UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2024

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File No. 001-38207

CELCUITY INC.

(Exact name of registrant as specified in its charter)

Delaware		No. 82-2863566
(State of incorporation)		(IRS Employer Identification No.)

16305 36th Avenue North; Suite 100

Minneapolis, Minnesota 55446

(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code: (763) 392-0767

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.001 par value per share		CELC		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES ☒ NO ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒

On August 7, 2024 there were 37,028,733 shares of the registrant’s common stock, $0.001 par value per share, outstanding.

Celcuity Inc.

Table of Contents

	PAGE

PART I. FINANCIAL INFORMATION
ITEM 1. Financial Statements (unaudited)	3
Condensed Balance Sheets as of June 30, 2024 and December 31, 2023	3
Condensed Statements of Operations for the three months and six months ended June 30, 2024 and 2023	4
Condensed Statements of Stockholders’ Equity for the three months and six months ended June 30, 2024	5
Condensed Statements of Stockholders’ Equity for the three months and six months ended June 30, 2023	6
Condensed Statements of Cash Flows for the six months ended June 30, 2024 and 2023	7
Notes to Unaudited Condensed Financial Statements	8
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	15
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk	23
ITEM 4. Controls and Procedures	23
PART II. OTHER INFORMATION
ITEM 1. Legal Proceedings	24
ITEM 1A. Risk Factors	24
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds	24
ITEM 3. Defaults Upon Senior Securities	24
ITEM 4. Mine Safety Disclosures	24
ITEM 5. Other Information	24
ITEM 6. Exhibits	25
Signatures	26

As used in this report, the terms “we,” “us,” “our,” “Celcuity,” and the “Company” mean Celcuity Inc., unless the context indicates another meaning.

PART I. FINANCIAL INFORMATION

ITEM 1. Financial Statements

Celcuity Inc.

Condensed Balance Sheets

	June 30, 2024			December 31, 2023
	(unaudited)
Assets
Current Assets:
Cash and cash equivalents	$	30,458,800		$	30,662,774
Investments		252,609,622			149,919,974
Other current assets		8,862,940			10,007,849
Total current assets		291,931,362			190,590,597
Property and equipment, net		308,444			228,782
Operating lease right-of-use assets		305,179			400,019
Total Assets	$	292,544,985		$	191,219,398
Liabilities and Stockholders’ Equity:
Current Liabilities:
Accounts payable	$	6,203,132		$	5,076,699
Operating lease liabilities		178,587			184,950
Accrued expenses		13,146,769			8,927,094
Total current liabilities		19,528,488			14,188,743
Operating lease liabilities		138,533			225,922
Note payable, non-current		96,193,172			37,035,411
Total Liabilities		115,860,193			51,450,076
Commitments and Contingencies (Note 5)		-			-
Stockholders’ Equity:
Preferred stock, $0.001 par value: 2,500,000 shares authorized; 317,577 and 854,134 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively		318			854
Common stock, $0.001 par value: 65,000,000 shares authorized; 37,014,751 and 25,506,012 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively		37,015			25,506
Additional paid-in capital		382,057,737			299,818,965
Accumulated deficit		(205,410,278	)		(160,076,003	)
Total Stockholders’ Equity		176,684,792			139,769,322
Total Liabilities and Stockholders’ Equity	$	292,544,985		$	191,219,398

See accompanying notes to the Condensed financial statements

Condensed Statements of Operations

(unaudited)

	2024			2023			2024			2023
	Three Months Ended June 30,						Six Months Ended June 30,
	2024			2023			2024			2023

Operating expenses:

Research and development	$	22,496,975		$	13,746,082		$	43,144,534		$	25,024,575
General and administrative		1,786,111			1,309,403			3,632,387			2,578,447
Total operating expenses		24,283,086			15,055,485			46,776,921			27,603,022
Loss from operations		(24,283,086	)		(15,055,485	)		(46,776,921	)		(27,603,022	)

Other income (expense)
Interest expense		(2,260,583	)		(1,314,996	)		(3,661,295	)		(2,557,008	)
Interest income		2,821,849			1,782,794			5,103,941			3,633,926
Other income (expense), net		561,266			467,798			1,442,646			1,076,918
Net loss before income taxes		(23,721,820	)		(14,587,687	)		(45,334,275	)		(26,526,104	)
Income tax benefits		-			-			-			-
Net loss	$	(23,721,820	)	$	(14,587,687	)	$	(45,334,275	)	$	(26,526,104	)

Net loss per share, basic and diluted	$	(0.62	)	$	(0.66	)	$	(1.26	)	$	(1.22	)

Weighted average common shares outstanding, basic and diluted		38,444,163			21,957,140			36,028,109			21,819,772

See accompanying notes to the Condensed financial statements

Celcuity Inc.

Condensed Statements of Changes in Stockholders’ Equity

Three and Six Months Ended June 30, 2024

	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, 2023		25,506,012	$	25,506		854,134		$	854		$	299,818,965		$	(160,076,003	)	$	139,769,322
Stock-based compensation		-		-		-			-			1,331,346			-			1,331,346
Exercise of common stock warrants, net of shares withheld for exercise price		1,742,763		1,742		-			-			14,007,409			-			14,009,151
Exercise of common stock options, net of shares withheld for exercise price		36,550		37		-			-			239,263			-			239,300
Conversion of preferred to common stock		3,488,570		3,489		(348,857	)		(349	)		(3,140	)		-			-
Net loss		-		-		-			-			-			(21,612,455	)		(21,612,455	)
Balance at March 31, 2024 (unaudited)		30,773,895	$	30,774		505,277		$	505		$	315,393,843		$	(181,688,458	)	$	133,736,664
Stock-based compensation		1,429		1		-			-			1,410,512			-			1,410,513
Employee stock purchases		20,426		20		-			-			131,226			-			131,246
Conversion of preferred to common stock		1,877,000		1,878		(187,700	)		(187	)		(1,691	)		-			-
Exercise of common stock warrants, net of shares withheld for exercise price		19,390		19		-			-			172,967			-			172,986
Exercise of common stock options, net of shares withheld for exercise price		16,197		17		-			-			95,694			-			95,711
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		-		-		-			-			-			(23,721,820	)		(23,721,820	)
Balance at June 30, 2024 (unaudited)		37,014,751	$	37,015		317,577		$	318		$	382,057,737		$	(205,410,278	)	$	176,684,792

See accompanying notes to the Condensed financial statements

Celcuity Inc.

Condensed Statements of Changes in Stockholders’ Equity

Three and Six Months Ended June 30, 2023

	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		-		-		-			-			1,273,282			-			1,273,282
Exercise of common stock options, net of shares withheld for exercise price		24,122		24		-			-			127,898			-			127,922
Conversion of preferred to common stock		250,000		250		(25,000	)		(25	)		(225	)		-			-
Issuance costs associated with private placement offering		-		-		-			-			(7,486	)		-			(7,486	)
Net loss		-		-		-			-			-			(11,938,417	)		(11,938,417	)
Balance at March 31, 2023 (unaudited)		21,941,372	$	21,941		1,095,873		$	1,096		$	231,439,035		$	(108,235,304	)	$	123,226,768
Balance		21,941,372	$	21,941		1,095,873		$	1,096		$	231,439,035		$	(108,235,304	)	$	123,226,768
Stock-based compensation		1,958		2		-			-			1,276,980			-			1,276,982
Employee stock purchases		17,477		17		-			-			102,621			-			102,638
Conversion of preferred to common stock		100,000		100		(10,000	)		(10	)		(90	)		-			-
Exercise of common stock options, net of shares withheld for exercise price		21,086		22		-			-			113,618			-			113,640
Net loss		-		-		-			-			-			(14,587,687	)		(14,587,687	)
Balance at June 30, 2023 (unaudited)		22,081,893	$	22,082		1,085,873		$	1,086		$	232,932,164		$	(122,822,991	)	$	110,132,341
Balance		22,081,893	$	22,082		1,085,873		$	1,086		$	232,932,164		$	(122,822,991	)	$	110,132,341

See accompanying notes to the Condensed financial statements

Celcuity Inc.

Condensed Statements of Cash Flows

(unaudited)

	2024			2023
	Six Months Ended June 30,
	2024			2023
Cash flows from operating activities:
Net loss	$	(45,334,275	)	$	(26,526,104	)
Adjustments to reconcile net loss to net cash and cash equivalents used for operations:
Depreciation		60,672			81,269
Stock-based compensation		2,741,858			2,550,264
Amortization of debt issuance costs and discount		302,302			116,218
Payment-in-Kind interest		858,096			886,688
Non-cash operating lease expense, net		1,088			1,975
Change in accrued interest income		(638,836	)		41,188
Changes in operating assets and liabilities:
Other current assets		1,471,542			86,666
Accounts payable		1,182,816			421,091
Accrued expenses		4,219,675			(189,145	)
Net cash used for operating activities		(35,135,062	)		(22,529,890	)

Cash flows from investing activities:
Proceeds from maturities of investments		260,389,589			143,873,027
Purchases of investments		(362,767,031	)		(113,903,646	)
Purchases of property and equipment		(153,949	)		(11,841	)
Net cash (used for) provided by investing activities		(102,531,391	)		29,957,540

Cash flows from financing activities:
Proceeds from exercise of common stock warrants		14,182,137			-
Proceeds from exercise of employee stock options		335,013			241,562
Proceeds from employee stock purchases		131,246			102,638
Proceeds from follow-on offering, net of underwriting discounts and offering costs		56,258,027			-
Proceeds from note payable, net of debt issuance costs and discount of $2,429,917		59,234,003			-
Proceeds from an ATM offering, net of issuance costs		7,356,107			-
Payments for secondary registration statement costs		(34,054	)		(99,540	)
Payments for debt issuance costs		-			(2,716	)
Payments for finance leases		-			(2,449	)
Net cash provided by financing activities		137,462,479			239,495
Net change in cash and cash equivalents		(203,974	)		7,667,145

Cash and cash equivalents:
Beginning of period		30,662,774			24,571,557
End of period	$	30,458,800		$	32,238,702

Supplemental disclosure of cash flow information:
Interest paid	$	2,500,897		$	1,554,103
Supplemental disclosures of non-cash investing and financing activities:
Offering and registration statement costs included in accounts payable	$	13,645		$	2,143
Property and equipment included in accounts payable	$	-		$	19,993
Non-cash interest receivable	$	326,633		$	-
Common stock warrants issued with note payable transaction	$	1,228,911		$	-

See accompanying notes to the Condensed financial statements

CELCUITY INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited)

(For the Three and Six Months Ended June 30, 2024 and 2023)

1. Organization

Nature of Business

Celcuity Inc., a Delaware corporation (the “Company”), is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications. The Company’s lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, was initiated in the first quarter of 2024 and is currently enrolling patients. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is expected to begin enrolling patients in the second quarter of 2025. 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 unaudited 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 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, 2023 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, 2023 and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. Operating results for the three and six months ended June 30, 2024 are not necessarily indicative of the results to be expected during the remainder of the current year or for any 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 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.

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 diagnostic tests, ability to obtain regulatory approval of its diagnostic tests, the clinical and commercial success of its initial drug product, 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.

Clinical Trial Costs

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. As the current VIKTORIA-1 Phase 3 and CELC-G-201 Phase 1b/2 trials ramp up site activation and patient enrollment, the Company’s estimated expenses in future periods and actual services performed may vary from these estimates, and these estimates may become more significant. Changes in these estimates that result in material changes to the Company’s prepaid assets or accrued expenses could materially affect the Company’s results of operations.

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, 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:


	June 30,
	2024		2023

Preferred stock on an as-if-converted to common stock basis		3,175,770		10,858,730
Options to purchase common stock

SEC Form 10-Q filed by Celcuity Inc.