Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 14, 2022 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2022 | |
Entity File Number | 001-39169 | |
Entity Registrant Name | Kiromic BioPharma, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 46-4762913 | |
Entity Address, Address Line One | 7707 Fannin Street | |
Entity Address, Address Line Two | Suite 140 | |
Entity Address, City or Town | Houston | |
Entity Address State Or Province | TX | |
Entity Address, Postal Zip Code | 77054 | |
City Area Code | 832 | |
Local Phone Number | 968-4888 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | KRBP | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 18,246,718 | |
Entity Central Index Key | 0001792581 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Current Assets: | ||
Cash and cash equivalents | $ 432,700 | $ 25,353,900 |
Accounts receivable | 16,200 | |
Prepaid expenses and other current assets | 1,705,500 | 1,699,400 |
Total current assets | 2,138,200 | 27,069,500 |
Property and equipment, net | 8,685,500 | 3,629,000 |
Operating lease right-of-use asset | 2,164,500 | |
Other assets | 31,100 | 31,100 |
Total Assets | 13,019,300 | 30,729,600 |
Current Liabilities: | ||
Accounts payable | 6,494,100 | 2,214,300 |
Accrued expenses and other current liabilities | 604,000 | 741,000 |
Note payable | 454,500 | |
Accrued litigation liability | 3,463,000 | |
Operating lease liability - short term | 547,800 | |
Total current liabilities | 11,108,900 | 3,409,800 |
Operating lease liability - long term | 1,626,300 | |
Total Liabilities | 12,735,200 | 3,409,800 |
Commitments and contingencies | ||
Stockholders' Equity: | ||
Common stock, $0.001 par value: 300,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 15,843,191 shares and 15,488,516 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 9,300 | 9,300 |
Preferred stock, $0.0001 par value: 60,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 24,000,000 shares designated as Series A-1 Preferred Stock and 16,500,000 shares designated as Series B Preferred Stock as of September 30, 2022 and December 31, 2021 | ||
Additional paid-in capital | 95,154,500 | 94,527,000 |
Accumulated deficit | (94,879,700) | (67,216,500) |
Total Stockholders' Equity | 284,100 | 27,319,800 |
Total Liabilities and Stockholders' Equity | $ 13,019,300 | $ 30,729,600 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized | 300,000,000 | 300,000,000 |
Common stock, issued | 15,843,191 | 15,488,516 |
Common stock, outstanding | 15,843,191 | 15,488,516 |
Preferred stock, authorized | 60,000,000 | 60,000,000 |
Preferred Stock | ||
Preferred stock, par value ( in dollars per share) | $ 0.0001 | $ 0.0001 |
Series A-1 Preferred Stock | ||
Preferred stock, authorized | 24,000,000 | 24,000,000 |
Series B Preferred Stock | ||
Preferred stock, authorized | 16,500,000 | 16,500,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 3,784,200 | $ 3,486,700 | $ 10,590,700 | $ 8,030,400 |
General and administrative | 4,611,700 | 2,655,600 | 13,602,600 | 7,040,700 |
Total operating expenses | 8,395,900 | 6,142,300 | 24,193,300 | 15,071,100 |
Loss from operations | (8,395,900) | (6,142,300) | (24,193,300) | (15,071,100) |
Other income (expense) | ||||
Gain on loan extinguishment | 105,800 | |||
Litigation settlement loss contingency | (3,463,000) | (3,463,000) | ||
Other income | 18,000 | 18,000 | ||
Interest expense | (1,400) | (500) | (6,900) | (6,300) |
Total other income (expense) | (3,464,400) | 17,500 | (3,469,900) | 117,500 |
Net loss | $ (11,860,300) | $ (6,124,800) | $ (27,663,200) | $ (14,953,600) |
Net loss per share, basic | $ (0.75) | $ (0.40) | $ (1.78) | $ (1.50) |
Net loss per share, diluted | $ (0.75) | $ (0.40) | $ (1.78) | $ (1.50) |
Weighted average common shares outstanding, basic | 15,840,454 | 15,366,075 | 15,706,079 | 10,048,170 |
Weighted average common shares outstanding, diluted | 15,840,454 | 15,366,075 | 15,706,079 | 10,048,170 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance at beginning of period at Dec. 31, 2020 | $ 1,200 | $ 52,988,700 | $ (41,627,800) | $ 11,362,100 |
Balance at beginning of period (in shares) at Dec. 31, 2020 | 7,332,999 | |||
Common stock discount amortization | 24,700 | 24,700 | ||
Warrants underlying common stock issuance | (24,700) | (24,700) | ||
Stock compensation expense | 945,200 | 945,200 | ||
Net loss | (3,854,500) | (3,854,500) | ||
Balance at end of period at Mar. 31, 2021 | $ 1,200 | 53,933,900 | (45,482,300) | 8,452,800 |
Balance at end of period (in shares) at Mar. 31, 2021 | 7,332,999 | |||
Balance at beginning of period at Dec. 31, 2020 | $ 1,200 | 52,988,700 | (41,627,800) | 11,362,100 |
Balance at beginning of period (in shares) at Dec. 31, 2020 | 7,332,999 | |||
Net loss | (14,953,600) | |||
Balance at end of period at Sep. 30, 2021 | $ 9,300 | 94,083,200 | (56,581,400) | 37,511,100 |
Balance at end of period (in shares) at Sep. 30, 2021 | 15,477,518 | |||
Balance at beginning of period at Mar. 31, 2021 | $ 1,200 | 53,933,900 | (45,482,300) | 8,452,800 |
Balance at beginning of period (in shares) at Mar. 31, 2021 | 7,332,999 | |||
Common stock discount amortization | 24,900 | 24,900 | ||
Warrants underlying common stock issuance | (24,900) | (24,900) | ||
Exercised stock options | $ 100 | 125,300 | 125,400 | |
Exercised stock options (in shares) | 18,891 | |||
Released restricted stock units (in shares) | 35,610 | |||
Stock compensation expense | 1,268,600 | 1,268,600 | ||
Net loss | (4,974,300) | (4,974,300) | ||
Balance at end of period at Jun. 30, 2021 | $ 1,300 | 55,327,800 | (50,456,600) | 4,872,500 |
Balance at end of period (in shares) at Jun. 30, 2021 | 7,387,500 | |||
Common stock discount amortization | (85,500) | (85,500) | ||
Common stock issuance net of issuance costs and discount amortization | $ 8,000 | 36,144,400 | 36,152,400 | |
Common stock issuance net of issuance costs and discount amortization (in shares) | 8,000,000 | |||
Warrants underlying common stock issuance | 1,051,200 | 1,051,200 | ||
Common shares issued for Insilico Solutions LLC Membership Purchase Agreement | 400,000 | 400,000 | ||
Common shares issued for Insilico Solutions LLC Membership Purchase Agreement (in shares) | 50,189 | |||
Restricted stock units issued for Insilico Solutions LLC Membership Purchase Agreement | 140,000 | 140,000 | ||
Restricted stock units issued for Insilico Solutions LLC Membership Purchase Agreement (in shares) | 33,177 | |||
Released restricted stock units (in shares) | 6,652 | |||
Stock compensation expense | 1,105,300 | 1,105,300 | ||
Net loss | (6,124,800) | (6,124,800) | ||
Balance at end of period at Sep. 30, 2021 | $ 9,300 | 94,083,200 | (56,581,400) | 37,511,100 |
Balance at end of period (in shares) at Sep. 30, 2021 | 15,477,518 | |||
Balance at beginning of period at Dec. 31, 2021 | $ 9,300 | 94,527,000 | (67,216,500) | 27,319,800 |
Balance at beginning of period (in shares) at Dec. 31, 2021 | 15,488,516 | |||
Common stock discount amortization | 85,100 | 85,100 | ||
Warrants underlying common stock issuance | (85,100) | (85,100) | ||
Released restricted stock units (in shares) | 97,071 | |||
Stock compensation expense | 80,100 | 80,100 | ||
Net loss | (7,367,800) | (7,367,800) | ||
Balance at end of period at Mar. 31, 2022 | $ 9,300 | 94,607,100 | (74,584,300) | 20,032,100 |
Balance at end of period (in shares) at Mar. 31, 2022 | 15,585,587 | |||
Balance at beginning of period at Dec. 31, 2021 | $ 9,300 | 94,527,000 | (67,216,500) | 27,319,800 |
Balance at beginning of period (in shares) at Dec. 31, 2021 | 15,488,516 | |||
Net loss | (27,663,200) | |||
Balance at end of period at Sep. 30, 2022 | $ 9,300 | 95,154,500 | (94,879,700) | 284,100 |
Balance at end of period (in shares) at Sep. 30, 2022 | 15,843,191 | |||
Balance at beginning of period at Mar. 31, 2022 | $ 9,300 | 94,607,100 | (74,584,300) | 20,032,100 |
Balance at beginning of period (in shares) at Mar. 31, 2022 | 15,585,587 | |||
Common stock discount amortization | 85,900 | 85,900 | ||
Warrants underlying common stock issuance | (85,900) | (85,900) | ||
Released restricted stock units (in shares) | 253,525 | |||
Stock compensation expense | 184,200 | 184,200 | ||
Net loss | (8,435,100) | (8,435,100) | ||
Balance at end of period at Jun. 30, 2022 | $ 9,300 | 94,791,300 | (83,019,400) | 11,781,200 |
Balance at end of period (in shares) at Jun. 30, 2022 | 15,839,112 | |||
Common stock discount amortization | 86,900 | 86,900 | ||
Warrants underlying common stock issuance | (86,900) | (86,900) | ||
Released restricted stock units (in shares) | 4,079 | |||
Stock compensation expense | 363,200 | 363,200 | ||
Net loss | (11,860,300) | (11,860,300) | ||
Balance at end of period at Sep. 30, 2022 | $ 9,300 | $ 95,154,500 | $ (94,879,700) | $ 284,100 |
Balance at end of period (in shares) at Sep. 30, 2022 | 15,843,191 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (27,663,200) | $ (14,953,600) |
Adjustments to reconcile net loss to net cash used for operating activities: | ||
Depreciation | 1,118,500 | 331,200 |
Amortization | 2,200 | |
Stock compensation expense | 627,500 | 3,319,100 |
Gain on loan extinguishment | (105,800) | |
Operating lease interest expense | 273,000 | |
Changes in operating assets and liabilities, net of effects from acquisitions: | ||
Accounts receivable | 16,200 | 20,200 |
Prepaid expenses and other current assets | (6,100) | (168,500) |
Accounts payable | 2,928,100 | 216,000 |
Accrued expenses and other current liabilities | (137,000) | 182,900 |
Accrued litigation liability | 3,463,000 | |
Operating lease liability | (263,400) | |
Net cash used for operating activities | (19,643,400) | (11,156,300) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (4,823,300) | (797,500) |
Cash received from acquisition | 84,000 | |
Net cash used for investing activities | (4,823,300) | (713,500) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | 40,000,000 | |
Issuance costs | (2,881,900) | |
Exercise of stock options | 125,400 | |
Loan repayments | (454,500) | (362,400) |
Net cash provided by financing activities | (454,500) | 36,881,100 |
Net change in cash and cash equivalents | (24,921,200) | 25,011,300 |
Cash and cash equivalents: | ||
Beginning of year | 25,353,900 | 10,150,500 |
End of period | 432,700 | 35,161,800 |
Supplemental disclosures of non-cash investing and financing activities: | ||
Accruals for property and equipment | 1,351,700 | 46,500 |
Cash paid for interest on note payable | 6,900 | 6,300 |
Common stock issuance for acquisition | 400,000 | |
Restricted stock units granted for acquisition | 140,000 | |
Acquisitions net of cash acquired | $ 456,000 | |
ASC 842 right-of-use asset/liability implementation | 2,232,700 | |
Right-of-use asset/liability acquired through lease liability | $ 204,800 |
ORGANIZATION
ORGANIZATION | 9 Months Ended |
Sep. 30, 2022 | |
ORGANIZATION | |
ORGANIZATION | KIROMIC BIOPHARMA, INC. Notes to Condensed Consolidated Financial Statements (Unaudited) 1. ORGANIZATION Nature of Business Kiromic BioPharma, Inc. and subsidiaries (the "Company") is a clinical stage fully integrated biotherapeutics company formed under the Texas Business Organizations Code in December 2012. The Company is an artificial intelligence-driven, end-to-end CAR-T and gene therapy company, developing the first multi-indication allogeneic CAR-T cell therapy, that exploits the natural potency of Gamma Delta T-cells (“GDTs”) to target solid cancers. The Company maintains offices in Houston, Texas. The Company has not generated any revenues to date. From a development standpoint, the Company utilizes innovative engineered and non-engineered GDT manufacturing technologies and is developing proprietary, virus-free gene editing tools, to develop novel therapies for solid tumors that we believe will be effective and cost-efficient. The Procel, Isocel, and Deltacel product platform candidates consist of allogeneic cell therapy candidates that are currently in the preclinical development stage. Our Procel product candidate consists of engineered GDTs targeting PD-L1. Our Isocel product candidate consists of engineered GDTs targeting Mesothelin Isoform 2 positive tumors (“Iso-Meso”). Our Deltacel product candidate consists of non-engineered GDTs that have been expanded, enriched, and activated ex-vivo through a proprietary process, and are used to treat solid tumors regardless of the specific tumor antigen expression. The Company currently has one clinical trial candidate with the Procel product candidate platform titled ALEXIS-PRO-1. The Company currently has one clinical trial candidate with the Isocel product candidate platform titled ALEXIS-ISO-1. The ALEXIS-PRO-1 clinical trial candidate is our allogeneic GDT therapy product candidate targeting PD-L1. The ALEXIS-ISO-1 clinical trial candidate is our allogeneic GDT therapy product candidate targeting an isoform of Mesothelin that is preferentially present on tumor cells, namely Iso-Meso. The Company filed two investigational new drug (“IND”) applications in May 2021 for ALEXIS-PRO-1 and ALEXIS-ISO-1. The Food and Drug Administration (“FDA”) placed these applications under a clinical hold in June 2021. On July 13, 2021, the Company received the FDA’s formal clinical hold letters, which asked the Company to address key components regarding the chemical, manufacturing, and control components of the IND applications. Those components included tracing of all reagents used in manufacturing, flow chart of manufacturing processes, and certificate of analysis. The Company is currently working on addressing the FDA’s comments. Going Concern— These condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred significant losses and negative cash flows from operations since inception and expects to incur additional losses until such time that it can generate significant revenue from the commercialization of its product candidates. The Company had negative cash flow from operations of $19,643,400 for the nine months ended September 30, 2022, and an accumulated deficit of $94,879,700 as of September 30, 2022. To date, the Company has relied on equity and debt financing to fund its operations. The Company’s product candidates are still in the early stages of development, and substantial additional financing will be needed by the Company to fund its operations and ongoing research and development efforts prior to the commercialization, if any, of its product candidates. The Company does not have sufficient cash on hand or available liquidity to meet its obligations through the twelve months following the date the condensed consolidated financial statements are issued. This condition raises substantial doubt about the Company’s ability to continue as a going concern. Given its projected operating requirements and its existing cash and cash equivalents, management’s plans include evaluating different strategies to obtain the required funding of future operations. These plans may include, but are not limited to, obtaining funding from current or new investors. However, there can be no assurance that the Company will be able to secure financing, or if available, that it will be sufficient to meet its needs or on favorable terms. Therefore, the plans cannot be deemed probable of being implemented. As a result, the Company has concluded that management’s plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern. In the event the Company is unable to secure financing sufficient to allow it to meet its obligations as they become due, the Company may need to file a voluntary petition for relief under the United States Bankruptcy Code in order to implement a restructuring plan or liquidation. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP") for interim financial information (Accounting Standards Codification ("ASC") 270, Interim Reporting) and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information necessary for a full presentation of financial position, results of operations, and cash flows in conformity with GAAP. Operating results for interim periods are not necessarily indicative of results that may be expected for the fiscal year as a whole. In the opinion of management, the condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been condensed or omitted. These interim financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in our Form 10-K for the year ended December 31, 2021. The results of operations for the period ended September 30, 2022 are not necessarily indicative of the operating results that may be expected for a full year. The condensed consolidated balance sheet as of December 31, 2021 contains financial information taken from the audited Company consolidated financial statements as of that date. All intercompany balances were eliminated upon consolidation. Use of Estimates Concentrations of Credit Risk and Other Uncertainties The Company is subject to certain risks and uncertainties from changes in any of the following areas that the Company believes could have a material adverse effect on future financial position or results of operations: the ability to obtain regulatory approval and market acceptance of, and reimbursement for, the Company’s product candidates; the performance of third-party clinical research organizations and manufacturers; protection of the intellectual property; litigation or claims against the Company based on intellectual property, patent, product, regulatory or other factors; the Company’s ability to attract and retain employees necessary to support commercial success; and changes in the industry or customer requirements including the emergence of competitive products with new capabilities. Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which such temporary differences are expected to be recovered or settled. The Company records valuation allowances to reduce deferred income tax assets to the amount that is more likely than not to be realized. The Company records uncertain tax positions in accordance with ASC 740, Income Taxes Research and Development Expense The Company accrues and expenses costs of services provided by contract research organizations in connection with preclinical studies and contract manufacturing organizations engaged to manufacture clinical trial material, costs of licensing technology, and costs of services provided by research organizations and service providers. Upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred if the technology is not expected to have any alternative future uses other than the specific research and development project for which it was intended. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed rather than when the payment is made. Stock-Based Compensation Compensation—Stock Compensation The Company estimates the grant-date fair value of stock options using the Black-Scholes model and the assumptions used to value such stock options are determined as follows: Expected Term. Risk-Free Interest Rate. Volatility. Dividend Yield. Common Stock Valuations. During the three and nine months ended September 30, 2022 and 2021, the closing price listed on the Nasdaq Capital Market for the Company’s common stock on the date of the grant was used as the common stock valuation. Segment Data Recently Issued Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, Leases standard liability In June 2016, FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326) |
NET LOSS PER SHARE OF COMMON ST
NET LOSS PER SHARE OF COMMON STOCK | 9 Months Ended |
Sep. 30, 2022 | |
NET LOSS PER COMMON SHARE | |
NET LOSS PER SHARE OF COMMON STOCK | 3. NET LOSS PER SHARE OF COMMON STOCK Basic and diluted net loss per share of common stock is determined by dividing net loss less deemed dividends by the weighted-average shares of common stock outstanding during the period. For all periods presented, the shares of common stock underlying the stock options, and restricted stock units have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted-average shares of common stock outstanding used to calculate both basic and diluted loss per share of common stock are the same. The following table illustrates the computation of basic and diluted earnings per share: Three Months Ended Nine Months Ended September 30, September30, 2022 2021 2022 2021 Net loss $ (11,860,300) $ (6,124,800) $ (27,663,200) $ (14,953,600) Less: Initial Public Offering Common Stock discount amortization (25,200) (25,200) (74,800) (74,800) Less: Public Offering Common Stock discount amortization (61,700) (60,300) (183,100) (60,300) Net loss attributable to common shareholders, basic and diluted $ (11,947,200) $ (6,210,300) $ (27,921,100) $ (15,088,700) Weighted average common shares outstanding, basic and diluted 15,840,454 15,366,075 15,706,079 10,048,170 Net loss per common share, basic and diluted $ (0.75) $ (0.40) $ (1.78) $ (1.50) For the three months ended September 30, 2022 and 2021, there were 0 and 6,698 restricted stock units that were potentially dilutive securities excluded from the computations of diluted weighted-average shares of common stock. For the nine months ended September 30, 2022 and 2021, there were 0 and 73,366 restricted stock units that were potentially dilutive securities excluded from the computations of diluted weighted-average shares of common stock. In addition, while not considered potentially dilutive securities under the treasury stock method, there were 595,049 vested and outstanding restricted stock units that had not been released to grantees as of September 30, 2022 which were not included in calculation of weighted average common shares outstanding, basic and diluted. The Company plans to release these shares to the grantees before the end of the year. Since there is a possibility that any portion of those shares could be sold as part of the release, the shares will be released in compliance with the Company’s insider trading policy when there is an open trading window and grantees are not in possession of any material non-public information. |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 9 Months Ended |
Sep. 30, 2022 | |
PROPERTY AND EQUIPMENT | |
PROPERTY AND EQUIPMENT | 4. PROPERTY AND EQUIPMENT Property and equipment consisted of the following as of September 30, 2022 and December 31, 2021: September 30, December 31, 2022 2021 Equipment $ 2,722,800 $ 1,593,100 Leasehold improvements 7,193,700 1,464,700 Office furniture, fixtures, and equipment 137,300 16,600 Software 359,500 359,500 Construction in progress 422,200 1,226,600 10,835,500 4,660,500 Less: Accumulated depreciation (2,150,000) (1,031,500) Total $ 8,685,500 $ 3,629,000 Depreciation expense was $536,600 and $128,800 for the three months ended September 30, 2022 and 2021, respectively, and $1,118,500 and $331,200 for the nine months ended September 30, 2022 and 2021, respectively. |
ACCRUED EXPENSES AND OTHER CURR
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 9 Months Ended |
Sep. 30, 2022 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 5. Accrued expenses and other current liabilities consisted of the following as of September 30, 2022 and December 31, 2021: September 30, December 31, 2022 2021 Accrued consulting and outside services $ 137,400 $ 467,100 Accrued compensation 466,600 273,900 Total $ 604,000 $ 741,000 |
LOAN PAYABLE
LOAN PAYABLE | 9 Months Ended |
Sep. 30, 2022 | |
LOAN PAYABLE | |
LOAN PAYABLE | 6. On May 1, 2020, the Company received a loan in the principal amount of $115,600 (the “SBA Loan”) under the Paycheck Protection Program (“PPP”), which was established under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) administered by the U.S. Small Business Administration (the “SBA”). During the year ended December 31, 2020, the Company applied for forgiveness of the SBA Loan in accordance with the terms of the CARES Act. On February 16, 2021, the SBA granted forgivenes s of the SBA Loan and all applicable interest. On the date of forgiveness, the principal and accrued interest totaled $105,800 . The forgiveness was classified as a gain on loan extinguishment in the condensed consolidated statement of operations the condensed consolidated statement of operations during the nine months ended September 30, 2021. |
NOTE PAYABLE
NOTE PAYABLE | 9 Months Ended |
Sep. 30, 2022 | |
NOTE PAYABLE | |
NOTE PAYABLE | 7. In November 2021, the Company entered into a financing arrangement for its Director and Officer Insurance policy. The total amount financed was approximately $665,900 with an annual interest rate of 4.59% , to be paid over a period of ten months . As of September 30, 2022 and December 31, 2021, the remaining payable balance on the financed amount was $0 and $454,500 , respectively. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2022 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | 8. License Agreements Legal Proceedings The Company disputes Terrell’s claims and allegations in the Action and intends to vigorously defend against them. On May 21, 2021, the Company filed a motion to dismiss Terrell’s claims in the actions with prejudice, arguing that (i) Terrell’s options-related claims fail because his 2014 and January 2017 agreements were explicitly superseded by a later options agreement, under which Terrell relinquished his prior options; and (ii) Terrell is not entitled to indemnification because the Action relates to contracts between the Company and Terrell in his personal capacity, and not in connection with any activities or duties of Terrell in his official capacity as former director. In response to the motion, filed on June 21, 2021, Terrell withdrew his claim for indemnification, but opposed the portion seeking dismissal of his declaratory judgment claim. The motion was fully briefed with the filing of the Company’s reply brief on July 7, 2021. Oral argument was held before the Vice Chancellor on October 20, 2021. During oral argument, the Vice Chancellor invited the parties to submit supplemental letter briefs on the question of whether the Court of Chancery even had the authority to adjudicate the Action in light of the delegation of authority in Terrell’s most recent stock option agreement with the Company (the “SOA”) to the Company’s Compensation Committee to resolve all disputes regarding the interpretation of the SOA. The parties submitted simultaneous supplemental letters briefs on this issue on November 15, 2021. On January 20, 2022, the Vice Chancellor issued her decision on our motion to dismiss, ruling that the Action is stayed until the Compensation Committee itself resolves whether it has sole authority to resolve the parties’ contract interpretation dispute. Subsequently, the parties agreed upon a process for coordinating submissions and/or presentations to the Compensation Committee. The parties made their respective written submissions to the Compensation Committee on March 31, 2022, and on July 21, 2022, the Compensation Committee determined that (i) the Compensation Committee has sole authority under the SOA to resolve the parties’ contract interpretation dispute, and (ii) Terrell’s most recent options agreement superseded and nullified any option rights Terrell may have had under his prior agreements. On August 2, 2022, the Vice Chancellor issued an order dismissing the Action for lack of subject matter jurisdiction. On August 23, 2022, Terrell filed a notice of appeal of the Vice Chancellor’s order of dismissal to the Delaware Supreme Court. That same day, the Delaware Supreme Court set a briefing schedule for the appeal, under which Terrell’s opening brief and appendix were due October 7, 2022, Kiromic’s answering brief and appendix are due November 7, 2022, and Terrell’s reply appellate brief is due 15 days thereafter. Terrell filed his opening brief and appendix on October 7, 2022, and Kiromic is set to file its answering brief on November 7, 2022. The Delaware Supreme Court has not yet designated this appeal for oral argument. In a separate matter, on or about August 17 and 23, 2021, Tony Tontat, who at the time was the Chief Financial Officer and a member of the Board, submitted substantially identical reports (the “Complaints”) through the Company’s complaint hotline. These Complaints, alleged, among other topics, risks associated with the Company’s public disclosures in securities filings and in statements made to the public, investors, and potential investors regarding (i) the anticipated timing of the FDA authorization of the IND applications and (ii) the anticipated timing of human clinical trials. These Complaints were subsequently submitted to the Audit Committee of the Board. After receiving the Complaints, the Audit Committee recommended that the Board form, and the Board did in turn form, a Special Committee comprised of three independent directors (the “Special Committee”) to review the Complaints and other related issues (the “Internal Review”). The Special Committee retained an independent counsel to assist it in conducting the Internal Review. On February 2, 2022, following the conclusion of the Internal Review, the Company’s Special Committee reported the results of its Internal Review to the Board. The Board approved certain actions to address the fact that the Company had received communications from the FDA on June 16 and June 17, 2021 that the FDA was placing the IND applications that the Company submitted to the FDA on May 14 and May 17, 2021 for the ALEXIS-PRO-1 and ALEXIS-ISO-1 product candidates, respectively, on clinical hold (the “June 16 and 17 FDA Communications”). The Company did not disclose the June 16 and 17, 2021 FDA Communications in the Registration Statement on Form S-1 (Registration No. 333-257427) that was filed on June 25, 2021 and declared effective on June 29, 2021, nor the final prospectus contained therein dated June 29, 2021 (collectively, the “Registration Statement”). The Company then consummated a public offering of $40 million of its common stock pursuant to the Registration Statement on July 2, 2021. On July 13, 2021, the Company received the FDA’s formal clinical hold letters, which asked the Company to address key components regarding the chemical, manufacturing, and control components of the IND applications. On July 16, 2021, the Company issued a press release disclosing that it had received comments from the FDA on the two INDs, but did not use the term “clinical hold.” The Company did not disclose the clinical hold in its Form 10-Q for the fiscal quarter ended June 30, 2021 that was filed with the Securities and Exchange Commission on August 13, 2021. On August 13, 2021, the Company issued a press release announcing that these INDs were placed on clinical hold. As a result of the disclosure omission of the June 16 and 17 FDA Communications, on March 7, 2022, entities related to Sabby Management LLC (the “Sabby Entities”) and Empery Asset Management, LP (the “Empery Entities”) filed a complaint in the United States District Court for the Southern District of New York asserting claims against the Company and certain current and former officers and directors of the Company for alleged violations of Sections 11, 12, and 15 of the Securities Act of 1933 in connection with the purchase of common stock through the Company’s public offering that closed on July 2, 2021. On July 1, 2022, the defendants filed motions to dismiss the complaint. In response, on July 22, 2022, the plaintiffs amended their complaint to, among other things, include the Company’s underwriters on the July 2, 2021 public offering, ThinkEquity LLC, as a defendant. The plaintiffs seek unspecified damages; rescission to the extent they still hold the Company’s securities, or if sold, rescissory damages; reasonable costs and expenses, including attorneys’ and experts’ fees; and other unspecified equitable and injunctive relief. The two parties reached a settlement agreement in principle on September 26, 2022, which the Company’s board of directors approved on September 27, 2022. The settlement contained a cash component of As part of the settlement, the Company also agreed to issue convertible notes (the “Settlement Notes”) in the aggregate principal amount of $1,656,720 to each of the Empery Entities and the Sabby Entities. The Settlement Notes are convertible into shares (the “Conversion Shares”) of the Company’s common stock at an initial conversion price per share of $0.3068 and can be convertible into a maximum of 5,400,000 shares of the Company’s common stock to each of the Empery Entities and Sabby Entities, subject to the adjustment of the conversion price and a beneficial ownership limitation equivalent to 9.99% . This settlement loss is considered probable and resulted in an expense charged as a separate line item within Other expenses on the condensed consolidated statement of operations and related accrued litigation liability totaling $3,463,000 on the balance sheet. This amount excludes any legal and others costs that were incurred in connection with the defense of this action, and any legal and other costs incurred by the other defendants that we are required to reimburse. Subject to certain exceptions, the Company is obligated to indemnify the defendants in this action, including ThinkEquity, for their reasonable costs incurred in connection with this action and those costs could be substantial. On November 2, 2022, the United States District Court for the Southern District of New York granted a motion jointly filed by the plaintiffs and defendants, pursuant to which the Settlement Notes will be unrestricted and exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), and the Conversion Shares, when issued upon conversion of the Settlement Notes in accordance with the terms set forth therein, will also be unrestricted and exempt from the registration requirements of the Securities Act. Similarly, the Company has evaluated that it is reasonably possible that other unasserted claims in future litigation and losses may occur. However, the Company is unable to estimate any possible range of loss attributed to other unasserted claims at this time. On August 5, 2022, Ronald H. Karp filed a class action complaint in the United States District Court for the Southern District of New York covering the same subject matter as the Sabby Entities’ and Empery Entities’ claim discussed above asserting claims against the Company and certain current and former officers and directors for alleged violations of Sections 11, 12, and 15 of the Securities Act of 1933 in connection with the purchase of common stock through the Company’s public offering that closed on July 2, 2021 and Section 10(b) of the Exchange Act of 1934 and Rule 10b-5 promulgated thereunder in connection with the certain statements and acts made by the defendants between June 25, 2021 and August 13, 2021. The Company has evaluated the Karp class claims and has determined that it is not possible to estimate a potential range of loss at this time. The Company regularly assesses all contingencies and believes, based on information presently known, the Company is not involved in any other matters that would have a material effect on the Company’s financial position, results of operations or cash flows. |
LEASES
LEASES | 9 Months Ended |
Sep. 30, 2022 | |
Leases | |
LEASES | 9 . The Company adopted FASB ASU No. 2016-02, Leases (Topic 842) on January 1, 2022, using the modified retrospective method, in which it did not restate prior periods. Upon adoption, the Company elected the package of practical expedients permitted under the transition guidance within Topic 842 which, among other things, allowed the Company to carry forward the historical lease classification. In our implementation of ASU No. 2016-02 the Company elected to discount lease obligations using our incremental borrowing rate, which is derived from information available at the lease commencement date, in determining the present value of lease payments. The Company’s incremental borrowing rate represents the rate of interest that it would have to pay to borrow over a similar term an amount equal to the lease payments in a similar economic environment. The Company considers publicly available data for instruments with similar terms and characteristics when determining its incremental borrowing rates. In addition, we elected the practical expedient to account for the lease and non-lease components on a combined basis. The Company intends to use the full lease term under the existing lease agreement as the lease term, which is currently set to expire on April 30, 2026. As of September 30, 2022, the Company is not able to determine if any renewal options will be exercised. The Company leases its premises in Houston, Texas under an operating lease which was renewed on November 19, 2020. This renewed lease agreement will commence under an operating lease agreement that is noncancelable from commencement until May 1, 2024. On March 22, 2021, the Company’s board of directors approved a lease expansion within its premises in Houston, Texas. The amended lease agreement commenced on August 1, 2021 under an operating lease agreement that is noncancelable from commencement until May 1, 2024. The amended lease agreement adds approximately 15,385 square feet. The Company has the option to cancel the lease thereafter until the agreement expires on May 1, 2026. The termination date is effective after a 90-day notice of cancellation. Two further amendments were executed in 2021. The agreements commenced on November 1, 2021, and December 1, 2021 under an operating lease agreement that is noncancelable from commencement until May 1, 2024. The amended lease agreement adds approximately 3,684 square feet. The Company has the option to cancel the lease thereafter until the agreement expires on May 1, 2026. The termination date is effective after a 90-day notice of cancellation. An amendment to the lease agreement was executed in January 2022 and commenced May 1, 2022. The amendment will add approximately 9,352 square feet. The Company has the option to cancel the lease thereafter until the agreement expires on May 1, 2026. The termination date is effective after a 90-day If the Company exercises the cancellation option, the Company must also pay the lessor a termination payment equal to three months of base rent. The following table indicates the balance sheet line items that include the right-of-use assets and lease liabilities for our operating lease: September 30, 2022 Operating lease Right-of-Use Asset Operating lease $ 2,164,500 Total right-of use asset 2,164,500 Lease Liabilities Operating lease - short term $ (547,800) Operating lease - long term (1,626,300) Total lease liabilities (2,174,100) For the three and nine months ended September 30, 2022, the components of lease expense were as follows: Three Months Ended Nine Months Ended September 30, September 30, Operating lease cost allocated to research and development expense $ 132,700 $ 346,400 Operating lease cost allocated to general and administrative expense 38,900 145,200 Total lease expense $ 171,600 $ 491,600 Weighted-average remaining lease term 3.59 3.59 Weighted-average discount rate 7.12 % 7.12 % As of September 30, 2022 the maturities of the Company’s operating lease liabilities were as follows: Maturity of Lease Liabilities Operating lease 2022 $ 169,400 2023 684,300 2024 687,700 2025 694,300 2026 232,600 Total lease payments 2,468,300 Less: imputed interest (294,200) Present value of lease payments 2,174,100 The Company maintains a month to month lease in Arlington, VA, which is considered a short term lease. The Company elected to exclude this lease from the determination of the right-of-use asset and lease liability, as permitted under ASC 842. The Company will recognize the lease payments in profit or loss in the statement of operations on a straight-line basis over the term of the lease. The monthly rent expense as of June 30, 2022 is $2,500 per month. For the three and nine months ended September 30, 2022, short-term lease expense was $7,500 and $22,500, respectively. Under ASC 840, rent expense recognized under the leases was $126,900 and $270,800 for the three and nine months ended September 30, 2021. |
STOCKHOLDERS EQUITY
STOCKHOLDERS EQUITY | 9 Months Ended |
Sep. 30, 2022 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | 10 . Common Stock On July 2, 2021, the Company received net proceeds of $37,118,100 from its public offering, after deducting underwriting discounts and commissions of $2,494,900 and other offering expenses of $457,000 incurred. The Company issued and sold 8,000,000 shares of common stock in the public offering at a price of $5.00 per share. Below is a table that outlines the initial value of issuances allocated to the IPO and public offering of common stock and the IPO and public offering common stock discount amortization, during the three and nine months ended September 30: 2022 2021 Common Stock Balance at January 1, $ 48,264,300 $ 11,975,400 Common stock initial public offering discount amortization 24,700 24,700 Common stock public offering discount amortization 60,400 — Balance at March 31, $ 48,349,400 $ 12,000,100 Common stock initial public offering discount amortization 24,900 24,900 Common stock public offering discount amortization 61,000 — Balance at June 30, $ 48,435,300 $ 12,025,000 Common stock issuance from public offering, net of underwriting discounts and commissions and other offering expenses — 37,118,100 Common stock public offering discount — (1,051,200) Common stock initial public offering discount amortization 25,200 25,200 Common stock public offering discount amortization 61,700 60,300 Balance at September 30, $ 48,522,200 $ 48,177,400 Representative’s Warrants In connection with the IPO on October 15, 2020, the Company granted the underwriters warrants (the “Underwriters’ Warrants”) to purchase an aggregate of 62,500 shares of common stock at an exercise price of $15.00 per share, which is 125% of the initial public offering price. The Underwriters’ Warrants have a five-year term and were not exercisable prior to April 13, 2021. All of the Underwriters’ Warrants were outstanding and exercisable at September 30, 2022. These warrants were equity classified. As of September 30, 2022 and December 31, 2021, the warrant fair values of $182,500 and $257,300, respectively, is reflected as additional paid-in capital. In connection with the public offering on July 2, 2021, the Company granted the underwriters warrants (the “Additional Underwriters’ Warrants”) to purchase an aggregate of 400,000 shares of common stock at an exercise price of $6.25 per share, which is 125% of the initial public offering price. The Additional Underwriters’ Warrants have a five-year term and are not exercisable prior to January 2, 2022. All of the Additional Underwriters’ Warrants were outstanding at September 30, 2022. These warrants were equity classified. As of September 30, 2022 and December 31, 2021, the fair value of the warrants was $746,200 and $929,300, respectively, and is reflected as additional paid-in capital. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2022 | |
STOCK-BASED COMPENSATION | |
STOCK-BASED COMPENSATION | 11. 2017 Stock Incentive Plan— Stock Options There were no stock option grants from the 2017 Plan during the nine months ended September 30, 2022. The Black-Scholes option-pricing model was used to estimate the fair value of stock option grants with the following weighted-average assumptions for the nine months ended September 30, 2021: September 30, 2021 Risk-free interest rate 1.09 % Expected volatility 83.34 % Expected life (years) 6.22 Expected dividend yield 0 % The following table summarizes the activity for all stock options outstanding at September 30 under the 2017 Plan: 2022 2021 Weighted Weighted Average Average Exercise Exercise Shares Price Shares Price Options outstanding at beginning of year 380,909 $ 8.57 489,718 $ 10.03 Granted — — 147,038 8.47 Exercised — — (18,891) 6.64 Cancelled and forfeited (42,037) 9.19 (64,427) 17.67 Balance at September 30 338,872 $ 8.49 553,438 $ 8.84 Options exercisable at September 30: 336,108 $ 8.53 369,020 $ 8.87 Weighted average grant date fair value for options granted during the year: $ — $ 8.47 The intrinsic value of the options exercised during the nine months ended September 30, 2021 was $33,000 . In addition, the weighted average remaining contractual life for the options is 5.28 years and 6.49 years as of September 31, 2022 and 2021, respectively. The options have no intrinsic value as of September 30, 2022 or 2021, respectively. Total stock compensation expense recognized from stock-based compensation awards classified as stock options were recognized in the condensed consolidated statements of operations for the three and nine months ended September 30, 2022 and 2021 as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Research and development $ 9,000 $ 44,500 $ 61,000 $ 86,400 General and administrative 8,000 32,500 23,000 189,400 Total $ 17,000 $ 77,000 $ 84,000 $ 275,800 On August 20, 2020, the Board canceled and terminated 15,792 stock options, granted during the quarter ended June 30, 2020, to four non-employees. Thereafter, on August 20, 2020, the Board granted 21,112 stock options to the same individuals with a grant date fair value of $12.81 per share. There were 3,959 stock option grants that were considered vested on the grant date. The effects of the stock option modifications resulted in $0 and $34,900 of stock compensation expense allocable to general and administrative for the three and nine months ended September 30, 2021, respectively. Included in that amount were $0 and $16,000 of incremental compensation costs resulting from the modifications for the three and nine months ended September 30, 2021, respectively. There were no effects stock option modifications during the three and nine months ended September 30, 2022. As of September 30, 2022, total unrecognized stock compensation expense is $20,900 related to unvested stock options to be recognized over the remaining weighted-average vesting period of 0.42 years. 2017 Stock Incentive Plan—Restricted Stock Units The 2017 Plan permits the Company to grant equity awards for up to 1,708,615 shares of the Company’s common stock awards, including incentive stock options; non-statutory stock options; and conditional share awards to employees, directors, and consultants of the Company. All granted shares that are canceled, forfeited, or expired are returned to the 2017 Plan and are available for grant in conjunction with the issuance of new common stock awards. Restricted stock units (“RSUs”) vest over a specified amount of time or when certain performance metrics are achieved by the Company. In the nine months ended September 30, 2022 and 2021, the fair value of the shares of common stock underlying restricted stock units was determined by the closing stock price listed on the Nasdaq Capital Market on the grant date. The following table summarizes the activity for all RSUs outstanding at September 30 under the 2017 Plan: 2022 2021 Weighted Average Weighted Average Grant Date Grant Date Fair Value Fair Value Shares Per Share Shares Per Share Nonvested RSUs at beginning of year, as restated 510,851 $ 12.48 946,245 $ 12.81 Granted — — 166,660 7.98 Vested (11,980) 9.90 (37,802) 6.51 Cancelled and forfeited (338,988) 12.75 (136,445) 12.79 Nonvested RSUs at September 30, 159,883 $ 12.18 938,658 $ 12.28 Subsequent to the issuance of the December 31, 2021 consolidated financial statements, the Company identified an error related to the calculation of the number of vested shares of restricted stock units related to the Company’s 2017 Equity Incentive Plan. The Company used an incorrect number of vested shares of restricted stock units for the year ended December 31, 2021. Accordingly, the Company restated the number of vested shares of restricted stock units for the year ended December 31, 2021 from 37,802 shares to 393,909 shares, and the resulting total non-vested restricted stock units at December 31, 2021 from 866,958 shares to 510,851 shares. Additionally, the weighted average grant date fair value of vested shares for the year ended December 31, 2021 was restated from $6.51 per share to $11.21 per share, and the weighted average grant date fair value for total nonvested restricted stock units as of December 31, 2021 was restated from $12.16 per share to $12.48 per share. This change did not have any impact on our earnings per share calculations, nor did it have any impact on any previous disclosures related to potentially dilutive securities excluded from the computations of diluted weighted-average shares of common stock outstanding. The Company has evaluated the materiality of this error and concluded that it is not material to the December 31, 2021 consolidated financial statements. Further, the Company will also prospectively restate the previously reported financial information for the related error in future and annual filings for the year ending December 31, 2022. Total stock compensation expense recognized from stock-based compensation awards classified as restricted stock units were recognized in the condensed consolidated statements of operations for the three and nine months ended September 30, 2022 and 2021, as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Research and development $ 17,300 $ 99,400 $ 31,200 $ 2,000,600 General and administrative 21,100 866,900 16,400 939,800 Total $ 38,400 $ 966,300 $ 47,600 $ 2,940,400 On August 20, 2020, the board of directors canceled and terminated RSUs, granted during the quarter ended June 30, 2020. The cancelled RSUs were originally granted to individuals with a grant date fair value of $ per share. Thereafter, on August 20, 2020, the board of directors granted RSUs to the same individuals with a grant date fair value of $ per share. of the RSU grants were considered vested on the grant date. The RSU grants were modified for employees and non-employees. The effects of the RSU modifications resulted in $62,300 and $108,500 of stock compensation expense allocable to research and development and general and administrative, respectively, during the three months ended September 30, 2021. Included in those amounts were incremental compensation costs of $11,500 and $25,300 of stock compensation expense allocable to research and development and general and administrative, respectively, during the three months ended September 30, 2021. The effects of the RSU modifications resulted in $598,900 and $1,286,800 of stock compensation expense allocable to research and development and general and administrative, respectively, during the nine months ended September 30, 2021. Included in those amounts were incremental compensation costs of $52,500 and $115,200 of stock compensation expense allocable to research and development and general and administrative, respectively, during the nine months ended September 30, 2021. There was no effect from RSU modifications during the three and nine months ended September 30, 2022. 2021 Stock Incentive Plan—Restricted Stock Units The 2021 Plan permits the Company to grant equity awards for up to 1,217,292 shares of the Company’s common stock awards, including incentive stock options; non-statutory stock options; and conditional share awards to employees, directors, and consultants of the Company. All granted shares that are canceled, forfeited, or expired are returned to the 2021 Plan and are available for grant in conjunction with the issuance of new common stock awards. RSUs vest over a specified amount of time or when certain performance metrics are achieved by the Company. In the nine months ended September 30, 2022, the fair value of the shares of common stock underlying restricted stock units was determined by the closing stock price listed on the Nasdaq Capital Market on the grant date. The following table summarizes the activity for all RSUs outstanding at September 30, 2022 and 2021 under the 2021 Plan: 2022 2021 Weighted Average Weighted Average Grant Date Grant Date Fair Value Fair Value Shares Per Share Shares Per Share Nonvested RSUs at beginning of year 62,049 $ 5.52 — $ — Granted 738,298 0.41 102,613 5.20 Vested (595,581) 1.28 (37,900) 4.75 Cancelled and forfeited (7,936) 4.22 — — Nonvested RSUs at September 30, 196,830 $ 1.44 64,713 $ 5.46 Total stock compensation expense recognized from stock-based compensation awards classified as restricted stock units were recognized in the condensed consolidated statements of operations for the three and nine months ended September 30, 2022 and 2021, as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Research and development $ 21,800 $ 11,000 $ 47,500 $ 11,000 General and administrative 220,000 51,000 249,800 91,900 Total $ 241,800 $ 62,000 $ 297,300 $ 102,900 2021 Stock Incentive Plan — Stock Options The Black-Scholes option-pricing model was used to estimate the fair value of stock options with the following weighted average assumptions for the three and nine months ended September 30: 2022 Risk-free interest rate 2.99 % Expected volatility 119.55 % Expected life (years) 5.1 Expected dividend yield 0 % In the nine months ended September 30, 2022, the fair value of the common shares underlying the stock options was determined by the closing stock price listed on the Nasdaq Capital Market on the grant date. The following table summarizes the activity for all stock options outstanding at September 30 under the 2021 Plan: 2022 Weighted Average Exercise Shares Price Options outstanding at beginning of year — $ — Granted 734,400 0.43 Exercised — — Cancelled and forfeited — — Balance at September 30 734,400 $ 0.43 Options exercisable at September 30: 550,800 $ 0.43 Weighted average grant date fair value for options granted during the year: $ 0.36 In addition, the stock options had weighted average remaining contractual life of 9.75 years. The stock options generated stock compensation expense of $66,000 and $198,600 during the three and nine months ended September 30, 2022. All of the stock compensation expense was allocated to general and administrative expense on the condensed consolidated statement of operations. As of September 30, 2022, total unrecognized stock compensation expense is $65,300, related to unvested stock options to be recognized over the remaining weighted-average vesting period of 0.25 years. |
INCOME TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 2022 | |
INCOME TAXES | |
INCOME TAXES | 12. The Company’s effective tax rate from continuing operations was 0% for the three and nine months ended September 30, 2022 and 2021. The Company recorded no income tax provision for the three and nine months ended September 30, 2022 or 2021. The provision for income taxes during the interim reporting periods is calculated by applying an estimate of the annual effective tax rate for the full fiscal year to “ordinary” income or loss for the reporting period. Each quarter, the estimate of the annual effective tax rate is updated, and if the estimated effective tax rate changes, a cumulative adjustment is made. There is a potential for volatility of the effective tax rate due to several factors, including changes in the mix of the pre-tax income and the jurisdictions to which it relates, changes in tax laws, business reorganizations and settlements with taxing authorities. The income tax rates vary from the US federal statutory rate of 21% primarily due to the full valuation allowance on the Company’s deferred tax assets. The Company has recorded the full valuation allowance based on an evaluation of both positive and negative evidence, including latest forecasts and cumulative losses in recent years. The Company has concluded that it was more likely than not that none of its deferred tax assets would be realized. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2022 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | 13. Joseph Podmore Class Action Litigation On October 3, 2022, Joseph Podmore (“Podmore”) filed a class action complaint in the United States District Court for the Southern District of New York covering the same subject matter as the Sabby Entities’ and Empery Entities’ claim discussed above asserting claims against the Company and certain current and former officers and directors for alleged violations of Sections 11, 12, and 15 of the Securities Act in connection with the purchase of common stock through the Company’s public offering that closed on July 2, 2021 and Section 10(b) of the Exchange Act of 1934 and Rule 10b-5 promulgated thereunder in connection with the certain statements and acts made by the defendants between June 25, 2021 and August 13, 2021. The Company has evaluated the Podmore class claims and has determined that it is not possible to estimate a potential range of loss at this time. Stipulation of Settlement and Mutual Release with Sabby Entities and Empery Entities On October 10, 2022, the Company and certain current and former officers and directors of the Company (together with the Company, the “Defendants”) entered into a Stipulation of Settlement and Mutual Release (the “Initial Settlement Agreements”) with the Empery Entities and with the Sabby Entities (collectively, the “Plaintiffs”), respectively, in connection with a case filed by the Plaintiffs against the Defendants for alleged violations of Sections 11, 12, and 15 of the Securities Act in connection with the purchase of Company’s common stock through the Company’s public offering that closed on July 2, 2021. The Plaintiffs and the Defendants agreed to dismiss the case with prejudice against all Defendants (including ThinkEquity, LLC) with no admission of liability. As part of the Settlement, the Company agreed to (a) make a $75,000 cash payment to each of the Empery Entities and Sabby Entities and (b) issue the Settlement Notes in the aggregate principal amount of $1,656,720 to each of the Empery Entities and Sabby Entities. The Settlement Notes are convertible into shares of the Company’s common stock (the “Conversion Shares”) at an initial conversion price per share of $0.3068 (the “Conversion Price”), s ubject to a beneficial ownership limitation equivalent to 9.99% (“Beneficial Ownership Limitation”). On October 27, 2022, the Defendants entered into an Amended Stipulation of Settlement and Mutual Release with the Empery Entities (the “Amended Empery Settlement Agreement”) and Sabby (together with the Amended Empery Settlement Agreement, the “Amended Settlement Agreements”), respectively. On November 2, 2022, the Court granted the Joint Motion, pursuant to which the Settlement Notes will be unrestricted and exempt from the registration requirements of the Securities Act, and the Conversion Shares, when issued upon conversion of the Settlement Notes in accordance with the terms set forth therein, will also be unrestricted and exempt from the registration requirements of the Securities Act. Standby Equity Purchase Agreement Financing On October 13, 2022, the Company entered into a Standby Equity Purchase Agreement (the “SEPA”) with YA II PN, Ltd. (the “Investor”). Pursuant to the SEPA, the Company has the right to sell to the Investor up to $5,000,000 (the “Commitment Amount”) of its shares of common stock, par value $0.001 per share (“Common Stock”), subject to increase by an additional $3,000,000 of Common Stock at the Company’s election (the “Commitment Increase”), at the Company’s request any time during the commitment period commencing on October 13, 2022 and terminating on the earliest of (i) the first day of the month following the 24-month anniversary of the SEPA or (ii) the date on which the Investor has paid for shares of Common Stock equal to the Commitment Amount. The shares would be purchased at 95.0% of the Market Price (as defined in the agreement) and would be subject to certain limitations, including that the Investor could not purchase any shares that would result in it owning more than 9.99% of the outstanding Common Stock after such purchase (the "Ownership Limitation") or an aggregate of 19.9% of the outstanding Common Stock as of the date of the SEPA (the "Exchange Cap"). The Exchange Cap will not apply under certain circumstances, including to any sales of Common Stock under the SEPA that equal or exceed $0.3111, representing the lower of (i) the closing price of the Common Stock as reflected on Nasdaq.com immediately preceding the date of the SEPA, or (ii) the average closing price of the Common Stock for the five trading days immediately preceding the date of the SEPA. Pursuant to the SEPA, the Company also paid a subsidiary of the Investor, a structuring fee in the amount of $10,000 and issued to the Investor 603,318 shares of Common Stock as a commitment fee on October 13, 2022 (the “Commitment Shares”). In the event of the Commitment Increase, the Company will issue to the Investor an additional number of shares of Common Stock determined by dividing $120,000 by the average of the daily VWAPs for the five trading days prior to the date of delivery by the Company of written notice of the Commitment Increase. In connection with the SEPA agreement, on October 31, 2022, the Company entered into a letter agreement with an accredited investor (the “Investor”), pursuant to which the Company agreed to issue to the Investor 1,000,000 shares (the “Shares”) of the Company’s common stock in consideration of the Investor’s services to the Company in identifying investors. The Company issued the Shares to the Investor on October 31, 2022. The Shares were issued in reliance upon the exemption from the registration requirements of the Securities Act, provided by Section 4(a)(2) of the Securities Act as sales by an issuer not involving any public offering. Senior Secured Convertible Note Financing On October 21, 2022 (the “Issuance Date”), the Company issued a 25% Senior Secured Convertible Promissory Note (the “Note”) to an accredited investor. The Note has a principal amount of $2,000,000, bears interest at a rate of 25% per annum (the “Stated Rate”) and matures on October 21, 2023 (the “Maturity Date”), on which date the principal balance and accrued but unpaid interest are due and payable. The Stated Rate will increase to 27% per annum or the highest rate then allowed under applicable law (whichever is lower) upon occurrence of an event of default, including the failure by the Company to make payment of principal or interest due under the Note on the Maturity Date, and The Note is convertible into shares of the Company’s Common Stock, at an initial conversion price of $0.35 per share, subject to a beneficial ownership limitation equivalent to 9.99% (the “Beneficial Ownership Limitation”) and a share cap of 3,287,699 shares (the “Share Cap”), representing 19.9% of the total issued and outstanding shares of Common Stock as of October 20, 2022. The unpaid principal of and interest on the Note constitute unsubordinated obligations of the Company and are senior and preferred in right of payment to all subordinated indebtedness and equity securities of the Company outstanding as of the Issuance Date; provided, however, that the Company may incur or guarantee additional indebtedness after the Issuance Date, whether such indebtedness are senior, pari passu or junior to the obligations under the Note, which are secured by all of the Company’s right, title and interest, in and to, (i) all fixtures (as defined in the Uniform Commercial Code, the “UCC”) and equipment (as defined in the UCC), and (ii) all of the Company’s intellectual property as specified in the Note, subject to certain exclusions as described in the Note. Pursuant to the Note, the Company is required to file a Registration Statement with the SEC to register the conversion shares within 30 days after the Conversion Share Delivery Date (as defined in the Note) and shall use its commercially reasonable efforts to have the Registration Statement declared effective by the SEC. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP") for interim financial information (Accounting Standards Codification ("ASC") 270, Interim Reporting) and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information necessary for a full presentation of financial position, results of operations, and cash flows in conformity with GAAP. Operating results for interim periods are not necessarily indicative of results that may be expected for the fiscal year as a whole. In the opinion of management, the condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been condensed or omitted. These interim financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in our Form 10-K for the year ended December 31, 2021. The results of operations for the period ended September 30, 2022 are not necessarily indicative of the operating results that may be expected for a full year. The condensed consolidated balance sheet as of December 31, 2021 contains financial information taken from the audited Company consolidated financial statements as of that date. All intercompany balances were eliminated upon consolidation. |
Use of Estimates | Use of Estimates |
Concentrations of Credit Risk and Other Uncertainties | Concentrations of Credit Risk and Other Uncertainties The Company is subject to certain risks and uncertainties from changes in any of the following areas that the Company believes could have a material adverse effect on future financial position or results of operations: the ability to obtain regulatory approval and market acceptance of, and reimbursement for, the Company’s product candidates; the performance of third-party clinical research organizations and manufacturers; protection of the intellectual property; litigation or claims against the Company based on intellectual property, patent, product, regulatory or other factors; the Company’s ability to attract and retain employees necessary to support commercial success; and changes in the industry or customer requirements including the emergence of competitive products with new capabilities. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which such temporary differences are expected to be recovered or settled. The Company records valuation allowances to reduce deferred income tax assets to the amount that is more likely than not to be realized. The Company records uncertain tax positions in accordance with ASC 740, Income Taxes |
Research and Development Expense | Research and Development Expense The Company accrues and expenses costs of services provided by contract research organizations in connection with preclinical studies and contract manufacturing organizations engaged to manufacture clinical trial material, costs of licensing technology, and costs of services provided by research organizations and service providers. Upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred if the technology is not expected to have any alternative future uses other than the specific research and development project for which it was intended. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed rather than when the payment is made. |
Stock-Based Compensation | Stock-Based Compensation Compensation—Stock Compensation The Company estimates the grant-date fair value of stock options using the Black-Scholes model and the assumptions used to value such stock options are determined as follows: Expected Term. Risk-Free Interest Rate. Volatility. Dividend Yield. Common Stock Valuations. During the three and nine months ended September 30, 2022 and 2021, the closing price listed on the Nasdaq Capital Market for the Company’s common stock on the date of the grant was used as the common stock valuation. |
Segment Data | Segment Data |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, Leases standard liability In June 2016, FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326) |
NET LOSS PER SHARE OF COMMON _2
NET LOSS PER SHARE OF COMMON STOCK (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
NET LOSS PER COMMON SHARE | |
Schedule of earnings per share, basic and diluted | Three Months Ended Nine Months Ended September 30, September30, 2022 2021 2022 2021 Net loss $ (11,860,300) $ (6,124,800) $ (27,663,200) $ (14,953,600) Less: Initial Public Offering Common Stock discount amortization (25,200) (25,200) (74,800) (74,800) Less: Public Offering Common Stock discount amortization (61,700) (60,300) (183,100) (60,300) Net loss attributable to common shareholders, basic and diluted $ (11,947,200) $ (6,210,300) $ (27,921,100) $ (15,088,700) Weighted average common shares outstanding, basic and diluted 15,840,454 15,366,075 15,706,079 10,048,170 Net loss per common share, basic and diluted $ (0.75) $ (0.40) $ (1.78) $ (1.50) |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
PROPERTY AND EQUIPMENT | |
Schedule of property and equipment | September 30, December 31, 2022 2021 Equipment $ 2,722,800 $ 1,593,100 Leasehold improvements 7,193,700 1,464,700 Office furniture, fixtures, and equipment 137,300 16,600 Software 359,500 359,500 Construction in progress 422,200 1,226,600 10,835,500 4,660,500 Less: Accumulated depreciation (2,150,000) (1,031,500) Total $ 8,685,500 $ 3,629,000 |
ACCRUED EXPENSES AND OTHER CU_2
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | |
Schedule of accrued expenses and other current liabilities | September 30, December 31, 2022 2021 Accrued consulting and outside services $ 137,400 $ 467,100 Accrued compensation 466,600 273,900 Total $ 604,000 $ 741,000 |
LEASES (Tables)
LEASES (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases | |
Schedule of lessee's operating lease right-of-use assets and lease liabilities | September 30, 2022 Operating lease Right-of-Use Asset Operating lease $ 2,164,500 Total right-of use asset 2,164,500 Lease Liabilities Operating lease - short term $ (547,800) Operating lease - long term (1,626,300) Total lease liabilities (2,174,100) |
Schedule of components of lease expense | Three Months Ended Nine Months Ended September 30, September 30, Operating lease cost allocated to research and development expense $ 132,700 $ 346,400 Operating lease cost allocated to general and administrative expense 38,900 145,200 Total lease expense $ 171,600 $ 491,600 Weighted-average remaining lease term 3.59 3.59 Weighted-average discount rate 7.12 % 7.12 % |
Schedule of maturities of operating lease liabilities | As of September 30, 2022 the maturities of the Company’s operating lease liabilities were as follows: Maturity of Lease Liabilities Operating lease 2022 $ 169,400 2023 684,300 2024 687,700 2025 694,300 2026 232,600 Total lease payments 2,468,300 Less: imputed interest (294,200) Present value of lease payments 2,174,100 |
STOCKHOLDERS EQUITY (Tables)
STOCKHOLDERS EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
STOCKHOLDERS' EQUITY | |
Schedule of initial value of issuances allocated to the IPO and public offering of common stock and the IPO and public offering common stock discount amortization | 2022 2021 Common Stock Balance at January 1, $ 48,264,300 $ 11,975,400 Common stock initial public offering discount amortization 24,700 24,700 Common stock public offering discount amortization 60,400 — Balance at March 31, $ 48,349,400 $ 12,000,100 Common stock initial public offering discount amortization 24,900 24,900 Common stock public offering discount amortization 61,000 — Balance at June 30, $ 48,435,300 $ 12,025,000 Common stock issuance from public offering, net of underwriting discounts and commissions and other offering expenses — 37,118,100 Common stock public offering discount — (1,051,200) Common stock initial public offering discount amortization 25,200 25,200 Common stock public offering discount amortization 61,700 60,300 Balance at September 30, $ 48,522,200 $ 48,177,400 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Stock Incentive Plan 2017 | Stock Options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of assumptions used to estimate fair value of stock options | September 30, 2021 Risk-free interest rate 1.09 % Expected volatility 83.34 % Expected life (years) 6.22 Expected dividend yield 0 % |
Schedule of stock option activity | 2022 2021 Weighted Weighted Average Average Exercise Exercise Shares Price Shares Price Options outstanding at beginning of year 380,909 $ 8.57 489,718 $ 10.03 Granted — — 147,038 8.47 Exercised — — (18,891) 6.64 Cancelled and forfeited (42,037) 9.19 (64,427) 17.67 Balance at September 30 338,872 $ 8.49 553,438 $ 8.84 Options exercisable at September 30: 336,108 $ 8.53 369,020 $ 8.87 Weighted average grant date fair value for options granted during the year: $ — $ 8.47 |
Schedule of stock-based compensation | Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Research and development $ 9,000 $ 44,500 $ 61,000 $ 86,400 General and administrative 8,000 32,500 23,000 189,400 Total $ 17,000 $ 77,000 $ 84,000 $ 275,800 |
Stock Incentive Plan 2017 | Restricted Stock Units | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of restricted stock unit activity | 2022 2021 Weighted Average Weighted Average Grant Date Grant Date Fair Value Fair Value Shares Per Share Shares Per Share Nonvested RSUs at beginning of year, as restated 510,851 $ 12.48 946,245 $ 12.81 Granted — — 166,660 7.98 Vested (11,980) 9.90 (37,802) 6.51 Cancelled and forfeited (338,988) 12.75 (136,445) 12.79 Nonvested RSUs at September 30, 159,883 $ 12.18 938,658 $ 12.28 |
Schedule of stock-based compensation | Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Research and development $ 17,300 $ 99,400 $ 31,200 $ 2,000,600 General and administrative 21,100 866,900 16,400 939,800 Total $ 38,400 $ 966,300 $ 47,600 $ 2,940,400 |
Stock Incentive Plan 2021 | Stock Options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of assumptions used to estimate fair value of stock options | 2022 Risk-free interest rate 2.99 % Expected volatility 119.55 % Expected life (years) 5.1 Expected dividend yield 0 % |
Schedule of stock option activity | 2022 Weighted Average Exercise Shares Price Options outstanding at beginning of year — $ — Granted 734,400 0.43 Exercised — — Cancelled and forfeited — — Balance at September 30 734,400 $ 0.43 Options exercisable at September 30: 550,800 $ 0.43 Weighted average grant date fair value for options granted during the year: $ 0.36 |
Stock Incentive Plan 2021 | Restricted Stock Units | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of restricted stock unit activity | 2022 2021 Weighted Average Weighted Average Grant Date Grant Date Fair Value Fair Value Shares Per Share Shares Per Share Nonvested RSUs at beginning of year 62,049 $ 5.52 — $ — Granted 738,298 0.41 102,613 5.20 Vested (595,581) 1.28 (37,900) 4.75 Cancelled and forfeited (7,936) 4.22 — — Nonvested RSUs at September 30, 196,830 $ 1.44 64,713 $ 5.46 |
Schedule of stock-based compensation | Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Research and development $ 21,800 $ 11,000 $ 47,500 $ 11,000 General and administrative 220,000 51,000 249,800 91,900 Total $ 241,800 $ 62,000 $ 297,300 $ 102,900 |
ORGANIZATION (Details)
ORGANIZATION (Details) - USD ($) | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
ORGANIZATION | |||
Cash flow from operations | $ (19,643,400) | $ (11,156,300) | |
Accumulated deficit | $ (94,879,700) | $ (67,216,500) |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property and Equipment (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||
Unrecognized tax benefits, interest or penalties | $ 0 | $ 0 | $ 0 | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Nonvested Stock Options (Details) | 9 Months Ended |
Sep. 30, 2022 | |
Nonvested Stock Options | |
Expected dividend yield | 0% |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Recently issued accounting pronouncements (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Sep. 30, 2022 | |
Adoption of accounting pronouncements | ||
Operating lease liability | $ 2,174,100 | |
Operating lease right-of-use asset | $ 2,164,500 | |
Cumulative Effect, Period of Adoption, Adjustment | ||
Adoption of accounting pronouncements | ||
Operating lease liability | $ 2,232,700 | |
Operating lease right-of-use asset | $ 2,232,700 | |
Accounting Standards Update [Extensible Enumeration] | us-gaap:AccountingStandardsUpdate201602Member |
NET LOSS PER SHARE OF COMMON _3
NET LOSS PER SHARE OF COMMON STOCK - Computation of basic and diluted earnings per share (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
NET LOSS PER COMMON SHARE | ||||||||
Net loss | $ (11,860,300) | $ (8,435,100) | $ (7,367,800) | $ (6,124,800) | $ (4,974,300) | $ (3,854,500) | $ (27,663,200) | $ (14,953,600) |
Less: Initial Public Offering Common Stock discount amortization | (25,200) | (25,200) | (74,800) | (74,800) | ||||
Less: public offering Common Stock discount amortization | (61,700) | (60,300) | (183,100) | (60,300) | ||||
Net loss attributable to common shareholders, basic | (11,947,200) | (6,210,300) | (27,921,100) | (15,088,700) | ||||
Net loss attributable to common shareholders, diluted | $ (11,947,200) | $ (6,210,300) | $ (27,921,100) | $ (15,088,700) | ||||
Weighted average common shares outstanding, basic | 15,840,454 | 15,366,075 | 15,706,079 | 10,048,170 | ||||
Weighted average common shares outstanding, diluted | 15,840,454 | 15,366,075 | 15,706,079 | 10,048,170 | ||||
Net loss per common share, basic | $ (0.75) | $ (0.40) | $ (1.78) | $ (1.50) | ||||
Net loss per common share, diluted | $ (0.75) | $ (0.40) | $ (1.78) | $ (1.50) |
NET LOSS PER SHARE OF COMMON _4
NET LOSS PER SHARE OF COMMON STOCK - Dilutive Securities Excluded From the Computations of Earnings Per Share (Details) - Restricted Stock Units - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Dilutive Securities Excluded From the Computations of Earnings Per Share | ||||
Potentially dilutive securities | 0 | 6,698 | 0 | 73,366 |
Units vested and outstanding but not yet released to the grantee. | 595,049 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
PROPERTY AND EQUIPMENT | |||||
Property, Plant and Equipment, Gross | $ 10,835,500 | $ 10,835,500 | $ 4,660,500 | ||
Less: Accumulated depreciation | (2,150,000) | (2,150,000) | (1,031,500) | ||
Total | 8,685,500 | 8,685,500 | 3,629,000 | ||
Depreciation | 536,600 | $ 128,800 | 1,118,500 | $ 331,200 | |
Equipment | |||||
PROPERTY AND EQUIPMENT | |||||
Property, Plant and Equipment, Gross | 2,722,800 | 2,722,800 | 1,593,100 | ||
Leasehold improvements | |||||
PROPERTY AND EQUIPMENT | |||||
Property, Plant and Equipment, Gross | 7,193,700 | 7,193,700 | 1,464,700 | ||
Office furniture, fixtures, and equipment | |||||
PROPERTY AND EQUIPMENT | |||||
Property, Plant and Equipment, Gross | 137,300 | 137,300 | 16,600 | ||
Software | |||||
PROPERTY AND EQUIPMENT | |||||
Property, Plant and Equipment, Gross | 359,500 | 359,500 | 359,500 | ||
Construction in progress | |||||
PROPERTY AND EQUIPMENT | |||||
Property, Plant and Equipment, Gross | $ 422,200 | $ 422,200 | $ 1,226,600 |
ACCRUED EXPENSES AND OTHER CU_3
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | ||
Accrued consulting and outside services | $ 137,400 | $ 467,100 |
Accrued compensation | 466,600 | 273,900 |
Total | $ 604,000 | $ 741,000 |
LOAN PAYABLE (Details)
LOAN PAYABLE (Details) - SBA Loan - USD ($) | Feb. 16, 2021 | May 01, 2020 |
Current loan payable | ||
Principal amount | $ 115,600 | |
Loan forgiveness | $ 105,800 |
NOTE PAYABLE (Details)
NOTE PAYABLE (Details) - USD ($) | 1 Months Ended | ||
Nov. 30, 2021 | Sep. 30, 2022 | Dec. 31, 2021 | |
Note payable | |||
Note payable | $ 454,500 | ||
Director and Officer Insurance Policy Financing | |||
Note payable | |||
Note payable | $ 665,900 | $ 0 | $ 454,500 |
Interest rate | 4.59% | ||
Note term | 10 months |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Legal proceedings (Details) | 9 Months Ended | ||||
Sep. 26, 2022 USD ($) item $ / shares | Jul. 02, 2021 USD ($) | Mar. 22, 2021 $ / shares shares | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | |
Legal proceedings | |||||
Proceeds from issuance of common stock | $ 40,000,000 | ||||
Accrued litigation liability | $ 3,463,000 | ||||
Strategic Alliance Agreement | |||||
Legal proceedings | |||||
Proceeds from issuance of common stock | $ 40,000,000 | ||||
Jason Terrell - 2014 Consulting Agreement | |||||
Legal proceedings | |||||
Number of stock options sought | shares | 500,000 | ||||
Stock option exercise price | $ / shares | $ 0.50 | ||||
Jason Terrell - 2017 Non-employee Director Options Agreement | |||||
Legal proceedings | |||||
Number of stock options sought | shares | 500,005 | ||||
Stock option exercise price | $ / shares | $ 0.17 | ||||
Sabby Entities | |||||
Legal proceedings | |||||
Cash settlement payments | $ 75,000 | ||||
Convertible notes issued in settlement of legal proceedings | $ 1,656,720 | ||||
Conversion price | $ / shares | $ 0.3068 | ||||
Maximum beneficial ownership percentage | 9.99% | ||||
Sabby Entities | Maximum | |||||
Legal proceedings | |||||
Maximum shares to be issued under conversion | item | 5,400,000 | ||||
Empery Entities | |||||
Legal proceedings | |||||
Cash settlement payments | $ 75,000 | ||||
Convertible notes issued in settlement of legal proceedings | $ 1,656,720 | ||||
Conversion price | $ / shares | $ 0.3068 | ||||
Maximum beneficial ownership percentage | 9.99% | ||||
Empery Entities | Maximum | |||||
Legal proceedings | |||||
Maximum shares to be issued under conversion | item | 5,400,000 |
LEASES - Lease information (Det
LEASES - Lease information (Details) | 2 Months Ended | 9 Months Ended | ||
May 01, 2022 USD ($) item | Aug. 01, 2021 USD ($) | Dec. 31, 2021 USD ($) item | Sep. 30, 2022 | |
Leases | ||||
Lease, Practical Expedients, Package [true false] | true | |||
Additional office space leased | 9,352 | 15,385 | 3,684 | |
Period of time after notice of cancellation that the lease effectively terminates | 90 days | 90 days | 90 days | |
Number of lease amendments executed | item | 2 | |||
Number of months rent due as a termination payment if lease cancellation option exercised | item | 3 | |||
Monthly rent - Years one and two | $ 4,800 | |||
Monthly rent - Years three and four | 4,896 | |||
Monthly rent - Year five | $ 5,000 |
LEASES - Balance sheet disclosu
LEASES - Balance sheet disclosures (Details) | Sep. 30, 2022 USD ($) |
Leases | |
Operating lease right-of-use asset | $ 2,164,500 |
Operating lease liability - short term | (547,800) |
Operating lease liability - long term | (1,626,300) |
Total lease liabilities | $ (2,174,100) |
LEASES - Components of lease ex
LEASES - Components of lease expense (Details) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 USD ($) | Sep. 30, 2022 USD ($) | |
Operating leases | ||
Operating lease cost | $ 171,600 | $ 491,600 |
Weighted-average remaining lease term | 3 years 7 months 2 days | 3 years 7 months 2 days |
Weighted-average discount rate | 7.12% | 7.12% |
Research and development | ||
Operating leases | ||
Operating lease cost | $ 132,700 | $ 346,400 |
General and administrative | ||
Operating leases | ||
Operating lease cost | $ 38,900 | $ 145,200 |
LEASES - Operating lease liabil
LEASES - Operating lease liability maturities (Details) | Sep. 30, 2022 USD ($) |
Operating leases | |
2022 | $ 169,400 |
2023 | 684,300 |
2024 | 687,700 |
2025 | 694,300 |
2026 | 232,600 |
Total lease payments | 2,468,300 |
Less: imputed interest | (294,200) |
Present value of lease payments | $ 2,174,100 |
LEASES - Short-term Lease (Deta
LEASES - Short-term Lease (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Leases | ||||
Short-term lease expense | $ 7,500 | $ 22,500 | ||
Monthly rent expense on short-term lease | $ 2,500 | |||
Rent expense | $ 126,900 | $ 270,800 |
STOCKHOLDERS EQUITY - Common St
STOCKHOLDERS EQUITY - Common Stock (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Jul. 02, 2021 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2021 | |
Common stock | ||||||||
Offering expenses | $ 2,881,900 | |||||||
Beginning balance | $ 48,435,300 | $ 48,349,400 | $ 48,264,300 | $ 12,025,000 | $ 12,000,100 | $ 11,975,400 | 11,975,400 | |
Common stock discount amortization | 86,900 | 85,900 | 85,100 | (85,500) | 24,900 | 24,700 | ||
Ending Balance | 48,522,200 | 48,435,300 | 48,349,400 | 48,177,400 | 12,025,000 | 12,000,100 | 48,177,400 | |
Initial Public Offering | ||||||||
Common stock | ||||||||
Common stock discount amortization | 25,200 | 24,900 | 24,700 | 25,200 | $ 24,900 | $ 24,700 | ||
Public Offering | ||||||||
Common stock | ||||||||
Proceeds from issuance of common stock net of issuance costs | $ 37,118,100 | |||||||
Underwriting discounts and commissions | 2,494,900 | |||||||
Offering expenses | $ 457,000 | |||||||
Shares issued | 8,000,000 | |||||||
Share price | $ 5 | |||||||
Common stock issuance, net of underwriting discounts and commissions and other offering expenses | 37,118,100 | |||||||
Common stock discount | (1,051,200) | $ (1,051,200) | ||||||
Common stock discount amortization | $ 61,700 | $ 61,000 | $ 60,400 | $ 60,300 |
STOCKHOLDERS EQUITY - Represent
STOCKHOLDERS EQUITY - Representative's Warrants (Details) - USD ($) | Jul. 02, 2021 | Oct. 15, 2020 | Sep. 30, 2022 | Dec. 31, 2021 |
Initial Public Offering | ||||
Weighted average valuation assumptions | ||||
Warrants fair value | $ 182,500 | $ 257,300 | ||
Common Stock Warrants - Representative | Initial Public Offering | ||||
Weighted average valuation assumptions | ||||
Warrants and Rights Outstanding, Term | 5 years | |||
Warrants | ||||
Number of warrants granted | 62,500 | |||
Warrant exercise price | $ 15 | |||
Exercise price as a percentage of the initial offering price | 125% | |||
Common Stock Warrants - Representative | Public Offering | ||||
Weighted average valuation assumptions | ||||
Warrants fair value | $ 746,200 | $ 929,300 | ||
Warrants and Rights Outstanding, Term | 5 years | |||
Warrants | ||||
Number of warrants granted | 400,000 | |||
Warrant exercise price | $ 6.25 | |||
Exercise price as a percentage of the initial offering price | 125% |
STOCK-BASED COMPENSATION - Weig
STOCK-BASED COMPENSATION - Weighted-average Assumptions (Details) | 9 Months Ended |
Sep. 30, 2022 | |
Weighted average assumptions | |
Expected dividend yield | 0% |
Stock Incentive Plan 2017 | Stock Options | |
Weighted average assumptions | |
Risk-free interest rate | 1.09% |
Expected volatility | 83.34% |
Expected life (years) | 6 years 2 months 19 days |
Expected dividend yield | 0% |
Stock Incentive Plan 2021 | Stock Options | |
Weighted average assumptions | |
Risk-free interest rate | 2.99% |
Expected volatility | 119.55% |
Expected life (years) | 5 years 1 month 6 days |
Expected dividend yield | 0% |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock Options (Details) - Stock Options - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Stock Incentive Plan 2017 | ||
Stock option activity | ||
Options outstanding at beginning of year | 380,909 | 489,718 |
Granted | 147,038 | |
Exercised | (18,891) | |
Cancelled and forfeited | (42,037) | (64,427) |
Balance at end of period | 338,872 | 553,438 |
Options exercisable at September 30: | 336,108 | 369,020 |
Intrinsic value of options exercised | $ 33,000 | |
Weighted average exercise price | ||
Options outstanding at beginning of year | $ 8.57 | $ 10.03 |
Granted | 8.47 | |
Exercised | 6.64 | |
Cancelled and forfeited | 9.19 | 17.67 |
Balance at end of period | 8.49 | 8.84 |
Options exercisable at September 30: | $ 8.53 | 8.87 |
Weighted average grant date fair value for options granted and expected to be vested during the year: | $ 8.47 | |
Additional stock option information | ||
Options outstanding, weighted average remaining contractual life | 5 years 3 months 10 days | 6 years 5 months 26 days |
Options exercisable, aggregate intrinsic value | $ 0 | $ 0 |
Stock Incentive Plan 2021 | ||
Stock option activity | ||
Granted | 734,400 | |
Balance at end of period | 734,400 | |
Options exercisable at September 30: | 550,800 | |
Weighted average exercise price | ||
Granted | $ 0.43 | |
Balance at end of period | 0.43 | |
Options exercisable at September 30: | 0.43 | |
Weighted average grant date fair value for options granted and expected to be vested during the year: | $ 0.36 |
STOCK-BASED COMPENSATION - St_2
STOCK-BASED COMPENSATION - Stock Option Modifications (Details) - Stock Options | 3 Months Ended | 9 Months Ended | |||
Aug. 20, 2020 employee $ / shares shares | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) $ / shares shares | Sep. 30, 2021 USD ($) $ / shares shares | |
Stock Incentive Plan 2017 | |||||
Stock compensation expense | |||||
Stock compensation expense | $ 17,000 | $ 77,000 | $ 84,000 | $ 275,800 | |
Cancelled and forfeited | shares | 42,037 | 64,427 | |||
Number of individuals affected by modifications | employee | 4 | ||||
Granted | shares | 147,038 | ||||
Weighted average grant date fair value for options granted and expected to be vested during the year: | $ / shares | $ 8.47 | ||||
Effect of modifications on stock compensation expense | 0 | $ 0 | |||
Total unrecognized stock compensation expense | 20,900 | $ 20,900 | |||
Weighted-average period over which cost not yet recognized is expected to be recognized | 5 months 1 day | ||||
Stock Incentive Plan 2017 | Research and development | |||||
Stock compensation expense | |||||
Stock compensation expense | 9,000 | 44,500 | $ 61,000 | $ 86,400 | |
Stock Incentive Plan 2017 | General and administrative | |||||
Stock compensation expense | |||||
Stock compensation expense | 8,000 | 32,500 | $ 23,000 | 189,400 | |
Effect of modifications on stock compensation expense | 0 | 34,900 | |||
Incremental compensation costs | $ 0 | $ 16,000 | |||
Stock Incentive Plan 2017 | Four Nonemployees | |||||
Stock compensation expense | |||||
Cancelled and forfeited | shares | 15,792 | ||||
Granted | shares | 21,112 | ||||
Weighted average grant date fair value for options granted and expected to be vested during the year: | $ / shares | $ 12.81 | ||||
Options vested | shares | 3,959 | ||||
Stock Incentive Plan 2021 | |||||
Stock compensation expense | |||||
Granted | shares | 734,400 | ||||
Weighted average grant date fair value for options granted and expected to be vested during the year: | $ / shares | $ 0.36 | ||||
Total unrecognized stock compensation expense | 65,300 | $ 65,300 | |||
Weighted-average remaining contractual life | 9 years 9 months | ||||
Weighted-average period over which cost not yet recognized is expected to be recognized | 3 months | ||||
Stock Incentive Plan 2021 | General and administrative | |||||
Stock compensation expense | |||||
Stock compensation expense | $ 66,000 | $ 198,600 |
STOCK-BASED COMPENSATION - Rest
STOCK-BASED COMPENSATION - Restricted Stock Units (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Aug. 20, 2020 individual employee $ / shares shares | Sep. 30, 2022 USD ($) $ / shares shares | Sep. 30, 2021 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) $ / shares shares | Sep. 30, 2021 USD ($) $ / shares shares | Dec. 31, 2021 $ / shares shares | Jun. 30, 2021 shares | Jan. 31, 2017 shares | |
Stock Incentive Plan 2017 | Restricted Stock Units | ||||||||
Restricted stock units | ||||||||
Authorized shares | 1,708,615 | |||||||
Number of individuals affected by modifications | individual | 5 | |||||||
Stock compensation expense | $ | $ 38,400 | $ 966,300 | $ 47,600 | $ 2,940,400 | ||||
Effect of modifications on stock compensation expense | $ | $ 0 | $ 0 | ||||||
Restricted stock unit activity | ||||||||
Nonvested RSUs at beginning of year | 510,851 | 946,245 | 946,245 | |||||
Granted | 946,245 | 166,660 | ||||||
Vested | 0 | (11,980) | (37,802) | |||||
Cancelled and forfeited | (709,334) | (338,988) | (136,445) | |||||
Nonvested RSUs at end of period | 159,883 | 938,658 | 159,883 | 938,658 | 510,851 | |||
Weighted average grant day fair value per share | ||||||||
Nonvested RSUs at beginning of year | $ / shares | $ 12.48 | $ 12.81 | $ 12.81 | |||||
Granted | $ / shares | $ 12.81 | 7.98 | ||||||
Vested | $ / shares | 9.90 | 6.51 | ||||||
Cancelled and forfeited | $ / shares | $ 12.87 | 12.75 | 12.79 | |||||
Nonvested RSUs at end of period | $ / shares | $ 12.18 | $ 12.28 | $ 12.18 | $ 12.28 | $ 12.48 | |||
Stock Incentive Plan 2017 | Restricted Stock Units | Research and development | ||||||||
Restricted stock units | ||||||||
Stock compensation expense | $ | $ 17,300 | $ 99,400 | $ 31,200 | $ 2,000,600 | ||||
Effect of modifications on stock compensation expense | $ | 62,300 | 598,900 | ||||||
Incremental compensation costs | $ | 11,500 | 52,500 | ||||||
Stock Incentive Plan 2017 | Restricted Stock Units | General and administrative | ||||||||
Restricted stock units | ||||||||
Stock compensation expense | $ | 21,100 | 866,900 | $ 16,400 | 939,800 | ||||
Effect of modifications on stock compensation expense | $ | 108,500 | 1,286,800 | ||||||
Incremental compensation costs | $ | 25,300 | 115,200 | ||||||
Stock Incentive Plan 2017 | Restricted Stock Units | Non-Employees | ||||||||
Restricted stock units | ||||||||
Number of individuals affected by modifications | individual | 2 | |||||||
Stock Incentive Plan 2017 | Restricted Stock Units | Employees | ||||||||
Restricted stock units | ||||||||
Number of individuals affected by modifications | employee | 3 | |||||||
Stock Incentive Plan 2017 | Restricted Stock Units | Previously Reported | ||||||||
Restricted stock unit activity | ||||||||
Nonvested RSUs at beginning of year | 866,958 | |||||||
Vested | (37,802) | |||||||
Nonvested RSUs at end of period | 866,958 | |||||||
Weighted average grant day fair value per share | ||||||||
Nonvested RSUs at beginning of year | $ / shares | $ 12.16 | |||||||
Vested | $ / shares | $ 6.51 | |||||||
Nonvested RSUs at end of period | $ / shares | $ 12.16 | |||||||
Stock Incentive Plan 2017 | Restricted Stock Units | Restated | ||||||||
Restricted stock unit activity | ||||||||
Nonvested RSUs at beginning of year | 510,851 | |||||||
Vested | (393,909) | |||||||
Nonvested RSUs at end of period | 510,851 | |||||||
Weighted average grant day fair value per share | ||||||||
Nonvested RSUs at beginning of year | $ / shares | $ 12.48 | |||||||
Vested | $ / shares | $ 11.21 | |||||||
Nonvested RSUs at end of period | $ / shares | $ 12.48 | |||||||
Stock Incentive Plan 2021 | Maximum | ||||||||
Restricted stock units | ||||||||
Authorized shares | 1,217,292 | |||||||
Stock Incentive Plan 2021 | Restricted Stock Units | ||||||||
Restricted stock units | ||||||||
Stock compensation expense | $ | $ 241,800 | $ 62,000 | $ 297,300 | $ 102,900 | ||||
Restricted stock unit activity | ||||||||
Nonvested RSUs at beginning of year | 62,049 | |||||||
Granted | 738,298 | 102,613 | ||||||
Vested | (595,581) | (37,900) | ||||||
Cancelled and forfeited | (7,936) | |||||||
Nonvested RSUs at end of period | 196,830 | 64,713 | 196,830 | 64,713 | 62,049 | |||
Weighted average grant day fair value per share | ||||||||
Nonvested RSUs at beginning of year | $ / shares | $ 5.52 | |||||||
Granted | $ / shares | 0.41 | $ 5.20 | ||||||
Vested | $ / shares | 1.28 | 4.75 | ||||||
Cancelled and forfeited | $ / shares | 4.22 | |||||||
Nonvested RSUs at end of period | $ / shares | $ 1.44 | $ 5.46 | $ 1.44 | $ 5.46 | $ 5.52 | |||
Stock Incentive Plan 2021 | Restricted Stock Units | Research and development | ||||||||
Restricted stock units | ||||||||
Stock compensation expense | $ | $ 21,800 | $ 11,000 | $ 47,500 | $ 11,000 | ||||
Stock Incentive Plan 2021 | Restricted Stock Units | General and administrative | ||||||||
Restricted stock units | ||||||||
Stock compensation expense | $ | $ 220,000 | $ 51,000 | $ 249,800 | $ 91,900 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
INCOME TAXES | ||||
Effective tax rate from continuing operations | 0% | 0% | 0% | 0% |
Income tax provision | $ 0 | $ 0 | $ 0 | $ 0 |
Federal statutory rate | 21% | 21% | 21% | 21% |
Realized deferred tax assets | $ 0 | $ 0 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) | 1 Months Ended | ||||||||
Oct. 31, 2022 shares | Oct. 21, 2022 USD ($) | Oct. 20, 2022 USD ($) $ / shares | Oct. 13, 2022 USD ($) D $ / shares shares | Oct. 10, 2022 USD ($) $ / shares | Sep. 26, 2022 USD ($) item $ / shares | Nov. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) $ / shares | Dec. 31, 2021 USD ($) $ / shares | |
Subsequent events | |||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | |||||||
Note payable | $ 454,500 | ||||||||
Director and Officer Insurance Policy Financing | |||||||||
Subsequent events | |||||||||
Note payable | $ 665,900 | $ 0 | $ 454,500 | ||||||
Interest rate | 4.59% | ||||||||
Note term | 10 months | ||||||||
Empery Entities | |||||||||
Subsequent events | |||||||||
Cash settlement payments | $ 75,000 | ||||||||
Convertible notes issued in settlement of legal proceedings | $ 1,656,720 | ||||||||
Conversion price | $ / shares | $ 0.3068 | ||||||||
Maximum beneficial ownership percentage | 9.99% | ||||||||
Empery Entities | Maximum | |||||||||
Subsequent events | |||||||||
Maximum shares to be issued under conversion | item | 5,400,000 | ||||||||
Sabby Entities | |||||||||
Subsequent events | |||||||||
Cash settlement payments | $ 75,000 | ||||||||
Convertible notes issued in settlement of legal proceedings | $ 1,656,720 | ||||||||
Conversion price | $ / shares | $ 0.3068 | ||||||||
Maximum beneficial ownership percentage | 9.99% | ||||||||
Sabby Entities | Maximum | |||||||||
Subsequent events | |||||||||
Maximum shares to be issued under conversion | item | 5,400,000 | ||||||||
Subsequent Event | 25% Senior Secured Convertible Promissory Note | Convertible promissory notes | |||||||||
Subsequent events | |||||||||
Conversion price | $ / shares | $ 0.35 | ||||||||
Maximum beneficial ownership percentage | 9.99% | ||||||||
Interest rate (as a percent) | 25% | ||||||||
Convertible promissory notes | $ 2,000,000 | ||||||||
Maximum shares to be issued under conversion | 3,287,699 | ||||||||
Interest rate increase to per annum | 27% | ||||||||
Percentage of total issued and outstanding shares | 19.90% | ||||||||
Subsequent Event | SEPA | |||||||||
Subsequent events | |||||||||
Conversion price | $ / shares | $ 0.3068 | ||||||||
Maximum beneficial ownership percentage | 9.99% | ||||||||
Commitment amount | $ 5,000,000 | ||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | ||||||||
Amount of increase (decrease) in commitment to sell shares | $ 3,000,000 | ||||||||
Term of anniversary | 24 months | ||||||||
Percentage of market price | 95% | ||||||||
Percentage of outstanding common stock on the date of agreement | 19.90% | ||||||||
Threshold value of applicability of exchange cap | $ 0.3111 | ||||||||
Number of trading days proceeding the date of agreement | D | 5 | ||||||||
Amount of cash outflow for structuring fee | $ 10,000 | ||||||||
Number of shares issued during period as in lieu of commitment fee | shares | 603,318 | ||||||||
Amount of dividing factor for calculation of additional number of common stock to be issued | $ 120,000 | ||||||||
Number of trading days prior to the date of delivery | D | 5 | ||||||||
Shares issued for services | shares | 1,000,000 | ||||||||
Subsequent Event | Empery Entities | |||||||||
Subsequent events | |||||||||
Cash settlement payments | $ 75,000 | ||||||||
Convertible notes issued in settlement of legal proceedings | $ 1,656,720 | ||||||||
Conversion price | $ / shares | $ 0.3068 | ||||||||
Maximum beneficial ownership percentage | 9.99% | ||||||||
Subsequent Event | Sabby Entities | |||||||||
Subsequent events | |||||||||
Cash settlement payments | $ 75,000 | ||||||||
Convertible notes issued in settlement of legal proceedings | $ 1,656,720 | ||||||||
Maximum beneficial ownership percentage | 9.99% |