Celcuity (CELC) 10-Q 11 Aug 23 2023 Q2 Quarterly report Financial data

Cover

Cover - shares	6 Months Ended
	Jun. 30, 2023	Aug. 04, 2023
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Jun. 30, 2023
Document Fiscal Period Focus	Q2
Document Fiscal Year Focus	2023
Current Fiscal Year End Date	--12-31
Entity File Number	001-38207
Entity Registrant Name	CELCUITY INC.
Entity Central Index Key	0001603454
Entity Tax Identification Number	82-2863566
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	16305 36th Avenue North; Suite 100
Entity Address, City or Town	Minneapolis
Entity Address, State or Province	MN
Entity Address, Postal Zip Code	55446
City Area Code	(763)
Local Phone Number	392-0767
Title of 12(b) Security	Common Stock, $0.001 par value per share
Trading Symbol	CELC
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		22,090,143

Condensed Balance Sheets

Condensed Balance Sheets - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Current Assets:
Cash and cash equivalents	$ 32,238,702	$ 24,571,557
Investments	114,005,385	144,015,954
Deposits	22,009	22,009
Deferred transaction costs	79,088	33,195
Payroll tax receivable		203,665
Prepaid assets	6,461,156	6,344,157
Total current assets	152,806,340	175,190,537
Property and equipment, net	210,858	260,294
Operating lease right-of-use assets	499,993	246,266
Total Assets	153,517,191	175,697,097
Current Liabilities:
Accounts payable	3,019,282	2,627,076
Finance lease liabilities		2,449
Operating lease liabilities	191,333	191,749
Accrued expenses	3,871,135	4,060,280
Total current liabilities	7,081,750	6,881,554
Operating lease liabilities	317,120	61,002
Note payable, non-current	35,985,980	34,983,074
Total Liabilities	43,384,850	41,925,630
Commitments and Contingencies (Note 5)
Stockholders’ Equity:
Preferred stock, $0.001 par value: 2,500,000 shares authorized; 1,085,873 and 1,120,873 shares issued and outstanding as of June 30, 2023 and December 31, 2022	1,086	1,121
Common stock, $0.001 par value: 65,000,000 shares authorized as of June 30, 2023 and December 31, 2022, respectively; 22,081,893 and 21,667,250 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively	22,082	21,667
Additional paid-in capital	232,932,164	230,045,566
Accumulated deficit	(122,822,991)	(96,296,887)
Total Stockholders’ Equity	110,132,341	133,771,467
Total Liabilities and Stockholders’ Equity	$ 153,517,191	$ 175,697,097

Condensed Balance Sheets (Paren

Condensed Balance Sheets (Parenthetical) - $ / shares	Jun. 30, 2023	Dec. 31, 2022
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	2,500,000	2,500,000
Preferred stock, shares issued	1,085,873	1,120,873
Preferred stock, shares outstanding	1,085,873	1,120,873
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	65,000,000	65,000,000
Common stock, shares issued	22,081,893	21,667,250
Common stock, shares outstanding	22,081,893	21,667,250

Condensed Statements of Operati

Condensed Statements of Operations (Unaudited) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Operating expenses:
Research and development	$ 13,746,082	$ 8,367,687	$ 25,024,575	$ 15,064,000
General and administrative	1,309,403	1,233,040	2,578,447	2,044,332
Total operating expenses	15,055,485	9,600,727	27,603,022	17,108,332
Loss from operations	(15,055,485)	(9,600,727)	(27,603,022)	(17,108,332)
Other income (expense)
Interest expense	(1,314,996)	(455,445)	(2,557,008)	(890,446)
Interest income	1,782,794	95,646	3,633,926	103,805
Other income (expense), net	467,798	(359,799)	1,076,918	(786,641)
Net loss before income taxes	(14,587,687)	(9,960,526)	(26,526,104)	(17,894,973)
Income tax benefits
Net loss	$ (14,587,687)	$ (9,960,526)	$ (26,526,104)	$ (17,894,973)
Net loss per share, basic	$ (0.66)	$ (0.67)	$ (1.22)	$ (1.20)
Net loss per share, diluted	$ (0.66)	$ (0.67)	$ (1.22)	$ (1.20)
Weighted average common shares outstanding, basic	21,957,140	14,930,538	21,819,772	14,923,900
Weighted average common shares outstanding, diluted	21,957,140	14,930,538	21,819,772	14,923,900

Condensed Statements of Changes

Condensed Statements of Changes in Stockholders' Equity (Unaudited) - USD ($)	Common Stock [Member]	Preferred Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Total
Beginning balance, value at Dec. 31, 2021	$ 14,919		$ 124,622,405	$ (55,926,847)	$ 68,710,477
Beginning balance, shares at Dec. 31, 2021	14,918,887
Stock-based compensation			756,271		756,271
Exercise of common stock options, net of shares withheld for exercise price	$ 1		7,413		7,414
Exercise of common stock options, net of shares withheld for exercise price, shares	1,415
Net loss				(7,934,447)	(7,934,447)
Ending balance, value at Mar. 31, 2022	$ 14,920		125,386,089	(63,861,294)	61,539,715
Ending balance, shares at Mar. 31, 2022	14,920,302
Beginning balance, value at Dec. 31, 2021	$ 14,919		124,622,405	(55,926,847)	68,710,477
Beginning balance, shares at Dec. 31, 2021	14,918,887
Net loss					(17,894,973)
Ending balance, value at Jun. 30, 2022	$ 14,941		126,995,610	(73,821,820)	53,188,731
Ending balance, shares at Jun. 30, 2022	14,941,334
Beginning balance, value at Mar. 31, 2022	$ 14,920		125,386,089	(63,861,294)	61,539,715
Beginning balance, shares at Mar. 31, 2022	14,920,302
Stock-based compensation	$ 3		1,519,456		1,519,459
Stock-based compensation, shares	3,273
Exercise of common stock options, net of shares withheld for exercise price	$ 2		9,540		9,542
Exercise of common stock options, net of shares withheld for exercise price, shares	1,871
Net loss				(9,960,526)	(9,960,526)
Employee stock purchases	$ 16		80,525		80,541
Employee stock purchases, shares	15,888
Ending balance, value at Jun. 30, 2022	$ 14,941		126,995,610	(73,821,820)	53,188,731
Ending balance, shares at Jun. 30, 2022	14,941,334
Beginning balance, value at Dec. 31, 2022	$ 21,667	$ 1,121	230,045,566	(96,296,887)	133,771,467
Beginning balance, shares at Dec. 31, 2022	21,667,250	1,120,873
Stock-based compensation			1,273,282		1,273,282
Stock-based compensation, shares
Exercise of common stock options, net of shares withheld for exercise price	$ 24		127,898		127,922
Exercise of common stock options, net of shares withheld for exercise price, shares	24,122
Conversion of preferred to common stock	$ 250	$ (25)	(225)
Conversion of preferred to common stock, shares	250,000	(25,000)
Issuance costs associated with private placement offering			(7,486)		(7,486)
Net loss				(11,938,417)	(11,938,417)
Ending balance, value at Mar. 31, 2023	$ 21,941	$ 1,096	231,439,035	(108,235,304)	123,226,768
Ending balance, shares at Mar. 31, 2023	21,941,372	1,095,873
Beginning balance, value at Dec. 31, 2022	$ 21,667	$ 1,121	230,045,566	(96,296,887)	133,771,467
Beginning balance, shares at Dec. 31, 2022	21,667,250	1,120,873
Net loss					(26,526,104)
Ending balance, value at Jun. 30, 2023	$ 22,082	$ 1,086	232,932,164	(122,822,991)	110,132,341
Ending balance, shares at Jun. 30, 2023	22,081,893	1,085,873
Beginning balance, value at Mar. 31, 2023	$ 21,941	$ 1,096	231,439,035	(108,235,304)	123,226,768
Beginning balance, shares at Mar. 31, 2023	21,941,372	1,095,873
Stock-based compensation	$ 2		1,276,980		1,276,982
Stock-based compensation, shares	1,958
Exercise of common stock options, net of shares withheld for exercise price	$ 22		113,618		113,640
Exercise of common stock options, net of shares withheld for exercise price, shares	21,086
Conversion of preferred to common stock	$ 100	$ (10)	(90)
Conversion of preferred to common stock, shares	100,000	(10,000)
Net loss				(14,587,687)	(14,587,687)
Employee stock purchases	$ 17		102,621		102,638
Employee stock purchases, shares	17,477
Ending balance, value at Jun. 30, 2023	$ 22,082	$ 1,086	$ 232,932,164	$ (122,822,991)	$ 110,132,341
Ending balance, shares at Jun. 30, 2023	22,081,893	1,085,873

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows (Unaudited) - USD ($)	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Cash flows from operating activities:
Net loss	$ (26,526,104)	$ (17,894,973)
Adjustments to reconcile net loss to net cash used for operations:
Depreciation	81,269	108,436
Stock-based compensation	2,550,264	2,275,730
Amortization of debt issuance costs and discount	116,218	179,539
Payment-in-Kind interest	886,688	205,998
Non-cash operating lease, net	1,975	(1,686)
Change in accrued interest income	41,188
Changes in operating assets and liabilities:
Payroll tax receivable	203,665	203,464
Prepaid assets and deposits	(116,999)	(3,879,197)
Accounts payable	421,091	705,145
Accrued expenses	(189,145)	875,412
Net cash used for operating activities	(22,529,890)	(17,222,132)
Cash flows from investing activities:
Proceeds from maturities of investments	143,873,027
Purchases of investments	(113,903,646)
Purchases of property and equipment	(11,841)	(34,621)
Net cash provided by (used for) investing activities	29,957,540	(34,621)
Cash flows from financing activities:
Proceeds from exercise of employee stock options	241,562	16,956
Proceeds from employee stock purchases	102,638	80,541
Payments for secondary registration statement costs	(99,540)	(213,381)
Payments for debt issuance costs	(2,716)
Payments for finance leases	(2,449)	(2,920)
Net cash provided by (used for) financing activities	239,495	(118,804)
Net change in cash and cash equivalents	7,667,145	(17,375,557)
Cash and cash equivalents:
Beginning of period	24,571,557	84,286,381
End of period	32,238,702	66,910,824
Supplemental disclosure of cash flow information:
Interest paid	1,554,103	504,909
Supplemental disclosures of non-cash investing and financing activities:
Offering and registration statement costs included in accounts payable	2,143	100,422
Offering and registration statement costs included in accrued expenses		5,000
Property and equipment included in accounts payable	$ 19,993

Organization

Organization	6 Months Ended
	Jun. 30, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Organization	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 multiple solid tumor indications. The Company’s lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. Its CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies. The Company was co-founded in 2012 by Brian F. Sullivan and Dr. Lance G. Laing and is based in Minnesota. The Company has not generated any revenues to date.

Basis of Presentation, Summary

Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements	6 Months Ended
	Jun. 30, 2023
Accounting Policies [Abstract]
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements	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, 2022 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, 2022 and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Operating results for the three and six months ended June 30, 2023 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 trial ramps up site activation and patient enrollment, the Company’s estimated expenses in future periods and actual services performed may vary from these estimates, and these estimates may become more significant. Changes in these estimates that result in material changes to the Company’s prepaid assets or accrued expenses could materially affect the Company’s results of operations. Recently Adopted Accounting Pronouncements In June 2016 and related amendments, the FASB issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments – Credit Losses (Topic 326). This guidance changes the methodology to be used to measure credit losses for certain financial instruments and financial assets. The new methodology requires the recognition of an allowance that reflects the current estimate of credit losses expected to be incurred over the life of the financial asset. The Company adopted this standard effective January 1, 2023. The adoption of the standard did not have a material impact on the Company’s consolidated financial statements.

Net Loss Per Common Share

Net Loss Per Common Share	6 Months Ended
	Jun. 30, 2023
Earnings Per Share [Abstract]
Net Loss Per Common Share	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 options and warrants have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted-average shares outstanding used to calculate both basic and diluted loss per common share is the same. For the three and six months ended June 30, 2023 and 2022, potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding were preferred stock on an as-if-converted to common stock basis of 10,858,730 zero 2,185,567 1,782,782 7,266,102 377,652 1,958 3,273

Investments

Investments	6 Months Ended
	Jun. 30, 2023
Investments, All Other Investments [Abstract]
Investments	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 agencies 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 table summarizes the Company’s held-to-maturity investment securities at amortized cost as of June 30, 2023 and December 31, 2022: Schedule of Investment Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value June 30, 2023 Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value U.S. Treasury Bills $ 114,005,385 $ 30,500 $ - $ 114,035,885 Total $ 114,005,385 $ 30,500 $ - $ 114,035,885 Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value December 31, 2022 Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value Governmental Agency Securities $ 46,230,893 $ 29,517 $ - $ 46,260,410 U.S. Treasury Bills 97,785,061 41,639 - 97,826,700 Total $ 144,015,954 $ 71,156 $ - $ 144,087,110 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.

Commitments

Commitments	6 Months Ended
	Jun. 30, 2023
Commitments and Contingencies Disclosure [Abstract]
Commitments	5. Commitments Operating Lease 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. The Company recorded an incremental $ 355,578 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, CMO’s, and CRO’s. The Company currently has four Phase 2 clinical trial agreements in place to evaluate targeted therapies selected with one of our CELsignia tests. Timing of milestone payments related to the Phase 2 clinical trials are uncertain and the contracts generally provide for termination following a certain period after notice, therefore the Company believes that non-cancelable obligations under the agreements are not material. The Company also has a license agreement in place with Pfizer to research, develop, manufacture and commercialize gedatolisib. In conjunction with the license agreement, the Company continued a Phase 1b study – B2151009 related to gedatolisib. These patients subsequently transitioned to an Expanded Access study – CELC-G-001. Contracts related to the Expanded Access study, are generally based on time and material. In addition, contracts related to the Company’s Phase 3 clinical study (VIKTORIA-1) are generally cancelable with reasonable notice within 120 days and the Company’s obligations under these contracts are primarily based on services performed through termination dates plus certain cancelation charges, if any, as defined in each of the respective agreements. In addition, these agreements may, from time to time, be subjected to amendments as a result of any change orders executed by the parties. As of June 30, 2023, the Company had only one material non-cancelable contractual commitment with respect to these arrangements, which totaled approximately $ 2.0

Stockholders_ Equity

Stockholders’ Equity	6 Months Ended
	Jun. 30, 2023
Equity [Abstract]
Stockholders’ Equity	6. Stockholders’ Equity Capital Stock At December 31, 2022, the Company’s authorized capital stock consisted of 65,000,000 .001 21,667,250 2,500,000 .001 1,120,873 On March 31, 2023, one of the Company’s preferred shareholders elected to convert 25,000 250,0000 5.75 On June 29, 2023, one of the Company’s preferred shareholders elected to convert 10,000 100,0000 5.75 At June 30, 2023, the Company’s authorized capital stock consisted of 65,000,000 22,081,893 2,500,000 1,850,000 1,085,873 no

Stock-Based Compensation

Stock-Based Compensation	6 Months Ended
	Jun. 30, 2023
Share-Based Payment Arrangement [Abstract]
Stock-Based Compensation	7. Stock-Based Compensation The following table summarizes the activity for all stock options outstanding for the six months ended June 30: Schedule of Stock Options Activity 2023 2022 Shares Weighted Average Exercise Price Shares Weighted Average Exercise Price Options outstanding at beginning of year 1,976,586 $ 6.34 1,315,321 $ 11.97 Granted 310,798 10.74 550,747 6.52 Exercised (45,208 ) 5.34 (3,286 ) 5.16 Forfeited (56,609 ) 7.67 (80,000 ) 13.01 Balance at June 30 2,185,567 $ 6.96 1,782,782 $ 5.75 Options exercisable at June 30: 1,346,587 $ 5.97 724,666 $ 6.02 Weighted Average Grant Date Fair Value for options granted during the period: $ 7.42 $ 4.34 The following table summarizes additional information about stock options outstanding and exercisable at June 30, 2023: 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 2,185,567 7.76 $ 6.96 $ 9,018,037 1,346,587 $ 5.97 $ 6,900,392 The Company recognized stock-based compensation expense for stock options of $ 1,228,284 1,460,031 2,450,612 2,169,540 776,324 5.50 37,690 428,343 77,302 428,343 228,000 311,000 13.44 16,920 25,755 33,844 53,784 139,000 203,750 5.10 6,826 11,601 13,934 23,216 6,000 The Black-Scholes option-pricing model was used to estimate the fair value of equity-based awards with the following weighted-average assumptions for the six months ended June 30: Schedule of Assumptions for Fair Value of Equity-based Awards 2023 2022 Risk-free interest rate 3.41 4.14 % 1.68 3.1 % Expected volatility 78.0 79.8 % 76.2 78.3 % Expected life (years) 5.25 6.08 5.29 6.08 Expected dividend yield 0 % 0 % The inputs for the Black-Scholes valuation 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 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. 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 were granted to members of the Company’s board during the three months ended June 30, 2023 and 2022. The Company had 1,958 3,273 3,273 2,964 4,052 6,775 8,694 27,119 The Company initially reserved a maximum of 750,000 102,998 149,189 216,673 increase automatically on January 1 of each year from 2024 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, subject to the board’s discretion to reduce the amount of the increase in any particular year. 500,000 1,000,000 1,500,000 1,702,461 Total unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized as follows: Schedule of Unrecognized Compensation Cost 2023 $ 1,878,430 2024 2,588,676 2025 1,602,483 2026 614,044 2027 94,968 Total estimated compensation cost to be recognized $ 6,778,601 The Company recognized stock-based compensation expense related to its employee stock purchase plan of $ 44,646 52,653 90,958 79,071 100,000 51,499 74,594 108,337 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. 283,008 The Company recognized total stock-based compensation expense as follows for the three and six months ended June 30: Schedule of Stock-based Compensation Expense 2023 2022 2023 2022 Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Stock-based compensation expense in operating expenses: Research and development $ 639,511 $ 810,664 $ 1,293,982 $ 1,261,183 General and administrative 637,471 708,795 1,256,282 1,014,547 Total $ 1,276,982 $ 1,519,459 $ 2,550,264 $ 2,275,730

Debt

Debt	6 Months Ended
	Jun. 30, 2023
Debt Disclosure [Abstract]
Debt	8. Debt On April 8, 2021, the Company entered into a loan and security agreement (the “Loan Agreement”) with Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership (“Innovatus”) in its capacity as Collateral Agent and sole Lender. On August 9, 2022, the Company amended the Loan Agreement. Under the amended Loan Agreement, Innovatus, as Lender, has agreed to loan up to $ 75 50 35 15 20 Long-term debt consisted of the following at June 30, 2023 and December 31, 2022: Schedule of Long-term Debt June 30, 2023 December 31, 2022 Note payable $ 35,000,000 $ 35,000,000 Add: PIK interest (added to principal) 1,641,763 755,075 Less: unamortized debt issuance costs (598,107 ) (707,001 ) Less: unamortized debt discount (57,676 ) (65,000 ) Total long-term debt $ 35,985,980 $ 34,983,074 Future principal payments, including the incurred PIK interest, are as follows: Schedule of Long Term Debt Future Principal Payments Years Ending December 31, 2025 $ 13,740,661 2026 18,320,882 2027 4,580,220 Total $ 36,641,763

Basis of Presentation, Summar_2

Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies)	6 Months Ended
	Jun. 30, 2023
Accounting Policies [Abstract]
Basis of Presentation	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, 2022 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, 2022 and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Operating results for the three and six months ended June 30, 2023 are not necessarily indicative of the results to be expected during the remainder of the current year or for any future period.
Accounting Estimates	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	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	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 trial ramps up site activation and patient enrollment, the Company’s estimated expenses in future periods and actual services performed may vary from these estimates, and these estimates may become more significant. Changes in these estimates that result in material changes to the Company’s prepaid assets or accrued expenses could materially affect the Company’s results of operations.
Recently Adopted Accounting Pronouncements	Recently Adopted Accounting Pronouncements In June 2016 and related amendments, the FASB issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments – Credit Losses (Topic 326). This guidance changes the methodology to be used to measure credit losses for certain financial instruments and financial assets. The new methodology requires the recognition of an allowance that reflects the current estimate of credit losses expected to be incurred over the life of the financial asset. The Company adopted this standard effective January 1, 2023. The adoption of the standard did not have a material impact on the Company’s consolidated financial statements.

Investments (Tables)

Investments (Tables)	6 Months Ended
	Jun. 30, 2023
Investments, All Other Investments [Abstract]
Schedule of Investment	The following table summarizes the Company’s held-to-maturity investment securities at amortized cost as of June 30, 2023 and December 31, 2022: Schedule of Investment Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value June 30, 2023 Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value U.S. Treasury Bills $ 114,005,385 $ 30,500 $ - $ 114,035,885 Total $ 114,005,385 $ 30,500 $ - $ 114,035,885 Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value December 31, 2022 Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value Governmental Agency Securities $ 46,230,893 $ 29,517 $ - $ 46,260,410 U.S. Treasury Bills 97,785,061 41,639 - 97,826,700 Total $ 144,015,954 $ 71,156 $ - $ 144,087,110

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	6 Months Ended
	Jun. 30, 2023
Share-Based Payment Arrangement [Abstract]
Schedule of Stock Options Activity	The following table summarizes the activity for all stock options outstanding for the six months ended June 30: Schedule of Stock Options Activity 2023 2022 Shares Weighted Average Exercise Price Shares Weighted Average Exercise Price Options outstanding at beginning of year 1,976,586 $ 6.34 1,315,321 $ 11.97 Granted 310,798 10.74 550,747 6.52 Exercised (45,208 ) 5.34 (3,286 ) 5.16 Forfeited (56,609 ) 7.67 (80,000 ) 13.01 Balance at June 30 2,185,567 $ 6.96 1,782,782 $ 5.75 Options exercisable at June 30: 1,346,587 $ 5.97 724,666 $ 6.02 Weighted Average Grant Date Fair Value for options granted during the period: $ 7.42 $ 4.34
Schedule of Stock Options Outstanding and Exercisable	The following table summarizes additional information about stock options outstanding and exercisable at June 30, 2023: 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 2,185,567 7.76 $ 6.96 $ 9,018,037 1,346,587 $ 5.97 $ 6,900,392
Schedule of Assumptions for Fair Value of Equity-based Awards	The Black-Scholes option-pricing model was used to estimate the fair value of equity-based awards with the following weighted-average assumptions for the six months ended June 30: Schedule of Assumptions for Fair Value of Equity-based Awards 2023 2022 Risk-free interest rate 3.41 4.14 % 1.68 3.1 % Expected volatility 78.0 79.8 % 76.2 78.3 % Expected life (years) 5.25 6.08 5.29 6.08 Expected dividend yield 0 % 0 %
Schedule of Unrecognized Compensation Cost	Total unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized as follows: Schedule of Unrecognized Compensation Cost 2023 $ 1,878,430 2024 2,588,676 2025 1,602,483 2026 614,044 2027 94,968 Total estimated compensation cost to be recognized $ 6,778,601
Schedule of Stock-based Compensation Expense	The Company recognized total stock-based compensation expense as follows for the three and six months ended June 30: Schedule of Stock-based Compensation Expense 2023 2022 2023 2022 Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Stock-based compensation expense in operating expenses: Research and development $ 639,511 $ 810,664 $ 1,293,982 $ 1,261,183 General and administrative 637,471 708,795 1,256,282 1,014,547 Total $ 1,276,982 $ 1,519,459 $ 2,550,264 $ 2,275,730

Debt (Tables)

Debt (Tables)	6 Months Ended
	Jun. 30, 2023
Debt Disclosure [Abstract]
Schedule of Long-term Debt	Long-term debt consisted of the following at June 30, 2023 and December 31, 2022: Schedule of Long-term Debt June 30, 2023 December 31, 2022 Note payable $ 35,000,000 $ 35,000,000 Add: PIK interest (added to principal) 1,641,763 755,075 Less: unamortized debt issuance costs (598,107 ) (707,001 ) Less: unamortized debt discount (57,676 ) (65,000 ) Total long-term debt $ 35,985,980 $ 34,983,074
Schedule of Long Term Debt Future Principal Payments	Future principal payments, including the incurred PIK interest, are as follows: Schedule of Long Term Debt Future Principal Payments Years Ending December 31, 2025 $ 13,740,661 2026 18,320,882 2027 4,580,220 Total $ 36,641,763

Net Loss Per Common Share (Deta

Net Loss Per Common Share (Details Narrative) - shares	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Share-Based Payment Arrangement, Option [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	2,185,567	1,782,782	2,185,567	1,782,782
Warrant [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	7,266,102	377,652	7,266,102	377,652
Restricted Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	1,958	3,273	1,958	3,273
Common Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	10,858,730	0	10,858,730	0

Schedule of Investment (Details

Schedule of Investment (Details) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]
Amortized Cost, as Adjusted	$ 114,005,385	$ 144,015,954
Gross Unrealized Holding Gains	30,500	71,156
Gross Unrealized Holding Losses
Estimated Fair Value	114,035,885	144,087,110
US Treasury Securities [Member]
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]
Amortized Cost, as Adjusted	114,005,385	97,785,061
Gross Unrealized Holding Gains	30,500	41,639
Gross Unrealized Holding Losses
Estimated Fair Value	$ 114,035,885	97,826,700
US Government Agencies Debt Securities [Member]
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]
Amortized Cost, as Adjusted		46,230,893
Gross Unrealized Holding Gains		29,517
Gross Unrealized Holding Losses
Estimated Fair Value		$ 46,260,410

Commitments (Details Narrative)

Commitments (Details Narrative) - USD ($)	1 Months Ended
	Mar. 31, 2023	Jun. 30, 2023
Commitments and Contingencies Disclosure [Abstract]
Increase in operating ROU asset and lease liability	$ 355,578
Non-cancelable contractual commitment		$ 2,000,000

Stockholders_ Equity (Details N

Stockholders’ Equity (Details Narrative) - USD ($)			6 Months Ended
	Jun. 29, 2023	Mar. 31, 2023	Jun. 30, 2023	Dec. 31, 2022
Class of Stock [Line Items]
Common stock, shares authorized			65,000,000	65,000,000
Common stock, par or stated value per share			$ 0.001	$ 0.001
Common stock, shares outstanding			22,081,893	21,667,250
Preferred stock, shares authorized			2,500,000	2,500,000
Preferred stock, par or stated value per share			$ 0.001	$ 0.001
Preferred stock, shares outstanding			1,085,873	1,120,873
Declared Dividend			$ 0
Series A Convertible Preferred Stock [Member]
Class of Stock [Line Items]
Number of shares converted	10,000	25,000
Conversion price	$ 5.75	$ 5.75
Common Stock [Member]
Class of Stock [Line Items]
Number of shares issued in conversion	100	250
Series A Preferred Stock [Member]
Class of Stock [Line Items]
Preferred stock, shares authorized			1,850,000

Schedule of Stock Options Activ

Schedule of Stock Options Activity (Details) - Share-Based Payment Arrangement, Option [Member] - $ / shares	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Offsetting Assets [Line Items]
Shares, Options outstanding at beginning of year	1,976,586	1,315,321
Weighted Average Exercise Price, Options outstanding at beginning of year	$ 6.34	$ 11.97
Shares, Granted	310,798	550,747
Weighted Average Exercise Price, Granted	$ 10.74	$ 6.52
Shares, Exercised	(45,208)	(3,286)
Weighted Average Exercise Price, Exercised	$ 5.34	$ 5.16
Shares, Forfeited	(56,609)	(80,000)
Weighted Average Exercise Price, Forfeited	$ 7.67	$ 13.01
Shares, Options outstanding at end of year	2,185,567	1,782,782
Weighted Average Exercise Price, Options outstanding at end of year	$ 6.96	$ 5.75
Shares, options exercisable	1,346,587	724,666
Weighted Average Exercise Price, Options exercisable	$ 5.97	$ 6.02
Weighted Average Grant Date Fair Value for options granted during the period	$ 7.42	$ 4.34

Schedule of Stock Options Outst

Schedule of Stock Options Outstanding and Exercisable (Details) - Share-Based Payment Arrangement, Option [Member]	6 Months Ended
	Jun. 30, 2023 USD ($) $ / shares shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Options outstanding | shares	2,185,567
Options outstanding, weighted average remaining contractual life	7 years 9 months 3 days
Options outstanding, weighted average exercise price | $ / shares	$ 6.96
Options outstanding, aggregate intrinsic value | $	$ 9,018,037
Options exercisable | shares	1,346,587
Options exercisable, weighted average exercise price | $ / shares	$ 5.97
Options exercisable, aggregate intrinsic value | $	$ 6,900,392

Schedule of Assumptions for Fai

Schedule of Assumptions for Fair Value of Equity-based Awards (Details)	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Risk-free interest rate, minimum	3.41%	1.68%
Risk-free interest rate maximum	4.14%	3.10%
Expected volatility, minimum	78%	76.20%
Expected volatility, maximum	79.80%	78.30%
Expected dividend yield	0%	0%
Minimum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected life (years)	5 years 3 months	5 years 3 months 14 days
Maximum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected life (years)	6 years 29 days	6 years 29 days

Schedule of Unrecognized Compen

Schedule of Unrecognized Compensation Cost (Details)	Jun. 30, 2023 USD ($)
Share-Based Payment Arrangement [Abstract]
2023	$ 1,878,430
2024	2,588,676
2025	1,602,483
2026	614,044
2027	94,968
Total estimated compensation cost to be recognized	$ 6,778,601

Schedule of Stock-based Compens

Schedule of Stock-based Compensation Expense (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total	$ 1,276,982	$ 1,519,459	$ 2,550,264	$ 2,275,730
Research and Development Expense [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total	639,511	810,664	1,293,982	1,261,183
General and Administrative Expense [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total	$ 637,471	$ 708,795	$ 1,256,282	$ 1,014,547

Stock-Based Compensation (Detai

Stock-Based Compensation (Details Narrative) - USD ($)					3 Months Ended		6 Months Ended
	May 12, 2022	May 12, 2021	May 10, 2018	Oct. 25, 2017	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022	May 11, 2023	Jan. 01, 2023	May 31, 2022	Jan. 01, 2022	Dec. 31, 2021	Jan. 01, 2021	May 31, 2020
May 2022 Exercise Price Modification [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock option awards shares modified											776,324
Stock option exercise price per share											$ 5.50
Modification on stock-based compensation					$ 37,690	$ 428,343	$ 77,302	$ 428,343
Remaining stock based compensation expense related to modification							228,000
December 2021 Exercise Price Modification [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock option awards shares modified													311,000
Stock option exercise price per share													$ 13.44
Modification on stock-based compensation					16,920	25,755	33,844	53,784
Remaining stock based compensation expense related to modification							139,000
May 2020 Exercise Price Modification [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock option awards shares modified															203,750
Stock option exercise price per share															$ 5.10
Modification on stock-based compensation					$ 6,826	11,601	13,934	23,216
Remaining stock based compensation expense related to modification							$ 6,000
2017 Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock, shares reserved for issuance	1,000,000			750,000					1,500,000	216,673		149,189		102,998
Stock option description				increase automatically on January 1 of each year from 2024 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, subject to the board’s discretion to reduce the amount of the increase in any particular year.
Additional shares authorized under plan	500,000	500,000
Shares available for issuance					1,702,461		1,702,461
Share-Based Payment Arrangement, Option [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Recognized stock-based compensation expense					$ 1,228,284	1,460,031	$ 2,450,612	2,169,540
Restricted Stock [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Recognized stock-based compensation expense					$ 4,052	$ 6,775	$ 8,694	$ 27,119
Restricted stock awards outstanding					1,958	3,273	1,958	3,273
Restricted stock awards vested					3,273	2,964
Employee Stock Purchase Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Recognized stock-based compensation expense					$ 44,646	$ 52,653	$ 90,958	$ 79,071
Common stock, shares reserved for issuance			100,000
Stock option description			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.
Shares available for issuance					283,008		283,008
Change in common stock, shares reserved for issuance										108,337		74,594		51,499

Schedule of Long-term Debt (Det

Schedule of Long-term Debt (Details) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Debt Disclosure [Abstract]
Note payable	$ 35,000,000	$ 35,000,000
Add: PIK interest (added to principal)	1,641,763	755,075
Less: unamortized debt issuance costs	(598,107)	(707,001)
Less: unamortized debt discount	(57,676)	(65,000)
Total long-term debt	$ 35,985,980	$ 34,983,074

Schedule of Long Term Debt Futu

Schedule of Long Term Debt Future Principal Payments (Details)	Jun. 30, 2023 USD ($)
Debt Disclosure [Abstract]
2025	$ 13,740,661
2026	18,320,882
2027	4,580,220
Total	$ 36,641,763

Debt (Details Narrative)

Debt (Details Narrative) - Innovatus Life Sciences [Member] - USD ($) $ in Millions	Jun. 30, 2023	Dec. 22, 2022	Aug. 09, 2022	Apr. 08, 2021
Amended Loan Agreement [Member]
Short-Term Debt [Line Items]
Funded contingent loan, outstanding	$ 35
Amended Loan Agreement [Member] | Term A Loan [Member]
Short-Term Debt [Line Items]
Non-contingent loan, amount				$ 15
Amended Loan Agreement [Member] | Term B Loan [Member]
Short-Term Debt [Line Items]
Non-contingent loan, amount		$ 20
Amended Loan Agreement [Member]
Short-Term Debt [Line Items]
Unfunded contingent maximum loan, amount			$ 75
Increase from original loan amount			$ 50