Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 03, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2022 | |
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, $0.001 par value per share | |
Trading Symbol | CELC | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Elected Not To Use the Extended Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 15,459,739 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Current Assets: | ||
Cash and cash equivalents | $ 57,483,776 | $ 84,286,381 |
Deposits | 22,009 | 22,009 |
Deferred transaction costs | 349,147 | 22,144 |
Payroll tax receivable | 260,926 | 298,764 |
Prepaid assets | 6,578,252 | 722,677 |
Total current assets | 64,694,110 | 85,351,975 |
Property and equipment, net | 302,005 | 312,444 |
Operating lease right-of-use assets | 295,535 | 241,901 |
Total Assets | 65,291,650 | 85,906,320 |
Current Liabilities: | ||
Accounts payable | 3,168,198 | 1,507,099 |
Finance lease liabilities | 3,916 | 5,850 |
Operating lease liabilities | 194,643 | 189,858 |
Accrued expenses | 3,278,315 | 802,893 |
Total current liabilities | 6,645,072 | 2,505,700 |
Finance lease liabilities | 2,449 | |
Operating lease liabilities | 107,830 | 61,771 |
Note payable, non-current | 15,013,407 | 14,625,923 |
Total Liabilities | 21,766,309 | 17,195,843 |
Commitments and Contingencies (Note 4) | ||
Stockholders’ Equity: | ||
Preferred stock, $0.001 par value: 2,500,000 shares authorized; 0 shares issued and outstanding as of September 30, 2022 and December 31, 2021 | ||
Common stock, $0.001 par value: 65,000,000 and 25,000,000 shares authorized as of September 30, 2022 and December 31, 2021, respectively; 14,942,958 and 14,918,887 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 14,943 | 14,919 |
Additional paid-in capital | 128,225,939 | 124,622,405 |
Accumulated deficit | (84,715,541) | (55,926,847) |
Total Stockholders’ Equity | 43,525,341 | 68,710,477 |
Total Liabilities and Stockholders’ Equity | $ 65,291,650 | $ 85,906,320 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par or stated value per share | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 2,500,000 | 2,500,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par or stated value per share | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 65,000,000 | 65,000,000 |
Common stock, shares issued | 14,942,958 | 14,918,887 |
Common stock, shares outstanding | 14,942,958 | 14,918,887 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 9,621,505 | $ 4,960,515 | $ 24,685,505 | $ 20,266,965 |
General and administrative | 1,022,050 | 639,271 | 3,066,382 | 1,768,058 |
Total operating expenses | 10,643,555 | 5,599,786 | 27,751,887 | 22,035,023 |
Loss from operations | (10,643,555) | (5,599,786) | (27,751,887) | (22,035,023) |
Other income (expense) | ||||
Interest expense | (537,661) | (433,072) | (1,428,108) | (824,283) |
Interest income | 287,495 | 5,612 | 391,301 | 7,803 |
Loss on sale of fixed assets | (263) | |||
Other income (expense), net | (250,166) | (427,460) | (1,036,807) | (816,743) |
Net loss before income taxes | (10,893,721) | (6,027,246) | (28,788,694) | (22,851,766) |
Income tax benefits | ||||
Net loss | $ (10,893,721) | $ (6,027,246) | $ (28,788,694) | $ (22,851,766) |
Net loss per share, basic and diluted | $ (0.75) | $ (0.41) | $ (1.95) | $ (1.78) |
Weighted average common shares outstanding, basic and diluted | 14,938,224 | 14,877,619 | 14,928,727 | 12,867,484 |
Condensed Statements of Changes
Condensed Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2020 | $ 10,300 | $ 38,013,551 | $ (26,321,581) | $ 11,702,270 |
Beginning balance, shares at Dec. 31, 2020 | 10,299,822 | |||
Stock-based compensation | 449,098 | 449,098 | ||
Exercise of common stock options, net of shares withheld for exercise price | $ 13 | (13) | ||
Exercise of common stock options, net of shares withheld for exercise price, shares | 12,707 | |||
Net loss | (2,791,668) | (2,791,668) | ||
Exercise of common stock warrants | $ 1 | 11,256 | 11,257 | |
Exercise of common stock warrants, shares | 1,185 | |||
Issuance of common stock upon closing of follow-on offering, net of underwriting discounts and offering costs | $ 1,971 | 25,766,522 | 25,768,493 | |
Issuance of common stock upon closing of follow-on offering, net of underwriting discounts and offering costs, shares | 1,971,100 | |||
Issuance of common stock in an at-the-market (“ATM”) offering | $ 3 | 38,959 | 38,962 | |
Issuance of common stock in an at-the-market ("ATM") offering, shares | 3,082 | |||
Issuance costs associated with ATM offering | (3,868) | (3,868) | ||
Ending balance, value at Mar. 31, 2021 | $ 12,288 | 64,275,505 | (29,113,249) | 35,174,544 |
Ending balance, shares at Mar. 31, 2021 | 12,287,896 | |||
Beginning balance, value at Dec. 31, 2020 | $ 10,300 | 38,013,551 | (26,321,581) | 11,702,270 |
Beginning balance, shares at Dec. 31, 2020 | 10,299,822 | |||
Net loss | (22,851,766) | |||
Ending balance, value at Sep. 30, 2021 | $ 14,906 | 123,632,827 | (49,173,347) | 74,474,386 |
Ending balance, shares at Sep. 30, 2021 | 14,905,898 | |||
Beginning balance, value at Mar. 31, 2021 | $ 12,288 | 64,275,505 | (29,113,249) | 35,174,544 |
Beginning balance, shares at Mar. 31, 2021 | 12,287,896 | |||
Stock-based compensation | $ 3 | 540,314 | 540,317 | |
Stock-based compensation, shares | 2,964 | |||
Exercise of common stock options, net of shares withheld for exercise price | $ 9 | 36,850 | 36,859 | |
Exercise of common stock options, net of shares withheld for exercise price, shares | 9,136 | |||
Net loss | (14,032,852) | (14,032,852) | ||
Employee stock purchases | $ 6 | 25,811 | 25,817 | |
Employee stock purchases, shares | 5,496 | |||
Issuance of common stock warrants, note payable | 289,839 | 289,839 | ||
Issuance of common stock, licensing agreement | $ 349 | 4,999,651 | 5,000,000 | |
Issuance of common stock, licensing agreement, shares | 349,406 | |||
Ending balance, value at Jun. 30, 2021 | $ 12,655 | 70,167,970 | (43,146,101) | 27,034,524 |
Ending balance, shares at Jun. 30, 2021 | 12,654,898 | |||
Stock-based compensation | 699,916 | 699,916 | ||
Exercise of common stock options, net of shares withheld for exercise price | $ 1 | 5,099 | 5,100 | |
Exercise of common stock options, net of shares withheld for exercise price, shares | 1,000 | |||
Net loss | (6,027,246) | (6,027,246) | ||
Issuance of common stock upon closing of follow-on offering, net of underwriting discounts and offering costs | $ 2,250 | 52,759,842 | 52,762,092 | |
Issuance of common stock upon closing of follow-on offering, net of underwriting discounts and offering costs, shares | 2,250,000 | |||
Ending balance, value at Sep. 30, 2021 | $ 14,906 | 123,632,827 | (49,173,347) | 74,474,386 |
Ending balance, shares at Sep. 30, 2021 | 14,905,898 | |||
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 | ||
Stock-based compensation, shares | ||||
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 | (28,788,694) | |||
Ending balance, value at Sep. 30, 2022 | $ 14,943 | 128,225,939 | (84,715,541) | 43,525,341 |
Ending balance, shares at Sep. 30, 2022 | 14,942,958 | |||
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 | |||
Stock-based compensation | 1,223,054 | 1,223,054 | ||
Stock-based compensation, shares | 250 | |||
Exercise of common stock options, net of shares withheld for exercise price | $ 2 | 7,275 | 7,277 | |
Exercise of common stock options, net of shares withheld for exercise price, shares | 1,374 | |||
Net loss | (10,893,721) | (10,893,721) | ||
Ending balance, value at Sep. 30, 2022 | $ 14,943 | $ 128,225,939 | $ (84,715,541) | $ 43,525,341 |
Ending balance, shares at Sep. 30, 2022 | 14,942,958 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (28,788,694) | $ (22,851,766) |
Adjustments to reconcile net loss to net cash used for operations: | ||
Depreciation | 161,981 | 240,206 |
Stock-based compensation | 3,498,784 | 1,689,331 |
Issuance of common stock, licensing agreement | 5,000,000 | |
Amortization of debt issuance costs and discount | 284,184 | 173,361 |
Payment-in-Kind interest | 311,764 | 196,348 |
Non-cash operating lease, net | (2,791) | (7,681) |
Loss on sale of fixed assets | 263 | |
Changes in operating assets and liabilities: | ||
Payroll tax receivable | 37,838 | (166,309) |
Prepaid assets and deposits | (5,855,575) | (120,311) |
Accounts payable | 1,553,176 | 1,553,381 |
Accrued expenses | 2,270,422 | 105,239 |
Net cash used for operating activities | (26,528,911) | (14,187,938) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (46,724) | (71,959) |
Proceeds from sale of property and equipment | 500 | |
Net cash used for investing activities | (46,724) | (71,459) |
Cash flows from financing activities: | ||
Proceeds from exercise of common stock warrants | 11,257 | |
Proceeds from exercise of employee stock options | 24,233 | 41,959 |
Proceeds from employee stock purchases | 80,541 | 25,817 |
Proceeds from follow-on offering, net of underwriting discounts and offering costs | 78,530,585 | |
Proceeds from note payable, net of debt issuance costs and discount of $652,061 | 14,347,939 | |
Payments for debt issuance costs | (8,463) | |
Gross proceeds from an ATM offering | 38,962 | |
Payments for secondary registration statement costs | (318,897) | (3,868) |
Payments for finance leases | (4,384) | (4,353) |
Net cash (used for) provided by financing activities | (226,970) | 92,988,298 |
Net change in cash and cash equivalents | (26,802,605) | 78,728,901 |
Cash and cash equivalents: | ||
Beginning of period | 84,286,381 | 11,637,911 |
End of period | 57,483,776 | 90,366,812 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 832,161 | 454,573 |
Supplemental disclosures of non-cash investing and financing activities: | ||
Property and equipment included in accounts payable | 104,818 | |
Offering and registration statement costs included in accounts payable | 11,230 | |
Deferred financing costs and offering and registration statement costs included in accrued expenses | 205,000 | |
Issuance of common stock warrants and final fee recognized as discount to note payable | $ 964,839 |
Condensed Statements of Cash _2
Condensed Statements of Cash Flows (Unaudited) (Parenthetical) | Sep. 30, 2022 USD ($) |
Statement of Cash Flows [Abstract] | |
Debt issuance costs and discount | $ 652,061 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2022 | |
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, reversible dual inhibitor that selectively targets all Class I PI3K isoforms and mTOR. 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. The Company initiated a Phase 3 study evaluating gedatolisib in patients with HR+/HER2- advanced breast cancer in 2022. 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 | 9 Months Ended |
Sep. 30, 2022 | |
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, 2021 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, 2021 and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. Operating results for the three and nine months ended September 30, 2022 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 initial drug product, gedatolisib, the clinical and commercial success of its diagnostic tests, ability to obtain regulatory approval of its drug product, gedatolisib, ability to obtain regulatory approval of its diagnostic tests, 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 accrues for these costs based on factors such as estimates of the work completed and in accordance with service agreements with its third-party service providers. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its prepaid assets or accrued expenses. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed, number of patients enrolled, and the rate of patient enrollments may vary from the Company’s estimates, resulting in an adjustment to expense in future periods. 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. Application of New or Revised Accounting Standards Pursuant to the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), a company constituting an “emerging growth company” is, among other things, entitled to rely upon certain reduced reporting requirements. The Company is an emerging growth company but has irrevocably elected not to take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. As a result, the Company will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for public companies that are not emerging growth companies. The Company’s emerging growth company filer status will cease on its Form 10-K filing for the year ended December 31, 2022. Recently Adopted Accounting Pronouncements In May 2021, the FASB issued ASU No. 2021-04, Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options, which provides guidance on how an issuer should account for modifications made to equity-classified written call options. The guidance in the ASU requires the issuer to treat the modification of an equity-classified warrant that does not cause the warrant to become liability-classified as an exchange of the original warrant for a new warrant. The issuer should measure the effect of a modification as the difference between the fair value of the modified warrant and the fair value of that warrant immediately before modification. The standard is effective for all entities for all fiscal years beginning after December 15, 2021. The Company adopted this accounting standard effective January 1, 2022, and based on the standard, determined that the Representative’s Warrant amendment was equity-classified, treated as a deemed dividend within Additional Paid-in Capital, and the estimated incremental fair value of the modification for the Representative’s Warrant at the date of amendment was $ 271,988 |
Net Loss Per Common Share
Net Loss Per Common Share | 9 Months Ended |
Sep. 30, 2022 | |
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 nine months ended September 30, 2022 and 2021, potentially dilutive securities excluded from the computations of diluted weighted-average shares outstanding were options to purchase 1,919,114 1,184,721 309,652 378,442 3,273 2,964 In accordance with ASU 2021-04, for purposes of calculating basic and diluted net loss per share for the three- and nine-month periods ended September 30, 2022, the reported net loss was increased by approximately $ 272,000 .02 |
Commitments
Commitments | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | 4. Commitments Operating and Finance Leases The Company leases its corporate space in Minneapolis, Minnesota. In September 2017, the Company entered into a non-cancelable operating lease agreement for building space. The lease commenced, and the Company moved to the facility in May 2018, in conjunction with the termination of its then existing lease. Rent expense is recorded on a straight-line basis over the lease term. In July 2020, the Company signed an amendment to extend this lease through April 30, 2022. The lease amendment provides for monthly rent, real estate taxes and operating expenses. As a result of the lease amendment, the Company recorded an incremental $ 197,211 193,571 195,437 In May 2018, the Company entered into a non-cancelable finance lease agreement for office equipment with a five-year term. The underlying assets are included in furniture and equipment. The lease contains a bargain purchase option at the end of the lease. When an implicit rate is not provided, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of the lease payments. 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 five 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 study and 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 September 30, 2022, the Company had only one material non-cancelable contractual commitment with respect to these arrangements, which totaled approximately $ 2.5 |
Stockholders_ Equity
Stockholders’ Equity | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Stockholders’ Equity | 5. Stockholders’ Equity On September 13, 2022, the Company entered into a First Amendment to Representative’s Warrant (the “Warrant Amendment”) with Craig-Hallum Capital Group LLC (“Craig-Hallum”), amending the terms of that certain Representative’s Warrant, dated September 22, 2017 (the “Representative’s Warrant”) issued by the Company to Craig-Hallum in connection with the Company’s initial public offering. Under the terms of the Warrant Amendment, (i) the number of shares of the Company’s common stock issuable upon exercise of the Representative’s Warrant was reduced from 138,000 70,000 September 19, 2025 271,988 On September 1, 2022, the Company held a Special Meeting of Stockholders, at which the Company’s stockholders approved a proposal to amend the Company’s Certificate of Incorporation to increase the authorized number of the Company’s Common Stock from 30,000,000 65,000,000 On May 15, 2022, the Company entered into a securities purchase agreement with certain institutional and other accredited investors for the sale of Company common stock, preferred stock that may be convertible into common stock and warrants initially exercisable for preferred stock for $ 100 5.75 0.40 40% 142,241 On February 4, 2022, the Company entered into an Open Market Sale Agreement SM 50,000,000 3.0% 500,000 10.35 5.2 4.8 On July 1, 2021, the Company completed a follow-on offering whereby it sold 2,250,000 25.00 56.3 3.4 0.1 On February 26, 2021, the Company completed a follow-on offering whereby it sold 1,971,100 257,100 14.00 27.6 1.6 0.2 On June 5, 2020, the Company entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with B. Riley FBR, Inc. (the “Agent”). Pursuant to the ATM Agreement, the Company was able to offer and sell from time to time, at its option, shares of common stock having an aggregate offering price of up to $ 10,000,000 0.001 During the nine months ended September 30, 2022 and 2021, the Company sold 0 3,082 12.64 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 6. Stock-Based Compensation The following table summarizes the activity for all stock options outstanding for the nine months ended September 30: Schedule of Stock Options Activity 2022 2021 Shares Weighted Average Exercise Price Shares Weighted Average Exercise Price Options outstanding at beginning of year 1,315,321 $ 11.97 849,949 $ 9.33 Granted 720,047 7.19 402,550 23.04 Exercised (4,660 ) 5.20 (40,620 ) 7.26 Forfeited (111,594 ) 10.86 (27,158 ) 19.07 Balance at September 30 1,919,114 $ 6.08 1,184,721 $ 13.84 Options exercisable at September 30: 882,215 $ 5.92 560,915 $ 9.45 Weighted Average Grant Date Fair Value for options granted during the period: $ 4.87 $ 15.28 The following table summarizes additional information about stock options outstanding and exercisable at September 30, 2022: 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 1,919,114 7.98 $ 6.08 $ 7,791,703 882,215 $ 5.92 $ 3,779,591 The Company recognized stock-based compensation expense for stock options of $ 1,162,751 673,022 3,329,969 1,611,575 776,324 5.50 49,088 477,431 389,000 311,000 13.44 21,778 0 75,562 0 219,000 203,750 5.10 7,681 12,602 30,897 34,396 27,000 The Black-Scholes option-pricing model was used to estimate the grant date fair value of equity-based awards with the following weighted-average assumptions for the nine months ended September 30: Schedule of Assumptions for Fair Value of Equity-based Awards 2022 2021 Risk-free interest rate 1.68 3.93 0.63 1.16% Expected volatility 76.2 79.6% 76.6 76.9% Expected life (years) 5.29 6.25 5.0 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. The Company had 3,273 2,964 250 0 7,245 20,792 36,686 59,359 The Company initially reserved a maximum of 750,000 102,540 102,998 149,189 increase automatically on January 1 each year from 2023 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 31 500,000 1,000,000 325,094 Total unrecognized compensation cost related to stock options and restricted stock is estimated to be recognized as follows for the year ended: Schedule of Unrecognized Compensation Cost 2022 $ 1,116,837 2023 3,277,254 2024 2,130,739 2025 1,333,749 2026 176,866 Total estimated compensation cost to be recognized $ 8,035,445 The Company recognized stock-based compensation expense related to its employee stock purchase plan of $ 53,058 6,102 132,129 18,397 100,000 51,270 51,499 74,594 the number of shares equal to 0.5% of the total outstanding number of shares 208,929 The Company recognized total stock-based compensation expense as follows for the three and nine months ended September 30: Schedule of Stock-based Compensation Expense 2022 2021 2022 2021 Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Stock-based compensation expense in operating expenses: Research and development $ 676,524 $ 434,597 $ 1,937,707 $ 1,017,855 General and administrative 546,530 265,319 1,561,077 671,476 Total $ 1,223,054 $ 699,916 $ 3,498,784 $ 1,689,331 |
Debt
Debt | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Debt | 7. 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. The Lender agreed to loan up to $ 25 15.0 5 5 The Loan Agreement also contains certain events of default, warranties and covenants of the Company. In connection with each funding of the Term Loans, the Company is required to issue Innovatus a warrant (the “Warrants”) to purchase a number of shares of the Company’s stock equal to 2.5% of the principal amount of the relevant Term Loan funded by the exercise price, which will be based on the lower of (i) $14.40 per share or (ii) the volume weighted price per share of the Company’s stock for the five-trading day period ending on the last trading day immediately preceding the funding date of the Term C loan . The warrants may be exercised on a cashless basis and are immediately exercisable through the tenth anniversary of the applicable funding date. In connection with the first tranche of the Term Loans, the Company issued a warrant to Innovatus to purchase 26,042 shares of the Company’s common stock at an exercise price of $ 14.40 per share. The company evaluated the warrant under ASC 470, debt, and recognized an additional debt discount of approximately $ 0.3 million based on the relative fair value of the base instruments and warrants. The company calculated the fair value of the warrant using the Black-Scholes model. In connection with the funding of the first tranche of the Term Loans, a final fee of approximately $ 0.7 0.1 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 15 20 100 10 20 10 100 Under the amended Loan Agreement, Innovatus has the right, at its election and until August 9, 2025, the third anniversary of the loan amendment date, to convert into Common Stock up to (1) 20% of the outstanding principal amount of term A loan, and (ii) an additional 7% of the amount by which the aggregate principal amount of the funded term B, C, D, and E loans exceed $35 million, provided that the aggregate outstanding principal amount of all term loans is at least $35 million, which such conversion based upon a price per share equal to $10.00 The Company is entitled to make interest-only payments for forty-eight months, or up to sixty months from the original Loan Agreement date if certain conditions are met. The Term Loans will mature on April 8, 2027, the sixth anniversary of the initial funding date, and will bear interest at a rate equal to the sum of (a) the greater of (i) Prime Rate (as defined in the amended Loan Agreement) or (ii) 3.25%, plus 5.7%. Additionally, the Company elected to make 4.95% of the interest rate as payable in-kind, which shall accrue as principal monthly. The Amended Loan Agreement includes certain other fees, such as a final fee of 4.5% of the funded loan amounts not converted into equity by the lender, which apply if prepayment, an event of default, or change of control occurs prior to August 9, 2025, the third anniversary of the Amendment date 3.0 The amended Loan Agreement remains secured by all assets of the Company. Proceeds will be used for working capital purposes and to fund the Company’s general business requirements. The amended Loan Agreement contains customary representations and warranties and covenants, subject to customary carve outs, and includes financial covenants related to or based upon liquidity, trailing twelve months revenue and the funded loan amounts. In connection with the original and amended Loan Agreement and the funding of the first tranche of the Term Loans, the Company incurred debt issuance costs of approximately $ 0.7 Long-term debt consisted of the following: Schedule of Long-term Debt September 30, 2022 Note payable $ 15,000,000 Add: Payment-in-Kind interest (added to principal) 611,765 Add: final fee 675,000 Less: unamortized debt issuance costs (481,304 ) Less: unamortized debt discount (792,054 ) Total long-term debt $ 15,013,407 Future principal payments, including the final fee, are as follows: Schedule of Long Term Debt Future Principal Payments Years Ending December 31, 2024 $ 5,854,412 2025 7,805,882 2026 2,626,471 Total $ 16,286,765 |
License Agreement
License Agreement | 9 Months Ended |
Sep. 30, 2022 | |
License Agreement | |
License Agreement | 8. License Agreement On April 8, 2021, the Company entered into a license agreement with Pfizer to research, develop, manufacture and commercialize gedatolisib, a potent, well-tolerated, reversible dual inhibitor that selectively targets all Class I PI3K isoforms and mTOR. The Company paid Pfizer $ 5.0 5.0 The Company is also required to make milestone payments to Pfizer upon achievement of certain development and commercial milestone events, up to an aggregate of $ 335.0 The Company has the right to terminate the license agreement for convenience upon 90 days’ prior written notice. Pfizer may not terminate the agreement for convenience. Either the Company or Pfizer may terminate the license agreement if the other party is in material breach and such breach is not cured within the specified cure period. In addition, either the Company or Pfizer may terminate the license agreement in the event of specified insolvency events involving the other party. |
Basis of Presentation, Summar_2
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
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, 2021 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, 2021 and the related footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. Operating results for the three and nine months ended September 30, 2022 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 initial drug product, gedatolisib, the clinical and commercial success of its diagnostic tests, ability to obtain regulatory approval of its drug product, gedatolisib, ability to obtain regulatory approval of its diagnostic tests, 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 accrues for these costs based on factors such as estimates of the work completed and in accordance with service agreements with its third-party service providers. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its prepaid assets or accrued expenses. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed, number of patients enrolled, and the rate of patient enrollments may vary from the Company’s estimates, resulting in an adjustment to expense in future periods. 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. |
Application of New or Revised Accounting Standards | Application of New or Revised Accounting Standards Pursuant to the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), a company constituting an “emerging growth company” is, among other things, entitled to rely upon certain reduced reporting requirements. The Company is an emerging growth company but has irrevocably elected not to take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. As a result, the Company will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for public companies that are not emerging growth companies. The Company’s emerging growth company filer status will cease on its Form 10-K filing for the year ended December 31, 2022. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In May 2021, the FASB issued ASU No. 2021-04, Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options, which provides guidance on how an issuer should account for modifications made to equity-classified written call options. The guidance in the ASU requires the issuer to treat the modification of an equity-classified warrant that does not cause the warrant to become liability-classified as an exchange of the original warrant for a new warrant. The issuer should measure the effect of a modification as the difference between the fair value of the modified warrant and the fair value of that warrant immediately before modification. The standard is effective for all entities for all fiscal years beginning after December 15, 2021. The Company adopted this accounting standard effective January 1, 2022, and based on the standard, determined that the Representative’s Warrant amendment was equity-classified, treated as a deemed dividend within Additional Paid-in Capital, and the estimated incremental fair value of the modification for the Representative’s Warrant at the date of amendment was $ 271,988 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Options Activity | The following table summarizes the activity for all stock options outstanding for the nine months ended September 30: Schedule of Stock Options Activity 2022 2021 Shares Weighted Average Exercise Price Shares Weighted Average Exercise Price Options outstanding at beginning of year 1,315,321 $ 11.97 849,949 $ 9.33 Granted 720,047 7.19 402,550 23.04 Exercised (4,660 ) 5.20 (40,620 ) 7.26 Forfeited (111,594 ) 10.86 (27,158 ) 19.07 Balance at September 30 1,919,114 $ 6.08 1,184,721 $ 13.84 Options exercisable at September 30: 882,215 $ 5.92 560,915 $ 9.45 Weighted Average Grant Date Fair Value for options granted during the period: $ 4.87 $ 15.28 |
Schedule of Stock Options Outstanding and Exercisable | The following table summarizes additional information about stock options outstanding and exercisable at September 30, 2022: 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 1,919,114 7.98 $ 6.08 $ 7,791,703 882,215 $ 5.92 $ 3,779,591 |
Schedule of Assumptions for Fair Value of Equity-based Awards | The Black-Scholes option-pricing model was used to estimate the grant date fair value of equity-based awards with the following weighted-average assumptions for the nine months ended September 30: Schedule of Assumptions for Fair Value of Equity-based Awards 2022 2021 Risk-free interest rate 1.68 3.93 0.63 1.16% Expected volatility 76.2 79.6% 76.6 76.9% Expected life (years) 5.29 6.25 5.0 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 for the year ended: Schedule of Unrecognized Compensation Cost 2022 $ 1,116,837 2023 3,277,254 2024 2,130,739 2025 1,333,749 2026 176,866 Total estimated compensation cost to be recognized $ 8,035,445 |
Schedule of Stock-based Compensation Expense | The Company recognized total stock-based compensation expense as follows for the three and nine months ended September 30: Schedule of Stock-based Compensation Expense 2022 2021 2022 2021 Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Stock-based compensation expense in operating expenses: Research and development $ 676,524 $ 434,597 $ 1,937,707 $ 1,017,855 General and administrative 546,530 265,319 1,561,077 671,476 Total $ 1,223,054 $ 699,916 $ 3,498,784 $ 1,689,331 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | Long-term debt consisted of the following: Schedule of Long-term Debt September 30, 2022 Note payable $ 15,000,000 Add: Payment-in-Kind interest (added to principal) 611,765 Add: final fee 675,000 Less: unamortized debt issuance costs (481,304 ) Less: unamortized debt discount (792,054 ) Total long-term debt $ 15,013,407 |
Schedule of Long Term Debt Future Principal Payments | Future principal payments, including the final fee, are as follows: Schedule of Long Term Debt Future Principal Payments Years Ending December 31, 2024 $ 5,854,412 2025 7,805,882 2026 2,626,471 Total $ 16,286,765 |
Basis of Presentation, Summar_3
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Details Narrative) | Sep. 13, 2022 USD ($) |
Accounting Policies [Abstract] | |
Incremental fair value of warrant | $ 271,988 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Deemed dividend | $ 272,000 | $ 272,000 | ||
Increased net loss per share basic and diluted | $ 0.02 | $ 0.02 | ||
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 | 1,919,114 | 1,184,721 | 1,919,114 | 1,184,721 |
Warrant [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share | 309,652 | 378,442 | 309,652 | 378,442 |
Restricted Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share | 3,273 | 2,964 | 3,273 | 2,964 |
Commitments (Details Narrative)
Commitments (Details Narrative) - USD ($) | 1 Months Ended | |||
Jul. 31, 2022 | Jul. 31, 2021 | Jul. 31, 2020 | Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Increase in operating ROU asset and lease liability | $ 195,437 | $ 193,571 | $ 197,211 | |
Non-cancelable contractual commitment | $ 2,500,000 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 9 Months Ended | ||||||||||||
Oct. 12, 2022 | Sep. 13, 2022 | May 15, 2022 | Feb. 04, 2022 | Jul. 02, 2021 | Jul. 01, 2021 | Feb. 26, 2021 | Feb. 26, 2021 | Jun. 05, 2020 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 01, 2022 | Dec. 31, 2021 | |
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Warrants maturity date | Sep. 19, 2025 | ||||||||||||
Estimated incremental fair value of the warrants | $ 271,988 | ||||||||||||
Common stock, shares authorized | 65,000,000 | 65,000,000 | |||||||||||
Incurred transaction fee | $ 142,241 | ||||||||||||
Common stock par value | $ 0.001 | $ 0.001 | |||||||||||
ATM Agreement [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Sale of stock number of shares issued in transaction | 0 | 3,082 | |||||||||||
Average selling price per share | $ 12.64 | $ 12.64 | |||||||||||
ATM Agreement [Member] | Placement Shares [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Aggregate offering price, common stock shares | $ 10,000,000 | ||||||||||||
Common stock par value | $ 0.001 | ||||||||||||
Follow-on Offering [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Issuance of public offering price per shares | $ 25 | $ 14 | $ 14 | ||||||||||
Sale of stock number of shares issued in transaction | 2,250,000 | 1,971,100 | |||||||||||
Gross proceeds from public offering | $ 56,300,000 | $ 27,600,000 | |||||||||||
Deducting underwriting discounts | 3,400,000 | $ 1,600,000 | |||||||||||
Offering expenses | $ 100,000 | $ 200,000 | $ 200,000 | ||||||||||
Follow-on Offering [Member] | Underwriter [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Sale of stock number of shares issued in transaction | 257,100 | ||||||||||||
Subsequent Event [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Issuance of public offering price per shares | $ 10.35 | ||||||||||||
Sale of stock number of shares issued in transaction | 500,000 | ||||||||||||
Gross proceeds from public offering | $ 5,200,000 | ||||||||||||
Gross proceeds net of commissions and offering expenses | $ 4,800,000 | ||||||||||||
Securities Purchase Agreement [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Sale of stock, value | $ 100,000,000 | ||||||||||||
Issuance of public offering price per shares | $ 5.75 | ||||||||||||
Conversion price per share | $ 0.40 | ||||||||||||
Purchase Agreement [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Percentage of warrant exercise price | 40% | ||||||||||||
Open Market Sale Agreement [Member] | Jefferies LLC [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Aggregate offering price, common stock shares | $ 50,000,000 | ||||||||||||
Aggregate offering price, commission percentage | 3% | ||||||||||||
Maximum [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Common stock issuable | 138,000 | ||||||||||||
Common stock, shares authorized | 65,000,000 | ||||||||||||
Minimum [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Common stock issuable | 70,000 | ||||||||||||
Common stock, shares authorized | 30,000,000 |
Schedule of Stock Options Activ
Schedule of Stock Options Activity (Details) - Share-Based Payment Arrangement, Option [Member] - $ / shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Options outstanding beginning balance | 1,315,321 | 849,949 |
Weighted Average Exercise Price, beginning balance | $ 11.97 | $ 9.33 |
Options outstanding shares, Granted | 720,047 | 402,550 |
Weighted Average Exercise Price, Granted | $ 7.19 | $ 23.04 |
Options outstanding shares, Exercised | (4,660) | (40,620) |
Weighted Average Exercise Price, Exercised | $ 5.20 | $ 7.26 |
Options outstanding shares, Forfeited | (111,594) | (27,158) |
Weighted Average Exercise Price, Forfeited | $ 10.86 | $ 19.07 |
Options outstanding ending balance | 1,919,114 | 1,184,721 |
Weighted Average Exercise Price, ending balance | $ 6.08 | $ 13.84 |
Options exercisable, ending balance | 882,215 | 560,915 |
Weighted Average Exercisable, ending balance | $ 5.92 | $ 9.45 |
Weighted Average Grant Date Fair Value for options granted | $ 4.87 | $ 15.28 |
Schedule of Stock Options Outst
Schedule of Stock Options Outstanding and Exercisable (Details) - Share-Based Payment Arrangement, Option [Member] - USD ($) | 9 Months Ended | |||
Sep. 30, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2020 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Options outstanding | 1,919,114 | 1,315,321 | 1,184,721 | 849,949 |
Options outstanding, weighted average remaining contractual life | 7 years 11 months 23 days | |||
Options outstanding, weighted average exercise price | $ 6.08 | $ 11.97 | $ 13.84 | $ 9.33 |
Options outstanding, aggregate intrinsic value | $ 7,791,703 | |||
Options exercisable | 882,215 | 560,915 | ||
Options exercisable, weighted average exercise price | $ 5.92 | $ 9.45 | ||
Options exercisable, aggregate intrinsic value | $ 3,779,591 |
Schedule of Assumptions for Fai
Schedule of Assumptions for Fair Value of Equity-based Awards (Details) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected dividend yield | 0% | 0% |
Minimum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Risk-free interest rate | 1.68% | 0.63% |
Expected volatility | 76.20% | 76.60% |
Expected life (years) | 5 years 3 months 14 days | 5 years |
Maximum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Risk-free interest rate | 3.93% | 1.16% |
Expected volatility | 79.60% | 76.90% |
Expected life (years) | 6 years 3 months | 6 years 29 days |
Schedule of Unrecognized Compen
Schedule of Unrecognized Compensation Cost (Details) | Sep. 30, 2022 USD ($) |
Share-Based Payment Arrangement [Abstract] | |
2022 | $ 1,116,837 |
2023 | 3,277,254 |
2024 | 2,130,739 |
2025 | 1,333,749 |
2026 | 176,866 |
Total estimated compensation cost to be recognized | $ 8,035,445 |
Schedule of Stock-based Compens
Schedule of Stock-based Compensation Expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total | $ 1,223,054 | $ 699,916 | $ 3,498,784 | $ 1,689,331 |
Research and Development Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total | 676,524 | 434,597 | 1,937,707 | 1,017,855 |
General and Administrative Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total | $ 546,530 | $ 265,319 | $ 1,561,077 | $ 671,476 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||||||||||
May 12, 2021 | Oct. 25, 2017 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | May 31, 2022 | Jan. 01, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | May 31, 2020 | Jan. 01, 2020 | May 10, 2018 | |
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 | 149,189 | 102,998 | 102,540 | ||||||||
Stock option description | increase automatically on January 1 each year from 2023 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 | ||||||||||||
Additional shares authorized under plan | 500,000 | ||||||||||||
Shares available for issuance | 325,094 | 325,094 | |||||||||||
In May 2022 [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 | $ 49,088 | $ 477,431 | |||||||||||
Remaining stock based compensation expense related to modification | 389,000 | ||||||||||||
In December 2021 [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 | 21,778 | $ 0 | 75,562 | $ 0 | |||||||||
Remaining stock based compensation expense related to modification | 219,000 | ||||||||||||
In May 2020 [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 | 7,681 | 12,602 | 30,897 | 34,396 | |||||||||
Remaining stock based compensation expense related to modification | 27,000 | ||||||||||||
Equity Option [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Recognized stock-based compensation expense | 1,162,751 | 673,022 | 3,329,969 | 1,611,575 | |||||||||
Restricted Stock [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Recognized stock-based compensation expense | $ 7,245 | $ 20,792 | $ 36,686 | $ 59,359 | |||||||||
Restricted stock awards outstanding | 3,273 | 2,964 | 3,273 | 2,964 | |||||||||
Restricted stock awards vested | 250 | 0 | |||||||||||
Employee Stock Purchase Plan [Member] | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||
Recognized stock-based compensation expense | $ 53,058 | $ 6,102 | $ 132,129 | $ 18,397 | |||||||||
Common stock, shares reserved for issuance | 74,594 | 51,499 | 51,270 | 100,000 | |||||||||
Stock option description | the number of shares equal to 0.5% of the total outstanding number of shares | ||||||||||||
Shares available for issuance | 208,929 | 208,929 |
Schedule of Long-term Debt (Det
Schedule of Long-term Debt (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
Note payable | $ 15,000,000 | |
Add: Payment-in-Kind interest (added to principal) | 611,765 | |
Add: final fee | 675,000 | |
Less: unamortized debt issuance costs | (481,304) | |
Less: unamortized debt discount | (792,054) | |
Total long-term debt | $ 15,013,407 | $ 14,625,923 |
Schedule of Long Term Debt Futu
Schedule of Long Term Debt Future Principal Payments (Details) | Sep. 30, 2022 USD ($) |
Debt Disclosure [Abstract] | |
2024 | $ 5,854,412 |
2025 | 7,805,882 |
2026 | 2,626,471 |
Total | $ 16,286,765 |
Debt (Details Narrative)
Debt (Details Narrative) - USD ($) | Aug. 09, 2022 | Aug. 09, 2022 | May 16, 2022 | Apr. 08, 2021 | Sep. 30, 2022 |
Short-Term Debt [Line Items] | |||||
Debt discount, amount | $ 792,054 | ||||
Private placement | $ 100,000,000 | ||||
Prepayment fee, percentage | 3% | ||||
Private Placement [Member] | |||||
Short-Term Debt [Line Items] | |||||
Private placement | $ 100,000,000 | ||||
Innovatus Life Sciences [Member] | Security and Loan agreement [Member] | |||||
Short-Term Debt [Line Items] | |||||
Non contigent term A loan, funded | $ 15,000,000 | ||||
Innovatus Life Sciences [Member] | Amended Loan Agreement [Member] | Term B Loan [Member] | |||||
Short-Term Debt [Line Items] | |||||
Unfunded contingent loan, amount | $ 20,000,000 | $ 20,000,000 | |||
Innovatus Life Sciences [Member] | Amended Loan Agreement [Member] | Term C Loan [Member] | |||||
Short-Term Debt [Line Items] | |||||
Unfunded contingent loan, amount | 10,000,000 | 10,000,000 | |||
Innovatus Life Sciences [Member] | Amended Loan Agreement [Member] | Term D Loan [Member] | |||||
Short-Term Debt [Line Items] | |||||
Unfunded contingent loan, amount | 20,000,000 | 20,000,000 | |||
Innovatus Life Sciences [Member] | Amended Loan Agreement [Member] | Term E Loan [Member] | |||||
Short-Term Debt [Line Items] | |||||
Unfunded contingent loan, amount | $ 10,000,000 | $ 10,000,000 | |||
Security and Loan agreement [Member] | Innovatus Life Sciences [Member] | |||||
Short-Term Debt [Line Items] | |||||
Line of credit faciltiy, maximum borrowing capacity | 25,000,000 | ||||
Non contigent term A loan, funded | 15,000,000 | ||||
Term B loan to be funded before March 31, 2022 | 5,000,000 | ||||
Term C loan to be funded before March 31, 2023 | $ 5,000,000 | ||||
Warrant or Right, Reason for Issuance, Description | The Loan Agreement also contains certain events of default, warranties and covenants of the Company. In connection with each funding of the Term Loans, the Company is required to issue Innovatus a warrant (the “Warrants”) to purchase a number of shares of the Company’s stock equal to 2.5% of the principal amount of the relevant Term Loan funded by the exercise price, which will be based on the lower of (i) $14.40 per share or (ii) the volume weighted price per share of the Company’s stock for the five-trading day period ending on the last trading day immediately preceding the funding date of the Term C loan | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 26,042 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 14.40 | ||||
Debt Instrument, Unamortized Discount (Premium), Net | $ 300,000 | ||||
Final fee payable to lender, amount | 700,000 | ||||
Debt discount, amount | $ 100,000 | ||||
Amended Loan Agreement [Member] | |||||
Short-Term Debt [Line Items] | |||||
Loan convertible to stock percentage, description | (1) 20% of the outstanding principal amount of term A loan, and (ii) an additional 7% of the amount by which the aggregate principal amount of the funded term B, C, D, and E loans exceed $35 million, provided that the aggregate outstanding principal amount of all term loans is at least $35 million, which such conversion based upon a price per share equal to $10.00 | ||||
Debt instrument interest rate description | The Company is entitled to make interest-only payments for forty-eight months, or up to sixty months from the original Loan Agreement date if certain conditions are met. The Term Loans will mature on April 8, 2027, the sixth anniversary of the initial funding date, and will bear interest at a rate equal to the sum of (a) the greater of (i) Prime Rate (as defined in the amended Loan Agreement) or (ii) 3.25%, plus 5.7%. Additionally, the Company elected to make 4.95% of the interest rate as payable in-kind, which shall accrue as principal monthly. The Amended Loan Agreement includes certain other fees, such as a final fee of 4.5% of the funded loan amounts not converted into equity by the lender, which apply if prepayment, an event of default, or change of control occurs prior to August 9, 2025, the third anniversary of the Amendment date | ||||
Amended Loan Agreement [Member] | Innovatus Life Sciences [Member] | |||||
Short-Term Debt [Line Items] | |||||
Face amount | $ 75,000,000 | $ 75,000,000 | |||
Increase from original loan amount | $ 50,000,000 | $ 50,000,000 | |||
Original and Amended Loan Agreement [Member] | |||||
Short-Term Debt [Line Items] | |||||
Debt issuance costs | $ 700,000 |
License Agreement (Details Narr
License Agreement (Details Narrative) $ in Millions | Apr. 08, 2021 USD ($) |
Pfizer, Inc. [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Milestone payments | $ 335 |
License Agreement [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Upfront fees | 5 |
Value of shares issued for equity grant | $ 5 |