Cover
Cover | 9 Months Ended |
Sep. 30, 2023 | |
Entity Addresses [Line Items] | |
Document Type | S-1/A |
Amendment Flag | true |
Amendment Description | Amendment No. 1 |
Entity Registrant Name | CINGULATE INC. |
Entity Central Index Key | 0001862150 |
Entity Tax Identification Number | 86-3825535 |
Entity Incorporation, State or Country Code | DE |
Entity Address, Address Line One | 1901 W. 47th Place |
Entity Address, City or Town | Kansas City |
Entity Address, State or Province | KS |
Entity Address, Postal Zip Code | 66205 |
City Area Code | (913) |
Local Phone Number | 942-2300 |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | true |
Elected Not To Use the Extended Transition Period | false |
Business Contact [Member] | |
Entity Addresses [Line Items] | |
Entity Address, Address Line One | Cingulate Inc. |
Entity Address, Address Line Two | 1901 W. 47th Place |
Entity Address, City or Town | Kansas City |
Entity Address, State or Province | KS |
Entity Address, Postal Zip Code | 66205 |
City Area Code | (913) |
Local Phone Number | 942-2300 |
Contact Personnel Name | Shane J. Schaffer |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | |||
Cash and cash equivalents | $ 1,986,313 | $ 5,356,276 | $ 16,492,745 |
Short-term investments | 933 | ||
Miscellaneous receivables | 5,836 | 234,432 | 690,248 |
Prepaid expenses and other current assets | 910,286 | 2,278,944 | 1,698,353 |
Total current assets | 2,902,435 | 7,869,652 | 18,882,279 |
Property and equipment, net | 2,531,330 | 2,904,787 | 3,145,378 |
Operating lease right-of-use assets | 436,493 | 630,618 | 858,600 |
Total assets | 5,870,258 | 11,405,057 | 22,886,257 |
Current liabilities: | |||
Accounts payable | 1,670,436 | 762,357 | 264,687 |
Accrued expenses | 692,008 | 894,635 | 601,300 |
Note payable | 3,000,000 | 5,000,000 | |
Finance lease liability, current | 16,805 | 16,053 | 15,096 |
Operating lease liability, current | 353,183 | 339,755 | 295,595 |
Total current liabilities | 5,732,432 | 7,012,800 | 1,176,678 |
Long-term liabilities: | |||
Finance lease liability, net of current | 8,792 | 21,487 | 37,534 |
Operating lease liability, net of current | 225,368 | 488,748 | 828,503 |
Total long-term liabilities | 234,160 | 510,235 | 866,037 |
Total liabilities | 5,966,592 | 7,523,035 | 2,042,715 |
Stockholders’ Equity | |||
Common Stock, $0.0001 par value; 240,000,000 shares authorized and 868,940 and 565,470 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 88 | 57 | 57 |
Preferred Stock, $0.0001 par value; 10,000,000 shares authorized and 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022 | |||
Additional Paid-in-Capital | 85,912,324 | 73,290,461 | 72,575,584 |
Accumulated other comprehensive income | 165 | ||
Accumulated deficit | (86,008,746) | (69,408,496) | (51,732,264) |
Total stockholders’ equity | (96,334) | 3,882,022 | 20,843,542 |
Total liabilities and stockholders’ equity | $ 5,870,258 | $ 11,405,057 | $ 22,886,257 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | |||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 240,000,000 | 240,000,000 | 240,000,000 |
Common stock, shares issued | 868,940 | 565,470 | 565,470 |
Common stock, shares outstanding | 868,940 | 565,470 | 565,470 |
Preferred stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | ||||||
Research and development | $ 3,923,852 | $ 2,123,114 | $ 10,508,395 | $ 7,063,626 | $ 8,995,280 | $ 8,410,489 |
General and administrative | 1,825,822 | 1,845,248 | 5,453,643 | 5,963,067 | 8,506,438 | 12,268,909 |
Operating loss | (5,749,674) | (3,968,362) | (15,962,038) | (13,026,693) | (17,501,718) | (20,679,398) |
Interest and other income (expense), net | (229,380) | (58,885) | (638,212) | (44,512) | (174,514) | (30,593) |
Loss before income taxes | (5,979,054) | (4,027,247) | (16,600,250) | (13,071,205) | (17,676,232) | (20,709,991) |
Income tax benefit (expense) | ||||||
Net loss | (5,979,054) | (4,027,247) | (16,600,250) | (13,071,205) | $ (17,676,232) | $ (20,709,991) |
Other comprehensive income (loss): | ||||||
Change in unrealized loss on short-term investments | 3,249 | (166) | ||||
Comprehensive loss | $ (5,979,054) | $ (4,023,998) | $ (16,600,250) | $ (13,071,371) | ||
Net loss per share of common stock, basic | $ (6.05) | $ (7.12) | $ (23.24) | $ (23.12) | $ (31.26) | $ (55.87) |
Net loss per share of common stock, diluted | $ (6.05) | $ (7.12) | $ (23.24) | $ (23.12) | $ (31.26) | $ (55.87) |
Weighted average number of shares used in computing net loss per share of common stock, basic | 988,333 | 565,470 | 714,397 | 565,470 | 565,470 | 370,679 |
Weighted average number of shares used in computing net loss per share of common stock, diluted | 988,333 | 565,470 | 714,397 | 565,470 | 565,470 | 370,679 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Members Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Balance at Dec. 31, 2020 | $ 32,314,543 | $ (31,022,273) | $ 165 | $ 1,292,435 | ||
Balance, shares at Dec. 31, 2020 | ||||||
Members’ capital contributions | 7,104,957 | 7,104,957 | ||||
Unrealized losses on short-term investments | ||||||
Issuance of common stock in connection with At the Market Offering and Purchase Agreement, net of fees | $ 21 | 20,374,197 | 20,374,218 | |||
Issuance of common stock in connection with At the Market Offering and Purchase Agreement, net of fees, shares | 208,333 | |||||
Stock-based compensation expense | 43,835 | 43,835 | ||||
Conversion of LLC units to common stock in connection with Reorganization Merger | $ 36 | 39,419,464 | (39,419,500) | 0 | ||
Conversion of LLC units to common stock in connection with Reorganization Merger, shares | 357,137 | |||||
Modification of profits interests units in connection with Reorganization Merger | 12,738,088 | 12,738,088 | ||||
Net loss | (20,709,991) | (20,709,991) | ||||
Balance at Dec. 31, 2021 | $ 57 | 72,575,584 | (51,732,264) | 165 | 20,843,542 | |
Balance, shares at Dec. 31, 2021 | 565,470 | |||||
Stock-based compensation expense | 181,518 | 181,518 | ||||
Net loss | (5,003,511) | (5,003,511) | ||||
Unrealized losses on available for sale investments | (2,948) | (2,948) | ||||
Balance at Mar. 31, 2022 | $ 57 | 72,757,102 | (56,735,775) | (2,783) | 16,018,601 | |
Balance, shares at Mar. 31, 2022 | 565,470 | |||||
Balance at Dec. 31, 2021 | $ 57 | 72,575,584 | (51,732,264) | 165 | 20,843,542 | |
Balance, shares at Dec. 31, 2021 | 565,470 | |||||
Net loss | (13,071,205) | |||||
Balance at Sep. 30, 2022 | $ 57 | 73,169,944 | (64,803,469) | 8,366,532 | ||
Balance, shares at Sep. 30, 2022 | 565,470 | |||||
Balance at Dec. 31, 2021 | $ 57 | 72,575,584 | (51,732,264) | 165 | 20,843,542 | |
Balance, shares at Dec. 31, 2021 | 565,470 | |||||
Stock-based compensation expense | 800,796 | 800,796 | ||||
Net loss | (17,676,232) | (17,676,232) | ||||
Available for sale investments | (165) | (165) | ||||
IPO Costs | (85,919) | (85,919) | ||||
Balance at Dec. 31, 2022 | $ 57 | 73,290,461 | (69,408,496) | 3,882,022 | ||
Balance, shares at Dec. 31, 2022 | 565,470 | |||||
Balance at Mar. 31, 2022 | $ 57 | 72,757,102 | (56,735,775) | (2,783) | 16,018,601 | |
Balance, shares at Mar. 31, 2022 | 565,470 | |||||
Stock-based compensation expense | 207,186 | 207,186 | ||||
Net loss | (4,040,447) | (4,040,447) | ||||
Unrealized losses on available for sale investments | (466) | (466) | ||||
Balance at Jun. 30, 2022 | $ 57 | 72,964,288 | (60,776,222) | (3,249) | 12,184,874 | |
Balance, shares at Jun. 30, 2022 | 565,470 | |||||
Stock-based compensation expense | 205,656 | 205,656 | ||||
Net loss | (4,027,247) | (4,027,247) | ||||
Unrealized losses on available for sale investments | 3,249 | 3,249 | ||||
Balance at Sep. 30, 2022 | $ 57 | 73,169,944 | (64,803,469) | 8,366,532 | ||
Balance, shares at Sep. 30, 2022 | 565,470 | |||||
Balance at Dec. 31, 2022 | $ 57 | 73,290,461 | (69,408,496) | 3,882,022 | ||
Balance, shares at Dec. 31, 2022 | 565,470 | |||||
Stock-based compensation expense | 204,479 | 204,479 | ||||
Net loss | (4,004,887) | (4,004,887) | ||||
Balance at Mar. 31, 2023 | $ 57 | 73,494,940 | (73,413,383) | 81,614 | ||
Balance, shares at Mar. 31, 2023 | 565,470 | |||||
Balance at Dec. 31, 2022 | $ 57 | 73,290,461 | (69,408,496) | 3,882,022 | ||
Balance, shares at Dec. 31, 2022 | 565,470 | |||||
Net loss | (16,600,250) | |||||
Capital contribution in connection with conversion of related party note payable | 1,862,735 | |||||
Balance at Sep. 30, 2023 | $ 88 | 85,912,324 | (86,008,746) | (96,334) | ||
Balance, shares at Sep. 30, 2023 | 868,940 | |||||
Balance at Mar. 31, 2023 | $ 57 | 73,494,940 | (73,413,383) | 81,614 | ||
Balance, shares at Mar. 31, 2023 | 565,470 | |||||
Issuance of common stock in connection with At the Market Offering and Purchase Agreement, net of fees | $ 4 | 218,794 | 218,798 | |||
Issuance of common stock in connection with At the Market Offering and Purchase Agreement, net of fees, shares | 37,369 | |||||
Stock-based compensation expense | 217,376 | 217,376 | ||||
Net loss | (6,616,309) | (6,616,309) | ||||
Balance at Jun. 30, 2023 | $ 61 | 73,931,110 | (80,029,692) | (6,098,521) | ||
Balance, shares at Jun. 30, 2023 | 602,839 | |||||
Issuance of common stock in connection with At the Market Offering and Purchase Agreement, net of fees | $ 9 | 1,621,930 | 1,621,939 | |||
Issuance of common stock in connection with At the Market Offering and Purchase Agreement, net of fees, shares | 88,943 | |||||
Stock-based compensation expense | 236,251 | 236,251 | ||||
Net loss | (5,979,054) | (5,979,054) | ||||
Issuance of common stock in connection with private placement with WFIA | $ 9 | 999,991 | 1,000,000 | |||
Issuance of common stock in connection with private placement with WFIA, shares | 91,158 | |||||
Issuance of common stock and pre-funded warrants sold for cash in public offering, net of fees | $ 9 | 3,310,542 | 3,310,551 | |||
Issuance of common stock and pre-funded warrants sold for cash in public offering, net of fees, shares | 86,000 | |||||
Issuance of pre-funded warrants in connection with the conversion of related party note payable | 3,949,765 | 3,949,765 | ||||
Capital contribution in connection with conversion of related party note payable | 1,862,735 | 1,862,735 | ||||
Balance at Sep. 30, 2023 | $ 88 | $ 85,912,324 | $ (86,008,746) | $ (96,334) | ||
Balance, shares at Sep. 30, 2023 | 868,940 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) | 12 Months Ended |
Dec. 31, 2021 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Stock issuance costs | $ 4,627,079 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating activities: | ||||
Net loss | $ (16,600,250) | $ (13,071,205) | $ (17,676,232) | $ (20,709,991) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Depreciation | 410,593 | 304,287 | 394,011 | 708,317 |
Noncash compensation expense relating to modification of profits interest units | 12,738,088 | |||
Stock-based compensation | 658,106 | 594,360 | 800,796 | 43,835 |
Changes in operating assets and liabilities: | ||||
Miscellaneous receivables | 228,596 | 642,899 | 455,816 | (538,476) |
Prepaid expenses and other current assets | 1,368,658 | (293,140) | (580,591) | (1,258,857) |
Operating lease right-of-use assets | 194,125 | 167,828 | 227,982 | 100,124 |
Trade accounts payable and accrued expenses | 1,517,952 | 197,462 | 791,005 | (1,324,686) |
Operating lease liabilities | (263,380) | (249,952) | 44,160 | 61,427 |
Long-term portion of operating lease liability | (339,755) | (228,938) | ||
Other current liabilities | 13,428 | 31,147 | (23,615) | |
Net cash used in operating activities | (12,472,172) | (11,676,314) | (15,882,808) | (10,432,772) |
Investing activities: | ||||
Purchase of property and equipment | (37,136) | (10,400) | (153,420) | (814,736) |
Proceeds from sale of short-term investments | 933 | 933 | ||
Other | (165) | (165) | ||
Net cash used in investing activities | (37,136) | (9,632) | (152,652) | (814,736) |
Financing Activities: | ||||
Proceeds from issuance of common stock and pre-funded common stock purchase warrants, net of fees | 6,151,288 | 20,374,218 | ||
IPO issuance costs | (85,919) | |||
Members’ capital contributions | 7,104,957 | |||
Payments on notes payable | (500,335) | |||
Proceeds from note payable | 3,000,000 | 5,000,000 | 5,000,000 | |
Principal payments on finance lease obligations | (11,943) | (11,229) | (15,090) | (436,259) |
Net cash provided by financing activities | 9,139,345 | 4,988,771 | 4,898,991 | 26,542,581 |
Cash and cash equivalents: | ||||
Net decrease in cash and cash equivalents | (3,369,963) | (6,697,175) | (11,136,469) | 15,295,073 |
Cash and cash equivalents at beginning of year | 5,356,276 | 16,492,745 | 16,492,745 | 1,197,672 |
Cash and cash equivalents at end of period | 1,986,313 | 9,795,570 | 5,356,276 | 16,492,745 |
Non-cash activities | ||||
Property and equipment accrued but not paid at end of year | 279,730 | |||
Cash payments: | ||||
Interest paid | $ 10,266 | $ 10,291 | $ 19,000 | $ 114,725 |
Nature of the Business and Liqu
Nature of the Business and Liquidity | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | ||
Nature of the Business and Liquidity | (1) Nature of the Business and Liquidity Organization Cingulate Inc. is a biopharmaceutical company focused on the development of products utilizing its drug delivery platform technology that enables the formulation and manufacture of once-daily tablets of multi-dose therapies, with an initial focus on the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). The Company is developing two proprietary, first-line stimulant medications, CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine), for the treatment of ADHD intended for all patient segments: children, adolescents, and adults. CTx-1301 and CTx-1302 utilize a flexible core tableting technology with target product profile designed to deliver a rapid onset and last the entire active day with a controlled descent of plasma drug level and have favorable tolerability. The Company completed its first Phase 3 clinical trial for CTx-1301 with two additional Phase 3 trials in process. In addition, the Company has a third product to treat anxiety, CTx-2103, in a formulation stage. On November 14, 2012, Cingulate Therapeutics LLC (CTx), a Delaware limited liability company, was formed. On May 10, 2021, Cingulate Inc. (Cingulate, or the Company), a Delaware corporation and wholly-owned subsidiary of CTx, was formed to serve as a holding company, in anticipation of the Company becoming publicly traded. Through a Reorganization Merger which occurred in the third quarter of 2021, Cingulate effectively acquired CTx and all outstanding units of CTx were converted into shares of Cingulate common stock. CTx remains the entity through which the Company conducts operations. The consolidated financial statements and notes for the periods ended September 30, 2023 and 2022, represent the full consolidation of Cingulate and its subsidiaries, including CTx and all references to the Company represent this full consolidation. Liquidity The Company has incurred losses and negative cash flows from operations since inception. As a pre-revenue entity, the Company is dependent on the ability to raise capital to support operations until such time as the product candidates under development are U.S Food and Drug Administration (FDA) approved, manufactured, commercially available to the marketplace and produce revenues. The initial public offering, which was completed in December 2021, provided approximately $ 20.4 5.0 3.0 2.1 3.3 1 | (1) Nature of the Business and Liquidity Organization Cingulate Inc. is a biopharmaceutical company focused on the development of products utilizing its drug delivery platform technology that enables the formulation and manufacture of once-daily tablets of multi-dose therapies, with an initial focus on the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). The Company is developing two proprietary, first-line stimulant medications, CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine), for the treatment of ADHD intended for all patient segments: children, adolescents, and adults. CTx-1301 and CTx-1302 utilize a flexible core tableting technology with target product profile designed to deliver a rapid onset and last the entire active day with a controlled descent of plasma drug level and have favorable tolerability. The Company has initiated Phase 3 clinical trials for CTx-1301, with first patients in the adult dose-optimization study dosed in early 2023. In addition, the Company has a third product to treat anxiety, CTx-2103, in a formulation stage. On November 14, 2012, Cingulate Therapeutics LLC (CTx), a Delaware limited liability company, was formed. On May 10, 2021, Cingulate Inc. (Cingulate, or the Company), a Delaware corporation and wholly-owned subsidiary of CTx, was formed to serve as a holding company, in anticipation of the Company becoming publicly traded. Through a Reorganization Merger which occurred in the third quarter of 2021, Cingulate effectively acquired CTx and all outstanding units of CTx were converted into shares of Cingulate common stock. CTx remains the entity through which the Company conducts operations. CTx is the predecessor of Cingulate for financial reporting purposes. The consolidated financial statements and notes for the years ended December 31, 2022 and 2021 represent the full consolidation of Cingulate and its subsidiaries, including CTx and all references to the Company represent this full consolidation. Liquidity The Company has incurred losses and negative cash flows from operations since inception. As a pre-revenue entity, the Company is dependent on the ability to raise capital to support operations until such time as the product candidates under development are U.S Food and Drug Administration (FDA) approved, manufactured, commercially available to the marketplace and produce revenues. The IPO, which was completed in December 2021, provided the Company the ability to continue its research and development activities. In addition, the Company received proceeds of $ 5.0 2,650,000 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | ||
Summary of Significant Accounting Policies | (2) Summary of Significant Accounting Policies (a) Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP). The consolidated financial statements include the accounts of Cingulate and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. (b) Unaudited Interim Financial Information The accompanying consolidated balance sheet as of September 30, 2023, the consolidated statements of operations and comprehensive loss for the three and nine-month periods ended September 30, 2023 and 2022, the consolidated statements of stockholders’ equity for the three and nine-month periods ended September 30, 2023 and 2022, the consolidated statements of cash flows for the nine-month periods ended September 30, 2023 and 2022, and the related interim disclosures are unaudited. These unaudited consolidated financial statements include all adjustments necessary, consisting of only normal recurring adjustments, to fairly state the financial position and the results of operations and cash flows for interim periods in accordance with U.S. GAAP. Interim period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The accompanying consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto as of and for the year ended December 31, 2022. (c) Concentration of Credit Risk The Company maintains cash equivalent deposits, which at various times throughout the fiscal year exceeded the amounts insured by the Federal Deposit Insurance Corporation limit of $ 250,000 (d) Miscellaneous Receivables Miscellaneous receivables as of December 31, 2022, primarily consisted of employee retention tax credits for payroll costs incurred in 2020 and research and development tax credits. The Company analogized to IAS 20, Accounting for Government Grants and Disclosure of Government Assistance (e) Impairment of Long-lived Assets The Company assesses the carrying value of its long-lived assets, including property and equipment, as well as lease right of use (ROU) assets, when events or circumstances indicate that the carrying value of such assets may not be recoverable. These events or changes in circumstances may include a significant deterioration of operating results, changes in business plans, or changes in anticipated future cash flows. If an impairment indicator is present, the Company evaluates recoverability by a comparison of the carrying amount of the assets to future undiscounted cash flows expected to be generated by the assets. If the sum of the expected future cash flows is less than the carrying amount, the Company would recognize an impairment loss. An impairment loss would be measured by comparing the amount by which the carrying value exceeds the fair value of the long-lived asset groups. No impairment was recognized during the three or nine-month periods ended September 30, 2023 or 2022. (f) Stock-Based Compensation The Company measures employee and director stock-based compensation expense for all stock-based awards based on their grant date fair value using the Black-Scholes option-pricing model. For stock-based awards with service conditions, stock-based compensation expense is recognized over the requisite service period using the straight-line method. Forfeitures are recognized as they occur. See additional information in Note 11. | (2) Summary of Significant Accounting Policies (a) Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The consolidated financial statements include the accounts of Cingulate and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. (b) Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during a reporting period. Actual results could differ from estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the consolidated financial statements in the period they are determined to be necessary. (c) Concentration of Credit Risk The Company maintains cash equivalent deposits, which at various times throughout the fiscal year exceeded the amounts insured by the Federal Deposit Insurance Corporation limit of $ 250,000 (d) Cash and Cash Equivalents Bank demand deposit accounts and short-term liquid investments with an initial maturity of three months or less are considered cash and cash equivalents. Cash and cash equivalents as of December 31, 2022 and 2021 consisted of bank deposits and short-term money market funds. Cash and cash equivalents are carried at cost which is indicative of fair value. (e) Miscellaneous Receivables Miscellaneous receivables consist of payroll tax credits generated from the Company’s 2021 and 2020 federal income tax returns, which have not yet been received, as well as employee retention tax credits for payroll costs incurred in those years. The Company analyzed IAS 20, Accounting for Government Grants and Disclosure of Government Assistance (f) Property and Equipment, net Property and equipment, net are stated at cost, less accumulated depreciation. Maintenance and repairs are charged to expense when incurred. Property and equipment are depreciated using the straight-line method over the estimated remaining useful lives or, for leasehold improvements or leased assets under a financing lease, the life of the lease if shorter. (g) Leases The Company is a lessee in two noncancellable operating leases, relating to office space at the Kansas City headquarters office and the New Jersey office and two finance leases, for certain furniture and equipment, one of which the lease term ended on December 31, 2021. The Company determines if an arrangement is or contains a lease at contract inception. The Company recognizes a ROU asset and a lease liability at the lease commencement date. For operating leases, the lease liability is initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date. For finance leases, the lease liability is initially measured in the same manner and date as for operating leases and is subsequently measured at amortized cost using the effective-interest method. The Company determines the discount rate it uses to discount the unpaid lease payments to present value, which requires management judgement. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. The implicit rate was stated in the agreement for one of the Company’s leases; however, for the others, the implicit rate was not determinable as the Company did not have access to the lessor’s estimated residual value or the amount of the lessor’s deferred initial direct costs. Therefore, the Company uses its incremental borrowing rate as the discount rate for these leases. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. Because the Company has not been able to borrow on a collateralized basis, it has determined a synthetic credit rating based on factors that a credit rating agency would typically analyze when establishing an entity’s credit rating. Due to the fact that the Company is a pre-revenue entity, the Company determined that its incremental borrowing rate should be based on the composite CCC and lower bond spreads at the lease measurement dates plus a risk-free rate based on specific lease maturities. The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date, plus any initial direct costs incurred less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus initial direct costs, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of cumulative lease incentives received. Lease expense is recognized on a straight-line basis over the lease term which includes the accretion of the lease liability and amortization of the ROU asset. For finance leases, the ROU asset is subsequently amortized using the straight-line method from the lease commencement date to the earlier of the end of its useful life or the end of the lease term unless the lease transfers ownerships of the underlying asset to the Company or the Company is reasonably certain to exercise an option to purchase the underlying asset. In those cases, the ROU asset is amortized over the useful life of the underlying asset. Amortization of the ROU asset is recognized and presented separately from interest expense on the lease liability. ROU assets for operating and finance leases are evaluated for impairment losses. Under the long-lived assets impairment guidance in ASC Subtopic 360-10, Property and Equipment-Overall Operating lease ROU assets are presented as operating lease right-of-use assets on the consolidated balance sheet. The current and long-term portions of operating lease liabilities are presented separately on the consolidated balance sheet. Finance lease ROU assets are included in property, plant, and equipment. The current and long-term portions of finance lease liabilities are presented separately on the consolidated balance sheet. (h) Impairment of Long-lived Assets The Company assesses the carrying value of its long-lived assets, including property and equipment, as well as lease ROU assets, when events or circumstances indicate that the carrying value of such assets may not be recoverable. These events or changes in circumstances may include a significant deterioration of operating results, changes in business plans, or changes in anticipated future cash flows. If an impairment indicator is present, the Company evaluates recoverability by a comparison of the carrying amount of the assets to future undiscounted cash flows expected to be generated by the assets. If the sum of the expected future cash flows is less than the carrying amount, the Company would recognize an impairment loss. An impairment loss would be measured by comparing the amount by which the carrying value exceeds the fair value of the long-lived asset groups. No (i) Research and Development Research and development costs are expensed as incurred and include all direct and indirect costs associated with the development of the Company’s product candidates. These expenses include payments to third parties for research, development and manufacturing services, personnel costs and depreciation on manufacturing equipment. At the end of the reporting period, the Company compares payments made to third party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs. (j) Stock-Based Compensation The Company measures employee and director stock-based compensation expense for all stock-based awards based on their grant date fair value using the Black-Scholes option-pricing model. For stock-based awards with service conditions, stock-based compensation expense is recognized over the requisite service period using the straight-line method. Forfeitures are recognized as they occur. See additional information in Note 11. (k) Paycheck Protection Program On March 27, 2020, the U.S. federal government enacted the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”). The CARES Act includes a provision for a Paycheck Protection Program (“PPP”) administered by the U.S. Small Business Administration (“SBA”) and further amended by the Paycheck Protection Program Flexibility Act of 2020 (“PPP Flexibility Act”), which was enacted on June 5, 2020. In April 2020, the Company received a PPP Loan of $ 312,500 236,457 In July 2021, the Company was notified that the first PPP loan was forgiven by the SBA and in October 2021, the Company was notified that the second PPP loan was forgiven by the SBA. The Company analyzed IAS 20, Accounting for Government Grants and Disclosure of Government Assistance (l) Segments Operating segments are components of a Company for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision-maker in deciding how to allocate resources and in assessing performance. The Company currently operates in one operating business segment-drug development. (m) Income Taxes Cingulate Inc. is taxed as a C corporation under the Internal Revenue Code. Cingulate Inc. records deferred income taxes to reflect the impact of temporary differences between the recorded amounts of assets and liabilities for financial reporting purposes and such amounts as measured by tax laws and regulations. As of December 31, 2022, CTx is a wholly-owned disregarded entity of Cingulate Inc., and all of the activity for CTx, along with its wholly-owned subsidiary Cingulate Works Inc., is included in the calculation of the current and deferred tax assets and liabilities for Cingulate Inc. The Company determined that it was more likely than not that it would not realize its deferred tax assets, based on historical levels of income and future forecasts of taxable income, among other items, therefore a full valuation allowance is recorded. The Company has not identified any uncertain tax positions. There have been no interest or penalties recognized in the consolidated financial statements related to uncertain tax positions. In addition, no tax positions exist for which it is reasonably possible that the total amounts of unrecognized tax benefits will significantly increase or decrease within the next 12 months. The Company files income tax returns in the federal and various state jurisdictions. These federal income taxes are immaterial. The Company is no longer subject to U.S. federal income tax examinations by tax authorities for years before 2019. (n) Common Stock Purchase Warrants The Company issued warrants in connection with its IPO in December 2021. These equity instruments were valued at fair value when they were issued. See additional information in Note 12. (o) Net Loss per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period, without consideration to potential dilutive securities. Diluted net loss per common share is computed by dividing the net loss by the sum of the weighted average number of common shares outstanding during the period plus the number of potential dilutive instruments outstanding during the period using the simplified method. Diluted net loss per share is the same as basic net loss per share since the effect of potentially dilutive securities is anti-dilutive. |
Prepaid Expenses
Prepaid Expenses | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Prepaid Expenses | ||
Prepaid Expenses | (3) Prepaid Expenses Prepaid expenses consisted of the following at September 30, 2023 and December 31, 2022: Schedule of Prepaid Expenses September 30, December 31, 2023 2022 Research and development $ 413,431 $ 1,377,391 Insurance 339,676 472,152 Active pharmaceutical ingredients 77,422 209,156 Deferred capital raise costs - 100,339 Professional fees 20,775 61,524 Dues and subscriptions 38,284 37,684 Other 20,698 20,698 Total prepaid expenses $ 910,286 $ 2,278,944 | (3) Prepaid Expenses and Other Current Assets Prepaid Expenses Prepaid expenses and other current assets consisted of the following at December 31, 2022 and 2021: Schedule of Prepaid Expenses 2022 2021 Research and development $ 1,377,391 $ 643,917 Insurance 472,152 761,594 Active pharmaceutical ingredients 209,156 264,361 Deferred capital raise costs 100,339 - Professional fees 61,524 - Dues and subscriptions 37,684 - Other 20,698 28,481 Total prepaid expenses $ 2,278,944 $ 1,698,353 |
Property and Equipment
Property and Equipment | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | ||
Property and Equipment | (4) Property and Equipment Property and equipment, net consisted of the following at September 30, 2023 and December 31, 2022: Schedule of Property and Equipment Estimated Useful Life September 30, December 31, (in years) 2023 2022 Equipment 2 7 $ 4,342,832 $ 2,565,997 Furniture and fixtures 7 145,754 145,754 Computer equipment 5 41,898 41,898 Leasehold improvements 5 471,505 471,505 Construction-in-process- equipment - - 1,739,699 Property and equipment, gross 5,001,989 4,964,853 Less: accumulated depreciation (2,470,659 ) (2,060,066 ) Property and equipment, net $ 2,531,330 $ 2,904,787 Depreciation expense for the nine months ended September 30, 2023 was $ 410,593 304,287 154,663 101,429 | (4) Property and Equipment Property and equipment, net consists of the following at December 31, 2022 and 2021: Schedule of Property and Equipment Estimated Useful Life (in years) 2022 2021 Equipment 2 7 $ 2,565,997 $ 2,509,126 Furniture and fixtures 7 145,754 145,754 Computer equipment 5 41,898 41,898 Leasehold improvements 5 471,505 471,505 Construction-in-process- equipment - 1,739,699 1,643,150 Property and equipment, gross 4,964,853 4,811,433 Less: accumulated depreciation (2,060,066 ) (1,666,055 ) Property and equipment, net $ 2,904,787 $ 3,145,378 Depreciation expense was $ 394,011 708,317 |
Accrued Expenses
Accrued Expenses | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Payables and Accruals [Abstract] | ||
Accrued Expenses | (5) Accrued Expenses Accrued expenses consisted of the following at September 30, 2023 and December 31, 2022: Schedule of Accrued Expenses September 30, December 31, 2023 2022 Interest $ 157,339 $ 292,339 Research and development 253,524 - Professional fees 15,000 314,446 Employee bonuses 175,625 175,625 Active pharmaceutical ingredients 62,393 - Other 28,127 112,225 Accrued expenses $ 692,008 $ 894,635 | (5) Accrued Expenses Accrued expenses consisted of the following at December 31, 2022 and 2021: Schedule of Accrued Expenses 2022 2021 Interest $ 292,339 $ - Professional fees 314,446 71,570 Research and development - 250,000 CIP- Equipment - 279,730 Employee bonuses 175,625 - Active pharmaceutical ingredients Other 112,225 - Total accrued expenses $ 894,635 $ 601,300 |
Contingencies
Contingencies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Contingencies | (6) Contingencies The Company may, from time to time, be subject to legal proceedings and claims arising in the ordinary course of business and otherwise. A substantial legal liability against us could have an adverse effect on our business, financial condition and results of operations. The Company records legal costs associated with loss contingencies as incurred and establishes reserves when those matters present material loss contingencies that management determines to be both probable and reasonably estimable in accordance with ASC 450, Contingencies. | (6) Contingencies The Company may, from time to time, be subject to legal proceedings and claims arising in the ordinary course of business and otherwise. A substantial legal liability against us could have an adverse effect on our business, financial condition and results of operations. The Company records legal costs associated with loss contingencies as incurred and establishes reserves when those matters present material loss contingencies that management determines to be both probable and reasonably estimable in accordance with ASC 450, “Contingencies.” |
Related Party Note Payable
Related Party Note Payable | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Related Party Note Payable | ||
Related Party Note Payable | (7) Related Party Note Payable In August 2022, the Company received $ 5.0 15% 3.0 8.0 On September 8, 2023, the Company and CTx entered into a Note Conversion Agreement (Note Conversion Agreement) with WFIA, pursuant to which WFIA agreed to convert the original principal amount of $ 5.0 million under the note plus all accrued interest on the original principal, or $ 5,812,500 , by issuing pre-funded warrants (WFIA Pre-Funded Warrants) to purchase 341,912 shares of the Company’s common stock at a conversion price per WFIA Pre-Funded Warrant of $ 17.00 . The closing price of the Company’s common stock on Nasdaq on September 8, 2023, was $ 11.55 per share. The WFIA Pre-Funded Warrants have no expiration date and are exercisable immediately at an exercise price of $0.002 per share, to the extent that after giving effect to such exercise, WFIA and its affiliates would beneficially own, for purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended (Exchange Act), no more than 19.99% of the outstanding shares of common stock of the Company. The Company considered ASC 470-60, Troubled Debt Restructurings by Debtors 1,862,735 The remaining outstanding principal of the note of $3.0 million and all accrued and unpaid interest are due and payable on August 8, 2025, or 120 days following written demand made by WFIA during the first five business days of a calendar quarter. As of September 30, 2023 and December 31, 2022, $ 3.0 5.0 During the three months ended September 30, 2023, the Company recognized $ 237,500 677,500 | (7) Related Party Notes Payable Related Party Note Payable On August 10, 2022, the Company received $ 5,000,000 15% Outstanding principal and all accrued and unpaid interest are due and payable on August 8, 2025, or 120 days following written demand made by WFIA during the first five business days of a calendar quarter beginning April 1, 2023. 5,000,000 During the year ended December 31, 2022, the Company recognized $ 292,339 |
Members_ Capital
Members’ Capital | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Members’ Capital | (8) Members’ Capital Prior to the Reorganization Merger, the Company had multiple classes of Members’ capital, comprised of Founders Units, Class B, D, E, F and G Preferred Units, and Class C Profits Interests. Class B, E, F and G Preferred Units had similar rights specifically related to cash distributions as a return of invested capital. Class D Preferred Units had all the rights of Founders and the other Classes of Preferred Units plus some additional rights noted below. All classes of Members’ capital had voting rights. The Company maintained capital accounts for each Member. 3,243,201 Class F Preferred Units The CTx Board authorized 6,984,985 11.3 rd Class G Preferred Units The CTx Board authorized 12,000,000 2,998,184 6.7 Distributions, if any, from the Company were to be made first to the holders of Class B, D, E, F and G Preferred Units, pro rata in proportion to each such Member’s unreturned capital contributions. Distributions were then to be made to all Members including Founders Units, pro rata in proportion to the number of units held by each Member, with consideration given to the applicable distribution thresholds for Class C Profits Interests at which each was issued and as disclosed in each Profits Interest Unit agreement, as further described in Note 9. Costs associated with issuance of the Units is immaterial. Pursuant to the terms of the Reorganization Merger, all Units were converted into shares of common stock of Cingulate, as further described in Note 1. |
Profits Interest Plan
Profits Interest Plan | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
Profits Interest Plan | (9) Profits Interest Plan During 2017, the CTx Board established and adopted the Cingulate Therapeutics LLC Equity Incentive Plan (the “Plan”) to provide for issuance of Class C PIU’s to employees, CTx Members, Board members and service providers of the Company, as defined in the Plan, eligible to receive PIU’s as an incentive under the Plan. PIU’s were granted at the discretion of the Board of Managers of the Company and in some cases at the discretion of the Chief Executive Officer of the Company based upon Board authorization. The PIU’s were issued at a Distribution Threshold equal to the pre-money fair market valuation of the Company at the date of issuance. The Distribution Threshold was the amount by which a cash distribution, made pro rata to all Members, if any, must have been exceeded in order for a particular PIU holder to participate in the allocated distribution beyond that threshold. Based on the terms of the award, the Distribution Threshold was treated as a performance condition for purposes of financial statement recognition. The PIU’s vesting period with respect to the service condition was defined in the PIU award agreement and ranged from 30 days to three years with an average vesting period for all PIU’s granted of 107 days. As defined in the Company’s Operating Agreement, all PIU’s issued under the Plan entitled the holder to participate pro rata in the profits, if any, of the Company over the stated Distribution Threshold, assuming a cash distribution was generally made to all Members, subject to any preference or priorities of the other classes of Units. The Class C PIU’s also held voting rights on a one-for-one basis. Immediately prior to the Reorganization Merger, the Company had granted and issued 8,500,000 , Compensation – Stock Compensation, 8.5 57,900 12.7 8.2 4.5 The following summarizes the activity of the Company’s Plan: Summary of Stock Option Activity Distribution Profits Interest Thresholds Units (stated in millions) Outstanding at January 1, 2021 8,142,461 $ 25 120 Issued 357,539 $ 160 Forfeited - Converted to common shares upon Reorganization Merger (8,500,000 ) Outstanding at December 31, 2021 - Prior to the Reorganization Merger, the Company had issued all units available under the Plan and all units had vested based upon the vesting period as outlined in the PIU agreement. PIUs issued and outstanding prior to the Reorganization Merger, which was also the modification date, at the various distribution thresholds were as follows: Schedule of Various Distribution Thresholds Distribution Threshold $ (in millions): Year Granted $25 $40 $75 $80 $90 $120 $160 Total 2017 4,753,000 125,200 - - - - - 4,878,200 2018 - 661,525 217,725 22,883 - - - 902,133 2019 - - - - 377,524 458,924 - 836,448 2020 - - - 1,476,126 - 49,554 - 1,525,680 2021 357,539 357,539 Total 4,753,000 786,725 217,725 1,499,009 377,524 508,478 357,539 8,500,000 |
Stockholders_ Equity
Stockholders’ Equity | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Equity [Abstract] | ||
Stockholders’ Equity | (8) Stockholders’ Equity The Company has authorized 240,000,000 0.0001 10,000,000 0.0001 868,940 565,470 The holders of common stock are entitled to one vote for each share of common stock. In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, after the payment or provision for payment of all debts and liabilities of the Company, the holders of common stock shall be entitled to share in the remaining assets of the Company available for distribution, if any. Holders of the shares of common stock are entitled to dividends when, as and if declared by the Board of Directors. | (10) Stockholders’ Equity The Company has authorized 240,000,000 0.0001 10,000,000 0.0001 565,470 357,137 208,333 120.00 20.4 The holders of common stock are entitled to one vote for each share of common stock. In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, after the payment or provision for payment of all debts and liabilities of the Company, the holders of common stock shall be entitled to share in the remaining assets of the Company available for distribution, if any. Holders of the shares of common stock are entitled to dividends when, as and if declared by the Board of Directors. Stock Dividend On September 30, 2021, the Company effected a stock dividend of 0.0015 22,402 No Reverse Stock Splits On October 12, 2021, Cingulate effected a reverse stock split of its issued and outstanding shares of common stock at a ratio of 0.0350-for-1, and on November 29, 2021, Cingulate effected a second reverse stock split of its issued and outstanding shares of common stock at a ratio of 0.0321-for-1 (the “Reverse Stock Splits”). No fractional shares of common stock were issued in connection with either of the Reverse Stock Splits, and all such fractional interests were rounded down to the nearest whole number. All share data, per share data and related information for all periods presented in the accompanying consolidated financial statements have been retrospectively adjusted to reflect the effect of the Reverse Stock Splits, and subsequently adjusted for the Reverse Stock Split, described in Note 1. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Stock-Based Compensation | (11) Stock-Based Compensation In September 2021, the Company’s board of directors and stockholders adopted the 2021 Equity Incentive Plan (2021 Plan), which provides for the grant of incentive stock options and non-qualified stock options to purchase shares of the Company’s common stock, stock appreciation rights, restricted stock units, restricted or unrestricted shares of common stock, performance shares, performance units, incentive bonus awards, other stock-based awards and other cash-based awards. No awards may be made under the 2021 Plan on or after September 24, 2031, but the 2021 Plan will continue thereafter while previously granted awards remain outstanding. The maximum number of shares of common stock available for issuance in connection with options and other awards granted under the 2021 Plan is 139,116 66,678 The number of shares of common stock available for issuance under the 2021 Plan will automatically increase on January 1st of each year until the expiration of the 2021 Plan, in an amount equal to 5% percent of the total number of shares of our common stock outstanding on December 31st of the preceding calendar year, on a fully diluted basis, unless the board of directors takes action prior thereto to provide that there will not be an increase in the share reserve for such year or that the increase in the share reserve for such year will be of a lesser number of shares of common stock than would otherwise occur. The Company recorded stock-based compensation expense of $ 658,105 594,363 236,251 205,656 2,133,614 2,637,895 A summary of option activity under the Plan during the three and nine months ended September 30, 2023 is as follows: Summary of Option Activity Weighted-Average Aggregate Weighted-Average Remaining Contractual Intrinsic Shares Exercise Price Term (years) Value Outstanding at January 1, 2023 43,060 Granted 19,225 $ 35.00 9.92 Exercised - Forfeitures or expirations (281 ) Outstanding at March 31, 2023 62,004 $ 63.20 9.01 Granted 6,388 $ 19.20 9.98 Exercised - Forfeitures or expirations (899 ) Outstanding at June 30, 2023 67,493 $ 63.20 9.01 Granted 5,204 $ 12.20 9.89 Exercised - Forfeitures or expirations (50 ) Outstanding at September 30, 2023 72,647 $ 59.80 8.84 $ 10,607 Vested and expected to vest at September 30, 2023 72,647 Exercisable at September 30, 2023 16,816 The Company’s stock options issued qualify for equity accounting treatment under ASC 718, Compensation- Stock Compensation, Schedule of Fair Value Assumption Risk-free interest rate 4.073 % Expected term (in years) 5.9 Expected volatility 1.27 Expected dividend yield 0 % Risk-Free Interest Rate Expected Term: Expected Volatility Expected Dividend Yield The grant-date fair value of options granted during the three months ended September 30, 2023, ranged from $10.20 to $12.80 , and the grant date fair value of the options granted during the nine months ended September 30, 2023, ranged from ranged from $ 10.20 to $ 30.60. The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock. The fair value per share of common stock was $ 14.20 as of September 30, 2023, and $ 20.00 as of December 31, 2022, based upon the closing price of our common stock on the Nasdaq Capital Market on those dates. | (11) Stock-Based Compensation In September 2021, the Company’s board of directors and stockholders adopted the 2021 Equity Incentive Plan (the “2021 Plan”), which provides for the grant of incentive stock options and non-qualified stock options to purchase shares of the Company’s common stock, stock appreciation rights, restricted stock units, restricted or unrestricted shares of common stock, performance shares, performance units, incentive bonus awards, other stock-based awards and other cash-based awards. No awards may be made under the 2021 Plan on or after September 24, 2031, but the 2021 Plan will continue thereafter while previously granted awards remain outstanding. The maximum number of shares of common stock available for issuance in connection with options and other awards granted under the 2021 Plan is 96,391 53,340 The number of shares of common stock available for issuance under the 2021 Plan will automatically increase on January 1st of each year until the expiration of the 2021 Plan, in an amount equal to 5% percent of the total number of shares of our common stock outstanding on December 31st of the preceding calendar year, on a fully diluted basis, unless the board of directors takes action prior thereto to provide that there will not be an increase in the share reserve for such year or that the increase in the share reserve for such year will be of a lesser number of shares of common stock than would otherwise occur. The Company recorded stock-based compensation expense of $ 800,796 43,835 2,089,509 2,637,895 four years A summary of option activity under the Plan during the years ended December 31, 2022 and 2021 was as follows: Summary of Option Activity Weighted-Average Aggregate Weighted-Average Remaining Intrinsic Shares Exercise Price Contractual Term Value Outstanding at January 1, 2021 - Grants 26,173 $ 120.00 9.94 - Exercised - Forfeitures or expirations - Outstanding at December 31, 2021 26,173 Grants 20,882 $ 34.40 9.17 Exercised - Forfeitures or expirations (3,995 ) $ 69.20 Outstanding at December 31, 2022 43,060 $ 83.20 9.05 - Vested and expected to vest at December 31, 2022 43,060 Exercisable at December 31, 2022 8,451 The Company’s stock options issued qualify for equity accounting treatment under ASC 718 and are measured at fair value as of their grant date accordingly. The fair value of the options were estimated using a Black-Scholes model. The assumptions that the Company used to estimate the grant-date fair value of stock options granted to employees and directors were as follows, shown on a weighted average basis for the respective years ended: Schedule of Fair Value Assumption 2022 2021 Risk-free interest rate 1.889 % 0.012 % Expected term (in years) 5.98 6.25 Expected volatility 1.126 1.134 Expected dividend yield 0 % 0 % Risk-Free Interest Rate Expected Term: Expected Volatility Expected Dividend Yield zero The grant-date fair value of options granted during the year ended December 31, 2022 ranged from $ 17.20 23.20 102.60 The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock. Because there were no stock options with exercise prices lower than the fair value of the Company’s common stock, the aggregate intrinsic value is zero as of December 31, 2022 and 2021. |
Common Stock Purchase Warrants
Common Stock Purchase Warrants | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Common Stock Purchase Warrants | ||
Common Stock Purchase Warrants | (10) Common Stock Purchase Warrants In addition to the 346,261 shares of common stock and Pre-Funded Warrants issued in the September 2023 Offering, the Company issued Series A warrants to purchase up to 346,261 shares of common stock and Series B warrants to purchase up to 173,131 shares of common stock. The Series A and Series B warrants have an exercise price of $ 11.55 per share and are exercisable on the effective date of stockholder approval of the shares issuable pursuant to the warrants. The Series A warrants have a five -year term and the Series B warrants have a two -year term from the initial exercise date. The Company evaluated the Pre-Funded Warrants for liability or equity classification in accordance with the provisions of ASC Topic 480, Distinguishing Liabilities from Equity Derivatives and Hedging 260,260 3,006,008 In connection with the September 2023 Offering, the Company issued placement agent warrants to purchase up to 17,313 11.55 five The Series A, Series B and placement agent warrants issued in the September 2023 Offering were valued using a Black-Scholes model with a risk-free rate of 4.5 5.3 five two years 1.29 1.32 The following table summarizes the Company’s outstanding common stock purchase warrants as of September 30, 2023: Schedule of Warrants and Rights Outstanding Issuance Date Issuance Date Number of Exercise Fair Value Fair Value Warrants Price per Warrant Total December 2021 Initial Public Offering 239,584 $ 120.00 $ 95.3997 $ 22,856,242 December 2021 Underwriter Warrants 10,417 $ 150.00 $ 92.7969 966,665 September 2023 WFIA Pre-funded Warrants 341,912 $ 0.0001 $ 16.9999 5,812,500 September 2023 Public Offering Pre-funded Warrants 260,261 $ 0.0001 $ 11.5460 3,006,008 September 2023 Public Offering Series A Warrants 346,261 $ 11.60 $ 10.7999 3,739,612 September 2023 Public Offering Series B Warrants 173,131 $ 11.60 $ 8.3999 1,454,294 September 2023 Placement Agent Warrants 17,313 $ 14.40 $ 10.6000 183,518 Balance- September 30, 2023 1,388,879 $ 38,018,839 The Company has accounted for these warrants as equity-classified instruments under ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, Fair Value of the Warrants to Additional Paid in Capital Percent Fair of Total Amount Value Fair Value Allocated Common Stock and Pre-Funded Warrants $ 3,999,480 42.7 % $ 1,707,778 Series A, B and Placement Agent Warrants 5,377,424 57.3 % 2,291,702 Total $ 9,376,904 100 % $ 3,999,480 | (12) Common Stock Purchase Warrants For each of the 208,333 120.00 31,250 .001 239,583 120.00 warrants are exercisable from December 10, 2021 through December 10, 2026. In addition to the common stock purchase warrants noted above, the Company issued 10,417 150.00 warrants are exercisable from June 7, 2022 through December 10, 2026. The warrants were valued using a Black-Scholes model with a risk-free rate of .0082 5.0 1.24 The following table summarizes the Company’s outstanding warrants as of December 31, 2022 and 2021: Summary of Outstanding Warrants Grant Date Grant Date Number of Exercise Fair Value Fair Value Warrants Price per Warrant Total Balance- January 1, 2021 Underwritten public offering 239,583 $ 120.00 $ 95.4000993 $ 22,856,242 Issuance of underwriter warrants 10,417 $ 150.00 $ 92.7968705 966,665 Balance- December 31, 2021 250,000 $ 23,822,907 There were no warrants issued or exercised in 2022. The Company has accounted for these warrants as equity-classified instruments under ASC Subtopic 815-40, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, Schedule of Fair Value of Warrants to Additional Paid in Capital Percent Fair of Total Amount Value Fair Value Allocated Common Stock $ 25,000,000 51.2 % $ 12,800,000 Common Stock Purchase Warrants 23,822,907 48.8 % 12,200,000 Total $ 48,822,907 100 % $ 25,000,000 |
Income Taxes
Income Taxes | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Income Taxes | (12) Income Taxes Cingulate Inc. is taxed as a C corporation under the Internal Revenue Code. Cingulate Inc. records deferred income taxes to reflect the impact of temporary differences between the recorded amounts of assets and liabilities for financial reporting purposes and such amounts as measured by tax laws and regulations. CTx is a wholly-owned disregarded entity of Cingulate Inc., and all of the activity for CTx, along with its wholly-owned subsidiary Cingulate Works Inc., is included in the calculation of the current and deferred tax assets and liabilities for Cingulate Inc. No deferred income tax benefit or expense was recorded for the three-month periods ended September 30, 2023, and 2022 or the nine-month periods ended September 30, 2023 and 2022, for federal or state income taxes. Income tax expense differed from the expected expense computed by applying the U.S. Federal income tax rate as follows: Schedule of Effective Income Tax Rate Reconciliation Three Months Ended Three Months Ended Nine Months Ended Nine Months Ended Federal income tax benefit at statutory rate $ (1,255,601 ) $ (845,722 ) $ (3,486,052 ) $ (2,733,779 ) State income tax benefit (330,642 ) (222,707 ) (917,994 ) (719,896 ) Permanent differences 6,154 3,157 14,457 11,920 Change in valuation allowance 2,218,188 1,132,895 5,089,875 3,572,189 Prior period adjustment to actual (620,630 ) - (620,630 ) - Other (17,469 ) (67,623 ) (79,656 ) (130,434 ) Total income tax expense $ - $ - $ - $ - Evaluating the need for, and amount of, a valuation allowance for deferred tax assets often requires significant judgment and extensive analysis of all available evidence on a jurisdiction-by-jurisdiction basis. Such judgments require the Company to interpret existing tax law and other published guidance as applied to its circumstances. As part of this assessment, the Company considers both positive and negative evidence about its profitability and tax situation. A valuation allowance is provided if, based on available evidence, it is more likely than not that all or some portion of a deferred tax asset will not be realized. The Company determined that it was more likely than not that it would not realize its deferred tax assets, based on historical levels of income and future forecasts of taxable income, among other items. The Company recorded a valuation allowance of its net deferred tax assets totaling $ 10,988,821 5,580,595 The Company files income tax returns in the U.S. federal and various state jurisdictions. The Company is not subject to U.S. federal and state income tax examinations by tax authorities for years before 2018. The Company follows the provisions of FASB ASC 740, Income Taxes Schedule of Deferred Tax Assets and Liabilities September 30, 2023 December 31, 2022 Deferred income tax assets: Current: Research and development costs $ 723,577 $ 343,087 Other 59,126 59,018 Non-current: Net operating losses 5,862,906 3,381,215 Research and development costs 3,645,038 1,762,716 Research and development tax credit 756,122 - Unvested stock options 405,739 204,380 Patents 99,118 92,417 Right-of-use assets 45,265 63,563 Gross deferred income tax assets 11,596,891 5,906,396 Less: valuation allowance (10,988,821 ) (5,580,595 ) Net deferred income tax asset 608,070 325,801 Deferred income tax liabilities: Current: Accrual to cash - (11,228 ) Non-current Property and equipment (608,070 ) (314,573 ) Gross deferred income tax liabilities (608,070 ) (325,801 ) Net deferred tax asset (liability) $ - $ - | (13) Income Taxes Cingulate Inc. is taxed as a C corporation under the Internal Revenue Code. Cingulate Inc. records deferred income taxes to reflect the impact of temporary differences between the recorded amounts of assets and liabilities for financial reporting purposes and such amounts as measured by tax laws and regulations. CTx is a wholly-owned disregarded entity of Cingulate Inc., and all of the activity for CTx, along with its wholly-owned subsidiary Cingulate Works Inc., is included in the calculation of the current and deferred tax assets and liabilities for Cingulate Inc. No Income tax expense differed from the expected expense computed by applying U.S. Federal income tax rate for the respective years ended as follows: Schedule of Effective Income Tax Rate Reconciliation December 31, 2022 December 31, 2021 Federal income tax benefit at statutory rate $ (3,712,008 ) $ (563,519 ) State income tax benefit (977,496 ) (148,393 ) Permanent differences 11,935 44,804 Change in valuation allowance 4,733,324 713,701 Prior period adjustment to actual Other (55,755 ) (46,593 ) Total income tax expense $ - $ - Evaluating the need for, and amount of, a valuation allowance for deferred tax assets often requires significant judgment and extensive analysis of all available evidence on a jurisdiction-by-jurisdiction basis. Such judgments require the Company to interpret existing tax law and other published guidance as applied to its circumstances. As part of this assessment, the Company considers both positive and negative evidence about its profitability and tax situation. A valuation allowance is provided if, based on available evidence, it is more likely than not that all or some portion of a deferred tax asset will not be realized. The Company determined that it was more likely than not that it would not realize its deferred tax assets, based on historical levels of income and future forecasts of taxable income, among other items. The Company recorded a valuation allowance of its net deferred tax assets totaling $ 5,580,595 and $ 847,269 , respectively, at December 31, 2022 and 2021, which was recorded as a component of income tax expense on the accompanying consolidated statements of operations and other comprehensive loss. The Company files income tax returns in the U.S. federal and various state jurisdictions. The Companies are not subject to U.S. federal and state income tax examinations by tax authorities for years before 2018. The Company follows the provisions of FASB ASC 740, Income Taxes Schedule of Deferred Tax Assets and Liabilities December 31, 2022 December 31, 2021 Deferred income tax assets: Current: Research and development costs $ 343,087 $ - Other 59,018 4,050 Non-current: Net operating losses 3,381,215 1,201,974 Research and development costs 1,762,716 - Research and development tax credit Unvested stock options 204,380 11,835 Patents 92,417 90,480 Right-of-use assets 63,563 49,606 Gross deferred income tax assets 5,906,396 1,357,945 Less: valuation allowance (5,580,595 ) (847,269 ) Net deferred income tax asset 325,801 510,676 Deferred income tax liabilities: Current: Accrual to cash (11,228 ) (105,075 ) Non-current Property and equipment (314,573 ) (405,601 ) Gross deferred income tax liabilities (325,801 ) (510,676 ) Net deferred tax asset (liability) $ - $ - |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases | |
Leases | (14) Leases In June, 2019, the Company executed a lease, which included expansion and renovation of previously leased space for the Kansas City office. The term of the lease is for a period of five years 30,453 33,145 201,600 The Company leases office space for its New Jersey based employees from a related party, as further described in Note 17. The base rent for this lease was $ 3,000 three In 2018, the Company entered into an 18-month operating lease for manufacturing equipment. Interim rent was incurred during installation of the equipment with the lease commencing in June 2018. Monthly lease payments for this leased equipment were $ 61,786 this lease was extended for a period of twenty-four months with a monthly lease payment of $ 37,072 In April 2020, the Company entered into a 60-month lease agreement for office furniture under a lease classified as a financing lease as title of the furniture transfers to the Company at the end of the lease term. Monthly lease payments are $ 1,491 6.12 The components of lease cost for the years ended December 31, 2022 and 2021 were as follows: Summary of Components of Lease Cost 2022 2021 Operating lease cost $ 338,787 $ 338,787 Finance lease cost: Amortization of right-of-use assets 10,990 409,927 Interest on lease liabilities 2,804 26,504 Total finance lease cost 13,794 436,431 Total lease cost $ 352,581 $ 775,218 Amounts reported in the consolidated balance sheets as of December 31, 2022 and 2021 were as follows: Summary of Lease Reported in Consolidated Balance Sheets 2022 2021 Operating Leases: Operating lease right-of-use assets $ 630,618 $ 858,600 Other current liabilities 339,755 295,595 Operating lease liabilities 488,748 828,503 Total operating lease liabilities 828,503 1,124,098 Finance leases: Property and equipment 76,928 76,928 Accumulated amortization (44,988 ) (29,602 ) Property and equipment, net 31,940 47,326 Current installments of obligations under finance leases 16,053 15,096 Long-term portion of obligations under finance leases 21,487 37,534 Long-term portion of obligations under finance leases 21,487 37,534 Total finance lease liabilities $ 37,540 $ 52,630 Other information relating to leases as of December 31, 2022 and 2021 was as follows: Summary of Other Information Relating to Leases 2022 2021 Supplemental cash flow information: Cash paid for amounts included in the measurement of lease liabilities: Operating cash flow from operating leases $ 36,000 $ 433,172 Operating cash flow from finance leases 3,698 26,504 Financing cash flow from finance leases 15,090 436,259 Reductions to ROU assets resulting from reductions to lease obligations: Operating leases 227,981 196,245 Finance leases 10,990 409,927 Weighted average remaining lease term: Operating leases 25 39 Finance leases 27 39 Weighted average discount rate: Operating leases 11.62 % 11.57 % Finance leases 6.12 % 6.12 % Maturities of lease liabilities under noncancellable leases as of December 31, 2022 are as follows: Summary of Maturity of Lease Liabilities Operating Finance leases leases 2023 414,800 17,900 2024 393,005 17,900 2025 132,580 4,475 Thereafter - - Total undiscounted lease payments 940,385 40,275 Less imputed interest (111,882 ) (2,742 ) Total lease liabilities $ 828,503 $ 37,533 |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Earnings Per Share [Abstract] | ||
Net Loss Per Share | (13) Net Loss Per Share Basic net loss per share is calculated by dividing net loss attributable to common shareholders by the weighted-average number of common shares and pre-funded warrants outstanding during the period. The pre-funded warrants are included in the calculation of the weighted-average number of shares outstanding because their exercise requires only nominal consideration for the delivery of shares. The following table sets forth the computation of the basic and diluted net loss per share for the three and nine months ended September 30, 2023 and 2022: Schedule of Net Loss Per Share Basic and Diluted Three Months Ended September 30, 2023 Three Months Ended September 30, 2022 Nine Months Ended September 30, 2023 Nine Months Ended September 30, 2022 Numerator: Net loss $ (5,979,054 ) $ (4,027,247 ) $ (16,600,250 ) $ (13,071,205 ) Denominator: Weighted average shares outstanding 988,333 565,470 714,397 565,470 Net loss per share, basic and diluted $ (6.05 ) $ (7.12 ) $ (23.24 ) $ (23.12 ) Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows for the three and nine-month periods ended September 30, 2023 and September 30, 2022: Schedule of Potentially Dilutive Securities September 30, 2023 September 30, 2022 Stock options issued under the 2021 Equity Incentive Plan 72,647 44,190 Common stock purchase warrants outstanding 786,704 250,000 Total 859,351 294,190 Antidilutive securities 859,351 294,190 | (15) Net Loss Per Share The following table sets forth the computation of the basic and diluted net loss per share for the year ended December 31, 2022 and 2021: Schedule of Net Loss Per Share Basic And Diluted 2022 2021 Numerator: Net loss $ (17,676,232 ) $ (20,709,991 ) Denominator: Weighted average common shares outstanding 565,470 370,679 Net loss per share, basic and diluted $ (31.26 ) $ (55.87 ) Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows: Schedule of Potentially Dilutive Securities 2022 2021 Stock options issued under the 2021 Equity Incentive Plan 43,060 26,164 Common stock purchase warrants outstanding 250,000 250,000 Total 293,060 276,164 |
License Agreement
License Agreement | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
License Agreement | (14) License Agreement CTx has a licensing agreement with a company related to the patents and licensed know-how for use in the development of CTx-1301, CTx-1302, and CTx-2103. Payments are to be made upon the occurrence of the following milestone events: ● $ 250,000 ● $ 250,000 ● $ 250,000 500,000 ● $ 250,000 As of December 31, 2022, the $ 250,000 | (16) License Agreement CTx has a licensing agreement with a company related to the patents and licensed know-how for use in the development of CTx-1301, CTx-1302, and CTx-2103. CTx will pay the following upon the occurrence of the following milestone events: ● $ 250,000 ● $ 250,000 ● $ 250,000 500,000 ● $ 250,000 The Company accrued the $ 250,000 |
Related Party Transactions
Related Party Transactions | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Related Party Transactions [Abstract] | ||
Related Party Transactions | (15) Related Party Transactions The general counsel of the Company is a partner with a law firm providing office facilities space that is leased by the Company. Rental expense incurred by the Company to the law firm was $ 27,000 9,000 A member of the Company’s Board of Directors, Peter Werth, is the manager of WFIA, the entity which provided $ 8.0 5.0 3.0 5.0 237,500 104,838 677,500 104,838 157,339 292,339 On August 11, 2023, the Company entered into a Securities Purchase Agreement with WFIA and issued, in a private placement priced at the market under Nasdaq rules, 91,158 10.97 1.0 | (17) Related Party Transactions A member of the Company’s Board of Directors, is a Senior Managing Director at Laidlaw & Company (UK) Ltd. Laidlaw & Company (UK) Ltd. acted as co-lead book-running underwriter for the Company’s IPO. The discounts and commissions paid to Laidlaw & Company (UK) Ltd. in connection with the IPO were approximately $ 500,000 The general counsel of the Company is a partner with a law firm providing office facilities space that is leased by the Company. Rental expense incurred by the Company to the law firm was $ 36,000 0 A member of the Company’s Board of Directors, Peter Werth, is the manager of WFIA, the entity which provided $ 5.0 292,339 5.0 292,339 |
Subsequent Events
Subsequent Events | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Subsequent Events [Abstract] | ||
Subsequent Events | (16) Subsequent Events Management evaluated events that occurred subsequent to September 30, 2023, through November 13, 2023, which is the date the interim financial statements were issued. | (18) Subsequent Events Management evaluated events that occurred subsequent to December 31, 2022 through March 10, 2023, which is the date the financial statements were issued. In January 2023, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC, as sales agent (“Wainwright”), pursuant to which the Company may offer and sell, from time to time through Wainwright, shares of its common stock for aggregate proceeds of up to $ 2,650,000 3 On , the Company entered into a Joint Commercialization Agreement with Indegene, Inc., pursuant to which |
Reverse Stock Split
Reverse Stock Split | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Reverse Stock Split | ||
Reverse Stock Split | (17) Reverse Stock Split On November 30, 2023, the Company completed a one-for-twenty reverse stock split (the “Reverse Stock Split”), which reduced the number of shares of the Company’s common stock that were issued and outstanding immediately prior to the effectiveness of the Reverse Stock Split. The number of shares of the Company’s authorized common stock was not affected by the Reverse Stock Split and the par value of the Company’s common stock remained unchanged at $ 0.0001 | (19) Reverse Stock Split On November 30, 2023, the Company completed a one-for-twenty reverse stock split (the “Reverse Stock Split”), which reduced the number of shares of the Company’s common stock that were issued and outstanding immediately prior to the effectiveness of the Reverse Stock Split. The number of shares of the Company’s authorized common stock was not affected by the Reverse Stock Split and the par value of the Company’s common stock remained unchanged at $ 0.0001 |
Sale of Securities
Sale of Securities | 9 Months Ended |
Sep. 30, 2023 | |
Sale Of Securities | |
Sale of Securities | (9) Sale of Securities Private Placement On August 11, 2023, the Company entered into a Securities Purchase Agreement with WFIA and issued, in a private placement priced at the market under Nasdaq rules 91,158 10.97 $1.0 Public Offering On September 11, 2023, the Company entered into a Securities Purchase Agreement with an institutional investor (September 2023 Offering) pursuant to which the Company issued 86,000 shares of its common stock at a combined price of $ 11.55 per share and accompanying Series A and Series B warrants and pre-funded warrants (Pre-Funded Warrants) to purchase up to an aggregate of 260,261 shares of its common stock at a combined purchase price of $ 11.55 per Pre-Funded Warrant, and accompanying Series A and Series B warrants, which represents the public offering price for the common stock less the $ 0.002 per share exercise price per share for each Pre-Funded Warrant. The September 2023 Offering closed on September 13, 2023. The Pre-Funded Warrants are exercisable at any time after the date of issuance and have no expiration date. The holder of Pre-Funded Warrants may not exercise the warrants if the holder, together with its affiliates, would beneficially own more than 4.99% (or, at the election of the holder, 9.99%) of the number of shares of common stock outstanding immediately after giving effect to such exercise. The September 2023 Offering resulted in gross proceeds to the Company of $ 3,999,480 before deducting $ 688,929 of placement agent fees and other offering expenses. See Note 10 for a description of Series A and Series B warrants issued in the September 2023 Offering. Conversion of Related Party Note On September 8, 2023, the Company issued WFIA Pre-Funded Warrants to purchase 341,912 shares of the Company’s common stock as part of the Note Conversion Agreement, as described in Note 7. The WFIA Pre-Funded Warrants have no expiration date and are exercisable immediately at an exercise price of $0.002 per share, to the extent that after giving effect to such exercise, WFIA and its affiliates would beneficially own, for purposes of Section 13(d) of the Exchange Act, no more than 19.99% of the outstanding shares of common stock of the Company. Purchase Agreement with Lincoln Park In April 2023, the Company entered into a purchase agreement (LP Purchase Agreement) and a registration rights agreement (Registration Rights Agreement) with Lincoln Park Capital Fund, LLC (Lincoln Park). Pursuant to the terms of the LP Purchase Agreement, Lincoln Park has agreed to purchase from the Company up to $ 12 million of the Company’s common stock subject to certain limitations and satisfaction of the conditions set forth in the LP Purchase Agreement. Pursuant to the terms of the Registration Rights Agreement, the Company filed with the SEC a registration statement to register for resale under the Securities Act 225,000 shares of common stock that have been or may be issued to Lincoln Park under the LP Purchase Agreement. Pursuant to the terms of the LP Purchase Agreement, at the time the Company signed the LP Purchase Agreement and the Registration Rights Agreement, the Company issued 18,402 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of common stock under the LP Purchase Agreement. The commitment shares were valued at $ 400,409 and recorded as an addition to equity for the issuance of the common stock and treated as a reduction to equity as a cost of capital to be raised under the LP Purchase Agreement. During the quarter ended September 30, 2023, the Company sold 12,000 196,167 25,500 450,427 At the Market Offering In January 2023, the Company entered into an At The Market Offering Agreement (ATM Agreement) with H.C. Wainwright & Co., LLC (HCW) pursuant to which the Company may issue and sell, from time to time, shares of the Company’s common stock having an aggregate offering price of up to $ 4.97 3% 76,943 1,595,429 82,410 1,696,407 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | ||
Basis of Presentation and Principles of Consolidation | (a) Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP). The consolidated financial statements include the accounts of Cingulate and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. | (a) Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The consolidated financial statements include the accounts of Cingulate and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates | (b) Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during a reporting period. Actual results could differ from estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the consolidated financial statements in the period they are determined to be necessary. | |
Concentration of Credit Risk | (c) Concentration of Credit Risk The Company maintains cash equivalent deposits, which at various times throughout the fiscal year exceeded the amounts insured by the Federal Deposit Insurance Corporation limit of $ 250,000 | (c) Concentration of Credit Risk The Company maintains cash equivalent deposits, which at various times throughout the fiscal year exceeded the amounts insured by the Federal Deposit Insurance Corporation limit of $ 250,000 |
Cash and Cash Equivalents | (d) Cash and Cash Equivalents Bank demand deposit accounts and short-term liquid investments with an initial maturity of three months or less are considered cash and cash equivalents. Cash and cash equivalents as of December 31, 2022 and 2021 consisted of bank deposits and short-term money market funds. Cash and cash equivalents are carried at cost which is indicative of fair value. | |
Miscellaneous Receivables | (d) Miscellaneous Receivables Miscellaneous receivables as of December 31, 2022, primarily consisted of employee retention tax credits for payroll costs incurred in 2020 and research and development tax credits. The Company analogized to IAS 20, Accounting for Government Grants and Disclosure of Government Assistance | (e) Miscellaneous Receivables Miscellaneous receivables consist of payroll tax credits generated from the Company’s 2021 and 2020 federal income tax returns, which have not yet been received, as well as employee retention tax credits for payroll costs incurred in those years. The Company analyzed IAS 20, Accounting for Government Grants and Disclosure of Government Assistance |
Property and Equipment, net | (f) Property and Equipment, net Property and equipment, net are stated at cost, less accumulated depreciation. Maintenance and repairs are charged to expense when incurred. Property and equipment are depreciated using the straight-line method over the estimated remaining useful lives or, for leasehold improvements or leased assets under a financing lease, the life of the lease if shorter. | |
Leases | (g) Leases The Company is a lessee in two noncancellable operating leases, relating to office space at the Kansas City headquarters office and the New Jersey office and two finance leases, for certain furniture and equipment, one of which the lease term ended on December 31, 2021. The Company determines if an arrangement is or contains a lease at contract inception. The Company recognizes a ROU asset and a lease liability at the lease commencement date. For operating leases, the lease liability is initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date. For finance leases, the lease liability is initially measured in the same manner and date as for operating leases and is subsequently measured at amortized cost using the effective-interest method. The Company determines the discount rate it uses to discount the unpaid lease payments to present value, which requires management judgement. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. The implicit rate was stated in the agreement for one of the Company’s leases; however, for the others, the implicit rate was not determinable as the Company did not have access to the lessor’s estimated residual value or the amount of the lessor’s deferred initial direct costs. Therefore, the Company uses its incremental borrowing rate as the discount rate for these leases. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. Because the Company has not been able to borrow on a collateralized basis, it has determined a synthetic credit rating based on factors that a credit rating agency would typically analyze when establishing an entity’s credit rating. Due to the fact that the Company is a pre-revenue entity, the Company determined that its incremental borrowing rate should be based on the composite CCC and lower bond spreads at the lease measurement dates plus a risk-free rate based on specific lease maturities. The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date, plus any initial direct costs incurred less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus initial direct costs, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of cumulative lease incentives received. Lease expense is recognized on a straight-line basis over the lease term which includes the accretion of the lease liability and amortization of the ROU asset. For finance leases, the ROU asset is subsequently amortized using the straight-line method from the lease commencement date to the earlier of the end of its useful life or the end of the lease term unless the lease transfers ownerships of the underlying asset to the Company or the Company is reasonably certain to exercise an option to purchase the underlying asset. In those cases, the ROU asset is amortized over the useful life of the underlying asset. Amortization of the ROU asset is recognized and presented separately from interest expense on the lease liability. ROU assets for operating and finance leases are evaluated for impairment losses. Under the long-lived assets impairment guidance in ASC Subtopic 360-10, Property and Equipment-Overall Operating lease ROU assets are presented as operating lease right-of-use assets on the consolidated balance sheet. The current and long-term portions of operating lease liabilities are presented separately on the consolidated balance sheet. Finance lease ROU assets are included in property, plant, and equipment. The current and long-term portions of finance lease liabilities are presented separately on the consolidated balance sheet. | |
Impairment of Long-lived Assets | (e) Impairment of Long-lived Assets The Company assesses the carrying value of its long-lived assets, including property and equipment, as well as lease right of use (ROU) assets, when events or circumstances indicate that the carrying value of such assets may not be recoverable. These events or changes in circumstances may include a significant deterioration of operating results, changes in business plans, or changes in anticipated future cash flows. If an impairment indicator is present, the Company evaluates recoverability by a comparison of the carrying amount of the assets to future undiscounted cash flows expected to be generated by the assets. If the sum of the expected future cash flows is less than the carrying amount, the Company would recognize an impairment loss. An impairment loss would be measured by comparing the amount by which the carrying value exceeds the fair value of the long-lived asset groups. No impairment was recognized during the three or nine-month periods ended September 30, 2023 or 2022. | (h) Impairment of Long-lived Assets The Company assesses the carrying value of its long-lived assets, including property and equipment, as well as lease ROU assets, when events or circumstances indicate that the carrying value of such assets may not be recoverable. These events or changes in circumstances may include a significant deterioration of operating results, changes in business plans, or changes in anticipated future cash flows. If an impairment indicator is present, the Company evaluates recoverability by a comparison of the carrying amount of the assets to future undiscounted cash flows expected to be generated by the assets. If the sum of the expected future cash flows is less than the carrying amount, the Company would recognize an impairment loss. An impairment loss would be measured by comparing the amount by which the carrying value exceeds the fair value of the long-lived asset groups. No |
Research and Development | (i) Research and Development Research and development costs are expensed as incurred and include all direct and indirect costs associated with the development of the Company’s product candidates. These expenses include payments to third parties for research, development and manufacturing services, personnel costs and depreciation on manufacturing equipment. At the end of the reporting period, the Company compares payments made to third party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs. | |
Stock-Based Compensation | (f) Stock-Based Compensation The Company measures employee and director stock-based compensation expense for all stock-based awards based on their grant date fair value using the Black-Scholes option-pricing model. For stock-based awards with service conditions, stock-based compensation expense is recognized over the requisite service period using the straight-line method. Forfeitures are recognized as they occur. See additional information in Note 11. | (j) Stock-Based Compensation The Company measures employee and director stock-based compensation expense for all stock-based awards based on their grant date fair value using the Black-Scholes option-pricing model. For stock-based awards with service conditions, stock-based compensation expense is recognized over the requisite service period using the straight-line method. Forfeitures are recognized as they occur. See additional information in Note 11. |
Paycheck Protection Program | (k) Paycheck Protection Program On March 27, 2020, the U.S. federal government enacted the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”). The CARES Act includes a provision for a Paycheck Protection Program (“PPP”) administered by the U.S. Small Business Administration (“SBA”) and further amended by the Paycheck Protection Program Flexibility Act of 2020 (“PPP Flexibility Act”), which was enacted on June 5, 2020. In April 2020, the Company received a PPP Loan of $ 312,500 236,457 In July 2021, the Company was notified that the first PPP loan was forgiven by the SBA and in October 2021, the Company was notified that the second PPP loan was forgiven by the SBA. The Company analyzed IAS 20, Accounting for Government Grants and Disclosure of Government Assistance | |
Segments | (l) Segments Operating segments are components of a Company for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision-maker in deciding how to allocate resources and in assessing performance. The Company currently operates in one operating business segment-drug development. | |
Income Taxes | (m) Income Taxes Cingulate Inc. is taxed as a C corporation under the Internal Revenue Code. Cingulate Inc. records deferred income taxes to reflect the impact of temporary differences between the recorded amounts of assets and liabilities for financial reporting purposes and such amounts as measured by tax laws and regulations. As of December 31, 2022, CTx is a wholly-owned disregarded entity of Cingulate Inc., and all of the activity for CTx, along with its wholly-owned subsidiary Cingulate Works Inc., is included in the calculation of the current and deferred tax assets and liabilities for Cingulate Inc. The Company determined that it was more likely than not that it would not realize its deferred tax assets, based on historical levels of income and future forecasts of taxable income, among other items, therefore a full valuation allowance is recorded. The Company has not identified any uncertain tax positions. There have been no interest or penalties recognized in the consolidated financial statements related to uncertain tax positions. In addition, no tax positions exist for which it is reasonably possible that the total amounts of unrecognized tax benefits will significantly increase or decrease within the next 12 months. The Company files income tax returns in the federal and various state jurisdictions. These federal income taxes are immaterial. The Company is no longer subject to U.S. federal income tax examinations by tax authorities for years before 2019. | |
Common Stock Purchase Warrants | (n) Common Stock Purchase Warrants The Company issued warrants in connection with its IPO in December 2021. These equity instruments were valued at fair value when they were issued. See additional information in Note 12. | |
Net Loss per Share | (o) Net Loss per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period, without consideration to potential dilutive securities. Diluted net loss per common share is computed by dividing the net loss by the sum of the weighted average number of common shares outstanding during the period plus the number of potential dilutive instruments outstanding during the period using the simplified method. Diluted net loss per share is the same as basic net loss per share since the effect of potentially dilutive securities is anti-dilutive. | |
Unaudited Interim Financial Information | (b) Unaudited Interim Financial Information The accompanying consolidated balance sheet as of September 30, 2023, the consolidated statements of operations and comprehensive loss for the three and nine-month periods ended September 30, 2023 and 2022, the consolidated statements of stockholders’ equity for the three and nine-month periods ended September 30, 2023 and 2022, the consolidated statements of cash flows for the nine-month periods ended September 30, 2023 and 2022, and the related interim disclosures are unaudited. These unaudited consolidated financial statements include all adjustments necessary, consisting of only normal recurring adjustments, to fairly state the financial position and the results of operations and cash flows for interim periods in accordance with U.S. GAAP. Interim period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The accompanying consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto as of and for the year ended December 31, 2022. |
Prepaid Expenses (Tables)
Prepaid Expenses (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Prepaid Expenses | ||
Schedule of Prepaid Expenses | Prepaid expenses consisted of the following at September 30, 2023 and December 31, 2022: Schedule of Prepaid Expenses September 30, December 31, 2023 2022 Research and development $ 413,431 $ 1,377,391 Insurance 339,676 472,152 Active pharmaceutical ingredients 77,422 209,156 Deferred capital raise costs - 100,339 Professional fees 20,775 61,524 Dues and subscriptions 38,284 37,684 Other 20,698 20,698 Total prepaid expenses $ 910,286 $ 2,278,944 | Prepaid expenses and other current assets consisted of the following at December 31, 2022 and 2021: Schedule of Prepaid Expenses 2022 2021 Research and development $ 1,377,391 $ 643,917 Insurance 472,152 761,594 Active pharmaceutical ingredients 209,156 264,361 Deferred capital raise costs 100,339 - Professional fees 61,524 - Dues and subscriptions 37,684 - Other 20,698 28,481 Total prepaid expenses $ 2,278,944 $ 1,698,353 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | ||
Schedule of Property and Equipment | Property and equipment, net consisted of the following at September 30, 2023 and December 31, 2022: Schedule of Property and Equipment Estimated Useful Life September 30, December 31, (in years) 2023 2022 Equipment 2 7 $ 4,342,832 $ 2,565,997 Furniture and fixtures 7 145,754 145,754 Computer equipment 5 41,898 41,898 Leasehold improvements 5 471,505 471,505 Construction-in-process- equipment - - 1,739,699 Property and equipment, gross 5,001,989 4,964,853 Less: accumulated depreciation (2,470,659 ) (2,060,066 ) Property and equipment, net $ 2,531,330 $ 2,904,787 | Property and equipment, net consists of the following at December 31, 2022 and 2021: Schedule of Property and Equipment Estimated Useful Life (in years) 2022 2021 Equipment 2 7 $ 2,565,997 $ 2,509,126 Furniture and fixtures 7 145,754 145,754 Computer equipment 5 41,898 41,898 Leasehold improvements 5 471,505 471,505 Construction-in-process- equipment - 1,739,699 1,643,150 Property and equipment, gross 4,964,853 4,811,433 Less: accumulated depreciation (2,060,066 ) (1,666,055 ) Property and equipment, net $ 2,904,787 $ 3,145,378 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Payables and Accruals [Abstract] | ||
Schedule of Accrued Expenses | Accrued expenses consisted of the following at September 30, 2023 and December 31, 2022: Schedule of Accrued Expenses September 30, December 31, 2023 2022 Interest $ 157,339 $ 292,339 Research and development 253,524 - Professional fees 15,000 314,446 Employee bonuses 175,625 175,625 Active pharmaceutical ingredients 62,393 - Other 28,127 112,225 Accrued expenses $ 692,008 $ 894,635 | Accrued expenses consisted of the following at December 31, 2022 and 2021: Schedule of Accrued Expenses 2022 2021 Interest $ 292,339 $ - Professional fees 314,446 71,570 Research and development - 250,000 CIP- Equipment - 279,730 Employee bonuses 175,625 - Active pharmaceutical ingredients Other 112,225 - Total accrued expenses $ 894,635 $ 601,300 |
Profits Interest Plan (Tables)
Profits Interest Plan (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of Various Distribution Thresholds | PIUs issued and outstanding prior to the Reorganization Merger, which was also the modification date, at the various distribution thresholds were as follows: Schedule of Various Distribution Thresholds Distribution Threshold $ (in millions): Year Granted $25 $40 $75 $80 $90 $120 $160 Total 2017 4,753,000 125,200 - - - - - 4,878,200 2018 - 661,525 217,725 22,883 - - - 902,133 2019 - - - - 377,524 458,924 - 836,448 2020 - - - 1,476,126 - 49,554 - 1,525,680 2021 357,539 357,539 Total 4,753,000 786,725 217,725 1,499,009 377,524 508,478 357,539 8,500,000 |
Equity Incentive Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Summary of Stock Option Activity | The following summarizes the activity of the Company’s Plan: Summary of Stock Option Activity Distribution Profits Interest Thresholds Units (stated in millions) Outstanding at January 1, 2021 8,142,461 $ 25 120 Issued 357,539 $ 160 Forfeited - Converted to common shares upon Reorganization Merger (8,500,000 ) Outstanding at December 31, 2021 - |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Summary of Option Activity | A summary of option activity under the Plan during the three and nine months ended September 30, 2023 is as follows: Summary of Option Activity Weighted-Average Aggregate Weighted-Average Remaining Contractual Intrinsic Shares Exercise Price Term (years) Value Outstanding at January 1, 2023 43,060 Granted 19,225 $ 35.00 9.92 Exercised - Forfeitures or expirations (281 ) Outstanding at March 31, 2023 62,004 $ 63.20 9.01 Granted 6,388 $ 19.20 9.98 Exercised - Forfeitures or expirations (899 ) Outstanding at June 30, 2023 67,493 $ 63.20 9.01 Granted 5,204 $ 12.20 9.89 Exercised - Forfeitures or expirations (50 ) Outstanding at September 30, 2023 72,647 $ 59.80 8.84 $ 10,607 Vested and expected to vest at September 30, 2023 72,647 Exercisable at September 30, 2023 16,816 | A summary of option activity under the Plan during the years ended December 31, 2022 and 2021 was as follows: Summary of Option Activity Weighted-Average Aggregate Weighted-Average Remaining Intrinsic Shares Exercise Price Contractual Term Value Outstanding at January 1, 2021 - Grants 26,173 $ 120.00 9.94 - Exercised - Forfeitures or expirations - Outstanding at December 31, 2021 26,173 Grants 20,882 $ 34.40 9.17 Exercised - Forfeitures or expirations (3,995 ) $ 69.20 Outstanding at December 31, 2022 43,060 $ 83.20 9.05 - Vested and expected to vest at December 31, 2022 43,060 Exercisable at December 31, 2022 8,451 |
Schedule of Fair Value Assumption | The Company’s stock options issued qualify for equity accounting treatment under ASC 718, Compensation- Stock Compensation, Schedule of Fair Value Assumption Risk-free interest rate 4.073 % Expected term (in years) 5.9 Expected volatility 1.27 Expected dividend yield 0 % | The Company’s stock options issued qualify for equity accounting treatment under ASC 718 and are measured at fair value as of their grant date accordingly. The fair value of the options were estimated using a Black-Scholes model. The assumptions that the Company used to estimate the grant-date fair value of stock options granted to employees and directors were as follows, shown on a weighted average basis for the respective years ended: Schedule of Fair Value Assumption 2022 2021 Risk-free interest rate 1.889 % 0.012 % Expected term (in years) 5.98 6.25 Expected volatility 1.126 1.134 Expected dividend yield 0 % 0 % |
Common Stock Purchase Warrants
Common Stock Purchase Warrants (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Common Stock Purchase Warrants | ||
Schedule of Warrants and Rights Outstanding | Schedule of Warrants and Rights Outstanding Issuance Date Issuance Date Number of Exercise Fair Value Fair Value Warrants Price per Warrant Total December 2021 Initial Public Offering 239,584 $ 120.00 $ 95.3997 $ 22,856,242 December 2021 Underwriter Warrants 10,417 $ 150.00 $ 92.7969 966,665 September 2023 WFIA Pre-funded Warrants 341,912 $ 0.0001 $ 16.9999 5,812,500 September 2023 Public Offering Pre-funded Warrants 260,261 $ 0.0001 $ 11.5460 3,006,008 September 2023 Public Offering Series A Warrants 346,261 $ 11.60 $ 10.7999 3,739,612 September 2023 Public Offering Series B Warrants 173,131 $ 11.60 $ 8.3999 1,454,294 September 2023 Placement Agent Warrants 17,313 $ 14.40 $ 10.6000 183,518 Balance- September 30, 2023 1,388,879 $ 38,018,839 | The following table summarizes the Company’s outstanding warrants as of December 31, 2022 and 2021: Summary of Outstanding Warrants Grant Date Grant Date Number of Exercise Fair Value Fair Value Warrants Price per Warrant Total Balance- January 1, 2021 Underwritten public offering 239,583 $ 120.00 $ 95.4000993 $ 22,856,242 Issuance of underwriter warrants 10,417 $ 150.00 $ 92.7968705 966,665 Balance- December 31, 2021 250,000 $ 23,822,907 |
Fair Value of the Warrants to Additional Paid in Capital | Fair Value of the Warrants to Additional Paid in Capital Percent Fair of Total Amount Value Fair Value Allocated Common Stock and Pre-Funded Warrants $ 3,999,480 42.7 % $ 1,707,778 Series A, B and Placement Agent Warrants 5,377,424 57.3 % 2,291,702 Total $ 9,376,904 100 % $ 3,999,480 | Schedule of Fair Value of Warrants to Additional Paid in Capital Percent Fair of Total Amount Value Fair Value Allocated Common Stock $ 25,000,000 51.2 % $ 12,800,000 Common Stock Purchase Warrants 23,822,907 48.8 % 12,200,000 Total $ 48,822,907 100 % $ 25,000,000 |
Income Taxes (Tables)
Income Taxes (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Schedule of Effective Income Tax Rate Reconciliation | Income tax expense differed from the expected expense computed by applying the U.S. Federal income tax rate as follows: Schedule of Effective Income Tax Rate Reconciliation Three Months Ended Three Months Ended Nine Months Ended Nine Months Ended Federal income tax benefit at statutory rate $ (1,255,601 ) $ (845,722 ) $ (3,486,052 ) $ (2,733,779 ) State income tax benefit (330,642 ) (222,707 ) (917,994 ) (719,896 ) Permanent differences 6,154 3,157 14,457 11,920 Change in valuation allowance 2,218,188 1,132,895 5,089,875 3,572,189 Prior period adjustment to actual (620,630 ) - (620,630 ) - Other (17,469 ) (67,623 ) (79,656 ) (130,434 ) Total income tax expense $ - $ - $ - $ - | Income tax expense differed from the expected expense computed by applying U.S. Federal income tax rate for the respective years ended as follows: Schedule of Effective Income Tax Rate Reconciliation December 31, 2022 December 31, 2021 Federal income tax benefit at statutory rate $ (3,712,008 ) $ (563,519 ) State income tax benefit (977,496 ) (148,393 ) Permanent differences 11,935 44,804 Change in valuation allowance 4,733,324 713,701 Prior period adjustment to actual Other (55,755 ) (46,593 ) Total income tax expense $ - $ - |
Schedule of Deferred Tax Assets and Liabilities | Schedule of Deferred Tax Assets and Liabilities September 30, 2023 December 31, 2022 Deferred income tax assets: Current: Research and development costs $ 723,577 $ 343,087 Other 59,126 59,018 Non-current: Net operating losses 5,862,906 3,381,215 Research and development costs 3,645,038 1,762,716 Research and development tax credit 756,122 - Unvested stock options 405,739 204,380 Patents 99,118 92,417 Right-of-use assets 45,265 63,563 Gross deferred income tax assets 11,596,891 5,906,396 Less: valuation allowance (10,988,821 ) (5,580,595 ) Net deferred income tax asset 608,070 325,801 Deferred income tax liabilities: Current: Accrual to cash - (11,228 ) Non-current Property and equipment (608,070 ) (314,573 ) Gross deferred income tax liabilities (608,070 ) (325,801 ) Net deferred tax asset (liability) $ - $ - | Schedule of Deferred Tax Assets and Liabilities December 31, 2022 December 31, 2021 Deferred income tax assets: Current: Research and development costs $ 343,087 $ - Other 59,018 4,050 Non-current: Net operating losses 3,381,215 1,201,974 Research and development costs 1,762,716 - Research and development tax credit Unvested stock options 204,380 11,835 Patents 92,417 90,480 Right-of-use assets 63,563 49,606 Gross deferred income tax assets 5,906,396 1,357,945 Less: valuation allowance (5,580,595 ) (847,269 ) Net deferred income tax asset 325,801 510,676 Deferred income tax liabilities: Current: Accrual to cash (11,228 ) (105,075 ) Non-current Property and equipment (314,573 ) (405,601 ) Gross deferred income tax liabilities (325,801 ) (510,676 ) Net deferred tax asset (liability) $ - $ - |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases | |
Summary of Components of Lease Cost | The components of lease cost for the years ended December 31, 2022 and 2021 were as follows: Summary of Components of Lease Cost 2022 2021 Operating lease cost $ 338,787 $ 338,787 Finance lease cost: Amortization of right-of-use assets 10,990 409,927 Interest on lease liabilities 2,804 26,504 Total finance lease cost 13,794 436,431 Total lease cost $ 352,581 $ 775,218 |
Summary of Lease Reported in Consolidated Balance Sheets | Amounts reported in the consolidated balance sheets as of December 31, 2022 and 2021 were as follows: Summary of Lease Reported in Consolidated Balance Sheets 2022 2021 Operating Leases: Operating lease right-of-use assets $ 630,618 $ 858,600 Other current liabilities 339,755 295,595 Operating lease liabilities 488,748 828,503 Total operating lease liabilities 828,503 1,124,098 Finance leases: Property and equipment 76,928 76,928 Accumulated amortization (44,988 ) (29,602 ) Property and equipment, net 31,940 47,326 Current installments of obligations under finance leases 16,053 15,096 Long-term portion of obligations under finance leases 21,487 37,534 Long-term portion of obligations under finance leases 21,487 37,534 Total finance lease liabilities $ 37,540 $ 52,630 |
Summary of Other Information Relating to Leases | Other information relating to leases as of December 31, 2022 and 2021 was as follows: Summary of Other Information Relating to Leases 2022 2021 Supplemental cash flow information: Cash paid for amounts included in the measurement of lease liabilities: Operating cash flow from operating leases $ 36,000 $ 433,172 Operating cash flow from finance leases 3,698 26,504 Financing cash flow from finance leases 15,090 436,259 Reductions to ROU assets resulting from reductions to lease obligations: Operating leases 227,981 196,245 Finance leases 10,990 409,927 Weighted average remaining lease term: Operating leases 25 39 Finance leases 27 39 Weighted average discount rate: Operating leases 11.62 % 11.57 % Finance leases 6.12 % 6.12 % |
Summary of Maturity of Lease Liabilities | Maturities of lease liabilities under noncancellable leases as of December 31, 2022 are as follows: Summary of Maturity of Lease Liabilities Operating Finance leases leases 2023 414,800 17,900 2024 393,005 17,900 2025 132,580 4,475 Thereafter - - Total undiscounted lease payments 940,385 40,275 Less imputed interest (111,882 ) (2,742 ) Total lease liabilities $ 828,503 $ 37,533 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Earnings Per Share [Abstract] | ||
Schedule of Net Loss Per Share Basic and Diluted | Schedule of Net Loss Per Share Basic and Diluted Three Months Ended September 30, 2023 Three Months Ended September 30, 2022 Nine Months Ended September 30, 2023 Nine Months Ended September 30, 2022 Numerator: Net loss $ (5,979,054 ) $ (4,027,247 ) $ (16,600,250 ) $ (13,071,205 ) Denominator: Weighted average shares outstanding 988,333 565,470 714,397 565,470 Net loss per share, basic and diluted $ (6.05 ) $ (7.12 ) $ (23.24 ) $ (23.12 ) | The following table sets forth the computation of the basic and diluted net loss per share for the year ended December 31, 2022 and 2021: Schedule of Net Loss Per Share Basic And Diluted 2022 2021 Numerator: Net loss $ (17,676,232 ) $ (20,709,991 ) Denominator: Weighted average common shares outstanding 565,470 370,679 Net loss per share, basic and diluted $ (31.26 ) $ (55.87 ) |
Schedule of Potentially Dilutive Securities | Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows for the three and nine-month periods ended September 30, 2023 and September 30, 2022: Schedule of Potentially Dilutive Securities September 30, 2023 September 30, 2022 Stock options issued under the 2021 Equity Incentive Plan 72,647 44,190 Common stock purchase warrants outstanding 786,704 250,000 Total 859,351 294,190 Antidilutive securities 859,351 294,190 | Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows: Schedule of Potentially Dilutive Securities 2022 2021 Stock options issued under the 2021 Equity Incentive Plan 43,060 26,164 Common stock purchase warrants outstanding 250,000 250,000 Total 293,060 276,164 |
Nature of the Business and Li_2
Nature of the Business and Liquidity (Details Narrative) - USD ($) | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Aug. 11, 2023 | Aug. 10, 2022 | May 31, 2023 | Jan. 31, 2023 | Aug. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | ||||||||||
Notes payable | $ 5,000,000 | $ 3,000,000 | $ 5,000,000 | |||||||
Issuance of stock | $ 3,300,000 | $ 6,151,288 | $ 20,374,218 | |||||||
Issuance of public offering | $ 20,400,000 | |||||||||
Notes payable | $ 2,100,000 | |||||||||
Private Placement [Member] | ||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||
Issuance of stock | $ 1,000,000 | |||||||||
Wainwright [Member] | Maximum [Member] | Subsequent Event [Member] | ||||||||||
Property, Plant and Equipment [Line Items] | ||||||||||
Issuance of stock | $ 2,650,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
May 31, 2023 | Feb. 28, 2021 | Apr. 30, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2023 | |
Short-Term Debt [Line Items] | ||||||
Federal deposit insurance corporation limit | $ 250,000 | $ 250,000 | ||||
Impairment of long lived assets | $ 0 | $ 0 | ||||
Proceeds from loan | $ 3,000,000 | |||||
Paycheck Protection Program [Member] | ||||||
Short-Term Debt [Line Items] | ||||||
Proceeds from loan | $ 236,457 | $ 312,500 |
Schedule of Prepaid Expenses (D
Schedule of Prepaid Expenses (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid Expenses | |||
Research and development | $ 413,431 | $ 1,377,391 | $ 643,917 |
Insurance | 339,676 | 472,152 | 761,594 |
Active pharmaceutical ingredients | 77,422 | 209,156 | 264,361 |
Deferred capital raise costs | 100,339 | ||
Professional fees | 20,775 | 61,524 | |
Dues and subscriptions | 38,284 | 37,684 | |
Other | 20,698 | 20,698 | 28,481 |
Total prepaid expenses | $ 910,286 | $ 2,278,944 | $ 1,698,353 |
Schedule of Property and Equipm
Schedule of Property and Equipment (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 5,001,989 | $ 4,964,853 | $ 4,811,433 |
Less: accumulated depreciation | (2,470,659) | (2,060,066) | (1,666,055) |
Property and equipment, net | 2,531,330 | 2,904,787 | 3,145,378 |
Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 4,342,832 | $ 2,565,997 | 2,509,126 |
Equipment [Member] | Minimum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, estimated useful life | 2 years | 2 years | |
Equipment [Member] | Maximum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, estimated useful life | 7 years | 7 years | |
Furniture and Fixtures [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 145,754 | $ 145,754 | 145,754 |
Property and equipment, estimated useful life | 7 years | 7 years | |
Computer Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 41,898 | $ 41,898 | 41,898 |
Property and equipment, estimated useful life | 5 years | 5 years | |
Leasehold Improvements [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 471,505 | $ 471,505 | 471,505 |
Property and equipment, estimated useful life | 5 years | 5 years | |
Construction in Progress Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 1,739,699 | $ 1,643,150 |
Property and Equipment (Details
Property and Equipment (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | ||||||
Depreciation expense | $ 154,663 | $ 101,429 | $ 410,593 | $ 304,287 | $ 394,011 | $ 708,317 |
Schedule of Accrued Expenses (D
Schedule of Accrued Expenses (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | |||
Interest | $ 157,339 | $ 292,339 | |
Professional fees | 15,000 | 314,446 | 71,570 |
Research and development | 253,524 | 250,000 | |
CIP- Equipment | 279,730 | ||
Employee bonuses | 175,625 | 175,625 | |
Active pharmaceutical ingredients | 62,393 | ||
Other | 28,127 | 112,225 | |
Accrued expenses | $ 692,008 | $ 894,635 | $ 601,300 |
Related Party Note Payable (Det
Related Party Note Payable (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||
Sep. 30, 2023 | Sep. 08, 2023 | Aug. 10, 2022 | May 31, 2023 | Aug. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Aug. 09, 2023 | May 09, 2023 | |
Issuance of debt | $ 5,000,000 | $ 3,000,000 | $ 5,000,000 | |||||||||
Debt instrument, description | The September 2023 Offering closed on September 13, 2023. The Pre-Funded Warrants are exercisable at any time after the date of issuance and have no expiration date. The holder of Pre-Funded Warrants may not exercise the warrants if the holder, together with its affiliates, would beneficially own more than 4.99% (or, at the election of the holder, 9.99%) of the number of shares of common stock outstanding immediately after giving effect to such exercise. | The WFIA Pre-Funded Warrants have no expiration date and are exercisable immediately at an exercise price of | ||||||||||
Interest expense | $ 237,500 | $ 104,838 | $ 677,500 | $ 104,838 | $ 292,339 | |||||||
Issuance of debt | 3,000,000 | |||||||||||
Debt principal amount | $ 3,000,000 | $ 8,000,000 | 3,000,000 | 3,000,000 | 5,000,000 | $ 8,000,000 | ||||||
Warrants and Rights Outstanding | $ 38,018,839 | $ 38,018,839 | $ 38,018,839 | $ 23,822,907 | ||||||||
Class of Warrant or Right, Outstanding | 1,388,879 | 1,388,879 | 1,388,879 | 250,000 | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.002 | |||||||||||
Capital contribution | $ 1,862,735 | $ 1,862,735 | ||||||||||
WFIA Pre Funded Warrants [Member] | ||||||||||||
Class of Warrant or Right, Outstanding | 341,912 | |||||||||||
WFIA Pre Funded Warrants [Member] | Note Conversion Agreement Axis [Member] | ||||||||||||
Debt principal amount | $ 5,000,000 | |||||||||||
Warrants and Rights Outstanding | $ 5,812,500 | |||||||||||
Class of Warrant or Right, Outstanding | 341,912 | |||||||||||
[custom:ClassOfWarrantOrRightFairValuePerWarrants-0] | $ 17 | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 11.55 | |||||||||||
Werth Family Investment Associates LLC [Member] | ||||||||||||
Issuance of debt | $ 5,000,000 | $ 5,000,000 | $ 3,000,000 | $ 5,000,000 | ||||||||
Unsecured interest percentage | 15% | 15% | ||||||||||
Debt instrument, description | The WFIA Pre-Funded Warrants have no expiration date and are exercisable immediately at an exercise price of | Outstanding principal and all accrued and unpaid interest are due and payable on August 8, 2025, or 120 days following written demand made by WFIA during the first five business days of a calendar quarter beginning April 1, 2023. | The remaining outstanding principal of the note of $3.0 million and all accrued and unpaid interest are due and payable on August 8, 2025, or 120 days following written demand made by WFIA during the first five business days of a calendar quarter. | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.002 |
Members_ Capital (Details Narra
Members’ Capital (Details Narrative) - USD ($) $ in Millions | Dec. 31, 2022 | Dec. 31, 2021 |
Preferred Units Class F [Member] | ||
Preferred Units [Line Items] | ||
Preferred units, issued | 3,243,201 | |
Preferred Units Class F [Member] | Cingulate Therapeutics L L C [Member] | ||
Preferred Units [Line Items] | ||
Preferred units, authorized | 6,984,985 | |
Issuance of preferred uniits | $ 11.3 | |
Preferred Units Class G [Member] | ||
Preferred Units [Line Items] | ||
Preferred units, issued | 3,243,201 | |
Preferred Units Class G [Member] | Cingulate Therapeutics L L C [Member] | ||
Preferred Units [Line Items] | ||
Preferred units, issued | 2,998,184 | |
Preferred units, authorized | 12,000,000 | |
Issuance of preferred uniits | $ 6.7 |
Summary of Stock Option Activit
Summary of Stock Option Activity (Details) - Equity Incentive Plan [Member] $ in Millions | 12 Months Ended |
Dec. 31, 2021 USD ($) shares | |
Defined Benefit Plan Disclosure [Line Items] | |
Number of stock options, outstanding at Beginning balance | 8,142,461 |
Number of stock options, issued | 357,539 |
Distribution of Thresholds, issued | $ | $ 160 |
Number of stock options, Forfeited | |
Converted to common shares upon Reorganization Merger, shares | (8,500,000) |
Number of stock options, outstanding at Ending balance | |
Minimum [Member] | |
Defined Benefit Plan Disclosure [Line Items] | |
Distribution of Thresholds, outstanding | $ | $ 25 |
Maximum [Member] | |
Defined Benefit Plan Disclosure [Line Items] | |
Distribution of Thresholds, outstanding | $ | $ 120 |
Schedule of Various Distributio
Schedule of Various Distribution Thresholds (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Distribution Threshold Twenty Five Million [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
2017 | $ 4,753,000 |
2018 | |
2019 | |
2020 | |
Total | 4,753,000 |
Distribution Threshold Forty Million [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
2017 | 125,200 |
2018 | 661,525 |
2019 | |
2020 | |
Total | 786,725 |
Distribution Threshold Seventy Five Million [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
2017 | |
2018 | 217,725 |
2019 | |
2020 | |
Total | 217,725 |
Distribution Threshold Eighty Million [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
2017 | |
2018 | 22,883 |
2019 | |
2020 | 1,476,126 |
Total | 1,499,009 |
Distribution Threshold Ninty Million [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
2017 | |
2018 | |
2019 | 377,524 |
2020 | |
Total | 377,524 |
Distribution Threshold One Twenty Million [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
2017 | |
2018 | |
2019 | 458,924 |
2020 | 49,554 |
Total | 508,478 |
Distribution Threshold One Sixty Million [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
2017 | |
2018 | |
2019 | |
2020 | |
2021 | 357,539 |
Total | 357,539 |
Distribution Threshold [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
2017 | 4,878,200 |
2018 | 902,133 |
2019 | 836,448 |
2020 | 1,525,680 |
2021 | 357,539 |
Total | $ 8,500,000 |
Profits Interest Plan (Details
Profits Interest Plan (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Noncash compensation expense | $ 12,738,088 | |
Equity Incentive Plan [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Stock option, granted | 8,500,000 | |
Conversion of stock into common shares | 57,900 | |
Noncash compensation expense | $ 12,700,000 | |
Equity Incentive Plan [Member] | General and Administrative Expense [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Noncash compensation expense | 8,200,000 | |
Equity Incentive Plan [Member] | Research and Development Expense [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Noncash compensation expense | $ 4,500,000 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2023 | |
Subsidiary, Sale of Stock [Line Items] | |||||
Common stock, shares authorized | 240,000,000 | 240,000,000 | 240,000,000 | 240,000,000 | |
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | |
Preferred stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Common stock, shares issued | 565,470 | 565,470 | 565,470 | 868,940 | |
Common stock, shares outstanding | 565,470 | 565,470 | 565,470 | 868,940 | |
Proceeds from public offering | $ 20,400,000 | ||||
Dividend common stock shares | 0.0015 | ||||
Aggregate common stock dividend | 22,402 | ||||
Reverse stock splits, description | On October 12, 2021, Cingulate effected a reverse stock split of its issued and outstanding shares of common stock at a ratio of 0.0350-for-1, and on November 29, 2021, Cingulate effected a second reverse stock split of its issued and outstanding shares of common stock at a ratio of 0.0321-for-1 (the “Reverse Stock Splits”). No fractional shares of common stock were issued in connection with either of the Reverse Stock Splits, and all such fractional interests were rounded down to the nearest whole number. All share data, per share data and related information for all periods presented in the accompanying consolidated financial statements have been retrospectively adjusted to reflect the effect of the Reverse Stock Splits, and subsequently adjusted for the Reverse Stock Split, described in Note 1. | ||||
Dividend Declared [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Dividends declared | $ 0 | ||||
IPO [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Common stock, shares issued | 208,333 | 208,333 | |||
Share issued price per share | $ 120 | $ 120 | |||
Proceeds from public offering | $ 20,400,000 | ||||
Reorganization Merger [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Common stock, shares issued | 357,137 | ||||
Common stock, shares outstanding | 357,137 |
Summary of Option Activity (Det
Summary of Option Activity (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Aggregate Intrinsic Value, Granted | $ 14.20 | $ 20 | ||||
2021 [Equity Incentive Plan Plan Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Number of stock options, outstanding at Beginning balance | 67,493 | 62,004 | 43,060 | 43,060 | 26,173 | |
Number of Shares, Granted | 5,204 | 6,388 | 19,225 | 20,882 | 26,173 | |
Weighted Average Exercise Price, Outstanding Beginning Balance | $ 12.20 | $ 19.20 | $ 35 | $ 34.40 | $ 120 | |
Weighted Average Remaining Contractual Term, Grants | 9 years 10 months 20 days | 9 years 11 months 23 days | 9 years 11 months 1 day | 9 years 2 months 1 day | 9 years 11 months 8 days | |
Aggregate intrinsic value, Grants | ||||||
Number of Shares, Exercised | ||||||
Number of Shares, Forfeitures or expirations | (50) | (899) | (281) | (3,995) | ||
Weighted Average Exercise Price, Forfeitures or expirations | $ 69.20 | |||||
Number of stock options, outstanding at Ending balance | 72,647 | 67,493 | 62,004 | 72,647 | 43,060 | 26,173 |
Weighted Average Exercise Price, Outstanding Ending Balance | $ 59.80 | $ 63.20 | $ 63.20 | $ 59.80 | $ 83.20 | |
Weighted Average Remaining Contractual Life (Years) Outstanding | 8 years 10 months 2 days | 9 years 3 days | 9 years 3 days | 9 years 18 days | ||
Aggregate intrinsic value, Outstanding Ending | ||||||
Shares, Vested and expected to vest | 72,647 | 72,647 | 43,060 | |||
Shares, Exercisable | 16,816 | 16,816 | 8,451 | |||
Weighted Average Exercise Price, Outstanding Ending Balance | $ 63.20 | $ 63.20 | $ 83.20 | $ 83.20 | ||
Aggregate Intrinsic Value, Granted | $ 10,607 |
Schedule of Fair Value Assumpti
Schedule of Fair Value Assumption (Details) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Payment Arrangement [Abstract] | |||
Risk-free interest rate | 4.073% | 1.889% | 0.012% |
Expected term (in years) | 5 years 10 months 24 days | 5 years 11 months 23 days | 6 years 3 months |
Expected volatility | 1.27% | 1.126% | 1.134% |
Expected dividend yield | 0% | 0% | 0% |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ 658,106 | $ 594,360 | $ 800,796 | $ 43,835 | ||
Expected dividend yield | 0% | 0% | 0% | |||
Grant-date fair value of options | $ 102.60 | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Grant Date Intrinsic Value | $ 14.20 | $ 20 | ||||
Minimum [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Grant-date fair value of options | $ 10.20 | $ 10.20 | 17.20 | |||
Maximum [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Grant-date fair value of options | 12.80 | $ 23.20 | ||||
Share-Based Payment Arrangement, Option [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ 800,796 | $ 43,835 | ||||
2021 [Equity Incentive Plan Plan Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Share based compensation, description | The number of shares of common stock available for issuance under the 2021 Plan will automatically increase on January 1st of each year until the expiration of the 2021 Plan, in an amount equal to 5% percent of the total number of shares of our common stock outstanding on December 31st of the preceding calendar year, on a fully diluted basis, unless the board of directors takes action prior thereto to provide that there will not be an increase in the share reserve for such year or that the increase in the share reserve for such year will be of a lesser number of shares of common stock than would otherwise occur. | |||||
Unrecognized compensation cost | $ 2,089,509 | $ 2,637,895 | ||||
Expected to be recognized, term | 4 years | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Grant Date Intrinsic Value | $ 10,607 | |||||
2021 [Equity Incentive Plan Plan Member] | Common Stock [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Number of shares common stock options | 53,340 | |||||
2021 [Equity Incentive Plan Plan Member] | Equity Option [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Number of shares common stock options | 96,391 | |||||
2021 Equity Incentive Plan [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Share based compensation, description | The number of shares of common stock available for issuance under the 2021 Plan will automatically increase on January 1st of each year until the expiration of the 2021 Plan, in an amount equal to 5% percent of the total number of shares of our common stock outstanding on December 31st of the preceding calendar year, on a fully diluted basis, unless the board of directors takes action prior thereto to provide that there will not be an increase in the share reserve for such year or that the increase in the share reserve for such year will be of a lesser number of shares of common stock than would otherwise occur. | |||||
Stock-based compensation expense | $ 236,251 | $ 205,656 | $ 658,105 | $ 594,363 | ||
Unrecognized compensation cost | $ 2,133,614 | $ 2,133,614 | $ 2,637,895 | |||
2021 Equity Incentive Plan [Member] | Common Stock [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Number of shares common stock options | 66,678 | 66,678 | ||||
2021 Equity Incentive Plan [Member] | Equity Option [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Number of shares common stock options | 139,116 | 139,116 |
Summary of Outstanding Warrants
Summary of Outstanding Warrants (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Common Stock Purchase Warrants | |
Number of warrants underwritten public offering | shares | 239,583 |
Exercise price of warrants underwritten public offering | $ 120 |
Grant date fair value per warrant underwritten public offering | $ 95.4000993 |
Grant date fair value underwritten public offering | $ | $ 22,856,242 |
Number of warrants issuance of underwriter warrants | shares | 10,417 |
Exercise price of warrants issuance of underwriter warrants | $ 150 |
[custom:ClassOfWarrantOrRightGrantDateFairValuePerWarrantIssuanceOfUnderwriterWarrants] | $ 92.7968705 |
Grant date fair value issuance of underwriter warrants | $ | $ 966,665 |
Number of warrants, ending balance | shares | 250,000 |
Grant date fair value, ending balance | $ | $ 23,822,907 |
Schedule of Fair Value of Warra
Schedule of Fair Value of Warrants to Additional Paid in Capital (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Fair value, Total | $ 9,376,904 | $ 48,822,907 |
Percent of Total Fair Value, Total | 100% | 100% |
Amount Allocated, Total | $ 3,999,480 | $ 25,000,000 |
Common Stock [Member] | ||
Fair value, Total | $ 3,999,480 | $ 25,000,000 |
Percent of Total Fair Value, Total | 42.70% | 51.20% |
Amount Allocated, Total | $ 1,707,778 | $ 12,800,000 |
Common Stock Purchase Warrants [Member] | ||
Fair value, Total | $ 23,822,907 | |
Percent of Total Fair Value, Total | 48.80% | |
Amount Allocated, Total | $ 12,200,000 |
Common Stock Purchase Warrant_2
Common Stock Purchase Warrants (Details Narrative) | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 | Sep. 11, 2023 $ / shares shares | Sep. 08, 2023 $ / shares | |
Warrant exercise price | $ / shares | $ 0.002 | ||||
Warrants exercisable, description | warrants are exercisable from December 10, 2021 through December 10, 2026. | ||||
Expected life | 5 years 10 months 24 days | 5 years 11 months 23 days | 6 years 3 months | ||
Number of warrants | 1,388,879 | 250,000 | |||
Issuance Date Fair Value Total | $ | $ 38,018,839 | $ 23,822,907 | |||
Warrants measurement input | 1.27% | 1.126% | 1.134% | ||
Series A Warrant [Member] | |||||
Purchase of warrants shares | 346,261 | ||||
Expected life | 5 years | ||||
Number of warrants | 86,000 | ||||
Series B Warrant [Member] | |||||
Purchase of warrants shares | 173,131 | ||||
Warrant exercise price | $ / shares | $ 11.55 | $ 0.002 | |||
Expected life | 2 years | ||||
Number of warrants | 260,261 | ||||
Pre-funded Warrants [Member] | |||||
Number of warrants | 260,260 | ||||
Issuance Date Fair Value Total | $ | $ 3,006,008 | ||||
Placement Agent Warrants [Member] | |||||
Warrant exercise price | $ / shares | $ 11.55 | ||||
Expected life | 5 years | ||||
Number of warrants | 17,313 | ||||
IPO [Member] | |||||
Purchase of warrants shares | 10,417 | ||||
Warrant exercise price | $ / shares | $ 150 | ||||
Warrants exercisable, description | warrants are exercisable from June 7, 2022 through December 10, 2026. | ||||
Warrant [Member] | |||||
Purchase of warrants shares | 346,261 | 239,583 | |||
Warrant exercise price | $ / shares | $ 120 | ||||
Warrant [Member] | Series A Warrant [Member] | |||||
Warrants measurement input | 129% | ||||
Warrant [Member] | Series B Warrant [Member] | |||||
Warrants measurement input | 132% | ||||
Warrant [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||
Warrants measurement input | 0.0082 | ||||
Warrant [Member] | Measurement Input, Risk Free Interest Rate [Member] | Series A Warrant [Member] | |||||
Warrants measurement input | 0.045 | ||||
Warrant [Member] | Measurement Input, Risk Free Interest Rate [Member] | Series B Warrant [Member] | |||||
Warrants measurement input | 0.053 | ||||
Warrant [Member] | Measurement Input, Expected Term [Member] | |||||
Expected life | 5 years | ||||
Warrant [Member] | Measurement Input, Price Volatility [Member] | |||||
Warrants measurement input | 1.24 | ||||
Warrant [Member] | IPO [Member] | |||||
Purchase of warrants shares | 208,333 | ||||
Warrant exercise price | $ / shares | $ 120 | ||||
Warrant [Member] | Over-Allotment Option [Member] | |||||
Purchase of warrants shares | 31,250 | ||||
Warrant exercise price | $ / shares | $ 0.001 |
Schedule of Effective Income Ta
Schedule of Effective Income Tax Rate Reconciliation (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||||||
Federal income tax benefit at statutory rate | $ (1,255,601) | $ (845,722) | $ (3,486,052) | $ (2,733,779) | $ (3,712,008) | $ (563,519) |
State income tax benefit | (330,642) | (222,707) | (917,994) | (719,896) | (977,496) | (148,393) |
Permanent differences | 6,154 | 3,157 | 14,457 | 11,920 | 11,935 | 44,804 |
Change in valuation allowance | 2,218,188 | 1,132,895 | 5,089,875 | 3,572,189 | 4,733,324 | 713,701 |
Prior period adjustment to actual | (620,630) | (620,630) | ||||
Other | (17,469) | (67,623) | (79,656) | (130,434) | (55,755) | (46,593) |
Total income tax expense |
Schedule of Deferred Tax Assets
Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Income Tax Disclosure [Abstract] | |||
Research and development costs | $ 723,577 | $ 343,087 | |
Other | 59,126 | 59,018 | 4,050 |
Net operating losses | 5,862,906 | 3,381,215 | 1,201,974 |
Research and development costs | 3,645,038 | 1,762,716 | |
Research and development tax credit | 756,122 | ||
Unvested stock options | 405,739 | 204,380 | 11,835 |
Patents | 99,118 | 92,417 | 90,480 |
Right-of-use assets | 45,265 | 63,563 | 49,606 |
Gross deferred income tax assets | 11,596,891 | 5,906,396 | 1,357,945 |
Less: valuation allowance | (10,988,821) | (5,580,595) | (847,269) |
Net deferred income tax asset | 608,070 | 325,801 | 510,676 |
Accrual to cash | (11,228) | (105,075) | |
Property and equipment | (608,070) | (314,573) | (405,601) |
Gross deferred income tax liabilities | (608,070) | (325,801) | (510,676) |
Net deferred tax asset (liability) |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |||
Deferred income tax expense benefit | $ 0 | $ 0 | |
Valuation allowance | $ 5,580,595 | $ 847,269 | $ 10,988,821 |
Summary of Components of Lease
Summary of Components of Lease Cost (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Leases | ||
Operating lease cost | $ 338,787 | $ 338,787 |
Amortization of right-of-use assets | 10,990 | 409,927 |
Interest on lease liabilities | 2,804 | 26,504 |
Total finance lease cost | 13,794 | 436,431 |
Total lease cost | $ 352,581 | $ 775,218 |
Summary of Lease Reported in Co
Summary of Lease Reported in Consolidated Balance Sheets (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Leases | |||
Operating lease right-of-use assets | $ 436,493 | $ 630,618 | $ 858,600 |
Other current liabilities | 339,755 | 295,595 | |
Operating lease liabilities | 225,368 | 488,748 | 828,503 |
Total operating lease liabilities | 828,503 | 1,124,098 | |
Property and equipment | 76,928 | 76,928 | |
Accumulated amortization | (44,988) | (29,602) | |
Property and equipment, net | 31,940 | 47,326 | |
Current installments of obligations under finance leases | 16,805 | 16,053 | 15,096 |
Long-term portion of obligations under finance leases | $ 8,792 | 21,487 | 37,534 |
Total finance lease liabilities | $ 37,540 | $ 52,630 |
Summary of Other Information Re
Summary of Other Information Relating to Leases (Details) - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Leases | ||||
Operating cash flow from operating leases | $ 36,000 | $ 433,172 | ||
Operating cash flow from finance leases | 3,698 | 26,504 | ||
Financing cash flow from finance leases | $ 11,943 | $ 11,229 | 15,090 | 436,259 |
Reductions to ROU assets resulting from reductions to lease obligations: Operating leases | 227,981 | 196,245 | ||
Reductions to ROU assets resulting from reductions to lease obligations: Finance leases | $ 10,990 | $ 409,927 | ||
Weighted average remaining lease term: Operating leases | 25 months | 39 months | ||
Weighted average remaining lease term: Finance leases | 27 months | 39 months | ||
Weighted average discount rate: operating leases | 11.62% | 11.57% | ||
Weighted average discount rate: Finance leases | 6.12% | 6.12% |
Summary of Maturity of Lease Li
Summary of Maturity of Lease Liabilities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Lessee, Lease, Description [Line Items] | ||
Total lease liabilities | $ 828,503 | $ 1,124,098 |
Total lease liabilities | 37,540 | $ 52,630 |
Operating Lease [Member] | ||
Lessee, Lease, Description [Line Items] | ||
2023 | 414,800 | |
2024 | 393,005 | |
2025 | 132,580 | |
Thereafter | ||
Total undiscounted lease payments | 940,385 | |
Less imputed interest | (111,882) | |
Total lease liabilities | 828,503 | |
Finance Leases [Member] | ||
Lessee, Lease, Description [Line Items] | ||
2023 | 17,900 | |
2024 | 17,900 | |
2025 | 4,475 | |
Thereafter | ||
Total undiscounted lease payments | 40,275 | |
Less imputed interest | (2,742) | |
Total lease liabilities | $ 37,533 |
Leases (Details Narrative)
Leases (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | |||||
Apr. 30, 2020 | Dec. 31, 2019 | Jun. 30, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2018 | Jan. 31, 2021 | |
Lessee, Lease, Description [Line Items] | |||||||
Rent expense per month | $ 1,491 | $ 37,072 | $ 61,786 | ||||
Operating lease extended term | this lease was extended for a period of twenty-four months with a monthly lease payment of $37,072. | ||||||
Lease description | In April 2020, the Company entered into a 60-month lease agreement for office furniture under a lease classified as a financing lease as title of the furniture transfers to the Company at the end of the lease term. Monthly lease payments are $1,491. The leased furniture is amortized on a straight-line basis over 7 years. The imputed interest rate relating to the lease obligation is 6.12% and the maturity date is March 2025. | ||||||
Percentage of imputed interest rat, lease obligation | 6.12% | ||||||
Kansas City Office [Member] | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Lease term | 5 years | ||||||
Lease incentive by lessor of tenant improvements | $ 201,600 | ||||||
Kansas City Office [Member] | Minimum [Member] | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Rent expense per month | 30,453 | ||||||
Kansas City Office [Member] | Maximum [Member] | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Rent expense per month | $ 33,145 | ||||||
Office Facilities Space [Member] | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Lease term | 3 years | ||||||
Rent expense per month | $ 3,000 | $ 3,000 |
Schedule of Net Loss Per Share
Schedule of Net Loss Per Share Basic And Diluted (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | ||||||||||
Net loss | $ (5,979,054) | $ (6,616,309) | $ (4,004,887) | $ (4,027,247) | $ (4,040,447) | $ (5,003,511) | $ (16,600,250) | $ (13,071,205) | $ (17,676,232) | $ (20,709,991) |
Weighted average common shares outstanding | 988,333 | 565,470 | 714,397 | 565,470 | 565,470 | 370,679 | ||||
Net loss per share, basic and diluted | $ (6.05) | $ (7.12) | $ (23.24) | $ (23.12) | $ (31.26) | $ (55.87) |
Schedule of Potentially Dilutiv
Schedule of Potentially Dilutive Securities (Details) - shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities | 859,351 | 294,190 | 293,060 | 276,164 |
Share-Based Payment Arrangement, Option [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities | 72,647 | 44,190 | 43,060 | 26,164 |
Warrant [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities | 786,704 | 250,000 | 250,000 | 250,000 |
License Agreement (Details Narr
License Agreement (Details Narrative) - Licensing Agreements [Member] - USD ($) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Phase 3 Clinical Trial [Member] | |||
Indefinite-Lived Intangible Assets [Line Items] | |||
Milestone payment | $ 250,000 | $ 250,000 | |
New Drug Application [Member] | |||
Indefinite-Lived Intangible Assets [Line Items] | |||
Milestone payment | 250,000 | 250,000 | |
CTx-1301 and CTx-1302 [Member] | |||
Indefinite-Lived Intangible Assets [Line Items] | |||
Milestone payment | 250,000 | 250,000 | |
CTx-2103 [Member] | |||
Indefinite-Lived Intangible Assets [Line Items] | |||
Milestone payment | 500,000 | 500,000 | |
CTx-2103 [Member] | |||
Indefinite-Lived Intangible Assets [Line Items] | |||
Milestone payment | $ 250,000 | 250,000 | |
CTx-1301 [Member] | |||
Indefinite-Lived Intangible Assets [Line Items] | |||
Accrued milestone payment | $ 250,000 | $ 250,000 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||
Sep. 11, 2023 | Aug. 11, 2023 | Aug. 10, 2022 | May 31, 2023 | Aug. 31, 2022 | Sep. 30, 2023 | Jun. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | May 09, 2023 | |
Related Party Transaction [Line Items] | |||||||||||||
Issuance of debt | $ 5,000,000 | $ 3,000,000 | $ 5,000,000 | ||||||||||
Interest expense | $ 237,500 | $ 104,838 | $ 677,500 | $ 104,838 | $ 292,339 | ||||||||
Accrued interest | 292,339 | ||||||||||||
Principal amount | $ 8,000,000 | 3,000,000 | 3,000,000 | 5,000,000 | $ 8,000,000 | ||||||||
Accrued interest | $ 157,339 | 157,339 | 292,339 | ||||||||||
Gross proceeds | $ 3,999,480 | ||||||||||||
Common Stock [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
New shares , issued | 88,943 | 37,369 | 208,333 | ||||||||||
Debt [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Principal amount | $ 5,000,000 | ||||||||||||
Werth Family Investment Associates LLC [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Issuance of debt | $ 5,000,000 | $ 5,000,000 | 3,000,000 | 5,000,000 | |||||||||
Office Facilities Space [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Annual rental expense | 36,000 | $ 36,000 | |||||||||||
Related Party [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Due to related party on lease | $ 0 | 0 | |||||||||||
Rental expense | $ 9,000 | $ 9,000 | $ 27,000 | $ 27,000 | |||||||||
IPO [Member] | Laidlaw And Company U K Ltd [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Payments of discounts and commissions | $ 500,000 | ||||||||||||
Private Placement [Member] | Common Stock [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
New shares , issued | 91,158 | ||||||||||||
Share price | $ 10.97 | ||||||||||||
Gross proceeds | $ 1 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||
Aug. 11, 2023 | Jan. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Subsequent Event [Line Items] | ||||||
Proceeds from issuance of common stock | $ 3,300,000 | $ 6,151,288 | $ 20,374,218 | |||
Wainwright [Member] | Subsequent Event [Member] | Common Stock [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Sale of stock commission percent | 3% | |||||
Wainwright [Member] | Maximum [Member] | Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Proceeds from issuance of common stock | $ 2,650,000 |
Reverse Stock Split (Details Na
Reverse Stock Split (Details Narrative) - $ / shares | Nov. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Subsequent Event [Line Items] | ||||
Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Common Stock, Par or Stated Value Per Share | $ 0.0001 |
Schedule of Warrants and Rights
Schedule of Warrants and Rights Outstanding (Details) - USD ($) | Sep. 30, 2023 | Sep. 08, 2023 | Dec. 31, 2022 |
Class of Warrant or Right [Line Items] | |||
Number of warrants | 1,388,879 | 250,000 | |
Exercise price | $ 0.002 | ||
Issuance Date Fair Value Total | $ 38,018,839 | $ 23,822,907 | |
December 2021 Initial Public Offering [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of warrants | 239,584 | ||
Exercise price | $ 120 | ||
Issuance Date Fair Value Per Warrant | $ 95.3997 | ||
Issuance Date Fair Value Total | $ 22,856,242 | ||
December 2021 Underwriter Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of warrants | 10,417 | ||
Exercise price | $ 150 | ||
Issuance Date Fair Value Per Warrant | $ 92.7969 | ||
Issuance Date Fair Value Total | $ 966,665 | ||
September 2023 WFIA Pre-funded Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of warrants | 341,912 | ||
Exercise price | $ 0.0001 | ||
Issuance Date Fair Value Per Warrant | $ 16.9999 | ||
Issuance Date Fair Value Total | $ 5,812,500 | ||
September 2023 Public Offering Pre-funded Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of warrants | 260,261 | ||
Exercise price | $ 0.0001 | ||
Issuance Date Fair Value Per Warrant | $ 11.5460 | ||
Issuance Date Fair Value Total | $ 3,006,008 | ||
September 2023 Public Offering Series A Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of warrants | 346,261 | ||
Exercise price | $ 11.60 | ||
Issuance Date Fair Value Per Warrant | $ 10.7999 | ||
Issuance Date Fair Value Total | $ 3,739,612 | ||
September 2023 Public Offering Series B Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of warrants | 173,131 | ||
Exercise price | $ 11.60 | ||
Issuance Date Fair Value Per Warrant | $ 8.3999 | ||
Issuance Date Fair Value Total | $ 1,454,294 | ||
September 2023 Placement Agent Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of warrants | 17,313 | ||
Exercise price | $ 14.40 | ||
Issuance Date Fair Value Per Warrant | $ 10.6000 | ||
Issuance Date Fair Value Total | $ 183,518 |
Fair Value of the Warrants to A
Fair Value of the Warrants to Additional Paid in Capital (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Fair value, Total | $ 9,376,904 | $ 48,822,907 |
Percent of Total Fair Value, Total | 100% | 100% |
Amount Allocated, Total | $ 3,999,480 | $ 25,000,000 |
Common Stock [Member] | ||
Fair value, Total | $ 3,999,480 | $ 25,000,000 |
Percent of Total Fair Value, Total | 42.70% | 51.20% |
Amount Allocated, Total | $ 1,707,778 | $ 12,800,000 |
Series A, B Placement Agent Warrants [Member] | ||
Fair value, Total | $ 5,377,424 | |
Percent of Total Fair Value, Total | 57.30% | |
Amount Allocated, Total | $ 2,291,702 |
Schedule of Net Loss Per Shar_2
Schedule of Net Loss Per Share Basic and Diluted (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Sale Of Securities | ||||||||||
Net loss | $ (5,979,054) | $ (6,616,309) | $ (4,004,887) | $ (4,027,247) | $ (4,040,447) | $ (5,003,511) | $ (16,600,250) | $ (13,071,205) | $ (17,676,232) | $ (20,709,991) |
Weighted average number of shares used in computing net loss per share of common stock, basic | 988,333 | 565,470 | 714,397 | 565,470 | 565,470 | 370,679 | ||||
Weighted average number of shares used in computing net loss per share of common stock, diluted | 988,333 | 565,470 | 714,397 | 565,470 | 565,470 | 370,679 | ||||
Net loss per share of common stock, basic | $ (6.05) | $ (7.12) | $ (23.24) | $ (23.12) | $ (31.26) | $ (55.87) | ||||
Net loss per share of common stock, diluted | $ (6.05) | $ (7.12) | $ (23.24) | $ (23.12) | $ (31.26) | $ (55.87) |
Sale of Securities (Details Nar
Sale of Securities (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||
Sep. 30, 2023 | Sep. 11, 2023 | Sep. 08, 2023 | Aug. 11, 2023 | Apr. 30, 2023 | Jan. 31, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Gross proceeds | $ 3,999,480 | |||||||||||
Class of Warrant or Right, Outstanding | 1,388,879 | 1,388,879 | 1,388,879 | 250,000 | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.002 | |||||||||||
Debt Instrument, Description | The September 2023 Offering closed on September 13, 2023. The Pre-Funded Warrants are exercisable at any time after the date of issuance and have no expiration date. The holder of Pre-Funded Warrants may not exercise the warrants if the holder, together with its affiliates, would beneficially own more than 4.99% (or, at the election of the holder, 9.99%) of the number of shares of common stock outstanding immediately after giving effect to such exercise. | The WFIA Pre-Funded Warrants have no expiration date and are exercisable immediately at an exercise price of | ||||||||||
Payments for Other Fees | $ 688,929 | |||||||||||
Proceeds from issuance of common stock and pre-funded common stock purchase warrants, net of fees | $ 3,300,000 | $ 6,151,288 | $ 20,374,218 | |||||||||
Stock Issued During Period, Value, New Issues | $ 1,621,939 | $ 218,798 | $ 20,374,218 | |||||||||
Purchase Agreement [Member] | Maximum [Member] | ||||||||||||
Proceeds from issuance of common stock and pre-funded common stock purchase warrants, net of fees | $ 12,000,000 | |||||||||||
ATM Agreement [Member] | H.C. Wain Wright and Co LLC [Member] | ||||||||||||
Proceeds from issuance of common stock and pre-funded common stock purchase warrants, net of fees | $ 1,595,429 | $ 1,696,407 | ||||||||||
Sale of stock | 76,943 | 82,410 | ||||||||||
Sale of stock commission percent | 3% | |||||||||||
ATM Agreement [Member] | Maximum [Member] | H.C. Wain Wright and Co LLC [Member] | ||||||||||||
Proceeds from issuance of common stock and pre-funded common stock purchase warrants, net of fees | $ 4,970,000 | |||||||||||
Series A Warrant [Member] | ||||||||||||
Class of Warrant or Right, Outstanding | 86,000 | |||||||||||
[custom:ClassOfWarrantOrRightFairValuePerWarrants-0] | $ 11.55 | |||||||||||
Series B Warrant [Member] | ||||||||||||
Class of Warrant or Right, Outstanding | 260,261 | 260,261 | 260,261 | |||||||||
[custom:ClassOfWarrantOrRightFairValuePerWarrants-0] | $ 11.55 | $ 11.55 | $ 11.55 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 11.55 | $ 0.002 | $ 11.55 | $ 11.55 | ||||||||
WFIA Pre Funded Warrants [Member] | ||||||||||||
Class of Warrant or Right, Outstanding | 341,912 | |||||||||||
Common Stock [Member] | ||||||||||||
New shares , issued | 88,943 | 37,369 | 208,333 | |||||||||
Stock Issued During Period, Value, New Issues | $ 9 | $ 4 | $ 21 | |||||||||
Common Stock [Member] | Purchase Agreement [Member] | ||||||||||||
New shares , issued | 18,402 | |||||||||||
Proceeds from issuance of common stock and pre-funded common stock purchase warrants, net of fees | $ 196,167 | $ 450,427 | ||||||||||
Issuance of common stock | 225,000 | |||||||||||
Stock Issued During Period, Value, New Issues | $ 400,409 | |||||||||||
Sale of stock | 12,000 | 25,500 | ||||||||||
Private Placement [Member] | ||||||||||||
Proceeds from issuance of common stock and pre-funded common stock purchase warrants, net of fees | $ 1,000,000 | |||||||||||
Private Placement [Member] | Common Stock [Member] | ||||||||||||
New shares , issued | 91,158 | |||||||||||
Share price | $ 10.97 | |||||||||||
Gross proceeds | $ 1 |