Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 01, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2023 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-40023 | |
Entity Registrant Name | GT BIOPHARMA, INC. | |
Entity Central Index Key | 0000109657 | |
Entity Tax Identification Number | 94-1620407 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 8000 Marina Blvd | |
Entity Address, Address Line Two | Suite 100 | |
Entity Address, City or Town | Brisbane | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94005 | |
City Area Code | 415 | |
Local Phone Number | 919-4040 | |
Title of 12(b) Security | Common Stock, $0.001 par value per share | |
Trading Symbol | GTBP | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 41,418,999 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 2,648 | $ 5,672 |
Short-term investments | 13,366 | 10,836 |
Prepaid expenses and other current assets | 38 | 54 |
Total Current Assets | 16,052 | 16,562 |
Operating lease right-of-use asset | 87 | 165 |
Deposits | 9 | 9 |
TOTAL ASSETS | 16,148 | 16,736 |
Current liabilities | ||
Accounts payable | 3,970 | 3,140 |
Accrued expenses | 1,028 | 1,669 |
Current operating lease liability | 92 | 110 |
Total Current Liabilities | 5,090 | 4,919 |
Non-current operating lease liability | 64 | |
Warrant liability | 1,053 | 19 |
Total Liabilities | 6,143 | 5,002 |
Stockholders’ Equity | ||
Convertible Preferred stock, par value $0.01, 15,000,000 shares authorized Series C - 96,230 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 1 | 1 |
Common stock, par value $0.001, 250,000,000 shares authorized, 41,418,999 shares and 32,722,452 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 42 | 33 |
Additional paid in capital | 689,065 | 686,168 |
Accumulated deficit | (679,103) | (674,468) |
Total Stockholders’ Equity | 10,005 | 11,734 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 16,148 | $ 16,736 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 15,000,000 | 15,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 250,000,000 | 250,000,000 |
Common stock, shares issued | 41,418,999 | 32,722,452 |
Common stock, shares outstanding | 41,418,999 | 32,722,452 |
Series C Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares issued | 96,230 | 96,230 |
Preferred stock, shares outstanding | 96,230 | 96,230 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
Revenues | ||||
Operating Expenses: | ||||
Research and development (including $0 and $201 expense from stock compensation granted to officers, directors and employees during the three months ended September 30, 2023 and 2022, and $13 and $327 for the nine months ended September 30, 2023 and 2022, respectively) | 1,364 | 2,743 | 5,109 | 5,969 |
Selling, general and administrative (including $0.5 million and $2.7 million expense from stock compensation granted to officers, directors and employees during the three months ended September 30, 2023 and 2022, respectively and $1.8 million and $3.5 million for the nine months ended September 30, 2023 and 2022, respectively) | 1,758 | 4,280 | 5,299 | 9,510 |
Loss from Operations | 3,122 | 7,023 | 10,408 | 15,479 |
Other (Income) Expense | ||||
Interest income | (216) | (107) | (600) | (151) |
Interest expense | 213 | |||
Change in fair value of derivative liability | (485) | (58) | (4,796) | (81) |
Gain on extinguishment of debt | (547) | |||
Unrealized (gain) loss on short term investments | (5) | 23 | (43) | 53 |
Total Other (Income) Expense | (706) | (142) | (5,773) | (179) |
Net Loss | $ (2,416) | $ (6,881) | $ (4,635) | $ (15,300) |
Net Loss Per Share - Basic | $ (0.06) | $ (0.22) | $ (0.12) | $ (0.48) |
Net Loss Per Share - Diluted | $ (0.06) | $ (0.22) | $ (0.12) | $ (0.48) |
Weighted average common shares outstanding - basic | 41,016,075 | 31,380,634 | 40,095,945 | 31,723,792 |
Weighted average common shares outstanding - diluted | 41,016,075 | 31,380,634 | 40,095,945 | 31,723,792 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parenthetical) - Officers Employees and Directors [Member] - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Research and Development Expense [Member] | ||||
Share-based payment arrangement, expense | $ 0 | $ 201 | $ 13 | $ 327 |
Selling, General and Administrative Expenses [Member] | ||||
Share-based payment arrangement, expense | $ 500 | $ 2,700 | $ 1,800 | $ 3,500 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Preferred Stock [Member] | Common Stock [Member] | Common Shares Issuable [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2021 | $ 1 | $ 32 | $ 1,113 | $ 674,348 | $ (653,584) | $ 21,910 |
Beginning balance, shares at Dec. 31, 2021 | 96,000 | 32,062,000 | 327,000 | |||
Issuance of common shares for services | 2,462 | 2,462 | ||||
Issuance of common shares for services, shares | 412,000 | |||||
Net loss | (15,300) | (15,300) | ||||
Equity compensation to officers, employees, and board of directors | $ 938 | 2,916 | 3,854 | |||
Equity compensation to officers, employees, and board of directors, shares | 242,000 | 378,000 | ||||
Issuance of common shares in settlement of vendors payable | $ 1 | 3,250 | 3,251 | |||
Issuance of common shares in settlement of vendors payable, shares | 1,222,000 | |||||
Cancellation of common stock upon settlement with former officer | $ (1) | (222) | (223) | |||
Cancellation of common stock upon settlement with former officer, shares | (1,845,000) | |||||
Cancellation of common stock | ||||||
Cancellation of common stock, shares | (291,000) | |||||
Common shares issued upon conversion of notes payable | $ (1,113) | 1,113 | ||||
Common shares issued upon conversion of notes payable, shares | 327,000 | (327,000) | ||||
Ending balance, value at Sep. 30, 2022 | $ 1 | $ 32 | $ 938 | 683,867 | (668,884) | 15,954 |
Ending balance, shares at Sep. 30, 2022 | 96,000 | 32,129,000 | 378,000 | |||
Beginning balance, value at Jun. 30, 2022 | $ 1 | $ 31 | 677,411 | (662,003) | 15,440 | |
Beginning balance, shares at Jun. 30, 2022 | 96,000 | 30,694,000 | ||||
Issuance of common shares for services | 1,200 | 1,200 | ||||
Issuance of common shares for services, shares | 135,000 | |||||
Net loss | (6,881) | (6,881) | ||||
Equity compensation to officers, employees, and board of directors | $ 938 | 2,006 | 2,944 | |||
Equity compensation to officers, employees, and board of directors, shares | 78,000 | 378,000 | ||||
Issuance of common shares in settlement of vendors payable | $ 1 | 3,250 | 3,251 | |||
Issuance of common shares in settlement of vendors payable, shares | 1,222,000 | |||||
Ending balance, value at Sep. 30, 2022 | $ 1 | $ 32 | $ 938 | 683,867 | (668,884) | 15,954 |
Ending balance, shares at Sep. 30, 2022 | 96,000 | 32,129,000 | 378,000 | |||
Beginning balance, value at Dec. 31, 2022 | $ 1 | $ 33 | 686,168 | (674,468) | 11,734 | |
Beginning balance, shares at Dec. 31, 2022 | 96,000 | 32,723,000 | ||||
Fair value of vested stock options | 1,337 | 1,337 | ||||
Issuance of common shares for services | 430 | 430 | ||||
Issuance of common shares for services, shares | 473,000 | |||||
Net loss | (4,635) | (4,635) | ||||
Private placement of common stock | $ 4 | 6,264 | 6,268 | |||
Private placement of common stock, shares | 3,600,000 | |||||
Initial recognition of fair value of warrant liability | (5,831) | (5,831) | ||||
Issuance of common stock for exercise of Prefunded Warrants | $ 3 | (3) | ||||
Issuance of common stock for exercise of Prefunded Warrants, shares | 2,900,000 | |||||
Issuance of common stock in settlement of accounts payable and accrued expenses | $ 2 | 700 | $ 702 | |||
Issuance of common stock in settlement of accounts payable, shares | 1,723,000 | |||||
Issuance of common shares in settlement of vendors payable, shares | 1,723,094 | |||||
Ending balance, value at Sep. 30, 2023 | $ 1 | $ 42 | 689,065 | (679,103) | $ 10,005 | |
Ending balance, shares at Sep. 30, 2023 | 96,000 | 41,419,000 | ||||
Beginning balance, value at Jun. 30, 2023 | $ 1 | $ 41 | 688,408 | (676,687) | 11,763 | |
Beginning balance, shares at Jun. 30, 2023 | 96,000 | 40,640,000 | ||||
Fair value of vested stock options | 433 | 433 | ||||
Issuance of common shares for services | $ 1 | 114 | 115 | |||
Issuance of common shares for services, shares | 400,000 | |||||
Issuance of common stock in settlement of accounts payable and accrued expenses | 110 | 110 | ||||
Issuance of common stock in settlement of accounts payable and accrued expenses, shares | 379,000 | |||||
Net loss | (2,416) | (2,416) | ||||
Ending balance, value at Sep. 30, 2023 | $ 1 | $ 42 | $ 689,065 | $ (679,103) | $ 10,005 | |
Ending balance, shares at Sep. 30, 2023 | 96,000 | 41,419,000 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |||||
Net loss | $ (2,416) | $ (6,881) | $ (4,635) | $ (15,300) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||
Stock based compensation – common shares for services | 430 | 5,713 | |||
Stock based compensation – vested stock options | 1,337 | 3,854 | |||
Change in fair value of warrant liability | (485) | (58) | (4,796) | (81) | |
Gain on extinguishment of debt | (547) | ||||
Unrealized (gain) loss on marketable securities | (43) | 53 | |||
Changes in operating assets and liabilities: | |||||
Decrease in prepaid expenses | 16 | 102 | |||
Increase in deposits | (9) | ||||
Decrease in operating lease right of use assets | 78 | 70 | |||
Increase (decrease) in accounts payable and accrued expenses | 1,437 | (5,259) | |||
(Decrease) in operating lease liability | (82) | (62) | |||
Net Cash Used in Operating Activities | (6,805) | (10,919) | |||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||
Sales (purchases) of investments | (2,487) | 4,639 | |||
Net Cash Provided by (Used in) Investing Activities | (2,487) | 4,639 | |||
CASH FLOWS FROM FINANCING ACTIVITIES | |||||
Proceeds from issuance of common stock and prefunded warrants | 6,268 | ||||
Cancellation of common stock upon settlement with former officer | (223) | ||||
Net Cash (Used in) Provided by Financing Activities | 6,268 | (223) | |||
Net Decrease in Cash | (3,024) | (6,503) | |||
Cash at Beginning of Period | 5,672 | 8,968 | $ 8,968 | ||
Cash at End of Period | $ 2,648 | $ 2,465 | 2,648 | 2,465 | $ 5,672 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | |||||
Interest | |||||
Income taxes paid | |||||
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES | |||||
Right-of-use assets exchanged for lease liabilities | 260 | ||||
Initial recognition of fair value of warrant liability | 5,831 | ||||
Fair value of common stock issued to settle accounts payable and accrued expenses | 700 | ||||
Common stock issued upon conversion of notes payable and accrued interest | $ 1,113 |
Organization and Operations
Organization and Operations | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Operations | Note 1 – Organization and Operations In 1965, the corporate predecessor of GT Biopharma, Inc. (Company), Diagnostic Data, Inc. was incorporated in the State of California. Diagnostic Data changed its incorporation to the State of Delaware in 1972 and changed its name to DDI Pharmaceuticals, Inc. in 1985. In 1994, DDI Pharmaceuticals merged with International BioClinical, Inc. and Bioxytech S.A. and changed its name to OXIS International, Inc. In July 2017, the Company changed its name to GT Biopharma, Inc. The Company is a clinical stage biopharmaceutical company focused on the development and commercialization of novel immune-oncology products based on our proprietary Tri-specific Killer Engager (TriKE®), and Tetra-specific Killer Engager (Dual Targeting TriKE®) platforms. The Company’s TriKE® and Dual Targeting TriKE® platforms generate proprietary therapeutics designed to harness and enhance the cancer killing abilities of a patient’s own natural killer cells (NK cells). |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2 – Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The consolidated condensed financial statements include the accounts of the Company and its wholly-owned subsidiaries, Oxis Biotech, Inc. and Georgetown Translational Pharmaceuticals, Inc. All intercompany transactions and balances have been eliminated in consolidation. The accompanying condensed consolidated financial statements are unaudited. These interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. Certain information and note disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC on March 30, 2023 (the “2022 Annual Report”). The consolidated balance sheets as of December 31, 2022 included herein, was derived from the audited consolidated financial statements as of that date. In the opinion of management, the accompanying unaudited condensed consolidated financial statements contain all adjustments necessary to fairly present the Company’s financial position and its results of operations for the interim periods reflected. Except as noted, all adjustments contained herein are of a normal recurring nature. Results of operations for the fiscal periods presented herein are not necessarily indicative of fiscal year-end results. Liquidity The accompanying consolidated financial statements have been prepared under the assumption that the Company will continue as a going concern. Such assumptions contemplate the realization of assets and satisfaction of liabilities in the normal course of business. For the nine months ended September 30, 2023, the Company recorded a net loss of $ 4.6 6.8 16.0 11.0 10.0 16.0 Historically, the Company has financed its operations through public and private sales of common stock, issuance of preferred and common stock, issuance of convertible debt instruments, and strategic collaborations. There can be no assurances that the Company will be able to secure additional financing on acceptable terms. In the event the Company does not generate sufficient cash flows from investing and financing activities, the Company will be forced to delay, reduce, or eliminate some or all of its discretionary spending, which could adversely affect the Company’s business prospects, ability to meet long-term liquidity needs or ability to continue its operations. COVID-19 The global COVID-19 pandemic continues to present uncertainty and unforeseeable risks to our operations and business plans. The Company has closely monitored recent developments, including the lifting of COVID-19 safety measures, the spread of new strains or variants of the coronavirus (such as the Delta and Omicron variants), and supply chain, raw materials and labor shortages. Thus, the full impact of the COVID-19 pandemic on the business and operations remains uncertain and will vary depending on the pandemic’s future impact on the third parties with whom the Company does business, as well as any legal or regulatory consequences resulting therefrom. The Company has been following the recommendations of health authorities to minimize exposure risk for its team members and may take further actions that alter our operations, including any required by federal, state or local authorities, or that it determines are in the best interests of its employees and other third parties with whom GT Biopharma does business. Accounting Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include accruals for potential liabilities, assumptions used in deriving the fair value of warrant liabilities, valuation of equity instruments issued for debt and services and realization of deferred tax assets. Actual results could differ from those estimates. Cash Equivalents and Short-Term Investments The Company considers highly liquid investments with maturities of three months or less at the date of acquisition as cash equivalents in the accompanying condensed consolidated financial statements. Total cash equivalents, which consist of money market funds, totaled approximately $ 2.5 5.5 The Company also invested its excess cash in commercial paper and corporate notes and bonds. Management generally determines the appropriate classification of its investments at the time of purchase. We classify these investments as short-term investments as part of current assets, based upon our ability and intent to use any and all of these investments as necessary to satisfy liquidity requirements that may arise from our business. Investments are carried at fair value with the unrealized holding gains and losses reported in the accompanying condensed consolidated statements of operations. Total short-term investments totaled approximately $ 13.4 10.8 Fair Value of Financial Instruments Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 820-10 requires entities to disclose the fair value of financial instruments, both assets and liabilities recognized and not recognized on the balance sheet for which it is practicable to estimate fair value. ASC 820-10 defines the fair value of a financial instrument as the amount at which the instrument could be exchanged in a current transaction between willing parties. The three levels of the fair value hierarchy are as follows: Level 1 Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the entity has the ability to access. Level 2 Valuations based on quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable data for substantially the full term of the assets or liabilities. Level 3 Valuations based on inputs that are unobservable, supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The carrying amount of the Company’s warrant liability of $ 1.1 0.02 The carrying amounts of the Company’s other financial assets and liabilities such as cash, other current assets, accounts payable and accrued expenses approximate their fair values because of the short maturity of these instruments. Derivatives and Liability-Classified Instruments The Company accounts for common stock warrants as either equity-classified or liability-classified instruments based on an assessment of the specific terms of the warrants and the guidance provided by the FASB in ASC 480 , Distinguishing Liabilities from Equity (ASC 480) Derivatives and Hedging (ASC 815) Stock-Based Compensation The Company accounts for share-based awards to employees, nonemployees, and consultants in accordance with the provisions of ASC 718, Compensation-Stock Compensation The Company values its equity awards using the Black-Scholes option pricing model, and accounts for forfeitures when they occur. Use of the Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term, and a risk-free interest rate. The Company estimates volatility using its own historical stock price volatility. The expected term of the instrument is estimated by using the simplified method to estimate expected term. The risk-free interest rate is estimated using comparable published federal funds rates. Research and Development Costs Costs incurred for research and development are expensed as incurred. The salaries, benefits, and overhead costs of personnel conducting research and development of the Company’s products are included in research and development costs. Purchased materials that do not have an alternative future use are also expensed. Leases The Company accounts for its leases in accordance with the guidance of ASC 842, Leases. The Company determines whether a contract is, or contains, a lease at inception. Right-of-use assets represent the Company’s right to use an underlying asset during the lease term, and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Right-of-use assets and lease liabilities are recognized at lease commencement based upon the estimated present value of unpaid lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at lease commencement in determining the present value of unpaid lease payments (see Note 8 – Operating Leases for the Company’s lease disclosures). Net Loss Per Share Basic loss per share is computed using the weighted-average number of common shares outstanding during the period. Common stock issuable is included in our calculation as of the date of the underlying agreement. Diluted loss per share is computed using the weighted-average number of common shares and the dilutive effect of contingent shares outstanding during the period. Potentially dilutive contingent shares, which primarily consist of stock issuable for the exercise of stock options and warrants, have been excluded from the diluted loss per share calculation because their effect is anti-dilutive. These following common stock equivalents were excluded in the computation of the net loss per share because their effect is anti-dilutive: Schedule of Anti-dilutive Securities September 30, 2023 September 30, 2022 (Unaudited) (Unaudited) Options to purchase common stock 3,737,952 1,835,452 Warrants to purchase common stock 9,148,880 2,337,274 Unvested restricted common stock - 295,588 Total anti-dilutive securities 12,886,832 4,468,314 Concentration Cash is deposited in one financial institution. The balances held at this financial institution at times may be in excess of Federal Deposit Insurance Corporation (“FDIC”) insurance limits of up to $ 250 The Company has a significant concentration of expenses incurred and accounts payable from a single vendor (see Note 4 – Accounts Payable for further information). Segments The Company determined its reporting units in accordance with ASC 280, “ Segment Reporting” (“ASC 280”). Management evaluates a reporting unit by first identifying its’ operating segments under ASC 280. The Company then evaluates each operating segment to determine if it includes one or more components that constitute a business. If there are components within an operating segment that meet the definition of a business, the Company evaluates those components to determine if they must be aggregated into one or more reporting units. If applicable, when determining if it is appropriate to aggregate different operating segments, the Company determines if the segments are economically similar and, if so, the operating segments are aggregated. Management has determined that the Company has one consolidated operating segment. The Company’s reporting segment reflects the manner in which its chief operating decision maker reviews results and allocates resources. The Company’s reporting segment meets the definition of an operating segment and does not include the aggregation of multiple operating segments. Recent Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Credit Losses – Measurement of Credit Losses on Financial Instruments In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the SEC did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statements. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | Note 3 – Fair Value of Financial Instruments The estimated fair values of financial instruments outstanding were as follow: Schedule of Estimated Fair Value of Financial Instrument September 30, 2023 (Unaudited) Unrealized Unrealized Fair Cost Gains Losses Value Short-term investments $ 13,323 $ 43 $ — $ 13,366 Total $ 13,323 $ 43 $ — $ 13,366 December 31, 2022 Unrealized Unrealized Fair Cost Gains Losses Value Short-term investments $ 10,866 $ — $ (30 ) $ 10,836 Total $ 10,866 $ — $ (30 ) $ 10,836 The following table represents the Company’s fair value hierarchy for its financial assets (cash equivalents and investments): Schedule of Fair Value Hierarchy Financial Assets Fair Value Level 1 Level 2 Level 3 September 30, 2023 (Unaudited) Fair Value Level 1 Level 2 Level 3 Money market funds $ 2,474 $ 2,474 $ — $ — Corporate notes and commercial paper 13,366 13,366 — — Total financial assets $ 15,840 $ 15,840 $ — $ — Fair Value Level 1 Level 2 Level 3 December 31, 2022 Fair Value Level 1 Level 2 Level 3 Money market funds $ 5,505 $ 5,505 $ — $ — Corporate notes and commercial paper 10,836 10,836 — — Total financial assets $ 16,341 $ 16,341 $ — $ — As of September 30, 2023, the fair value of the warrant liability amounted to $ 1,053 Schedule of Derivative Liability Transactions September 30, 2023 September 30, 2022 September 30, 2023 September 30, 2022 Three Months Ending Nine Months Ending September 30, 2023 September 30, 2022 September 30, 2023 September 30, 2022 (Unaudited) (Unaudited) (Unaudited) (Unaudited) Beginning balance $ 1,538 $ 115 $ 19 $ 138 Fair value upon issuance of warrants — — 5,830 — Change in fair value (485 ) (58 ) (4,796 ) (81 ) Ending balance $ 1,053 $ 57 $ 1,053 $ 57 |
Accounts Payable
Accounts Payable | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accounts Payable | Note 4 – Accounts Payable Accounts payable consisted of the following: Schedule of Accounts Payable September 30, 2023 December 31, 2022 (Unaudited) Accounts payable to a third-party manufacturer $ 3,144 $ 2,283 Other accounts payable 826 857 Total accounts payable $ 3,970 $ 3,140 Accounts payable $ 3,970 $ 3,140 The Company relies on a third-party contract manufacturing operation to produce and/or test our compounds used in our potential product candidates. In October 2020, the Company entered into a Master Services Agreement with a third-party product manufacturer to perform biologic development and manufacturing services on behalf of the Company. Associated with this, the Company has subsequently executed a number of Statements of Work for the research and development of products for use in clinical trials. On August 24, 2022, existing agreements with the third-party product manufacturer were amended. As part of the amendment, the third-party manufacturer agreed that services to be rendered in future periods, will be paid or settled at the Company’s discretion, in a combination of cash and issuance of the Company’s common stock. The amendment also eliminated future financial commitments of the Company. During the nine months ended September 30, 2023 the Company incurred $ 3.7 million in research and development expenses to account for services rendered by the third-party product manufacturer. In addition, the Company paid cash of $ 1.7 million and issued 1.3 million shares of its common stock with a fair value of $ 0.59 in settlement of accounts payable of $ 1.1 million, which resulted in a gain on settlement of $ 0.55 The shares were valued at the respective date of issuance. The outstanding accounts payable balance due to the third-party product manufacturer totaled $ 3.1 million and $ 2.3 million as of September 30, 2023 and December 31, 2022, respectively. |
Warrant Liability
Warrant Liability | 9 Months Ended |
Sep. 30, 2023 | |
Warrant Liability | |
Warrant Liability | Note 5 – Warrant Liability 2023 Warrants On January 4, 2023, as part of the private placement offering, the Company issued common stock, warrants to purchase up to an aggregate of 6,500,000 390,000 The Purchase Warrant provides for a value calculation for the Purchase Warrant using the Black Scholes model in the event of certain fundamental transactions. The fair value calculation provides for a floor on the volatility amount utilized in the value calculation at 100 5.8 As of September 30, 2023, the fair value of the warrant liability was $ 1.3 All changes in the fair value of the warrant liabilities are recognized as a change in fair value of warrant liability in the Company’s condensed consolidated statements of operations until they are either exercised or expire. The warrant liabilities for the Common Warrants and the Placement Agents Warrants were valued using a Binomial pricing model with the following weighted average assumptions: Schedule of Derivative Liabilities Assumptions Common Warrants and Placement Agents Warrants September 30, 2023 At Inception (Unaudited) (Unaudited) Stock price $ 0.24 $ 1.20 Risk-free interest rate 4.6 % 3.60 % Expected volatility 119.7 % 121.5 % Expected life (in years) 4.5 5.0 Expected dividend yield - - Fair value of warrants (in thousands) $ 1,053 $ 5,831 2020 Warrants The Company issued certain warrants during the year ended December 31, 2020 that contained a fundamental transaction provision that could give rise to an obligation to pay cash to the warrant holder upon occurrence of certain change in control type events. In accordance with ASC 480, the fair value of these warrants is classified as a liability in the Condensed Consolidated Balance Sheets and will be re-measured at the end of every reporting period with the change in value reported in the Condensed Consolidated Statements of Operations. The warrant liabilities for the 2020 Warrants were valued using a Binomial pricing model with the following assumptions: Schedule of Derivative Liabilities Assumptions September 30, December 31, 2023 2022 (Unaudited) Stock price $ 0.24 $ 0.89 Risk-free interest rate 4.95 % 4.22 % Expected volatility 89 % 109 % Expected life (in years) 1.8 2.6 Expected dividend yield - - Fair value of warrants $ 2 $ 19 During the three months and nine months ended September 30, 2023, the Company recognized a gain of $ 0.5 4.8 0.06 0.08 The risk-free interest rate was based on rates established by the Federal Reserve Bank. The Company uses the historical volatility of its common stock to estimate the future volatility for its common stock. The expected life of the warrant securities was determined by the remaining contractual life of the warrant instrument. The expected dividend yield was based on the fact that the Company has not paid dividends to its common stockholders in the past and does not expect to pay dividends to its common stockholders in the future. |
Stockholders_ Equity
Stockholders’ Equity | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity | Note 6 – Stockholders’ Equity The Company’s authorized capital as of September 30, 2023 was 250,000,000 0.001 15,000,000 0.01 Common Stock Private Placement of Common Stock On January 4, 2023, GT Biopharma received gross proceeds of $ 6.5 232 3,600,000 0.001 2,900,000 6,500,000 390,000 1.00 0.0001 1.25 1.00 0.9999 The Common Warrants and the Placement Agents Warrants contained a clause not considered to be within the Company’s control. The Company determined that the provision represented a variable that is not an input to the fair value of a “fixed-for-fixed” option as defined under ASC 815-40, and thus the Common Warrants and the Placement Agent Warrants are not considered indexed to the Company’s own stock and not eligible for an exception from derivative accounting. Accordingly, the Common Warrants and the Placement Agent Warrants were classified as a warrant liability, and $ 5.8 In May 2023, the 2,900,000 0.290 2,900,000 0.0001 Common Stock Issuable On February 16, 2021, because of the mandatory conversion of the notes payable and accrued interest in the aggregate amount of $ 38.8 11,413,322 11,086,024 327,298 1.1 Cancellation of Common Stock The Company cancelled 290,999 Common Stock Issued for Services During the three and nine months ended September 30, 2023, the Company issued 400 473 115 430 During the three and nine months ended September 30, 2022, the Company issued 135 412 1,200 2,462 Common Stock Issued for Accounts Payable During the nine months ended September 30, 2023, the Company issued a total of 1,723,094 shares of common stock with a fair value of $ 702 to settle accounts payable and accrued expenses of $ 1.2 million. As a result, the Company recorded a gain of $ 547 to account for the difference between the fair value of the common stock issued and the account payable settled. The common stock issued were valued at the respective date of their issuance. Preferred Stock Series C Preferred Stock At September 30, 2023 and December 31, 2022, there were 96,230 0.01 As a result of reverse stock splits in previous years and the agreement terms for adjusting the rights of the related shares, the 96,230 shares of Series C Preferred Stock are not convertible to common stock, have no voting rights, and in the event of liquidation, the holders of the Series C Preferred Stock would not participate in any distribution of the assets or surplus funds of the Company. The holders of Series C Preferred Stock also are not currently entitled to any dividends if and when declared by the Company’s board of directors (the “Board”). No dividends to holders of the Series C Preferred Stock were declared or unpaid as of and for the period ended September 30, 2023. Series K Preferred Stock On February 16, 2021, the Board designated 115,000 .01 Shares of the Series K Preferred Stock are convertible at any time, at the option of the holders, into shares of the Company’s common stock at an effective conversion rate of 100 As of September 30, 2023 and December 31, 2022, there were no Warrants and Options Common Stock Warrants Common stock warrant transactions for the nine months ended September 30, 2023 were as follows: Schedule of Warrant Activity Number of Weighted Average Warrants Exercise Price Warrant outstanding at December 31, 2022: 2,337,274 $ 5.30 Granted 9,790,000 0.71 Forfeited/canceled (78,394 ) 3.40 Exercised (2,900,000 ) 0.0001 Warrants outstanding at September 30, 2023 9,148,880 $ 2.11 Warrants exercisable at September 30, 2023 2,258,880 $ 5.45 The warrants had an exercise price greater than the market price, which resulted in no intrinsic value. Warrants outstanding as of September 30, 2023 are exercisable as follows: Schedule of Warrants Outstanding Warrants Outstanding Warrants Exercisable Range of Exercise Price Number Outstanding Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Number Exercisable Weighted Average Exercise Price $ 1.00 1.25 6,890,000 4.8 $ 1.01 - $ - 3.40 5.50 2,258,880 2.4 5.45 2,258,880 5.45 9,148,880 2,258,880 Common Stock Options Common stock option transactions for the nine months ended September 30, 2023 were as follows: Schedule of Options Activity Number of Weighted Average Options Exercise Price Options outstanding at December 31, 2022 1,630,452 $ 2.57 Granted 2,500,000 0.75 Forfeited/canceled (392,500 ) 2.81 Exercised - - Options outstanding at September 30, 2023 3,737,952 $ 1.32 Options vested and exercisable at September 30, 2023 2,833,651 $ 1.52 The Company recognized the corresponding stock compensation expense for options granted to certain consultants, employees, officers and directors based upon their vesting term. On January 27, 2023, the Company granted stock options to employees and members of its board of directors to purchase an aggregate of 2.0 0.85 10 1.4 On May 15, 2023, the Company granted stock options to a member of its board of directors to purchase 500,000 0.35 10 150 The Company used the following weighted average assumptions in the Black-Scholes Option Pricing model to compute the fair value of the stock options granted during the period ended September 30, 2023. Schedule of Stock Granted Assumptions Stock price $ $ 0.35 0.85 Risk-free interest rate 3.62 3.99 % Expected volatility 120.81 123.61 % Expected life (in years) 5.3 Expected dividend yield - For the three months and nine months ended September 30, 2023, the Company recognized stock compensation expense relating to the vesting of options granted in 2023 and prior years of $ 433 1,337 Options outstanding as of September 30, 2023 are exercisable as follows: Schedule of Options Outstanding Options Outstanding Options Exercisable Range of Exercise Price Number Outstanding Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Number Exercisable Weighted Average Exercise Price $ 2.48 1,237,952 8.8 $ 2.48 1,166,984 $ 2.48 0.85 2,000,000 9.4 0.85 1,500,000 0.85 0.35 500,000 9.7 0.35 166,667 0.35 3,737,952 2,833,651 At September 30, 2023, fair value of unvested options totaled $ 904 There was no intrinsic value of the outstanding options as of September 30, 2023 as the exercise price of these options was greater than the market price. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 7 – Commitments and Contingencies Litigation The Company is involved in certain legal proceedings that arise from time to time in the ordinary course of our business. Except for income tax contingencies, we record accruals for contingencies to the extent that our management concludes that the occurrence is probable and that the related amounts of loss can be reasonably estimated. Legal expenses associated with the contingency are expensed as incurred. There is no current or pending litigation of any significance with the exception of the matters that have arisen under, and are being handled in, the normal course of business. On May 11, 2023, our former interim Chief Executive Officer, Dr. Greg Berk, filed a complaint with the Occupational Safety and Health Administration alleging retaliation against him during his tenure at the Company for raising concerns related to the public disclosure of certain product timelines. The Company is vigorously defending this matter and believe it to be without merit. At this early stage in the proceedings, the Company is not able to determine the probability of the outcome of this matter or a range of reasonably expected losses, if any. On May 13, 2022, the Company made a claim against Michael Handelman, its former Chief Financial Officer, asserting that he misappropriated Company funds and shares of common stock, and failed to file the required SEC reports on Form 3 and Form 4 regarding each acquisition and disposition of the Company’s common stock. The Company seeks monetary damages estimated at $ 370 On May 24, 2023, TWF Global, LLC (“TWF”) filed a Complaint in the California Superior Court for the County of Los Angeles naming the Company as defendant. The Complaint alleges that TWF is the holder of two Convertible Promissory Notes (“Notes”) and that the Company did not deliver shares of common stock due on conversion in February 2021. TWF was seeking per diem liquidated damages based on the terms of alleged Notes. On July 14, 2023, the Company filed a motion to dismiss for improper forum because the terms of the Notes, as alleged, require disputes to be filed in New York state and federal courts. TWF has recently dismissed without prejudice its Complaint before the California Superior Court of Los Angeles. The Company also filed a Summons and Complaint for Interpleader against TWF and Z One LLC before the Supreme Court of the State of New York County of New York asking the Supreme Court to determine if the Company’s shares of common stock are properly registered to TWF or Z One LLC, as both of these entities have made conflicting demands for registration of the shares of common stock. The Company believes that TWF’s claims are without merit and will continue to defend vigorously against these claims. Significant Agreements Research and Development Agreements In June 2017, we entered into a co-development partnership agreement with Altor BioScience Corporation in which we will collaborate exclusively in the clinical development of a novel 161533 (GTB-3550) TriKE ® ® The Company is a party to a scientific research agreement with the Regents of the University of Minnesota (“UofMN”), effective June 16, 2021. This scientific research agreement aims to work with the Company with three major goals in mind: (1) support the Company’s TriKE ® ® ® ® ® ® 2.1 For the three months and nine months ended September 30, 2023 and 2022, the Company recorded an expense of $ 0.2 0.6 2.1 Patent and License Agreements 2016 Exclusive Patent License Agreement The Company is party to an exclusive worldwide license agreement with the Regents of the University of Minnesota, (“UofMN”), to further develop and commercialize cancer therapies using TriKE ® ® ® 200 100 4 6 250 5.0 3.1 1.0 250 5.0 500 The Company did no 2021 Patent License Agreement On March 26, 2021, the Company signed an agreement specific to the B7H3 targeted TriKE ® 20,000 5 2.5 5 250 2.0 3.1 1.0 250 5.0 500 The Company did no |
Operating Leases
Operating Leases | 9 Months Ended |
Sep. 30, 2023 | |
Operating Leases | |
Operating Leases | Note 8 – Operating Leases On November 19, 2021, the Company entered into a sublease with a third party for 4,500 commencement date of January 1, 2022 and maturing on June 30, 2024 247 On February 8, 2022, the Company entered into a copier lease which will end on February 7, 2025. As a result, the Company recognized additional ROU asset and liability of $ 13 As a result of these lease agreements, the Company recognized ROU asset and liability in the aggregate of $ 260 Rent expense related to these leases reflected as part of selling, general and administrative expenses on the Company’s Condensed Consolidated Statements of Operations totaled $ 29 88 29 58 Other information related to leases and future minimum lease payments under non-cancellable operating leases were as follows: Schedule of Other Information Related Leases Under Non-Cancellable September 30, 2023 September 30, 2022 (Unaudited) (Unaudited) Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 78 $ 79 Right-of-use assets obtained in exchange for lease liabilities: Operating leases $ 87 $ 260 Weighted-average remaining lease term (in years): Operating leases 0.8 2.0 Weighted-average discount rate: Operating leases 10 % 10 % Future minimum lease payments under non-cancellable operating leases were as follows: Schedule of Future Minimum Lease Payments September 30, 2023 (Unaudited) Within one year $ 95 After one year and within two years 2 Thereafter - Total future minimum lease payments $ 97 Less – discount (5 ) Lease liability $ 92 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The consolidated condensed financial statements include the accounts of the Company and its wholly-owned subsidiaries, Oxis Biotech, Inc. and Georgetown Translational Pharmaceuticals, Inc. All intercompany transactions and balances have been eliminated in consolidation. The accompanying condensed consolidated financial statements are unaudited. These interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. Certain information and note disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC on March 30, 2023 (the “2022 Annual Report”). The consolidated balance sheets as of December 31, 2022 included herein, was derived from the audited consolidated financial statements as of that date. In the opinion of management, the accompanying unaudited condensed consolidated financial statements contain all adjustments necessary to fairly present the Company’s financial position and its results of operations for the interim periods reflected. Except as noted, all adjustments contained herein are of a normal recurring nature. Results of operations for the fiscal periods presented herein are not necessarily indicative of fiscal year-end results. |
Liquidity | Liquidity The accompanying consolidated financial statements have been prepared under the assumption that the Company will continue as a going concern. Such assumptions contemplate the realization of assets and satisfaction of liabilities in the normal course of business. For the nine months ended September 30, 2023, the Company recorded a net loss of $ 4.6 6.8 16.0 11.0 10.0 16.0 Historically, the Company has financed its operations through public and private sales of common stock, issuance of preferred and common stock, issuance of convertible debt instruments, and strategic collaborations. There can be no assurances that the Company will be able to secure additional financing on acceptable terms. In the event the Company does not generate sufficient cash flows from investing and financing activities, the Company will be forced to delay, reduce, or eliminate some or all of its discretionary spending, which could adversely affect the Company’s business prospects, ability to meet long-term liquidity needs or ability to continue its operations. |
COVID-19 | COVID-19 The global COVID-19 pandemic continues to present uncertainty and unforeseeable risks to our operations and business plans. The Company has closely monitored recent developments, including the lifting of COVID-19 safety measures, the spread of new strains or variants of the coronavirus (such as the Delta and Omicron variants), and supply chain, raw materials and labor shortages. Thus, the full impact of the COVID-19 pandemic on the business and operations remains uncertain and will vary depending on the pandemic’s future impact on the third parties with whom the Company does business, as well as any legal or regulatory consequences resulting therefrom. The Company has been following the recommendations of health authorities to minimize exposure risk for its team members and may take further actions that alter our operations, including any required by federal, state or local authorities, or that it determines are in the best interests of its employees and other third parties with whom GT Biopharma does business. |
Accounting Estimates | Accounting Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include accruals for potential liabilities, assumptions used in deriving the fair value of warrant liabilities, valuation of equity instruments issued for debt and services and realization of deferred tax assets. Actual results could differ from those estimates. |
Cash Equivalents and Short-Term Investments | Cash Equivalents and Short-Term Investments The Company considers highly liquid investments with maturities of three months or less at the date of acquisition as cash equivalents in the accompanying condensed consolidated financial statements. Total cash equivalents, which consist of money market funds, totaled approximately $ 2.5 5.5 The Company also invested its excess cash in commercial paper and corporate notes and bonds. Management generally determines the appropriate classification of its investments at the time of purchase. We classify these investments as short-term investments as part of current assets, based upon our ability and intent to use any and all of these investments as necessary to satisfy liquidity requirements that may arise from our business. Investments are carried at fair value with the unrealized holding gains and losses reported in the accompanying condensed consolidated statements of operations. Total short-term investments totaled approximately $ 13.4 10.8 |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 820-10 requires entities to disclose the fair value of financial instruments, both assets and liabilities recognized and not recognized on the balance sheet for which it is practicable to estimate fair value. ASC 820-10 defines the fair value of a financial instrument as the amount at which the instrument could be exchanged in a current transaction between willing parties. The three levels of the fair value hierarchy are as follows: Level 1 Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the entity has the ability to access. Level 2 Valuations based on quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable data for substantially the full term of the assets or liabilities. Level 3 Valuations based on inputs that are unobservable, supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The carrying amount of the Company’s warrant liability of $ 1.1 0.02 The carrying amounts of the Company’s other financial assets and liabilities such as cash, other current assets, accounts payable and accrued expenses approximate their fair values because of the short maturity of these instruments. |
Derivatives and Liability-Classified Instruments | Derivatives and Liability-Classified Instruments The Company accounts for common stock warrants as either equity-classified or liability-classified instruments based on an assessment of the specific terms of the warrants and the guidance provided by the FASB in ASC 480 , Distinguishing Liabilities from Equity (ASC 480) Derivatives and Hedging (ASC 815) |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for share-based awards to employees, nonemployees, and consultants in accordance with the provisions of ASC 718, Compensation-Stock Compensation The Company values its equity awards using the Black-Scholes option pricing model, and accounts for forfeitures when they occur. Use of the Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term, and a risk-free interest rate. The Company estimates volatility using its own historical stock price volatility. The expected term of the instrument is estimated by using the simplified method to estimate expected term. The risk-free interest rate is estimated using comparable published federal funds rates. |
Research and Development Costs | Research and Development Costs Costs incurred for research and development are expensed as incurred. The salaries, benefits, and overhead costs of personnel conducting research and development of the Company’s products are included in research and development costs. Purchased materials that do not have an alternative future use are also expensed. |
Leases | Leases The Company accounts for its leases in accordance with the guidance of ASC 842, Leases. The Company determines whether a contract is, or contains, a lease at inception. Right-of-use assets represent the Company’s right to use an underlying asset during the lease term, and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Right-of-use assets and lease liabilities are recognized at lease commencement based upon the estimated present value of unpaid lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at lease commencement in determining the present value of unpaid lease payments (see Note 8 – Operating Leases for the Company’s lease disclosures). |
Net Loss Per Share | Net Loss Per Share Basic loss per share is computed using the weighted-average number of common shares outstanding during the period. Common stock issuable is included in our calculation as of the date of the underlying agreement. Diluted loss per share is computed using the weighted-average number of common shares and the dilutive effect of contingent shares outstanding during the period. Potentially dilutive contingent shares, which primarily consist of stock issuable for the exercise of stock options and warrants, have been excluded from the diluted loss per share calculation because their effect is anti-dilutive. These following common stock equivalents were excluded in the computation of the net loss per share because their effect is anti-dilutive: Schedule of Anti-dilutive Securities September 30, 2023 September 30, 2022 (Unaudited) (Unaudited) Options to purchase common stock 3,737,952 1,835,452 Warrants to purchase common stock 9,148,880 2,337,274 Unvested restricted common stock - 295,588 Total anti-dilutive securities 12,886,832 4,468,314 |
Concentration | Concentration Cash is deposited in one financial institution. The balances held at this financial institution at times may be in excess of Federal Deposit Insurance Corporation (“FDIC”) insurance limits of up to $ 250 The Company has a significant concentration of expenses incurred and accounts payable from a single vendor (see Note 4 – Accounts Payable for further information). |
Segments | Segments The Company determined its reporting units in accordance with ASC 280, “ Segment Reporting” (“ASC 280”). Management evaluates a reporting unit by first identifying its’ operating segments under ASC 280. The Company then evaluates each operating segment to determine if it includes one or more components that constitute a business. If there are components within an operating segment that meet the definition of a business, the Company evaluates those components to determine if they must be aggregated into one or more reporting units. If applicable, when determining if it is appropriate to aggregate different operating segments, the Company determines if the segments are economically similar and, if so, the operating segments are aggregated. Management has determined that the Company has one consolidated operating segment. The Company’s reporting segment reflects the manner in which its chief operating decision maker reviews results and allocates resources. The Company’s reporting segment meets the definition of an operating segment and does not include the aggregation of multiple operating segments. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Credit Losses – Measurement of Credit Losses on Financial Instruments In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the SEC did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Anti-dilutive Securities | These following common stock equivalents were excluded in the computation of the net loss per share because their effect is anti-dilutive: Schedule of Anti-dilutive Securities September 30, 2023 September 30, 2022 (Unaudited) (Unaudited) Options to purchase common stock 3,737,952 1,835,452 Warrants to purchase common stock 9,148,880 2,337,274 Unvested restricted common stock - 295,588 Total anti-dilutive securities 12,886,832 4,468,314 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Estimated Fair Value of Financial Instrument | The estimated fair values of financial instruments outstanding were as follow: Schedule of Estimated Fair Value of Financial Instrument September 30, 2023 (Unaudited) Unrealized Unrealized Fair Cost Gains Losses Value Short-term investments $ 13,323 $ 43 $ — $ 13,366 Total $ 13,323 $ 43 $ — $ 13,366 December 31, 2022 Unrealized Unrealized Fair Cost Gains Losses Value Short-term investments $ 10,866 $ — $ (30 ) $ 10,836 Total $ 10,866 $ — $ (30 ) $ 10,836 |
Schedule of Fair Value Hierarchy Financial Assets | The following table represents the Company’s fair value hierarchy for its financial assets (cash equivalents and investments): Schedule of Fair Value Hierarchy Financial Assets Fair Value Level 1 Level 2 Level 3 September 30, 2023 (Unaudited) Fair Value Level 1 Level 2 Level 3 Money market funds $ 2,474 $ 2,474 $ — $ — Corporate notes and commercial paper 13,366 13,366 — — Total financial assets $ 15,840 $ 15,840 $ — $ — Fair Value Level 1 Level 2 Level 3 December 31, 2022 Fair Value Level 1 Level 2 Level 3 Money market funds $ 5,505 $ 5,505 $ — $ — Corporate notes and commercial paper 10,836 10,836 — — Total financial assets $ 16,341 $ 16,341 $ — $ — |
Schedule of Derivative Liability Transactions | Schedule of Derivative Liability Transactions September 30, 2023 September 30, 2022 September 30, 2023 September 30, 2022 Three Months Ending Nine Months Ending September 30, 2023 September 30, 2022 September 30, 2023 September 30, 2022 (Unaudited) (Unaudited) (Unaudited) (Unaudited) Beginning balance $ 1,538 $ 115 $ 19 $ 138 Fair value upon issuance of warrants — — 5,830 — Change in fair value (485 ) (58 ) (4,796 ) (81 ) Ending balance $ 1,053 $ 57 $ 1,053 $ 57 |
Accounts Payable (Tables)
Accounts Payable (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accounts Payable | Accounts payable consisted of the following: Schedule of Accounts Payable September 30, 2023 December 31, 2022 (Unaudited) Accounts payable to a third-party manufacturer $ 3,144 $ 2,283 Other accounts payable 826 857 Total accounts payable $ 3,970 $ 3,140 Accounts payable $ 3,970 $ 3,140 |
Warrant Liability (Tables)
Warrant Liability (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Short-Term Debt [Line Items] | |
Schedule of Derivative Liabilities Assumptions | Schedule of Stock Granted Assumptions Stock price $ $ 0.35 0.85 Risk-free interest rate 3.62 3.99 % Expected volatility 120.81 123.61 % Expected life (in years) 5.3 Expected dividend yield - |
2023 Warrants [Member] | |
Short-Term Debt [Line Items] | |
Schedule of Derivative Liabilities Assumptions | The warrant liabilities for the Common Warrants and the Placement Agents Warrants were valued using a Binomial pricing model with the following weighted average assumptions: Schedule of Derivative Liabilities Assumptions Common Warrants and Placement Agents Warrants September 30, 2023 At Inception (Unaudited) (Unaudited) Stock price $ 0.24 $ 1.20 Risk-free interest rate 4.6 % 3.60 % Expected volatility 119.7 % 121.5 % Expected life (in years) 4.5 5.0 Expected dividend yield - - Fair value of warrants (in thousands) $ 1,053 $ 5,831 |
2020 Warrants [Member] | |
Short-Term Debt [Line Items] | |
Schedule of Derivative Liabilities Assumptions | The warrant liabilities for the 2020 Warrants were valued using a Binomial pricing model with the following assumptions: Schedule of Derivative Liabilities Assumptions September 30, December 31, 2023 2022 (Unaudited) Stock price $ 0.24 $ 0.89 Risk-free interest rate 4.95 % 4.22 % Expected volatility 89 % 109 % Expected life (in years) 1.8 2.6 Expected dividend yield - - Fair value of warrants $ 2 $ 19 |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Class of Warrant or Right [Line Items] | |
Schedule of Warrants Outstanding | Common stock warrant transactions for the nine months ended September 30, 2023 were as follows: Schedule of Warrant Activity Number of Weighted Average Warrants Exercise Price Warrant outstanding at December 31, 2022: 2,337,274 $ 5.30 Granted 9,790,000 0.71 Forfeited/canceled (78,394 ) 3.40 Exercised (2,900,000 ) 0.0001 Warrants outstanding at September 30, 2023 9,148,880 $ 2.11 Warrants exercisable at September 30, 2023 2,258,880 $ 5.45 |
Schedule of Options Activity | Common stock option transactions for the nine months ended September 30, 2023 were as follows: Schedule of Options Activity Number of Weighted Average Options Exercise Price Options outstanding at December 31, 2022 1,630,452 $ 2.57 Granted 2,500,000 0.75 Forfeited/canceled (392,500 ) 2.81 Exercised - - Options outstanding at September 30, 2023 3,737,952 $ 1.32 Options vested and exercisable at September 30, 2023 2,833,651 $ 1.52 |
Schedule of Stock Granted Assumptions | Schedule of Stock Granted Assumptions Stock price $ $ 0.35 0.85 Risk-free interest rate 3.62 3.99 % Expected volatility 120.81 123.61 % Expected life (in years) 5.3 Expected dividend yield - |
Schedule of Options Outstanding | Options outstanding as of September 30, 2023 are exercisable as follows: Schedule of Options Outstanding Options Outstanding Options Exercisable Range of Exercise Price Number Outstanding Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Number Exercisable Weighted Average Exercise Price $ 2.48 1,237,952 8.8 $ 2.48 1,166,984 $ 2.48 0.85 2,000,000 9.4 0.85 1,500,000 0.85 0.35 500,000 9.7 0.35 166,667 0.35 3,737,952 2,833,651 |
Warrants [Member] | |
Class of Warrant or Right [Line Items] | |
Schedule of Warrants Outstanding | Warrants outstanding as of September 30, 2023 are exercisable as follows: Schedule of Warrants Outstanding Warrants Outstanding Warrants Exercisable Range of Exercise Price Number Outstanding Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Number Exercisable Weighted Average Exercise Price $ 1.00 1.25 6,890,000 4.8 $ 1.01 - $ - 3.40 5.50 2,258,880 2.4 5.45 2,258,880 5.45 9,148,880 2,258,880 |
Operating Leases (Tables)
Operating Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Operating Leases | |
Schedule of Other Information Related Leases Under Non-Cancellable | Other information related to leases and future minimum lease payments under non-cancellable operating leases were as follows: Schedule of Other Information Related Leases Under Non-Cancellable September 30, 2023 September 30, 2022 (Unaudited) (Unaudited) Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 78 $ 79 Right-of-use assets obtained in exchange for lease liabilities: Operating leases $ 87 $ 260 Weighted-average remaining lease term (in years): Operating leases 0.8 2.0 Weighted-average discount rate: Operating leases 10 % 10 % |
Schedule of Future Minimum Lease Payments | Future minimum lease payments under non-cancellable operating leases were as follows: Schedule of Future Minimum Lease Payments September 30, 2023 (Unaudited) Within one year $ 95 After one year and within two years 2 Thereafter - Total future minimum lease payments $ 97 Less – discount (5 ) Lease liability $ 92 |
Schedule of Anti-dilutive Secur
Schedule of Anti-dilutive Securities (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total anti-dilutive securities | 12,886,832 | 4,468,314 |
Equity Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total anti-dilutive securities | 3,737,952 | 1,835,452 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total anti-dilutive securities | 9,148,880 | 2,337,274 |
Unvested Restricted Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total anti-dilutive securities | 295,588 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Jun. 30, 2023 | Dec. 31, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | |
Accounting Policies [Abstract] | ||||||||
Net loss | $ 2,416 | $ 6,881 | $ 4,635 | $ 15,300 | ||||
Cash used in operating activities | 6,805 | 10,919 | ||||||
Cash on hand and short term investment | 16,000 | 16,000 | ||||||
Working capital | 11,000 | 11,000 | ||||||
Stockholders' equity | 10,005 | $ 15,954 | 10,005 | $ 15,954 | $ 11,763 | $ 11,734 | $ 15,440 | $ 21,910 |
Cash and cash equivalents, and short-term investments | 16,000 | 16,000 | ||||||
Cash equivalents | 2,500 | 2,500 | 5,500 | |||||
Short-term investments | 13,366 | 13,366 | 10,836 | |||||
Derivative liability | 1,100 | 1,100 | $ 20 | |||||
Cash, FDIC Insured Amount | $ 250 | $ 250 |
Schedule of Estimated Fair Valu
Schedule of Estimated Fair Value of Financial Instrument (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Cost | $ 13,323 | $ 10,866 |
Unrealized gains | 43 | |
Unrealized losses | (30) | |
Fair value | 13,366 | 10,836 |
Short-Term Investments [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Cost | 13,323 | 10,866 |
Unrealized gains | 43 | |
Unrealized losses | (30) | |
Fair value | $ 13,366 | $ 10,836 |
Schedule of Fair Value Hierarch
Schedule of Fair Value Hierarchy Financial Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 15,840 | $ 16,341 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 15,840 | 16,341 |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | ||
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | ||
Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 2,474 | 5,505 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 2,474 | 5,505 |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | ||
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | ||
Corporate Notes And Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 13,366 | 10,836 |
Corporate Notes And Commercial Paper [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 13,366 | 10,836 |
Corporate Notes And Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | ||
Corporate Notes And Commercial Paper [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets |
Schedule of Derivative Liabilit
Schedule of Derivative Liability Transactions (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | ||||
Beginning balance | $ 1,538 | $ 115 | $ 19 | $ 138 |
Fair value upon issuance of warrants | 5,830 | |||
Change in fair value | (485) | (58) | (4,796) | (81) |
Ending balance | $ 1,053 | $ 57 | $ 1,053 | $ 57 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Details Narrative) - USD ($) $ in Thousands | Sep. 30, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Dec. 31, 2021 |
Derivative liability | $ 1,053 | $ 1,538 | $ 19 | $ 57 | $ 115 | $ 138 |
Warrant [Member] | ||||||
Derivative liability | $ 1,053 |
Schedule of Accounts Payable (D
Schedule of Accounts Payable (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Defined Benefit Plan Disclosure [Line Items] | ||
Accounts payable | $ 3,970 | $ 3,140 |
Other accounts payable | 826 | 857 |
Related Party [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Accounts payable | $ 3,144 | $ 2,283 |
Accounts Payable (Details Narra
Accounts Payable (Details Narrative) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Research and Development Expense | $ 1,364 | $ 2,743 | $ 5,109 | $ 5,969 | |
Stock Issued During Period, Value, New Issues | 6,268 | ||||
Accounts Payable, Current | 3,970 | 3,970 | $ 3,140 | ||
Third Party Product Manufacturer [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Accounts Payable, Current | 3,100 | $ 3,100 | $ 2,300 | ||
Common Stock [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Stock Issued During Period, Shares, New Issues | 3,600 | ||||
Stock Issued During Period, Value, New Issues | $ 4 | ||||
Service Agreement [Member] | Third Party Manufacturer [Member] | Common Stock [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Research and Development Expense | 3,700 | ||||
Cash | 1,700 | $ 1,700 | |||
Stock Issued During Period, Shares, New Issues | 1,300 | ||||
Stock Issued During Period, Value, New Issues | $ 590 | ||||
Accounts Payable, Current | $ 1,100 | 1,100 | |||
Gain (Loss) Related to Litigation Settlement | $ 550 |
Schedule of Derivative Liabil_2
Schedule of Derivative Liabilities Assumptions (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Jan. 04, 2023 USD ($) $ / shares | Sep. 30, 2023 USD ($) $ / shares | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) $ / shares | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) $ / shares | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Fair value of warrants | $ (485) | $ (58) | $ (4,796) | $ (81) | ||
Minimum [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Expected dividend yield | 3.62 | 3.62 | ||||
2023 Warrants [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Fair value of warrants | $ 5,831 | $ 1,053 | ||||
2020 Warrants [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Fair value of warrants | $ 2 | $ 19 | ||||
Measurement Input, Share Price [Member] | 2023 Warrants [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Expected dividend yield | $ / shares | 1.20 | 0.24 | 0.24 | |||
Measurement Input, Share Price [Member] | 2020 Warrants [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Expected dividend yield | $ / shares | 0.24 | 0.24 | 0.89 | |||
Measurement Input, Risk Free Interest Rate [Member] | 2023 Warrants [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Expected dividend yield | 3.60 | 4.6 | 4.6 | |||
Measurement Input, Risk Free Interest Rate [Member] | 2020 Warrants [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Expected dividend yield | 4.95 | 4.95 | 4.22 | |||
Measurement Input, Price Volatility [Member] | Minimum [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Expected dividend yield | 120.81 | 120.81 | ||||
Measurement Input, Price Volatility [Member] | 2023 Warrants [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Expected dividend yield | 121.5 | 119.7 | 119.7 | |||
Measurement Input, Price Volatility [Member] | 2020 Warrants [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Expected dividend yield | 89 | 89 | 109 | |||
Measurement Input, Expected Term [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Expected life (in years) | 5 years 3 months 18 days | |||||
Measurement Input, Expected Term [Member] | 2023 Warrants [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Expected life (in years) | 5 years | |||||
Measurement Input, Expected Term [Member] | 2023 Warrants [Member] | Minimum [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Expected life (in years) | 4 years 6 months | |||||
Measurement Input, Expected Term [Member] | 2020 Warrants [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Expected life (in years) | 1 year 9 months 18 days | 2 years 7 months 6 days | ||||
Measurement Input, Expected Dividend Rate [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Expected dividend yield | ||||||
Measurement Input, Expected Dividend Rate [Member] | 2023 Warrants [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Expected dividend yield | ||||||
Measurement Input, Expected Dividend Rate [Member] | 2020 Warrants [Member] | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Expected dividend yield |
Warrant Liability (Details Narr
Warrant Liability (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Jan. 04, 2023 | |
Change in fair value of derivative liability | $ (485) | $ (58) | $ (4,796) | $ (81) | |
Change in fair value of derivative liability | $ 60 | $ 80 | |||
Accounting Standards Update 2016-02 [Member] | |||||
Change in fair value of derivative liability | $ 500 | $ 4,800 | |||
Common Warrants [Member] | Pre Funded Warrants [Member] | |||||
Warrants to purchase | 6,500,000 | ||||
Placement Agent Warrant [Member] | Maximum [Member] | |||||
Warrants to purchase | 390,000 | ||||
Warrant [Member] | |||||
Volatility amount utilized in the value calculation percentage | 100% | ||||
Change in fair value of derivative liability | $ 1,300 | ||||
Purchase Warrant [Member] | |||||
Change in fair value of derivative liability | $ 5,800 |
Schedule of Warrant Activity (D
Schedule of Warrant Activity (Details) | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Equity [Abstract] | |
Warrants outstanding, beginning balance | shares | 2,337,274 |
Weighted average exercise price, beginning balance | $ / shares | $ 5.30 |
Number of warrants, granted | shares | 9,790,000 |
Weighted average exercise price, granted | $ / shares | $ 0.71 |
Number of warrants, forfeited | shares | (78,394) |
Weighted average exercise price, forfeited | $ / shares | $ 3.40 |
Number of warrants, exercised | shares | (2,900,000) |
Weighted average exercise price, exercised | $ / shares | $ 0.0001 |
Warrants outstanding, beginning balance | shares | 9,148,880 |
Weighted average exercise price, beginning balance | $ / shares | $ 2.11 |
Warrants exercisable, ending balance | shares | 2,258,880 |
Exercisable, ending balance | $ / shares | $ 5.45 |
Schedule of Warrants Outstandin
Schedule of Warrants Outstanding (Details) - $ / shares | 9 Months Ended | |||
May 15, 2023 | Jan. 27, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
Class of Warrant or Right [Line Items] | ||||
Warrants outstanding | 9,148,880 | 2,337,274 | ||
Warrants outstanding weighted average remaining contractual life (years) | 10 years | 10 years | ||
Warrants outstanding weighted average exercise price | $ 2.11 | $ 5.30 | ||
Warrants exercisable | 150,000 | 1,400,000 | 2,833,651 | |
Warrants exercisable weighted average exercise price | $ 5.45 | |||
Range One [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Range of upper excercise price, per share | $ 2.48 | |||
Warrants outstanding weighted average remaining contractual life (years) | 8 years 9 months 18 days | |||
Warrants outstanding weighted average exercise price | $ 2.48 | |||
Warrants exercisable | 1,166,984 | |||
Warrants exercisable weighted average exercise price | $ 2.48 | |||
Range Two [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Range of upper excercise price, per share | $ 0.85 | |||
Warrants outstanding weighted average remaining contractual life (years) | 9 years 4 months 24 days | |||
Warrants outstanding weighted average exercise price | $ 0.85 | |||
Warrants exercisable | 1,500,000 | |||
Warrants exercisable weighted average exercise price | $ 0.85 | |||
Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants outstanding | 9,148,880 | |||
Warrants exercisable | 2,258,880 | |||
Warrants [Member] | Range One [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Range of lower excercise price, per share | $ 1 | |||
Range of upper excercise price, per share | $ 1.25 | |||
Warrants outstanding | 6,890,000 | |||
Warrants outstanding weighted average remaining contractual life (years) | 4 years 9 months 18 days | |||
Warrants outstanding weighted average exercise price | $ 1.01 | |||
Warrants exercisable | ||||
Warrants exercisable weighted average exercise price | ||||
Warrants [Member] | Range Two [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Range of lower excercise price, per share | 3.40 | |||
Range of upper excercise price, per share | $ 5.50 | |||
Warrants outstanding | 2,258,880 | |||
Warrants outstanding weighted average remaining contractual life (years) | 2 years 4 months 24 days | |||
Warrants outstanding weighted average exercise price | $ 5.45 | |||
Warrants exercisable | 2,258,880 | |||
Warrants exercisable weighted average exercise price | $ 5.45 |
Schedule of Options Activity (D
Schedule of Options Activity (Details) | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Equity [Abstract] | |
Number of options outstanding, beginning | shares | 1,630,452 |
Weighted-Average Exercise Price, Beginning | $ / shares | $ 2.57 |
Number of options, Granted | shares | 2,500,000 |
Weighted-Average Exercise Price, Granted | $ / shares | $ 0.75 |
Number of options, Forfeited | shares | (392,500) |
Weighted-Average Exercise Price, Forfeited | $ / shares | $ 2.81 |
Number of options, Exercised | shares | |
Weighted-Average Exercise Price, Exercised | $ / shares | |
Number of options outstanding, ending | shares | 3,737,952 |
Weighted-Average Exercise Price, Beginning | $ / shares | $ 1.32 |
Number of options outstanding vested and exercisable | shares | 2,833,651 |
Weighted-Average Exercise Price, Ending | $ / shares | $ 1.52 |
Schedule of Stock Granted Assum
Schedule of Stock Granted Assumptions (Details) | 9 Months Ended |
Sep. 30, 2023 $ / shares | |
Measurement Input, Expected Term [Member] | |
Expected life (in years) | 5 years 3 months 18 days |
Measurement Input, Expected Dividend Rate [Member] | |
Expected dividend yield | |
Minimum [Member] | |
Stock price | $ 0.35 |
Expected dividend yield | 3.62 |
Minimum [Member] | Measurement Input, Price Volatility [Member] | |
Expected dividend yield | 120.81 |
Maximum [Member] | |
Stock price | $ 0.85 |
Expected dividend yield | 3.99 |
Maximum [Member] | Measurement Input, Price Volatility [Member] | |
Expected dividend yield | 123.61 |
Schedule of Options Outstanding
Schedule of Options Outstanding (Details) - $ / shares | 9 Months Ended | |||
May 15, 2023 | Jan. 27, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||||
Options outstanding | 3,737,952 | 1,630,452 | ||
Options outstanding remaining contractual life years | 10 years | 10 years | ||
Options outstanding weighted average exercise price | $ 2.11 | $ 5.30 | ||
Options exercisable | 150,000 | 1,400,000 | 2,833,651 | |
Options exercisable weighted average exercise price | $ 5.45 | |||
Range One [Member] | ||||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||||
Range of upper excercise price, per share | $ 2.48 | |||
Options outstanding | 1,237,952 | |||
Options outstanding remaining contractual life years | 8 years 9 months 18 days | |||
Options outstanding weighted average exercise price | $ 2.48 | |||
Options exercisable | 1,166,984 | |||
Options exercisable weighted average exercise price | $ 2.48 | |||
Range Two [Member] | ||||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||||
Range of upper excercise price, per share | $ 0.85 | |||
Options outstanding | 2,000,000 | |||
Options outstanding remaining contractual life years | 9 years 4 months 24 days | |||
Options outstanding weighted average exercise price | $ 0.85 | |||
Options exercisable | 1,500,000 | |||
Options exercisable weighted average exercise price | $ 0.85 | |||
Range Three [Member] | ||||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||||
Range of upper excercise price, per share | $ 0.35 | |||
Options outstanding | 500,000 | |||
Options outstanding remaining contractual life years | 9 years 8 months 12 days | |||
Options outstanding weighted average exercise price | $ 0.35 | |||
Options exercisable | 166,667 | |||
Options exercisable weighted average exercise price | $ 0.35 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||
May 15, 2023 | Jan. 27, 2023 | Jan. 04, 2023 | Feb. 16, 2021 | May 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Common stock, shares authorized | 250,000,000 | 250,000,000 | 250,000,000 | |||||||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | |||||||||
Preferred stock, shares authorized | 15,000,000 | 15,000,000 | 15,000,000 | |||||||||
Preferred stock, par value | $ 0.01 | $ 0.01 | $ 0.01 | |||||||||
Proceeds from private placement | $ 6,500,000 | |||||||||||
Direct offering | 41,418,999 | 41,418,999 | 32,722,452 | |||||||||
Change in fair value of derivative liability | $ (485,000) | $ (58,000) | $ (4,796,000) | $ (81,000) | ||||||||
Shares issued, value | 6,268,000 | |||||||||||
Number of shares cancelled in common stock | 290,999 | |||||||||||
Shares issued, value | $ 115,000 | $ 1,200,000 | $ 430,000 | $ 2,462,000 | ||||||||
[custom:StockIssuedDuringPeriodSharesCommonSharesInSettlementOfVendorsPayable] | 1,723,094 | |||||||||||
[custom:StockIssuedDuringPeriodFairValueCommonSharesInSettlementOfVendorsPayable] | $ 702,000 | |||||||||||
Debt Securities, Gain (Loss) | $ 547,000 | |||||||||||
Shares granted | $ 500,000 | $ 2,000,000 | ||||||||||
Price per share | $ 0.35 | $ 0.85 | ||||||||||
Expiry period | 10 years | 10 years | ||||||||||
Share vested value | 150,000 | 1,400,000 | 2,833,651 | 2,833,651 | ||||||||
Stock compensation expense unvested options | $ 904 | $ 904 | ||||||||||
Equity Option [Member] | Share-Based Payment Arrangement, Tranche Three [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Options granted | $ 433,000 | $ 1,337,000 | ||||||||||
Series C Preferred Stock [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Preferred stock, par value | $ 0.01 | $ 0.01 | $ 0.01 | |||||||||
Preferred stock, shares outstanding | 96,230 | 96,230 | 96,230 | |||||||||
Preferred stock, shares issued | 96,230 | 96,230 | 96,230 | |||||||||
Series K Preferred Stocks [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Preferred stock, par value | $ 0.01 | |||||||||||
Preferred stock shares designated | 115,000 | |||||||||||
Convertible shares issuable | 100 | |||||||||||
Series K Preferred Stock [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Preferred stock, shares outstanding | 0 | 0 | 0 | |||||||||
Preferred stock, shares issued | 0 | 0 | 0 | |||||||||
Board Of Directors Employees And Consultants [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Shares issued | 400 | 135 | 473 | 412 | ||||||||
Shares issued, value | $ 115,000 | $ 1,200,000 | $ 430,000 | $ 2,462,000 | ||||||||
Common Stock [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Preferred stock shares designated | 3,600,000 | |||||||||||
Debt converted amount | $ 38,800,000 | |||||||||||
Converted conversion of common stock | 11,413,322 | 11,086,024 | ||||||||||
Shares issued, value | $ 4,000 | |||||||||||
Shares issued | 400,000 | 135,000 | 473,000 | 412,000 | ||||||||
Shares issued, value | $ 1,000 | |||||||||||
[custom:StockIssuedDuringPeriodSharesCommonSharesInSettlementOfVendorsPayable] | 1,222,000 | 1,222,000 | ||||||||||
Accounts Payable | $ 1,200,000 | $ 1,200,000 | ||||||||||
Common Stock [Member] | Pre Funded Warrants [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Exercise price of warrant | $ 1 | |||||||||||
Warrants exercised | 2,900,000 | |||||||||||
Cash consideration | $ 290,000 | |||||||||||
Stock option exercised | 2,900,000 | |||||||||||
Common Warrant and Placement Agent Warrant [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Change in fair value of derivative liability | $ 5,800,000 | |||||||||||
Common Stock Issuable [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Preferred stock shares designated | 327,298 | |||||||||||
Shares issued, value | $ 1,100,000 | |||||||||||
Purchase Agreement [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Other offering expenses | $ 232,000 | |||||||||||
Purchase Agreement [Member] | Pre Funded Warrants [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Exercise price of warrant | $ 0.9999 | $ 0.0001 | ||||||||||
Purchase Agreement [Member] | Institutional Investor [Member] | Pre Funded Warrants [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Exercise price of warrant | $ 0.0001 | |||||||||||
Purchase Agreement [Member] | Common Stock [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Direct offering | 3,600,000 | |||||||||||
Warrant exercise price | $ 0.001 | |||||||||||
Preferred stock shares designated | 6,500,000 | |||||||||||
Exercise price of warrant | $ 1.25 | |||||||||||
Purchase Agreement [Member] | Prefunded Warrant [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Purchase of warrants | 2,900,000 | |||||||||||
Purchase Agreement [Member] | Placement Agent Warrant [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Preferred stock shares designated | 390,000 | |||||||||||
Purchase Agreement [Member] | Common Warrants [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Warrant exercise price | $ 1 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
May 13, 2022 | Mar. 26, 2021 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Loss Contingencies [Line Items] | ||||||
Monetary damages estimated amount | $ 370,000 | |||||
Project fees | $ 2,100,000 | |||||
Research and development expense | $ 1,364,000 | $ 2,743,000 | 5,109,000 | $ 5,969,000 | ||
Aggregate research and development expense | 2,100,000 | |||||
Scientific Research Agreement [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Research and development expense | 200,000 | $ 600,000 | 200,000 | $ 600,000 | ||
2016 Patent Exclusive License Agreement [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Research and development expense | 0 | 0 | ||||
Proceeds from upfront amount | 200,000 | 200,000 | ||||
Maintenance fee | 100,000 | |||||
Performance milestone payments | 3,100,000 | |||||
Sales milestone payments | 1,000,000 | |||||
Gross sales | 250,000,000 | |||||
Sales revenue | 5,000,000 | |||||
Cumulative gross sales | $ 500,000,000 | |||||
2016 Patent Exclusive License Agreement [Member] | Minimum [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Net sales percentage | 4% | |||||
Annual royalty payments | $ 250,000 | |||||
2016 Patent Exclusive License Agreement [Member] | Maximum [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Net sales percentage | 6% | |||||
Annual royalty payments | $ 5,000,000 | |||||
2021 Patent License Agreement [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Research and development expense | $ 0 | $ 0 | ||||
Maintenance fee | $ 2,000,000 | |||||
Annual royalty payments | 250 | |||||
Performance milestone payments | 3,100,000 | |||||
Sales milestone payments | 1,000,000 | |||||
Gross sales | 250,000,000 | |||||
Sales revenue | 5,000,000 | |||||
Cumulative gross sales | 500,000,000 | |||||
Upfront license fee | 20,000,000 | |||||
License maintenance fee, receivable | $ 5,000 | |||||
2021 Patent License Agreement [Member] | Minimum [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Net sales percentage | 2.50% | |||||
2021 Patent License Agreement [Member] | Maximum [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Net sales percentage | 5% |
Schedule of Other Information R
Schedule of Other Information Related Leases Under Non-Cancellable (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating Leases | ||
Operating cash flows from operating leases | $ 78 | $ 79 |
Operating leases | $ 87 | $ 260 |
Weighted average remaining lease term operating leases | 9 months 18 days | 2 years |
Weighted average discount rate operating leases | 10% | 10% |
Schedule of Future Minimum Leas
Schedule of Future Minimum Lease Payments (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Operating Leases | |
Within one year | $ 95 |
After one year and within two years | 2 |
Thereafter | |
Total future minimum lease payments | 97 |
Less – discount | (5) |
Lease liability | $ 92 |
Operating Leases (Details Narra
Operating Leases (Details Narrative) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||
Nov. 19, 2021 USD ($) ft² | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | Feb. 08, 2022 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Right of use asset | $ 87 | $ 87 | $ 165 | ||||
Right of use liability | 97 | 97 | |||||
Rent expense | 29 | $ 29 | 88 | $ 58 | |||
Lease Agreements [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Area of land | ft² | 4,500 | ||||||
Commencement date | commencement date of January 1, 2022 and maturing on June 30, 2024 | ||||||
Right of use asset | $ 247 | 260 | 260 | $ 13 | |||
Right of use liability | $ 260 | $ 260 | $ 13 |