Cover
Cover - $ / shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 07, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2024 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2024 | |
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 | |
Entity Address, Address Line Two | Avenue North | |
Entity Address, Address Line Three | 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 | 37,028,733 | |
Entity Listing, Par Value Per Share | $ 0.001 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
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 |
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 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
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 | 317,577 | 854,134 |
Preferred stock, shares outstanding | 317,577 | 854,134 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 65,000,000 | 65,000,000 |
Common stock, shares issued | 37,014,751 | 25,506,012 |
Common stock, shares outstanding | 37,014,751 | 25,506,012 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 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 | $ (0.62) | $ (0.66) | $ (1.26) | $ (1.22) |
Net loss per share, diluted | $ (0.62) | $ (0.66) | $ (1.26) | $ (1.22) |
Weighted average common shares outstanding, basic | 38,444,163 | 21,957,140 | 36,028,109 | 21,819,772 |
Weighted average common shares outstanding, diluted | 38,444,163 | 21,957,140 | 36,028,109 | 21,819,772 |
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 |
Balance at Dec. 31, 2022 | $ 21,667 | $ 1,121 | $ 230,045,566 | $ (96,296,887) | $ 133,771,467 |
Balance, shares at Dec. 31, 2022 | 21,667,250 | 1,120,873 | |||
Stock-based compensation | 1,273,282 | 1,273,282 | |||
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) | |||
Net loss | (11,938,417) | (11,938,417) | |||
Issuance costs associated with private placement offering | (7,486) | (7,486) | |||
Balance at Mar. 31, 2023 | $ 21,941 | $ 1,096 | 231,439,035 | (108,235,304) | 123,226,768 |
Balance, shares at Mar. 31, 2023 | 21,941,372 | 1,095,873 | |||
Balance at Dec. 31, 2022 | $ 21,667 | $ 1,121 | 230,045,566 | (96,296,887) | 133,771,467 |
Balance, shares at Dec. 31, 2022 | 21,667,250 | 1,120,873 | |||
Net loss | (26,526,104) | ||||
Balance at Jun. 30, 2023 | $ 22,082 | $ 1,086 | 232,932,164 | (122,822,991) | 110,132,341 |
Balance, shares at Jun. 30, 2023 | 22,081,893 | 1,085,873 | |||
Balance at Mar. 31, 2023 | $ 21,941 | $ 1,096 | 231,439,035 | (108,235,304) | 123,226,768 |
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 | ||||
Balance at Jun. 30, 2023 | $ 22,082 | $ 1,086 | 232,932,164 | (122,822,991) | 110,132,341 |
Balance, shares at Jun. 30, 2023 | 22,081,893 | 1,085,873 | |||
Balance at Dec. 31, 2023 | $ 25,506 | $ 854 | 299,818,965 | (160,076,003) | 139,769,322 |
Balance, shares at Dec. 31, 2023 | 25,506,012 | 854,134 | |||
Stock-based compensation | 1,331,346 | 1,331,346 | |||
Stock-based compensation, shares | |||||
Exercise of common stock warrants, net of shares withheld for exercise price | $ 1,742 | 14,007,409 | 14,009,151 | ||
Exercise of common stock warrants, net of shares withheld for exercise price, shares | 1,742,763 | ||||
Exercise of common stock options, net of shares withheld for exercise price | $ 37 | 239,263 | 239,300 | ||
Exercise of common stock options, net of shares withheld for exercise price, shares | 36,550 | ||||
Conversion of preferred to common stock | $ 3,489 | $ (349) | (3,140) | ||
Conversion of preferred to common stock, shares | 3,488,570 | (348,857) | |||
Net loss | (21,612,455) | (21,612,455) | |||
Balance at Mar. 31, 2024 | $ 30,774 | $ 505 | 315,393,843 | (181,688,458) | 133,736,664 |
Balance, shares at Mar. 31, 2024 | 30,773,895 | 505,277 | |||
Balance at Dec. 31, 2023 | $ 25,506 | $ 854 | 299,818,965 | (160,076,003) | 139,769,322 |
Balance, shares at Dec. 31, 2023 | 25,506,012 | 854,134 | |||
Net loss | (45,334,275) | ||||
Balance at Jun. 30, 2024 | $ 37,015 | $ 318 | 382,057,737 | (205,410,278) | 176,684,792 |
Balance, shares at Jun. 30, 2024 | 37,014,751 | 317,577 | |||
Balance at Mar. 31, 2024 | $ 30,774 | $ 505 | 315,393,843 | (181,688,458) | 133,736,664 |
Balance, shares at Mar. 31, 2024 | 30,773,895 | 505,277 | |||
Stock-based compensation | $ 1 | 1,410,512 | 1,410,513 | ||
Stock-based compensation, shares | 1,429 | ||||
Exercise of common stock warrants, net of shares withheld for exercise price | $ 19 | 172,967 | 172,986 | ||
Exercise of common stock warrants, net of shares withheld for exercise price, shares | 19,390 | ||||
Exercise of common stock options, net of shares withheld for exercise price | $ 17 | 95,694 | 95,711 | ||
Exercise of common stock options, net of shares withheld for exercise price, shares | 16,197 | ||||
Conversion of preferred to common stock | $ 1,878 | $ (187) | (1,691) | ||
Conversion of preferred to common stock, shares | 1,877,000 | (187,700) | |||
Net loss | (23,721,820) | (23,721,820) | |||
Employee stock purchases | $ 20 | 131,226 | 131,246 | ||
Employee stock purchases, shares | 20,426 | ||||
Issuance of common stock in an ATM offering | $ 435 | 7,641,765 | 7,642,200 | ||
Issuance of common stock in an ATM offering, shares | 435,414 | ||||
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 | 56,248,237 | 56,252,108 | ||
Issuance of common stock upon closing of follow-on offering, net of underwriting discounts and offering costs, shares | 3,871,000 | ||||
Issuance of common stock warrants, note payable | 1,228,911 | 1,228,911 | |||
Balance at Jun. 30, 2024 | $ 37,015 | $ 318 | $ 382,057,737 | $ (205,410,278) | $ 176,684,792 |
Balance, shares at Jun. 30, 2024 | 37,014,751 | 317,577 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 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 |
Condensed Statements of Cash _2
Condensed Statements of Cash Flows (Unaudited) (Parenthetical) | Jun. 30, 2024 USD ($) |
Statement of Cash Flows [Abstract] | |
Debt issuance costs and discount | $ 2,429,917 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure [Table] | ||||||
Net Income (Loss) | $ (23,721,820) | $ (21,612,455) | $ (14,587,687) | $ (11,938,417) | $ (45,334,275) | $ (26,526,104) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 | |
Insider Trading Arrangements [Line Items] | |
Rule 10b51 Arrangement Adopted | false |
Non-Rule 10b51 Arrangement Adopted | false |
Rule 10b51 Arrangement Terminated | false |
Non-Rule 10b51 Arrangement Terminated | false |
Organization
Organization | 6 Months Ended |
Jun. 30, 2024 | |
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 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. |
Basis of Presentation, Summary
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements | 6 Months Ended |
Jun. 30, 2024 | |
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, 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. |
Net Loss Per Common Share
Net Loss Per Common Share | 6 Months Ended |
Jun. 30, 2024 | |
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 preferred stock, options, warrants, and restricted stock have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted-average shares outstanding used to calculate both basic and diluted loss per common share are the same. The following table summarizes the potentially-dilutive shares excluded from the diluted weighted-average shares outstanding: Schedule of Potentially-Dilutive Shares Excluded from 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 3,266,969 2,185,567 Warrants to purchase common stock 5,600,234 7,266,102 Restricted common stock 1,079 1,958 Total 12,044,052 20,312,357 Pre-funded warrant shares of 5,747,787 zero |
Investments
Investments | 6 Months Ended |
Jun. 30, 2024 | |
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 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 investment securities and has 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 June 30, 2024 and December 31, 2023: Schedule of Investment June 30, 2024 Amortized Cost, Gross Gross Estimated U.S. Treasury Bills $ 252,609,622 $ 5,271 $ - $ 252,614,893 Total $ 252,609,622 $ 5,271 $ - $ 252,614,893 December 31, 2023 Amortized Cost, Gross Gross Estimated U.S. Treasury Bills $ 149,919,974 $ 30,995 $ - $ 149,950,969 Total $ 149,919,974 $ 30,995 $ - $ 149,950,969 The fair value of the Company’s held-to-maturity debt securities is determined based upon inputs, other than the quoted prices in active markets, that are observable either directly or indirectly and are classified as level 2 fair value instruments. |
Commitments
Commitments | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | 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, CMO’s, and CRO’s. The Company currently has two 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 Phase 1B and the Expanded Access studies are generally based on time and material. In addition, contracts related to the Company’s Phase 3 clinical study (VIKTORIA-1) and Phase 1b/2 clinical study (CELC-G-201) are generally cancelable with reasonable notice within 120 days and the Company’s obligations under these contracts are primarily based on services performed through termination dates plus certain cancelation charges, if any, as defined in each of the respective agreements. In addition, these agreements may, from time to time, be subjected to amendments as a result of any change orders executed by the parties. As of June 30, 2024, the Company had two material non-cancelable contractual commitments with respect to these arrangements, which totaled approximately $ 1.8 |
Stockholders_ Equity
Stockholders’ Equity | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Stockholders’ Equity | 6. Stockholders’ Equity Capital Stock At December 31, 2023, the Company’s authorized capital stock consisted of 65,000,000 .001 25,506,012 2,500,000 .001 854,134 On January 15, 2024, one of the Company’s preferred shareholders elected to convert 224,244 2,242,440 5.75 On March 14, 2024, one of the Company’s preferred shareholders elected to convert 50,000 500,000 5.75 On March 15, 2024, one of the Company’s investors exercised 1,739,080 8.05 14 Additional common stock warrants of 3,683 9,000 3,683 On March 19, 2024, one of the Company’s preferred shareholders elected to convert 43,913 439,130 5.75 On March 26, 2024, one of the Company’s preferred shareholders elected to convert 30,700 307,000 5.75 On May 31, 2024, one of the Company’s preferred shareholders elected to convert 100,000 1,000,000 5.75 On June 26, 2024, one of the Company’s preferred shareholders elected to convert 87,700 877,000 5.75 Common stock warrants of 19,390 173,000 19,390 At June 30, 2024, the Company’s authorized capital stock consisted of 65,000,000 37,014,751 2,500,000 1,850,000 317,577 no Sale and Issuance of Stock On April 22, 2024, pursuant to an Open Market Sale Agreement SM 285,714 shares of Common Stock in a single transaction at a price of $ 17.50 per share, generating gross proceeds of $ 5.0 million. On May 8, 2024, pursuant to an Open Market Sale Agreement with Jefferies LLC, as agent, the Company sold 149,700 17.65 2.6 Commissions and other offering expenses related to the Open Market Sale Agreement transactions were $ 0.3 On May 30, 2024, the Company entered into an underwriting agreement with Leerink Partners LLC, TD Securities (USA) LLC and Stifel, Nicolaus & Company, Incorporated as representatives of the several underwriters relating to the issuance and sale of 3,871,000 15.50 60 56.3 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
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 2024 2023 Shares Weighted Shares Weighted Options outstanding at beginning of year 2,815,392 $ 7.95 1,976,586 $ 6.34 Granted 552,179 15.77 310,798 10.74 Exercised (52,747 ) 6.35 (45,208 ) 5.34 Forfeited (47,855 ) 10.19 (56,609 ) 7.67 Balance at June 30 3,266,969 $ 9.27 2,185,567 $ 6.96 Options exercisable at June 30: 1,710,917 $ 6.80 1,346,587 $ 5.97 Weighted Average Grant Date Fair Value for options granted during the period: $ 10.83 $ 7.42 The following table summarizes additional information about stock options outstanding and exercisable at June 30, 2024: Schedule of Stock Options Outstanding and Exercisable Options Outstanding Options Exercisable Options Weighted Weighted Aggregate Options Weighted Aggregate 3,266,969 7.84 $ 9.27 $ 23,463,751 1,710,917 $ 6.80 $ 16,452,728 The Company recognized stock-based compensation expense for stock options of $ 1,329,807 1,228,284 2,619,999 2,450,612 776,324 5.50 26,692 37,690 53,411 77,302 110,000 311,000 13.44 15,763 16,920 31,527 33,844 66,000 203,750 5.10 0 6,826 696 13,934 0 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 2024 2023 Risk-free interest rate 3.94 4.71 % 3.41 4.14 % Expected volatility 74.8 76.10 % 78.0 79.8 % Expected life (years) 5.25 6.09 5.25 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, 2024 and 2023. The Company had 1,079 1,958 1,958 3,273 8,475 4,052 13,325 8,694 The Company initially reserved a maximum of 750,000 102,998 149,189 216,673 255,060 increase automatically on January 1 of each year from 2025 through 2027 by the number of shares equal to 1.0% of the aggregate number of outstanding shares of Company common stock as of the immediately preceding December 31. However, the Company’s board may reduce the amount of the increase in any particular year. At the Annual Meeting held on May 12, 2021 and May 12, 2022, the stockholders approved a one-time, 500,000 1,000,000 1,500,000 3,000,000 2,267,956 Total unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized at June 30, 2024: Schedule of Unrecognized Compensation Cost 2024 $ 2,883,195 2025 4,356,405 2026 3,048,001 2027 2,065,139 2028 244,019 Total estimated compensation cost to be recognized $ 12,596,759 The Company recognized stock-based compensation expense related to its employee stock purchase plan of $ 72,230 44,646 108,534 90,958 100,000 51,499 74,594 108,337 127,530 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. 373,739 The Company recognized total stock-based compensation expense as follows for the three and six months ended June 30: Schedule of Stock-based Compensation Expenses 2024 2023 2024 2023 Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Stock-based compensation expense in operating expenses: Research and development $ 978,037 $ 639,511 $ 1,810,216 $ 1,293,982 General and administrative 432,475 637,471 931,642 1,256,282 Total $ 1,410,512 $ 1,276,982 $ 2,741,858 $ 2,550,264 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Debt | 8. Debt On May 30, 2024, the Company entered into an Amended and Restated Loan and Security Agreement (the “A&R Loan Agreement”) with Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership (“Innovatus”), as collateral agent, and the Lenders including Innovatus in its capacity as a Lender and Oxford Finance LLC (“Oxford”), pursuant to which Innovatus and Oxford, as Lenders, have agreed to make certain term loans (“Term Loans”) to the Company in the aggregate principal amount of up to $ 180 Funding of the first $ 100 16.8 21.5 61.7 30 50 45 2.4 The Company is entitled to make interest-only payments for thirty-six months, or up to forty-eight months if certain conditions are met. The Term Loans will mature on May 1, 2029 and will bear interest at a rate equal to the sum of (a) the greater of (i) the Prime Rate (as defined in the A&R Loan Agreement) or (ii) 7.75%, plus (b) 2.85%, provided that 1.0% of such interest will be payable in-kind by adding an amount equal to such 1.0% of the outstanding principal amount to the then outstanding principal balance on a monthly basis through May 31, 2027. 20 10.00 26,042 14.40 The A&R Loan Agreement contains a Final Fee, which is equal to 4.5 900,000 1,500,000 4.5 In connection with the funding of each of the Term C Loan, the Term D Loan, the Term E Loan and the Term F Loan, the Company agreed to issue to Innovatus and Oxford warrants to purchase that number of shares of the Company’s common stock equal to 2.5 103,876 14.84 1.2 The Company evaluated the change of terms under ASC 470-50, “Debt – Modification and Extinguishment”, and concluded the change in terms did not result in significant and consequential changes to the economic substance of the debt and thus resulted in a modification of the debt and not an extinguishment of the debt. Long-term debt consisted of the following at June 30, 2024 and December 31, 2023: Schedule of Long-term Debt June 30, December 31, Note payable $ 100,000,000 $ 35,000,000 Add: Final fee 4,500,000 - Add: PIK interest (added to principal) 87,676 2,565,660 Less: unamortized debt issuance costs (2,089,840 ) (480,810 ) Less: unamortized debt discount (6,304,664 ) (49,439 ) Total long-term debt $ 96,193,172 $ 37,035,411 Future principal payments, including the incurred PIK interest and final fee, are as follows: Schedule of Long Term Debt Future Principal Payments Years Ending December 31, 2027 $ 30,461,467 2028 52,219,657 2029 21,906,552 Total $ 104,587,676 |
Basis of Presentation, Summar_2
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
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, 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 | 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 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. |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Potentially-Dilutive Shares Excluded from Diluted Weighted-Average Shares Outstanding | The following table summarizes the potentially-dilutive shares excluded from the diluted weighted-average shares outstanding: Schedule of Potentially-Dilutive Shares Excluded from 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 3,266,969 2,185,567 Warrants to purchase common stock 5,600,234 7,266,102 Restricted common stock 1,079 1,958 Total 12,044,052 20,312,357 |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Investments, All Other Investments [Abstract] | |
Schedule of Investment | The following tables summarize the Company’s held-to-maturity investment securities at amortized cost as of June 30, 2024 and December 31, 2023: Schedule of Investment June 30, 2024 Amortized Cost, Gross Gross Estimated U.S. Treasury Bills $ 252,609,622 $ 5,271 $ - $ 252,614,893 Total $ 252,609,622 $ 5,271 $ - $ 252,614,893 December 31, 2023 Amortized Cost, Gross Gross Estimated U.S. Treasury Bills $ 149,919,974 $ 30,995 $ - $ 149,950,969 Total $ 149,919,974 $ 30,995 $ - $ 149,950,969 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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 2024 2023 Shares Weighted Shares Weighted Options outstanding at beginning of year 2,815,392 $ 7.95 1,976,586 $ 6.34 Granted 552,179 15.77 310,798 10.74 Exercised (52,747 ) 6.35 (45,208 ) 5.34 Forfeited (47,855 ) 10.19 (56,609 ) 7.67 Balance at June 30 3,266,969 $ 9.27 2,185,567 $ 6.96 Options exercisable at June 30: 1,710,917 $ 6.80 1,346,587 $ 5.97 Weighted Average Grant Date Fair Value for options granted during the period: $ 10.83 $ 7.42 |
Schedule of Stock Options Outstanding and Exercisable | The following table summarizes additional information about stock options outstanding and exercisable at June 30, 2024: Schedule of Stock Options Outstanding and Exercisable Options Outstanding Options Exercisable Options Weighted Weighted Aggregate Options Weighted Aggregate 3,266,969 7.84 $ 9.27 $ 23,463,751 1,710,917 $ 6.80 $ 16,452,728 |
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 2024 2023 Risk-free interest rate 3.94 4.71 % 3.41 4.14 % Expected volatility 74.8 76.10 % 78.0 79.8 % Expected life (years) 5.25 6.09 5.25 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 at June 30, 2024: Schedule of Unrecognized Compensation Cost 2024 $ 2,883,195 2025 4,356,405 2026 3,048,001 2027 2,065,139 2028 244,019 Total estimated compensation cost to be recognized $ 12,596,759 |
Schedule of Stock-based Compensation Expenses | The Company recognized total stock-based compensation expense as follows for the three and six months ended June 30: Schedule of Stock-based Compensation Expenses 2024 2023 2024 2023 Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Stock-based compensation expense in operating expenses: Research and development $ 978,037 $ 639,511 $ 1,810,216 $ 1,293,982 General and administrative 432,475 637,471 931,642 1,256,282 Total $ 1,410,512 $ 1,276,982 $ 2,741,858 $ 2,550,264 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | Long-term debt consisted of the following at June 30, 2024 and December 31, 2023: Schedule of Long-term Debt June 30, December 31, Note payable $ 100,000,000 $ 35,000,000 Add: Final fee 4,500,000 - Add: PIK interest (added to principal) 87,676 2,565,660 Less: unamortized debt issuance costs (2,089,840 ) (480,810 ) Less: unamortized debt discount (6,304,664 ) (49,439 ) Total long-term debt $ 96,193,172 $ 37,035,411 |
Schedule of Long Term Debt Future Principal Payments | Future principal payments, including the incurred PIK interest and final fee, are as follows: Schedule of Long Term Debt Future Principal Payments Years Ending December 31, 2027 $ 30,461,467 2028 52,219,657 2029 21,906,552 Total $ 104,587,676 |
Schedule of Potentially-Dilutiv
Schedule of Potentially-Dilutive Shares Excluded from Diluted Weighted-Average Shares Outstanding (Details) - shares | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 12,044,052 | 20,312,357 |
Options To Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 3,266,969 | 2,185,567 |
Warrants To Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 5,600,234 | 7,266,102 |
Restricted Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 1,079 | 1,958 |
Preferred Stock On An As If Converted To Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 3,175,770 | 10,858,730 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details Narrative) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pre Funded Warrant [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Pre-funded warrant shares | 5,747,787 | 0 | 5,747,787 | 0 |
Schedule of Investment (Details
Schedule of Investment (Details) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] | ||
Debt Securities, Held-to-Maturity, Amortized Cost, before Allowance for Credit Loss | $ 252,609,622 | $ 149,919,974 |
Debt Securities, Held-to-Maturity, Accumulated Unrecognized Gain | 5,271 | 30,995 |
Debt Securities, Held-to-Maturity, Accumulated Unrecognized Loss | ||
Debt Securities, Held-to-Maturity, Fair Value | 252,614,893 | 149,950,969 |
US Treasury Securities [Member] | ||
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] | ||
Debt Securities, Held-to-Maturity, Amortized Cost, before Allowance for Credit Loss | 252,609,622 | 149,919,974 |
Debt Securities, Held-to-Maturity, Accumulated Unrecognized Gain | 5,271 | 30,995 |
Debt Securities, Held-to-Maturity, Accumulated Unrecognized Loss | ||
Debt Securities, Held-to-Maturity, Fair Value | $ 252,614,893 | $ 149,950,969 |
Commitments (Details Narrative)
Commitments (Details Narrative) $ in Millions | Jun. 30, 2024 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Non-cancelable contractual commitment | $ 1.8 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 6 Months Ended | |||||||||||||
Jun. 26, 2024 | May 31, 2024 | May 30, 2024 | May 08, 2024 | Apr. 22, 2024 | Mar. 26, 2024 | Mar. 19, 2024 | Mar. 15, 2024 | Mar. 14, 2024 | Jan. 15, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | Mar. 31, 2024 | Dec. 31, 2023 | |
Class of Stock [Line Items] | ||||||||||||||
Common stock, shares authorized | 65,000,000 | 65,000,000 | ||||||||||||
Common stock, par value | $ 0.001 | $ 0.001 | ||||||||||||
Common stock, shares outstanding | 37,014,751 | 25,506,012 | ||||||||||||
Preferred stock, shares authorized | 2,500,000 | 2,500,000 | ||||||||||||
Preferred stock, par value | $ 0.001 | $ 0.001 | ||||||||||||
Preferred stock, shares outstanding | 317,577 | 854,134 | ||||||||||||
Additional warrants exercised | 1,739,080 | 19,390 | 3,683 | |||||||||||
Class of warrant exercise price | $ 8.05 | |||||||||||||
Proceeds from warant exercise | $ 14,000,000 | $ 14,182,137 | ||||||||||||
Declared Dividend | $ 0 | |||||||||||||
Open Market Sale Agreement [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Commissions and other offering expenses | $ 300,000 | |||||||||||||
Open Market Sale Agreement [Member] | Jefferies LLC [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Sale of stock number of shares issued in transaction | 149,700 | 285,714 | ||||||||||||
Issuance of public offering price per share | $ 17.65 | $ 17.50 | ||||||||||||
Gross proceeds from public offering | $ 2,600,000 | $ 5,000,000 | ||||||||||||
Underwriting Agreement [Member] | Leerink Partners LLC [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Sale of stock number of shares issued in transaction | 3,871,000 | |||||||||||||
Issuance of public offering price per share | $ 15.50 | |||||||||||||
Gross proceeds from public offering | $ 60,000,000 | |||||||||||||
Net proceeds from public offering | $ 56,300,000 | |||||||||||||
Several Investors [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Additional warrants exercised | 19,390 | 3,683 | ||||||||||||
Cash | $ 173,000 | $ 9,000 | ||||||||||||
Series A Convertible Preferred Stock [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Number of shares converted | 87,700 | 100,000 | 30,700 | 43,913 | 50,000 | 224,244 | ||||||||
Cost basis of shares transferred | $ 5.75 | $ 5.75 | $ 5.75 | $ 5.75 | $ 5.75 | $ 5.75 | ||||||||
Common Stock [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Number of shares issued in conversion | 877,000 | 1,000,000 | 307,000 | 439,130 | 500,000 | 2,242,440 | ||||||||
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, 2024 | Jun. 30, 2023 | |
Offsetting Assets [Line Items] | ||
Options outstanding at beginning of year | 2,815,392 | 1,976,586 |
Options outstanding, weighted average exercise price at beginning of year | $ 7.95 | $ 6.34 |
Shares, Granted | 552,179 | 310,798 |
Weighted Average Exercise Price, Granted | $ 15.77 | $ 10.74 |
Shares, Exercised | (52,747) | (45,208) |
Weighted Average Exercise Price, Exercised | $ 6.35 | $ 5.34 |
Shares, Forfeited | (47,855) | (56,609) |
Weighted Average Exercise, Forfeited | $ 10.19 | $ 7.67 |
Options outstanding at end of year | 3,266,969 | 2,185,567 |
Options outstanding, weighted average exercise price at end of year | $ 9.27 | $ 6.96 |
Shares, options exercisable | 1,710,917 | 1,346,587 |
Weighted Average Exercise Price, Options exercisable | $ 6.80 | $ 5.97 |
Weighted Average Grant Date Fair Value for options granted during the period | $ 10.83 | $ 7.42 |
Schedule of Stock Options Outst
Schedule of Stock Options Outstanding and Exercisable (Details) - Share-Based Payment Arrangement, Option [Member] | 6 Months Ended |
Jun. 30, 2024 USD ($) $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Options outstanding | shares | 3,266,969 |
Options outstanding, weighted average remaining contractual life | 7 years 10 months 2 days |
Options outstanding, weighted average exercise price | $ / shares | $ 9.27 |
Options outstanding, aggregate intrinsic value | $ | $ 23,463,751 |
Options exercisable | shares | 1,710,917 |
Options exercisable, weighted average exercise price | $ / shares | $ 6.80 |
Options exercisable, aggregate intrinsic value | $ | $ 16,452,728 |
Schedule of Assumptions for Fai
Schedule of Assumptions for Fair Value of Equity-based Awards (Details) | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Risk-free interest rate, minimum | 3.94% | 3.41% |
Risk-free interest rate, maximum | 4.71% | 4.14% |
Expected volatility, minimum | 74.80% | 78% |
Expected volatility, maximum | 76.10% | 79.80% |
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 |
Maximum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected life (years) | 6 years 1 month 2 days | 6 years 29 days |
Schedule of Unrecognized Compen
Schedule of Unrecognized Compensation Cost (Details) | Jun. 30, 2024 USD ($) |
Share-Based Payment Arrangement [Abstract] | |
2024 | $ 2,883,195 |
2025 | 4,356,405 |
2026 | 3,048,001 |
2027 | 2,065,139 |
2028 | 244,019 |
Total estimated compensation cost to be recognized | $ 12,596,759 |
Schedule of Stock-based Compens
Schedule of Stock-based Compensation Expenses (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total | $ 1,410,512 | $ 1,276,982 | $ 2,741,858 | $ 2,550,264 |
Research and Development Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total | 978,037 | 639,511 | 1,810,216 | 1,293,982 |
General and Administrative Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total | $ 432,475 | $ 637,471 | $ 931,642 | $ 1,256,282 |
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, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | May 09, 2024 | Jan. 01, 2024 | 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 | ||||||||||||||||
Stock based compensation expense related to modification | $ 26,692 | $ 37,690 | $ 53,411 | $ 77,302 | |||||||||||||
Remaining stock based compensation expense related to modification | 110,000 | ||||||||||||||||
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 | ||||||||||||||||
Stock based compensation expense related to modification | 15,763 | 16,920 | 31,527 | 33,844 | |||||||||||||
Remaining stock based compensation expense related to modification | 66,000 | ||||||||||||||||
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 | ||||||||||||||||
Stock based compensation expense related to modification | $ 0 | 6,826 | 696 | 13,934 | |||||||||||||
Remaining stock based compensation expense related to modification | $ 0 | ||||||||||||||||
2017 Plan [Member] | |||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||
Common stock, shares reserved for issuance | 750,000 | 3,000,000 | 1,500,000 | ||||||||||||||
Change in common stock, shares reserved for issuance | 255,060 | 216,673 | 149,189 | 102,998 | |||||||||||||
Stock option description | increase automatically on January 1 of each year from 2025 through 2027 by the number of shares equal to 1.0% of the aggregate number of outstanding shares of Company common stock as of the immediately preceding December 31. However, the Company’s board may reduce the amount of the increase in any particular year. | ||||||||||||||||
Additional shares authorized under plan | 500,000 | 500,000 | |||||||||||||||
Total common stock, shares reserved for issuance | 1,000,000 | 1,000,000 | |||||||||||||||
Shares available for grant under the 2017 Plan | 2,267,956 | 2,267,956 | |||||||||||||||
Share-Based Payment Arrangement, Option [Member] | |||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||
Recognized stock-based compensation expense | $ 1,329,807 | 1,228,284 | $ 2,619,999 | 2,450,612 | |||||||||||||
Restricted Stock [Member] | |||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||
Recognized stock-based compensation expense | $ 8,475 | $ 4,052 | $ 13,325 | $ 8,694 | |||||||||||||
Restricted stock awards outstanding | 1,079 | 1,958 | 1,079 | 1,958 | |||||||||||||
Restricted stock awards vested | 1,958 | 3,273 | |||||||||||||||
Employee Stock Purchase Plan [Member] | |||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||
Recognized stock-based compensation expense | $ 72,230 | $ 44,646 | $ 108,534 | $ 90,958 | |||||||||||||
Common stock, shares reserved for issuance | 100,000 | ||||||||||||||||
Change in common stock, shares reserved for issuance | 127,530 | 108,337 | 74,594 | 51,499 | |||||||||||||
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 | 373,739 | 373,739 |
Schedule of Long-term Debt (Det
Schedule of Long-term Debt (Details) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Debt Disclosure [Abstract] | ||
Note payable | $ 100,000,000 | $ 35,000,000 |
Add: Final fee | 4,500,000 | |
Add: PIK interest (added to principal) | 87,676 | 2,565,660 |
Less: unamortized debt issuance costs | (2,089,840) | (480,810) |
Less: unamortized debt discount | (6,304,664) | (49,439) |
Total long-term debt | $ 96,193,172 | $ 37,035,411 |
Schedule of Long Term Debt Futu
Schedule of Long Term Debt Future Principal Payments (Details) | Jun. 30, 2024 USD ($) |
Debt Disclosure [Abstract] | |
2027 | $ 30,461,467 |
2028 | 52,219,657 |
2029 | 21,906,552 |
Total | $ 104,587,676 |
Debt (Details Narrative)
Debt (Details Narrative) - USD ($) | May 30, 2024 | Jun. 30, 2024 | Mar. 15, 2024 | Dec. 31, 2023 |
Debt Instrument [Line Items] | ||||
Final fee | $ 4,500,000 | |||
Warrants exercise price per share | $ 8.05 | |||
Amended And Restated Loan Agreement [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt instrument interest rate description | The Company is entitled to make interest-only payments for thirty-six months, or up to forty-eight months if certain conditions are met. The Term Loans will mature on May 1, 2029 and will bear interest at a rate equal to the sum of (a) the greater of (i) the Prime Rate (as defined in the A&R Loan Agreement) or (ii) 7.75%, plus (b) 2.85%, provided that 1.0% of such interest will be payable in-kind by adding an amount equal to such 1.0% of the outstanding principal amount to the then outstanding principal balance on a monthly basis through May 31, 2027. | |||
Amended And Restated Loan Agreement [Member] | Innovatus Life Sciences [Member] | ||||
Debt Instrument [Line Items] | ||||
Funded loan amount | $ 100 | |||
New borrowings | $ 2,400,000 | |||
Final fee percentage | 4.50% | |||
Final fee | $ 4,500,000 | |||
Term loan percentage | 2.50% | |||
Amended And Restated Loan Agreement [Member] | Innovatus Life Sciences [Member] | Warrant [Member] | ||||
Debt Instrument [Line Items] | ||||
Warrants issued | 103,876 | |||
Warrants exercise price per share | $ 14.84 | |||
Fair value of warrants | $ 1,200,000 | |||
Amended And Restated Loan Agreement [Member] | Innovatus Life Sciences [Member] | Term A Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Funded loan amount | $ 16,800,000 | |||
Loan conversion percentage | 20% | |||
Common stock price per share | $ 10 | |||
Amended And Restated Loan Agreement [Member] | Innovatus Life Sciences [Member] | Term B Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Funded loan amount | $ 21,500,000 | |||
Amended And Restated Loan Agreement [Member] | Innovatus Life Sciences [Member] | Term C Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Funded loan amount | 61,700,000 | |||
Amended And Restated Loan Agreement [Member] | Innovatus Life Sciences [Member] | Term D Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Funded loan amount | 30,000,000 | |||
Non utilization fee | 900,000 | |||
Amended And Restated Loan Agreement [Member] | Innovatus Life Sciences [Member] | Term E Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Funded loan amount | 50,000,000 | |||
Non utilization fee | 1,500,000 | |||
Amended And Restated Loan Agreement [Member] | Innovatus Life Sciences [Member] | Term F Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Funded loan amount | 45,000,000 | |||
Amended And Restated Loan Agreement [Member] | Innovatus Life Sciences [Member] | Maximum [Member] | ||||
Debt Instrument [Line Items] | ||||
Funded contingent loan, outstanding | $ 180,000,000 | |||
Prior Loan Agreement [Member] | Innovatus Life Sciences [Member] | ||||
Debt Instrument [Line Items] | ||||
Common stock price per share | $ 14.40 | |||
Common stock issued | 26,042 |