Convertible debt
195,083
-
Total Liabilities
359,041
129,504
Commitments and Contingencies (Note 5)
-
-
Stockholders’ Equity:
Preferred stock, $ 0.001 par value: 2,500,000 shares authorized; 188,838 and 317,577 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively.
-
-
Common stock, $ 0.001 par value: 95,000,000 shares authorized; 43,274,548 and 37,143,242 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively.
43
37
Additional paid-in capital
514,844
387,437
Accumulated deficit
( 397,924 )
( 271,855 )
Total Stockholders’ Equity
116,963
115,619
Total Liabilities and Stockholders’ Equity
$ 476,004
$ 245,123
See
accompanying notes to the condensed financial statements.
3
Celcuity
Inc.
Condensed
Statements of Operations
(in
thousands, except share and per share amounts)
(unaudited)
2025
2024
2025
2024
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Operating expenses:
Research and development
$ 34,915
$ 27,588
$ 107,364
$ 70,732
General and administrative
7,934
2,472
15,627
6,105
Total operating expenses
42,849
30,060
122,991
76,837
Loss from operations
( 42,849 )
( 30,060 )
( 122,991 )
( 76,837 )
Other (expense) income
Interest expense
( 4,595 )
( 3,344 )
( 10,982 )
( 7,005 )
Interest income
3,640
3,612
7,904
8,716
Other (expense) income, net
( 955 )
268
( 3,078 )
1,711
Net loss before income taxes
( 43,804 )
( 29,792 )
( 126,069 )
( 75,126 )
Income tax benefits
-
-
-
-
Net loss
$ ( 43,804 )
$ ( 29,792 )
$ ( 126,069 )
$ ( 75,126 )
Net loss per share, basic and diluted
$ ( 0.92 )
$ ( 0.70 )
$ ( 2.81 )
$ ( 1.96 )
Weighted average common shares outstanding, basic and diluted
47,589,731
42,793,047
44,785,236
38,299,548
See
accompanying notes to the condensed financial statements.
4
Celcuity
Inc.
Condensed
Statements of Changes in Stockholders’ Equity
Three
and Nine Months Ended September 30, 2025
(in
thousands, except share amounts)
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, 2024
37,143,242
$ 37
317,577
$ -
$ 387,437
$ ( 271,855 )
$ 115,619
Stock-based compensation
-
-
-
-
2,444
-
2,444
Stock-based compensation, shares
-
-
-
-
-
-
-
Exercise of common stock warrants
695,650
1
-
-
5,599
-
5,600
Exercise of common stock options, net of shares withheld for exercise price
500
-
-
-
2
-
2
Net loss
-
-
-
-
-
( 36,997 )
( 36,997 )
Balance at March 31, 2025 (unaudited)
37,839,392
38
317,577
-
395,482
( 308,852 )
86,668
Stock-based compensation
1,029
-
-
2,704
-
2,704
Employee stock purchases
26,966
-
-
253
-
253
Conversion of preferred stock to common stock
1,044,260
1
( 104,426 )
-
( 1 )
-
-
Exercise of common stock options, net of shares withheld for exercise price
2,561
-
-
-
18
-
18
Net loss
-
-
-
-
-
( 45,268 )
( 45,268 )
Balance at June 30, 2025 (unaudited)
38,914,208
39
213,151
-
398,456
( 354,120 )
44,375
Stock-based compensation
-
-
-
-
6,779
-
6,779
Issuance of common stock upon close of equity offering, net of underwriting discounts and offering costs
2,172,368
2
-
-
91,550
-
91,552
Exercise of common stock warrants, net of shares withheld for exercise price
1,654,809
2
-
-
12,868
-
12,870
Exercise of common stock options, net of shares withheld for exercise price
290,033
-
-
-
2,405
-
2,405
Issuance of common stock warrants in connection with note agreement
-
-
-
-
2,786
-
2,786
Conversion of preferred stock to common stock
243,130
-
( 24,313 )
-
-
-
-
Net loss
-
-
-
-
-
( 43,804 )
( 43,804 )
Balance at September 30, 2025 (unaudited)
43,274,548
$ 43
188,838
$ -
$ 514,844
$ ( 397,924 )
$ 116,963
See
accompanying notes to the condensed financial statements.
5
Celcuity
Inc.
Condensed
Statements of Changes in Stockholders’ Equity
Three
and Nine Months Ended September 30, 2024
(in
thousands, except share amounts)
Common Stock
Preferred Stock
Additional Paid-In
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balance at December 31, 2023
25,506,012
$ 26
854,134
$ 1
$ 299,819
$ ( 160,076 )
$ 139,770
Stock-based compensation
-
-
-
-
1,331
-
1,331
Exercise of common stock warrants, net of shares withheld for exercise price
1,742,763
2
-
-
14,007
-
14,009
Exercise of common stock options, net of shares withheld for exercise price
36,550
-
-
-
239
-
239
Conversion of preferred to common stock
3,488,570
3
( 348,857 )
( 3 )
-
-
Net loss
-
-
-
-
-
( 21,612 )
( 21,612 )
Balance at March 31, 2024 (unaudited)
30,773,895
$ 31
505,277
$ 1
$ 315,393
$ ( 181,688 )
$ 133,737
Stock-based compensation
1,429
-
-
-
1,411
-
1,411
Employee stock purchases
20,426
-
-
-
131
-
131
Conversion of preferred stock to common stock
1,877,000
2
( 187,700 )
( 1 )
( 1 )
-
-
Exercise of common stock warrants, net of shares withheld for exercise price
19,390
-
-
-
173
-
173
Exercise of common stock options, net of shares withheld for exercise price
16,197
-
-
-
96
-
96
Issuance of common stock in an ATM offering
435,414
-
-
-
7,642
-
7,642
Issuance costs associated with an ATM offering
-
-
-
-
( 264 )
-
( 264 )
Issuance of common stock upon closing of follow-on offering, net of underwriting discounts and offering costs
3,871,000
4
-
-
56,248
-
56,252
Issuance of common stock warrants, note payable
-
-
-
-
1,229
-
1,229
Net loss
-
-
-
-
-
( 23,722 )
( 23,722 )
Balance at June 30, 2024 (unaudited)
37,014,751
$ 37
317,577
$ -
$ 382,058
$ ( 205,410 )
$ 176,685
Balance
37,014,751
$ 37
317,577
$ -
$ 382,058
$ ( 205,410 )
$ 176,685
Stock-based compensation
-
-
-
-
1,931
-
1,931
Exercise of common stock warrants, net of shares withheld for exercise price
65,204
-
-
-
554
-
554
Exercise of common stock options, net of shares withheld for exercise price
36,312
-
-
-
331
-
331
Net loss
-
-
-
-
-
( 29,792 )
( 29,792 )
Balance at September 30, 2024 (unaudited)
37,116,267
$ 37
317,577
$ -
$ 384,874
$ ( 235,202 )
$ 149,709
Balance
37,116,267
$ 37
317,577
$ -
$ 384,874
$ ( 235,202 )
$ 149,709
See
accompanying notes to the condensed financial statements.
6
Celcuity
Inc.
Condensed
Statements of Cash Flows
(in
thousands)
(unaudited)
2025
2024
Nine Months Ended September 30,
2025
2024
Cash flows from operating activities:
Net loss
$ ( 126,069 )
$ ( 75,126 )
Adjustments to reconcile net loss to net cash and cash equivalents used in operations:
Depreciation
118
95
Stock-based compensation
11,927
4,673
Amortization of debt issuance costs and discount
1,866
780
Payment-in-Kind interest
773
1,111
Non-cash operating lease expense, net
( 5 )
-
Change in accrued interest income
( 840 )
( 1,113 )
Changes in operating assets and liabilities:
Other current assets
( 10,700 )
1,741
Accounts payable
1,785
4,094
Accrued expenses
4,264
8,048
Net cash used in operating activities
( 116,881 )
( 55,697 )
Cash flows from investing activities:
Proceeds from maturities of investments
229,045
415,135
Purchases of investments
( 396,342 )
( 515,558 )
Purchases of property and equipment
( 196 )
( 205 )
Net cash used in investing activities
( 167,493 )
( 100,628 )
Cash flows from financing activities:
Proceeds from exercise of common stock warrants
18,470
14,736
Proceeds from exercise of employee stock options
2,384
666
Proceeds from employee stock purchases
253
131
Proceeds from equity offering, net of underwriting discounts and offering costs
91,823
56,252
Proceeds from convertible note payable, net of debt issuance cost and discount of $ 5,774
195,476
-
Proceeds from note payable, net of debt issuance costs and discount of $ 2,248 and $ 2,438 in 2025 and 2024, respectively
27,752
59,226
Proceeds from an ATM offering, net of issuance costs
-
7,356
Payments for secondary registration statement costs
( 47 )
( 102 )
Net cash provided by financing activities
336,111
138,265
Net change in cash and cash equivalents
51,737
( 18,060 )
Cash and cash equivalents:
Beginning of period
22,515
30,663
End of period
$ 74,252
$ 12,603
Supplemental disclosure of cash flow information:
Interest paid
$ 7,421
$ 5,114
Supplemental disclosures of non-cash investing and financing activities:
Change in accounts payable attributed to offering and registration statement costs
$ 34
$ 45
Change in accounts payable attributed to property and equipment
$ 3
$ 14
Common stock warrants issued with note payable transaction
$ 2,786
$ 1,229
Offering costs accrued but unpaid at the end of the period
$ 273
$ -
See
accompanying notes to the condensed financial statements.
7
CELCUITY
INC.
FORM
10-Q
(For the Three and Nine Months
Ended September 30, 2025 and 2024)
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 kinase
inhibitor of the phosphatidylinositol 3-kinase (“PI3K”), serine/threonine-protein kinase protein kinase B (“AKT”),
mechanistic target of rapamycin (“mTOR”) pathway that binds to all Class I PI3K isoforms and the mTOR complexes, mTORC1 and
mTORC2. By targeting all Class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of the PI3K/AKT/mTOR (“PAM”)
pathway. Gedatolisib’s mechanism of action and pharmacokinetic properties are differentiated from other currently approved and
investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating
gedatolisib in combination with fulvestrant with or without palbociclib in patients with hormone receptor-positive (HR+), human epidermal
growth factor receptor 2-negative (HER2-) (“HR+/HER2-”) advanced breast cancer has completed enrollment of and reported detailed
results for cohort 1, patients with PIK3CA wild-type (“WT”) tumors, and has completed enrollment of cohort 2, patients
with PIK3CA mutant-type (“MT”) tumors. Our Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib in combination
with a cyclin-dependent kinase (“CDK”) 4/6 inhibitor and fulvestrant as first-line treatment for patients with endocrine
treatment resistant HR+/HER2- advanced breast cancer is currently enrolling patients. The first patient was dosed in July 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 ongoing. 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 revenue to date.
2.
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements
Basis
of Presentation
The
accompanying unaudited condensed financial statements include the accounts of the Company and have been prepared in accordance with Article
10 of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”). Accordingly, as permitted by Article
10, the unaudited condensed financial statements do not include all of the information required by accounting principles generally accepted
in the United States (“U.S. GAAP”). The balance sheet at December 31, 2024 was derived from the audited financial statements
at that date and does not include all the disclosures required by U.S. GAAP. In the opinion of management, all adjustments which are
of a normal recurring nature and necessary for a fair presentation have been reflected in the financial statements. These unaudited condensed
financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2024
and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. Operating
results for the three and nine months ended September 30, 2025 are not necessarily indicative of the results to be expected during the
remainder of the current year or for any other future period.
Accounting
Estimates
Management
uses estimates and assumptions in preparing these unaudited condensed 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
revenue 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.
Risks
and Uncertainties
The
Company is subject to risks common to companies in the development stage including, but not limited to, the clinical and commercial success
of its initial drug product, gedatolisib, the regulatory approval of 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.
8
CELCUITY INC.
FORM 10-Q
(For the Three and Nine Months
Ended September 30, 2025 and 2024)
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 our clinical trials and/or the commercial launch of our initial drug product, gedatolisib,
if approved by the U.S. Food and Drug Administration (“FDA”). 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 and VIKTORIA-2 Phase 3 clinical trials,
and the CELC-G-201 Phase 1b/2 clinical trial, 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.
3.
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, convertible notes, 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 potential common shares were not considered in the computation of diluted net loss per share as their effect would have been
anti-dilutive for the three and nine-month periods presented below:
Schedule of Potentially-Dilutive Shares Excluded from Diluted Weighted-Average Shares Outstanding
2025
2024
September 30,
2025
2024
Preferred stock on an as-if-converted to common stock
1,888,380
3,175,770
Options to purchase common stock
5,696,327
4,212,102
Warrants to purchase common stock
3,206,822
5,521,152
Convertible notes to common stock
5,296,053
-
Restricted common stock
1,029
1,079
Total
16,088,611
12,910,103
The
maximum number of shares issuable upon conversion of the Notes is 5,296,053 shares of common stock. However, based on the Company’s
current stock price, management does not expect the maximum number of shares to be issued. Due to the recent increase in the Company’s
stock price, the Conversion Price is currently above the minimum threshold, which would result in the issuance of approximately 3,923,002
shares if the Notes were converted in full as of September 30, 2025.
Pre-funded
warrant shares of 6,147,787 are included in the computation of basic and diluted net loss per share for each of the three and nine months
ended September 30, 2025 and 2024, as the pre-funded warrants are exercisable for nominal consideration.
9
CELCUITY INC.
FORM 10-Q
(For the Three and Nine Months
Ended September 30, 2025 and 2024)
4.
Investments
Debt
securities for which the Company has the positive intent and ability to hold to maturity are classified as held-to-maturity and reported
at historical cost adjusted for amortization of premiums and accretion of discounts. Expected credit losses, if any, are recorded through
the establishment of an allowance for credit losses. All of the Company’s held-to-maturity investment securities are U.S. Treasury
and agency securities that are guaranteed or otherwise supported by the United States government and have no history of credit losses.
Accordingly, the Company does not expect to incur any credit losses on held-to-maturity investment securities and has no allowance for
credit losses recorded for these securities.
The
following tables summarize the Company’s held-to-maturity investment securities at amortized cost as of September 30, 2025 and
December 31, 2024:
Schedule of Investment
(in thousands)
Amortized Cost, as Adjusted
Gross Unrealized Holding Gains
Gross Unrealized Holding Losses
Estimated Fair Value
September 30, 2025
(in thousands)
Amortized Cost, as Adjusted
Gross Unrealized Holding Gains
Gross Unrealized Holding Losses
Estimated Fair Value
U.S. Treasury Bills
$ 380,726
$ -
$ ( 56 )
$ 380,670
Total
$ 380,726
$ -
$ ( 56 )
$ 380,670
(in thousands)
Amortized Cost, as Adjusted
Gross Unrealized Holding Gains
Gross Unrealized Holding Losses
Estimated Fair Value
December 31, 2024
(in thousands)
Amortized Cost, as Adjusted
Gross Unrealized Holding Gains
Gross Unrealized Holding Losses
Estimated Fair Value
U.S. Treasury Bills
$ 212,589
$ 82
$ -
$ 212,671
Total
$ 212,589
$ 82
$ -
$ 212,671
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.
5.
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.
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, contract manufacturing organizations, and contract research
organizations. The Company has a license agreement in place with Pfizer Inc. (“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 subject to amendments as a result of any change orders executed by the parties. As of September 30, 2025, the Company had three
material non-cancelable contractual commitments with respect to these arrangements, which totaled approximately $ 3.3 million.
10
CELCUITY INC.
FORM 10-Q
(For the Three and Nine Months
Ended September 30, 2025 and 2024)
6.
Stockholders’ Equity
Capital
Stock
July
2025 Equity Offering
On
July 30, 2025, the Company entered into an underwriting agreement (the “Equity Underwriting Agreement”) with Jefferies LLC,
TD Securities (USA) LLC, and Leerink Partners LLC as representatives (the “Representatives”) of the several underwriters
named therein (collectively, the “Underwriters”) agreeing, subject to customary conditions, to issue and sell in a public
offering (i) 1,836,842 shares (the “Shares”) of the Company’s common stock, at a price to the public of $ 38.00 per
Share and (ii) in lieu of Shares to certain investors, pre-funded warrants to purchase up to 400,000 shares of common stock (the “Pre-Funded
Warrants”), at a price to the public of $ 37.999 per Pre-Funded Warrant, which represents the per share public offering price for
the Shares less the $ 0.001 per share exercise price for each such Pre-Funded Warrant (the “Equity Offering”). In addition,
pursuant to the Equity Underwriting Agreement, the Company granted the Underwriters an option to purchase up to an additional 335,526
shares of common stock (the “Option Shares”), less underwriting discounts and commissions. The Underwriters exercised their
option to purchase the Option Shares in full on July 30, 2025. The Equity Offering was completed on July 31, 2025.
The
net proceeds from the Equity Offering, after deducting underwriting discounts and commissions and offering expenses, were approximately
$ 91.6 million, including the proceeds from the Underwriters’ exercise of their option in full to purchase the Option Shares. The
Company may also receive nominal proceeds, if any, from the exercise of the Pre-Funded Warrants.
Each
Pre-Funded Warrant is exercisable for one share of common stock at an exercise price of $ 0.001 per share, or alternatively, at the election
of each holder, shares of common stock may be issued through a cashless exercise, with the net number of shares of common stock determined
according to the formula set forth in each Pre-Funded Warrant. The Pre-Funded Warrants are exercisable at any time after the date of
issuance until all of the Pre-Funded Warrants are exercised. A holder (together with its “attribution parties,” as defined
in the Pre-Funded Warrant) may not exercise any portion of the Pre-Funded Warrants if immediately after exercise, the holder (together
with its attribution parties), would beneficially own in excess of 4.99% of the number of shares of common stock outstanding immediately
after giving effect to the exercise. However, a holder may increase or decrease such percentage to any other percentage not in excess
of 19.99%, which increase or decrease shall not become effective until 61 days after notice from the holder to the Company.
Warrants
Exercised
In
September 2025, an investor exercised 104,340
warrants at an exercise price of $ 8.05 ,
which generated approximately $ 0.8
million in cash. The warrants were issued pursuant to a private
placement that closed on December 9, 2022. Also in September 2025, the placement agent from private placements that closed in January
and May 2016 exercised 7,917
warrants at an exercise price of $ 7.56 ,
which generated approximately $ 0.1
million in cash.
In
August 2025, investors exercised 200,000 warrants at an exercise price of $ 8.05 , which generated approximately $ 1.6 million in cash.
The warrants were issued pursuant to a private placement that closed on December 9, 2022. Also in August 2025, the underwriter of the
Company’s initial public offering that closed on September 22, 2017 exercised its warrants on a cashless basis. As a result, the
Company issued 55,592 shares of common stock upon the cashless exercise of 70,000 warrants.
In
July 2025, an investor exercised 1,286,960 warrants at an exercise price of $ 8.05 , which generated approximately $ 10.4 million in cash.
The warrants were issued pursuant to a private placement that closed on December 9, 2022.
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 on December 9, 2022.
11
CELCUITY INC.
FORM 10-Q
(For the Three and Nine Months
Ended September 30, 2025 and 2024)
Preferred
Stock Converted
In
September 2025, 24,313 shares of preferred stock were converted into 243,130 shares of common stock.
In
June 2025, 104,426 shares of preferred stock were converted into 1,044,260 shares of common stock
General
At
September 30, 2025, the Company’s authorized capital stock consisted of 95,000,000 shares of common stock, of which 43,274,548
shares were outstanding, and 2,500,000 shares of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock,
of which 188,838 shares were outstanding. As of September 30, 2025, no dividends have been declared on the Company’s capital stock.
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.
7.
Stock-Based Compensation
The
Company recognized total stock-based compensation expense as follows for the three and nine months ended September 30, 2025 and 2024:
Schedule of Stock-based Compensation Expenses
(in thousands)
2025
2024
2025
2024
Three Months Ended
Nine Months Ended
September 30,
September 30,
(in thousands)
2025
2024
2025
2024
Stock-based compensation expense in operating expenses:
Research and development
$ 2,057
$ 1,190
$ 5,285
$ 3,001
General and administrative
4,722
741
6,642
1,672
Total
$ 6,779
$ 1,931
$ 11,927
$ 4,673
Stock-based
compensation expense
$ 6,779
$ 1,931
$ 11,927
$ 4,673
2017
Plan
The
Company initially reserved a maximum of 750,000 shares of common stock for issuance under the 2017 Amended and Restated Stock Incentive
Plan (the “2017 Plan”). The number of shares reserved for issuance was automatically increased by 371,432 and 255,060 shares
on January 1, 2025 and 2024, respectively, and will increase automatically on January 1 of each year 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
the Annual Meeting held on May 13, 2025, the stockholders approved a 3,000,000 share increase to the number of shares reserved for issuance
under the 2017 Plan. The total remaining shares available for grant under the Company’s 2017 Plan as of September 30, 2025 was
2,864,444 .
12
CELCUITY INC.
FORM 10-Q
(For the Three and Nine Months
Ended September 30, 2025 and 2024)
Stock
Options
The
following table summarizes the activity for all stock options outstanding for the nine months ended September 30:
Schedule of Stock Options Activity
2025
2024
Shares
Weighted
Average
Exercise Price
Shares
Weighted
Average
Exercise Price
Options outstanding at beginning of year
4,306,977
$ 10.42
2,815,392
$ 7.95
Granted
1,927,598
30.56
1,557,479
16.37
Exercised
( 293,309 )
8.31
( 89,059 )
7.48
Forfeited and expired
( 244,939 )
11.51
( 71,710 )
9.95
Balance at September 30
5,696,327
$ 17.30
4,212,102
$ 11.04
Options exercisable at September 30:
2,480,759
$ 9.53
1,891,297
$ 7.11
Weighted Average Grant Date Fair Value for options granted during the period:
$ 21.63
$ 11.38
The
following table summarizes additional information about stock options outstanding and exercisable at September 30, 2025. The stock-based
compensation expense disclosed in the following paragraphs is shown in thousands.
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 ($000)
Options
Exercisable
Weighted
Average
Exercise Price
Aggregate
Intrinsic
Value ($000)
5,696,327
8.05
$ 17.30
185,003
2,480,759
$ 9.53
98,988
The
Company recognized stock-based compensation expense for stock options of $ 6,452 and $ 1,844 for the three months ended September 30, 2025
and 2024, respectively, and $ 11,088 and $ 4,463 for the nine months ended September 30, 2025 and 2024, respectively. In January 2025,
May 2022, December 2021 and May 2020, the Company modified previously granted stock option awards to certain employees. The total incremental
compensation expense recognized as a result of the modifications was $ 48 and $ 42 for the three months ended September 30, 2025 and 2024,
respectively, and $ 259 and $ 128 for the nine months ended September 30, 2025 and 2024, respectively. The effect of these modifications
on stock-based compensation over the remaining service periods will be $ 298 . During the three and nine months ended September 30, 2025,
options in the amount of 290,248 and 293,309 shares were exercised, respectively, with an intrinsic value of $ 11,921 and $ 12,052 , respectively.
Included in the options exercised in the quarter, there were 950 options exercised in a cashless exercise whereby 215 shares were used
to settle the exercise price and the remaining 735 shares were issued. During the three and nine months ended September 30, 2024, options
in the amount of 36,312 and 89,059 were exercised, respectively, with an intrinsic value of $ 211 and $ 662 , respectively.
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 for the performance-based awards, with the following weighted-average assumptions for the nine months ended September 30:
Schedule of Assumptions for Fair Value of Equity-based Awards
2025
2024
Risk-free
interest rate
3.64
to 4.65
%
3.48
to 4.71
%
Expected
volatility
74.4
to 78.2
%
71.2
to 76.1
%
Expected
life (years)
5.01
to 10.00
5.25
to 10.00
Expected
dividend yield
0
%
0
%
13
CELCUITY INC.
FORM 10-Q
(For the Three and Nine Months
Ended September 30, 2025 and 2024)
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 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.
Restricted
Stock Awards
Restricted
stock awards (“RSAs”) granted to members of the Company’s board during the nine months ended September 30, 2025 were
1,029 shares. There were no RSAs granted during the three months ended September 30, 2025. RSAs granted to members of the Company’s
board during the nine months ended September 30, 2024 were 1,429 shares. There were no RSAs granted during the three months ended September
30, 2024. During the three and nine months ended September 30, 2025, RSAs vested in the amount of zero shares and 1,709 shares, respectively.
During the three and nine months ended September 30, 2024, RSAs vested in the amount of zero shares and 2,308 shares, respectively. The
Company recognized stock-based compensation expense for RSAs of zero and $ 4 for the three months ended September 30, 2025 and 2024, respectively,
and $ 6 and $ 18 for the nine months ended September 30, 2025 and 2024, respectively. RSAs outstanding as of September 30, 2025 and September
30, 2024 were 1,029 shares and 1,079 shares, respectively.
Total
unrecognized compensation cost related to stock options and RSAs that is estimated to be recognized at September 30, 2025 is as follows:
Schedule of Unrecognized Compensation Cost
(in thousands)
2025
$ 5,807
2026
16,825
2027
13,038
2028
9,936
2029
4,417
Total estimated compensation cost to be recognized
$ 50,023
Employee
Stock Purchase Plan
The
Company recognized stock-based compensation expense related to its employee stock purchase plan of $ 327 and $ 83 for the three months
ended September 30, 2025 and 2024, respectively, and $ 833 and $ 192 for the nine months ended September 30, 2025 and 2024, respectively.
The number of shares reserved for issuance was automatically increased by 185,716 on January 1, 2025, and will increase automatically
on January 1 of each year through 2027 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 September 30, 2025 was 519,700 .
14
CELCUITY INC.
FORM 10-Q
(For the Three and Nine Months
Ended September 30, 2025 and 2024)
8.
Debt
July
2025 Convertible Notes Offering
On
July 30, 2025, the Company entered into an underwriting agreement (the “Note Underwriting Agreement”) with the Underwriters,
subject to customary conditions, to issue and sell in a public offering $ 175.0 million aggregate principal amount of the Company’s
2.750 % Senior Notes due 2031 (the “Notes”) to the Underwriters (the “Note Offering”). In addition, pursuant to
the Note Underwriting Agreement, the Company granted the Underwriters an option to purchase up to an additional $ 26.3 million aggregate
principal amount of Notes solely to cover over-allotments. On July 30, 2025, the Underwriters exercised such option to purchase an additional
$ 26.3 million aggregate principal amount of Notes. The issuance of $ 201.3 million aggregate principal amount of Notes was completed on August
1, 2025.
The
Notes were issued pursuant to, and are governed by, an indenture (the “Base Indenture”), dated as of August 1, 2025, between
the Company and U.S. Bank Trust Company, National Association, as trustee (the “Trustee”), as supplemented by a first supplemental
indenture (the “Supplemental Indenture,” and the Base Indenture, as supplemented by the Supplemental Indenture, the “Indenture”),
dated as of August 1, 2025, between the Company and the Trustee. The net proceeds from the Note Offering, after deducting underwriting
discounts and commissions and offering expenses, were approximately $ 194.9 million, including the proceeds from the Underwriters’
exercise of their over-allotment option in full.
The
Notes are general, unsecured, senior obligations of the Company. The Notes will accrue interest payable semi-annually in arrears on February
1 and August 1 of each year, beginning on February 1, 2026, at a rate equal to 2.750 % per year. In addition, special interest will accrue
on the Notes upon the occurrence of certain events relating to the Company’s failure to file certain reports with the SEC as provided
in the Indenture and as described below. The Notes also have customary provisions relating to the occurrence of “Events of Default”
(as defined in the Indenture) with certain interest penalty provisions. The Notes will mature on August 1, 2031, unless earlier converted,
redeemed or repurchased by the Company.
Noteholders
may convert their Notes at their option at any time prior to the close of business on the scheduled trading day immediately preceding
the maturity date based on an initial conversion rate of 19.4932 shares of common stock, per $ 1,000 principal amount of the Notes, which
is equivalent to an initial conversion price of approximately $ 51.30 per share of common stock. The conversion rate is subject to customary
adjustments upon the occurrence of certain events as described in the Indenture. In addition, if certain corporate events that constitute
a “Make-Whole Fundamental Change” (as defined in the Indenture) occur, then the conversion rate will, in certain circumstances,
be increased for a specified period of time.
The
Notes will be redeemable, in whole or in part (subject to certain limitations described below), at the Company’s option at any
time, and from time to time, on a redemption date on or after August 6, 2029 and on or before the 51st scheduled trading day immediately
before the maturity date, at a cash redemption price equal to the principal amount of the Notes to be redeemed, plus accrued and unpaid
interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of the common stock exceeds
130% of the conversion price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days
ending on, and including, the trading day immediately before the date the Company sends the related redemption notice; and (ii) the trading
day immediately before the date the Company sends such notice. However, the Company may not redeem less than all of the outstanding Notes
unless at least $50.0 million aggregate principal amount of Notes are outstanding and not called for redemption as of the time the Company
sends the related redemption notice. In addition, calling any Note for redemption will constitute a Make-Whole Fundamental Change with
respect to that Note, in which case the conversion rate applicable to the conversion of that Note will be increased in certain circumstances
if it is converted after it is called for redemption.
If
a “Fundamental Change” (as defined in the Indenture) occurs, then, subject to certain conditions and except as set forth
in the Indenture, noteholders may require the Company to repurchase their Notes at a cash repurchase price equal to the principal amount
of the Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date.
The definition in the Indenture of a Fundamental Change includes certain business combination transactions involving the Company and
certain de-listing events with respect to the common stock.
15
CELCUITY INC.
FORM 10-Q
(For the Three and Nine Months
Ended September 30, 2025 and 2024)
Lastly,
the Notes contain a beneficial ownership limitation, and as a result of such limitation, noteholders do not have the right to convert
all or any portion of the Notes held by such noteholder, to the extent that immediately prior to, or immediately after giving effect
to such conversion by such noteholder, together with its affiliates and any other persons acting as a group together with such noteholder
or any of such noteholder’s affiliates, would beneficially own in excess of 4.99% of the number of shares of our common stock outstanding
immediately prior to, and immediately after giving effect to, the conversion of all or any portion of the Notes; provided, that such
4.99% beneficial ownership can be increased or decreased at the discretion of the noteholder; provided further, that such limitation
in no event can exceed 19.99%.
The
issuance costs attributed to the Notes amounted to $ 6.3 million and were discounted from the Notes. The issuance cost discount is being
amortized to interest expense over the term of the Notes based on the effective interest rate method. For each of the three and nine
month periods ended September 30, 2025, discount amortization charged to interest expense related to the issuance costs was $ 0.2 million.
Amended
and Restated Loan and Security Agreement
Third
Amendment
On
September 9, 2025, the Company entered into the Third Amendment (the “Third Amendment”) to the Amended and Restated Loan
and Security Agreement (the “A&R Loan Agreement”) with Oxford Finance LLC, a Delaware limited liability company (“Oxford”),
as collateral agent and a lender, Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership (“Innovatus”),
as a lender, and the other lenders party thereto (together with Oxford and Innovatus, the “Lenders”), pursuant to which the
A&R Loan Agreement was amended to (i) replace Innovatus with Oxford as collateral agent; (ii) recognize the achievement of the Term
D Milestone (as defined in the A&R Loan Agreement, as amended by the Third Amendment (the “Amended A&R Loan Agreement”))
and provide for the immediate disbursement of the $ 30.0
million Term D Loan (as defined in the Amended A&R Loan
Agreement); (iii) increase the size of the Term E Loan (as defined in the Amended A&R Loan Agreement) from $ 50.0
million to up to $ 100.0
million, which Term E Loan may only be drawn upon FDA approval
of gedatolisib in second line wild-type advanced breast cancer patients post CDK4/6 inhibitor therapy; (iv) add three new up to $ 40.0
million Term F Loans (as defined in the Amended A&R Loan
Agreement), which may only be drawn upon achievement of certain trailing three months’ product revenue thresholds; (v) replace
the prior $ 45.0
million Term F Loan (as defined in the A&R Loan Agreement)
with a new $ 150.0
million Term G Loan (as defined in the Amended A&R Loan
Agreement), which continues to be available only in the Lenders’ sole discretion upon the Company’s request; (vi) require
an amendment fee payable by the Company to the Lenders in the amount of $ 50,000 ,
which was paid at the closing of the Third Amendment; (vii) make certain revisions to the non-utilization fee for the Term E Loan, and
add a new non-utilization fee for the Term F Loans, in each case equal to 3.0% of the applicable unfunded commitment, after taking into
consideration any reductions to the applicable term loan commitment that the Company may make by notice to the collateral agent before
the date that is eight weeks after the achievement of any applicable milestones; and (viii) extend the maturity date of the term loans
to November 1, 2029. The Term E Loan and each Term F Loan also are subject to other customary conditions and limits on when the Company
can request funding. With the disbursement of the $ 30.0 million Term D Loan, the Company received net proceeds of approximately
$ 27.8 million.
In accordance with the A&R Loan Agreement, a Final Fee
equal to 4.5 % of the $ 30.0 million Term D Loan was recognized and an additional $ 1.4 million was added to debt principal and a corresponding
debt discount to be amortized over the life of the loan.
In
connection with the Third Amendment, the Company issued warrants with an exercise price of $ 14.84 per share to purchase an aggregate
of 50,537 shares of the Company’s common stock to Innovatus, Oxford, and certain of its affiliates (the “Third Amendment
Warrants”). The Third Amendment Warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary
of the funding date of the Term D Loan. The number of shares of common stock for which each Third Amendment Warrant is exercisable and
the associated exercise price are subject to certain proportional adjustments as set forth in such Third Amendment Warrant.
16
CELCUITY INC.
FORM 10-Q
(For the Three and Nine Months
Ended September 30, 2025 and 2024)
A
portion of the proceeds from the Term D Loan in the amount of $ 2.8 million was allocated to the Third Amendment Warrants based on their
relative fair value to the underlying Term D Loan. The proceeds allocated to the Third Amendment Warrants were recorded as additional
paid in capital in the accompanying condensed consolidated balance sheets and were discounted from the Term D Loan. The relative fair
value of the Third Amendment Warrants was based on the Black-Scholes method with the following assumptions: risk-free interest rate of
4.08 %; expected volatility of 74.4 %; expected life of 10.0 years; and expected dividend yield 0 %. The underlying stock price used in
the analysis was the traded market price. The discount related to the Third Amendment Warrants is being amortized to interest expense
ratably over the term of the Term D Loan.
Second
Amendment
On
July 28, 2025, the Company entered into the Second Amendment (the “Second Amendment”) to the A&R Loan Agreement with
Innovatus, as collateral agent, and the Lenders including Innovatus in its capacity as a Lender and 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 was amended to (i) subject to certain terms and conditions, permit the issuance of
the Notes discussed above and certain transactions in connection therewith, including the conversion thereof settled solely in common
stock (together with cash in lieu of the issuance of any fractional share of common stock), (ii) permit capped call transactions in connection
with the pricing of the Notes, (iii) require an amendment fee payable by the Company to Oxford in the amount of $ 25,000 , which was paid
upon execution of the Second Amendment, and (iv) extend to May 9, 2026 the expiration date of Innovatus’ right 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 .
Further,
in connection with the release of the topline data from the wild-type cohort of the VIKTORIA-1 Phase 3 clinical trial, the Company achieved
the Term D Milestone (as defined in the A&R Loan Agreement) and therefore became eligible to draw an additional $ 30.0 million of
indebtedness under the Term D Loan (as defined in the A&R Loan Agreement). As described above, the Term D Loan was disbursed to the
Company in connection with the Third Amendment.
First
Amendment
On
May 13, 2025, the Company entered into the First Amendment (the “First Amendment”) to the A&R Loan Agreement, pursuant
to which the Company agreed to (i) pay Oxford an amendment fee of $40,000 on the effective date of the First Amendment, (ii) extend to
March 9, 2026 the expiration date of Innovatus’ right 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, (iii) extend the expiration date of the Term D Draw Period
to the earlier of (x) August 31, 2025 and (y) the occurrence of an Event of Default (as defined in the A&R Loan Agreement), (iv)
update the liquidity covenant to increase the Minimum Liquidity Percentage (as defined in the First Amendment) to 50% if the Company
had failed to achieve the Term D Milestone prior to June 1, 2025 and to decrease the Minimum Liquidity Percentage back to 30% if the
Company subsequently achieves the Term D Milestone prior to the end of the Term D Draw Period, and (v) release Innovatus and the Lenders
from any and all claims arising out of or related to the A&R Loan Agreement, the First Amendment and related documentation.
May
30, 2024 Amendment and Restatement
On
May 30, 2024, the Company entered into the A&R Loan Agreement. The A&R Loan Agreement amended and restated, 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”).
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”).
As described above, the Term D Loan was disbursed to the Company in connection with the Third Amendment. Prior to the Third Amendment,
the Company also would have become eligible to draw on a fifth tranche of $ 50 million (the “Term E Loan”), upon achievement
of certain clinical trial milestones and satisfaction of certain financial covenants. The Lenders also could have, in their sole discretion
upon the Company’s request, made additional term loans to the Company of $ 45 million (the “Term F Loan”). Funding of
these additional tranches was also subject to other customary conditions and limits on when the Company could have requested funding
for such tranches. Costs associated with the new borrowings were approximately $ 2.4 million.
17
CELCUITY INC.
FORM 10-Q
(For the Three and Nine Months
Ended September 30, 2025 and 2024)
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 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 are being used for working capital purposes and
to fund the Company’s general business requirements, including the ongoing Phase 3 VIKTORIA-1 clinical trial, the Phase 1b/2 CELC-G-201
clinical trial, and 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. Prior
to the Second Amendment, Innovatus also had 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 . 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 the Term E Loans. Following the disbursement of the Term D Loan in connection with the Third Amendment, the non-utilization
provisions related to the Term D Loan are no longer operative. 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 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 and the Term D Loans, 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 was, with respect to the Term C Loan, 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 Term D Loans, the exercise price was 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 Term D Loan funding. Prior to the
Third Amendment, the Company also was required to issue warrants to Innovatus and Oxford in connection with the funding of the Term E
Loan and the Term F Loan. 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.
18
CELCUITY INC.
FORM 10-Q
(For the Three and Nine Months
Ended September 30, 2025 and 2024)
The
Company evaluated the change of terms under ASC 470-50, “Debt – Modification and Extinguishment” with respect to the
Third Amendment, the Second Amendment, the First Amendment and the A&R Loan Agreement 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 September 30, 2025 and December 31, 2024:
Schedule of Long-term Debt
(in thousands)
September 30, 2025
December 31, 2024
Note payable
$ 130,000
$ 100,000
Add: Final fee
5,850
4,500
Add: PIK interest (added to principal)
1,366
593
Less: unamortized debt issuance costs
( 3,154 )
( 1,614 )
Less: unamortized debt discount
( 8,896 )
( 5,752 )
Total long-term debt
$ 125,166
$ 97,727
Future
principal payments, including the incurred PIK interest and Final Fee, are as follows:
Schedule of Long Term Debt Future Principal Payments
(in thousands)
Years Ending December 31,
2028
43,789
2029
93,427
Total
$ 137,216
9.
License Agreement
On
April 8, 2021, the Company entered into a license agreement with Pfizer to research, develop, manufacture and commercialize gedatolisib,
a potent, investigational, multi-target PAM inhibitor that potently targets all four Class I PI3K isoforms, mTORC1, and mTORC2 to induce
comprehensive blockade of the PAM pathway. 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
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. One of these milestone events requires a $ 5.0
million payment within 60 days following the FDA regulatory filing of a New Drug Application (“NDA”) for gedatolisib.
The FDA granted the Company’s request to submit its NDA via the FDA’s Real-Time Oncology Review (“RTOR”)
program, and the Company made its first NDA pre-submission in September 2025 and expects to complete its final
NDA submission to the FDA in the fourth quarter of 2025. The Company has recorded the $ 5.0 million NDA filing milestone as a
research and development expense in June 2025. 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 patent 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.
The
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.
10.
Subsequent Events
Warrants
Exercised
In
October 2025, investors exercised 2,930,420 warrants at an exercise price of $ 8.05 , which generated approximately $ 23.6 million
in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.