Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 12, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity File Number | 001-40652 | ||
Entity Registrant Name | INDAPTUS THERAPEUTICS, INC. | ||
Entity Central Index Key | 0001857044 | ||
Entity Tax Identification Number | 86-3158720 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 3 Columbus Circle | ||
Entity Address, Address Line Two | 15th Floor | ||
Entity Address, City or Town | New York | ||
Entity Address, State or Province | NY | ||
Entity Address, Postal Zip Code | 10019 | ||
City Area Code | (646) | ||
Local Phone Number | 427-2727 | ||
Title of 12(b) Security | Common stock, par value $0.01 | ||
Trading Symbol | INDP | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 Public Float | $ 13,286,909 | ||
Entity Common Stock, Shares Outstanding | 8,538,883 | ||
Documents Incorporated by Reference | Portions of the Registrant’s definitive proxy statement for its 2024 Annual Meeting of Stockholders, which the Registrant intends to file pursuant to Regulation 14A with the Securities and Exchange Commission not later than 120 days after December 31, 2023, are incorporated by reference into Part III of this Annual Report on Form 10-K. | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Auditor Name | HASKELL & WHITE LLP | ||
Auditor Firm ID | 200 | ||
Auditor Location | Irvine, California |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 13,362,053 | $ 9,626,800 |
Marketable securities | 16,806,009 | |
Prepaid expenses and other current assets | 633,156 | 811,433 |
Total current assets | 13,995,209 | 27,244,242 |
Non-current assets: | ||
Property and equipment, net | 735 | 2,019 |
Right-of-use asset | 173,206 | 79,294 |
Other assets | 754,728 | 738,251 |
Total non-current assets | 928,669 | 819,564 |
Total assets | 14,923,878 | 28,063,806 |
Current liabilities: | ||
Accounts payable and other current liabilities | 2,672,327 | 3,352,847 |
Operating lease liability, current portion | 101,705 | 80,494 |
Total current liabilities | 2,774,032 | 3,433,341 |
Non-current liabilities: | ||
Operating lease liability, net of current portion | 73,348 | |
Total non-current liabilities | 73,348 | |
Total liabilities | 2,847,380 | 3,433,341 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity: | ||
Common stock: $0.01 par value, 200,000,000 shares authorized as of December 31, 2023 and December 31, 2022; 8,401,047 shares issued and outstanding as of December 31, 2023 and December 31, 2022 | 84,011 | 84,011 |
Additional paid in capital | 57,409,643 | 54,443,705 |
Accumulated deficit | (45,417,156) | (29,993,685) |
Accumulated other comprehensive income | 96,434 | |
Total stockholders’ equity | 12,076,498 | 24,630,465 |
Total liabilities and stockholders’ equity | $ 14,923,878 | $ 28,063,806 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 8,401,047 | 8,401,047 |
Common stock, shares outstanding | 8,401,047 | 8,401,047 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating expenses: | ||
Research and development | $ 7,621,707 | $ 6,324,657 |
General and administrative | 8,756,767 | 8,586,249 |
Total operating expenses | 16,378,474 | 14,910,906 |
Loss from operations | (16,378,474) | (14,910,906) |
Other income, net | 955,003 | 588,108 |
Net loss | $ (15,423,471) | $ (14,322,798) |
Net loss available to common stockholders per share of common stock, basic | $ (1.83) | $ (1.73) |
Net loss available to common stockholders per share of common stock, diluted | $ (1.83) | $ (1.73) |
Weighted average number of shares used in calculating net loss per share, basic | 8,401,047 | 8,262,119 |
Weighted average number of shares used in calculating net loss per share,diluted | 8,401,047 | 8,262,119 |
Other comprehensive income: | ||
Reclassification adjustment for interest earned on marketable securities included in net loss | $ (430,993) | $ (110,002) |
Change in unrealized gain on marketable securities | 334,559 | 206,436 |
Comprehensive loss | $ (15,519,905) | $ (14,226,364) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Balance at Dec. 31, 2021 | $ 82,586 | $ 51,487,881 | $ (15,670,887) | $ 35,899,580 | |
Balance, shares at Dec. 31, 2021 | 8,258,597 | ||||
Stock-based compensation | 2,957,249 | 2,957,249 | |||
Issuance of initial commitment shares | $ 1,425 | (1,425) | |||
Issuance of initial commitment shares, shares | 142,450 | ||||
Reclassification adjustment for interest earned on marketable securities included in net loss | (110,002) | (110,002) | |||
Change in unrealized gain on marketable securities | 206,436 | 206,436 | |||
Net loss | (14,322,798) | (14,322,798) | |||
Balance at Dec. 31, 2022 | $ 84,011 | 54,443,705 | (29,993,685) | 96,434 | 24,630,465 |
Balance, shares at Dec. 31, 2022 | 8,401,047 | ||||
Stock-based compensation | 2,965,938 | 2,965,938 | |||
Reclassification adjustment for interest earned on marketable securities included in net loss | (430,993) | (430,993) | |||
Change in unrealized gain on marketable securities | 334,559 | 334,559 | |||
Net loss | (15,423,471) | (15,423,471) | |||
Balance at Dec. 31, 2023 | $ 84,011 | $ 57,409,643 | $ (45,417,156) | $ 12,076,498 | |
Balance, shares at Dec. 31, 2023 | 8,401,047 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (15,423,471) | $ (14,322,798) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 1,284 | 1,781 |
Stock-based compensation | 2,965,938 | 2,957,249 |
Realized gain on assets held for sale | (24,155) | |
Interest earned on marketable securities | (430,993) | (110,002) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 161,800 | 295,220 |
Accounts payable and other current liabilities | (680,520) | (1,154,829) |
Other assets | (721,774) | |
Operating lease right-of-use asset and liability, net | 647 | 961 |
Net cash used in operating activities | (13,405,315) | (13,078,347) |
Cash flows from investing activities: | ||
Proceeds received for assets held for sale | 172,555 | |
Purchase of marketable securities | (6,859,432) | (29,599,573) |
Maturity of marketable securities | 24,000,000 | 13,000,000 |
Net cash provided by (used in) investing activities | 17,140,568 | (16,427,018) |
Net increase (decrease) in cash and cash equivalents | 3,735,253 | (29,505,365) |
Cash and cash equivalents at beginning of year | 9,626,800 | 39,132,165 |
Cash and cash equivalents at end of year | 13,362,053 | 9,626,800 |
Noncash investing and financing activities | ||
ASC 842 lease renewal option exercise | 236,506 | |
Issuance of initial commitment shares | 1,425 | |
Change in accumulated other comprehensive (loss) income | (96,434) | 96,434 |
Supplemental cash flow disclosures | ||
Cash paid for income taxes | $ 1,600 | $ 2,400 |
GENERAL
GENERAL | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
GENERAL | NOTE 1: GENERAL Indaptus Therapeutics, Inc. and its wholly-owned subsidiaries, Decoy Biosystems, Inc. and Intec Pharma Ltd., collectively (the “Company”), is a biotechnology company dedicated to enhancing and expanding curative cancer immunotherapy for patients with unresectable or metastatic solid tumors and lymphomas, which are responsible for more than 90% of all cancer deaths. The Company is developing a novel, multi-targeted product that activates both innate and adaptive anti-tumor and anti-viral immune responses. Risks and uncertainties The Company is subject to a number of risks similar to those of other companies of similar size in its industry, including, but not limited to, the need for successful development of products, the need for additional capital (or financing) to fund operations (see below), competition from substitute products and services from larger companies, protection of proprietary technology, patent litigation, and dependence on key individuals. Going concern and management’s plans The Company has incurred net losses and utilized cash in operations since inception. For the year ended December 31, 2023, the Company incurred a net loss of approximately $ 15.4 45.4 13.4 As a result of these uncertainties, there is substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments to the carrying amounts and classifications of assets and liabilities that would result if the Company was unable to continue as a going concern. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2: SIGNIFICANT ACCOUNTING POLICIES Basis of presentation The consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”). Principles of consolidation The consolidated financial statements include the accounts of Indaptus and its subsidiaries. Intercompany balances and transactions have been eliminated upon consolidation. Use of estimates The preparation of financial statements in accordance with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting periods. The most significant estimates relate to the determination of the fair value of stock-based compensation and the determination of period-end obligations to certain contract research organizations. Management evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors, including the current economic environment, and makes adjustments when facts and circumstances dictate. These estimates are based on information available as of the date of the consolidated financial statements; therefore, actual results could differ from those estimates. Loss per share Loss per share, basic and diluted, is computed on the basis of the net loss for the period divided by the weighted average number of common stock outstanding during the period. Diluted loss per share is based upon the weighted average number of common stock and of common stock equivalents outstanding when dilutive. Common stock equivalents include outstanding stock options and warrants which are included under the treasury stock method when dilutive. The following number of stock options and warrants were excluded from the calculation of diluted loss per share because their effect would have been anti-dilutive for the periods presented (share data): SCHEDULE OF ANTI-DILUTIVE SECURITIES For the year ended December 31, 2023 2022 Outstanding stock options 1,979,196 1,600,830 Warrants 3,090,787 3,090,787 Cash and cash equivalents The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. As of December 31, 2023, and 2022, cash and cash equivalents consist primarily of checking and money market deposits. The Company’s cash balances exceed those that are federally insured; however, the Company believes it is not exposed to significant credit risk due to the financial strength of the depository institutions in which the cash and cash equivalents are held. To date, the Company has not recognized any losses caused by uninsured balances. Marketable securities The Company’s investments in marketable securities included U.S. treasury bonds that were classified as available-for-sale securities pursuant to Accounting Standards Codification (“ASC”) 320 “Investments — Debt Securities Property and equipment Property and equipment assets are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. The Company uses an estimated useful life of three years five years Patents The Company expenses patent costs, including related legal costs, as incurred and records such costs within general and administrative expense in the accompanying consolidated statements of operations. Research and development expenses Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, stock-based compensation expenses, payroll taxes and other employee benefits, subcontractors and materials used for research and development activities, including clinical trials and professional services. All costs associated with research and development are expensed as incurred. The Company accrues for expenses resulting from obligations under agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and other outside service providers for which payment flows do not match the periods over which services or materials are provided to the Company. Accruals are recorded based on estimates of services received and efforts expended pursuant to agreements with CROs, CMOs, and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through analysis with internal personnel and external service providers as to the progress or stage of completion of the services. In the event advance payments are made to a CRO, CMO, or other outside service provider, the payments will be recorded as a prepaid expense or other asset, which will be amortized or expensed as the contracted services are performed. General and administrative expenses General and administrative expenses include compensation, employee benefits, and stock-based compensation for executive management, finance administration and human resources, facility costs (including rent), professional service fees, and other general overhead costs, including depreciation, to support the Company’s operations. Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded for deferred tax assets if it is more likely than not that some portion or all of the deferred tax assets will not be realized in the foreseeable future. As of December 31, 2023, and 2022, the Company has recorded a full valuation allowance against its deferred tax assets. The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that is greater than 50% likely of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. The Company records interest related to unrecognized tax benefits in interest expense and penalties in general and administrative expenses. Stock-based compensation The Company measures and records the expense related to stock-based payment awards based on the fair value of those awards as determined using the Black-Scholes-Merton (“Black-Scholes”) model as of the date of grant. The Company recognizes stock-based compensation expense over the requisite service period of the individual grant, generally equal to the vesting period, on a straight-line basis. The Black-Scholes model requires the use of highly subjective and complex assumptions, which determine the fair value of stock-based payment awards, including the option’s expected term and the price volatility of the underlying stock. The Company estimates the fair value of options granted by using the Black-Scholes model with the following assumptions: Expected Volatility Expected Term Risk-Free Interest Rate Dividend Yield The Company has elected to recognize forfeitures as they occur. Fair value measurements Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company follows the established framework for measuring fair value and providing disclosures about fair value measurements. The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. ASC 820, Fair Value Measurement The following financial assets are measured and recorded at fair value on the Company’s consolidated balance sheet as of December 31, 2022. As of December 31, 2023, there were no such assets on the Company’s consolidated balance sheet. SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE MEASUREMENT December 31, 2022 Total Level 1 Level 2 Level 3 Marketable securities $ 16,806,009 $ - $ 16,806,009 $ - Total $ 16,806,009 $ - $ 16,806,009 $ - Segment information Operating segments are defined as components of an entity for which discrete financial information is available that is regularly reviewed by the Chief Operating Decision Maker (“CODM”). The Company’s Chief Executive Officer is the CODM. The CODM reviews financial information presented on a consolidated basis for purposes of making operating decisions, allocating resources, and evaluating financial performance. The Company currently operates in one business segment, which is biotechnology. The Company is not organized by market and is managed and operated as one business. Recently adopted accounting pronouncements On January 1, 2023, the Company adopted ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments . Recently issued accounting pronouncements In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
MARKETABLE SECURITIES
MARKETABLE SECURITIES | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
MARKETABLE SECURITIES | NOTE 3: MARKETABLE SECURITIES The Company’s investments in marketable securities included U.S. treasury bonds with maturities of less than one year. These investments were classified as available-for-sale and were recorded at fair value with unrealized gains and losses recorded in Accumulated Other Comprehensive Income (Loss). These investments were categorized as Level 2. As of December 31, 2023, the Company had no 16,806,009 |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid Expenses And Other Current Assets | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | NOTE 4: PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets are comprised of the following: SCHEDULE OF PREPAID EXPENSE AND OTHER CURRENT ASSETS For the year ended December 31, 2023 2022 Prepaid insurance $ 554,097 $ 610,208 Prepaid research and development 17,309 80,910 Other prepaid expenses 61,750 120,315 Total prepaid expenses and other current assets $ 633,156 $ 811,433 Prepaid expenses and other current assets $ 633,156 $ 811,433 |
ACCOUNTS PAYABLE AND OTHER CURR
ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES | NOTE 5: ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES Accounts payable and other current liabilities are comprised of the following: SCHEDULE OF ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES For the year ended December 31, 2023 2022 Accounts payable $ 806,004 $ 1,378,316 Accrued employee costs 1,213,054 1,216,242 Accrued professional fees 39,165 172,356 Accrued research and development 439,024 311,036 Accrued board fees 117,750 116,000 Delaware franchise taxes payable 40,000 128,929 Other accrued expenses 17,330 29,968 Total accounts payable and other current liabilities $ 2,672,327 $ 3,352,847 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | NOTE 6: STOCK-BASED COMPENSATION The Company has an equity incentive plan for grants to employees, officers, consultants, directors, and other service providers that was approved in 2021 (the “2021 Plan”). The maximum aggregate number of shares that may be issued pursuant to this 2021 Plan is 1,864,963 shares (the “Pool”); provided, however that the Pool will increase on January 1 of each calendar year beginning on January 1, 2022 and ending on and including January 1, 2024 (each, an “Evergreen Date”), in an amount equal to the lesser of (i) 3% of the total number of shares of common stock outstanding on the December 31st immediately preceding the applicable Evergreen Date and (ii) such lesser number of shares of common stock as determined to be appropriate by the Committee (as defined in the 2021 Plan) in its sole discretion. On January 1, 2022, January 1, 2023 and January 1, 2024 the Pool was increased by 247,758 252,031 252,031 1,864,963 The 2021 Plan provides for the grant of non-qualified stock options, incentive stock options, restricted stock awards, restricted stock units, unrestricted stock awards, stock appreciation rights and other forms of stock-based compensation. The 2021 Plan permits the Company’s board to change the type, terms and conditions of awards as circumstances may change. This flexibility to adjust the type of compensation to be granted is particularly important given current economic and world events. A summary of the stock option activity during the year ended December 31, 2023, is presented in the table below: SCHEDULE OF SHARE BASED COMPENSATION Weighted average Number of Exercise Remaining Intrinsic value Outstanding as of January 1, 2023 1,672,873 $ 13.01 8.5 $ - Granted 425,750 $ 1.70 - $ - Forfeited and cancelled (48,426 ) $ 4.34 - $ - Outstanding as of December 31, 2023 2,050,197 $ 10.90 7.9 $ 36,363 Exercisable as of December 31, 2023 1,184,749 $ 15.59 7.4 $ - Vested and expected to vest as of December 31, 2023 2,050,197 $ 10.90 7.9 $ 36,363 The following table summarizes the total stock-based compensation expense included in the consolidated statements of operations for the periods presented: SCHEDULE OF STOCK BASED COMPENSATION EXPENSES 2023 2022 For the year ended December 31, 2023 2022 Research and development $ 792,273 $ 709,527 General and administrative 2,173,665 2,247,722 Total stock-based compensation expense $ 2,965,938 $ 2,957,249 As of December 31, 2023, total compensation cost not yet recognized related to unvested stock options was approximately $ 2.2 0.7 The Company estimates the fair value of stock options on the date of grant using the Black-Scholes option-pricing model. The Black-Scholes option-pricing model requires estimates of highly subjective assumptions, which affect the fair value of each stock option. The weighted average inputs used to measure the value of the options granted during the years ended December 31, 2023 and 2022 are presented in the table below. The weighted average fair value of stock options issued during the years ended December 31, 2023 and 2022 was $ 1.43 3.27 SCHEDULE OF WEIGHTED AVERAGE INPUTS USED TO MEASURE VALUE OF OPTIONS GRANTED 2023 2022 Exercise price $ 1.70 $ 4.04 Expected term (in years) 5.8 5.8 Volatility 110.9 % 106.6 % Risk free rate 3.7 % 2.2 % Dividend yield 0.0 % 0.0 % The following table presents the exercise price of outstanding stock options as of December 31, 2023: SCHEDULE OF EXERCISE PRICE OF OUTSTANDING STOCK OPTIONS Exercise price Options $0.01 - $8.00 1,023,249 $ 0.01 8.00 1,023,249 $ 8.01 16.00 992,250 $ 16.01 34,698 Total 2,050,197 |
CAPITALIZATION
CAPITALIZATION | 12 Months Ended |
Dec. 31, 2023 | |
Capitalization | |
CAPITALIZATION | NOTE 7: CAPITALIZATION a. As of December 31, 2023 and December 31, 2022, the Company had 200,000,000 8,401,047 3,090,787 12.50 3.0 b. On June 1, 2022, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) which was amended on September 1, 2022 with H.C. Wainwright & Co., LLC, as sales agent (“Wainwright”), pursuant to which the Company may offer and sell, from time to time through Wainwright, shares of the Company’s common stock, par value $ 0.01 3.7 The issuance and sale of common stock by the Company under the ATM Agreement In March 2024, The Company sold 137,836 0.3 c. On December, 22, 2022, the Company entered into a purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), which provides that, upon the terms and subject to the conditions and limitations in the Purchase Agreement, Lincoln Park is committed to purchase up to an aggregate of $ 20.0 (i) issued to Lincoln Park 142,450 125,000 10,000,000 76,220 4,000,000 142,450 76,220 3,781,330 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 8: COMMITMENTS AND CONTINGENCIES Litigation On July 13, 2022, LTS Lohmann Therapie Systeme AG (“LTS”) filed a Request for Arbitration with the International Chamber of Commerce (“Request”), naming as respondent the Company’s subsidiary, Intec Pharma. The Request alleges that LTS is entitled to payment of Euro 2 1 1 On February 7, 2023, Intec Israel settled the dispute with LTS by paying Euro 800,000 860,000 345,000 365,000 From time to time, the Company could become involved in additional disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. Periodically, the Company reviews the status of significant matters, if any exist, and assesses its potential financial exposure. If the potential loss from any claim or legal claim is considered probable and the amount of such potential loss can be estimated, the Company accrues a liability for the estimated loss. Legal proceedings are subject to uncertainties, and the outcomes are difficult to predict. Because of such uncertainties, accruals are based on the best information available at the time. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation. Leases On October 1, 2021, the Company entered into a noncancelable two-year operating lease agreement for approximately 2,000 7,999 3 On April 19, 2023, the Company executed an amendment to the lease agreement to extend the lease through October 31, 2025. 236,506 9 Future minimum annual lease payments and a reconciliation to the Company’s operating lease liability under the Company’s noncancelable operating lease as of December 31, 2023 are as follows: SUMMARY OF MINIMUM LEASE PAYMENTS 2024 $ 101,705 2025 86,862 Total minimum lease payments 188,567 Less: amount representing interest (13,514 ) Present value of operating lease liability 175,053 Less: current portion (101,705 ) Operating lease liability, net of current portion $ 73,348 The Company recognized rent expense of $ 100,742 97,425 99,254 96,465 |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 9: INCOME TAXES As of December 31, 2023, the Company had net operating loss carry forwards that may be available to reduce future years’ taxable income. The Company’s provision for income taxes consisted of the following: SCHEDULE OF PROVISION FOR INCOME TAXES For the year ended December 31, 2023 2022 Computed “expected” tax benefit $ (3,238,593 ) $ (3,007,284 ) State taxes, net of federal benefit 1,304 (8,797 ) Non-deductible items 61,842 86,955 Change in deferred tax asset valuation allowance 2,509,496 (1,351,029 ) Stock-based compensation 613,167 544,640 Return-to-provision adjustments 41,316 3,662,174 Other 13,918 73,371 Income tax expense $ 2,450 $ 30 Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, and (b) operating losses and tax credit carryforwards. The Company’s net deferred tax assets were comprised of the following as of December 31, 2023 and 2022: SCHEDULE OF NET DEFERRED TAX ASSETS 2023 2022 Deferred tax assets: Net operating losses $ 51,846,000 $ 50,244,447 Capitalized research and development 2,162,872 1,054,824 Stock-based compensation 261,052 234,350 Accruals 220,923 447,973 Operating lease liabilities 36,761 16,960 Other 559 451 Total gross deferred tax assets 54,528,167 51,999,005 Deferred tax liabilities: Right-of-use asset (36,373 ) (16,707 ) Gross deferred tax liabilities (36,373 ) (16,707 ) Less: Deferred tax asset valuation allowance (54,491,794 ) (51,982,298 ) Total net deferred tax assets $ - $ - Deferred income tax assets and liabilities are recorded for differences between the financial statement and tax basis of the assets and liabilities that will result in taxable or deductible amounts in the future based on enacted laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. ASC 740 requires that the tax benefit of net operating losses, temporary differences and credit carryforwards be recorded as an asset to the extent that management assesses that realization is “more likely than not.” Realization of the future tax benefits is dependent on the Company’s ability to generate sufficient taxable income within the carryforward periods. Because of the Company’s recent history of operating losses, management believes that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not likely to be realized and, accordingly, has provided a full valuation allowance for the years ended December 31, 2023 and 2022. The net change in total valuation allowance for the years ended December 31, 2023 and 2022 was an increase of $ 2.5 1.5 At December 31, 2023, the Company has United States federal and state net operating loss (NOL) carryforwards of $ 26.9 7.4 0.8 26.1 7.4 198.6 The Company’s ability to utilize its net operating losses may be limited under Section 382 and 383 of the Internal Revenue Code. The limitations apply if an ownership change, as defined by Section 382, occurs. Generally, an ownership change occurs when certain shareholders increase their aggregate ownership by more than 50 percentage points over their lowest ownership percentage in a testing period (typically three years). Although the Company has not undergone a Section 382 analysis, it is possible that the utilization of the net operating losses could be substantially limited. Additionally, U.S. tax laws limit the time during which these carryforwards may be utilized against future taxes. As a result, the Company may not be able to take full advantage of these carryforwards for federal and state tax purposes. Future changes in stock ownership may also trigger an ownership change and, consequently, a Section 382 limitation. The Company recognizes the benefit of tax positions taken or expected to be taken in its tax returns in the consolidated financial statements when it is more likely than not that the position will be sustained upon examination by authorities. Recognized tax positions are measured at the largest amount of benefit that is greater than 50% likely of being realized upon settlement. The Company records interest related to unrecognized tax benefits in interest expense and penalties in general and administrative expenses. As of December 31, 2023 and 2022, the Company recorded no The Company files U.S. federal and various state income tax returns and is subject to the examination for tax years back to 2020 and 2019 for federal and state purposes, respectively, and its NOL’s dating back to inception are subject to adjustment by the taxing authorities if claimed on future tax filings for which the statute remain open to examination. The Company also files Israeli tax returns and is subject to examination for tax years back to 2019. The Company is not currently under audit by the Internal Revenue Service or other similar national, state and local authorities. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 10: SUBSEQUENT EVENTS The Company evaluated subsequent events from December 31, 2023, the date of these consolidated financial statements, through March 13, 2024, which represents the date the consolidated financial statements were issued, for events requiring recognition or disclosure in the consolidated financial statements for the year ended December 31, 2023. The Company concluded that no events have occurred that would require recognition or disclosure in the consolidated financial statements, except for the sale of 137,836 0.3 as described in Note 7(b). |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation The consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”). |
Principles of consolidation | Principles of consolidation The consolidated financial statements include the accounts of Indaptus and its subsidiaries. Intercompany balances and transactions have been eliminated upon consolidation. |
Use of estimates | Use of estimates The preparation of financial statements in accordance with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting periods. The most significant estimates relate to the determination of the fair value of stock-based compensation and the determination of period-end obligations to certain contract research organizations. Management evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors, including the current economic environment, and makes adjustments when facts and circumstances dictate. These estimates are based on information available as of the date of the consolidated financial statements; therefore, actual results could differ from those estimates. |
Loss per share | Loss per share Loss per share, basic and diluted, is computed on the basis of the net loss for the period divided by the weighted average number of common stock outstanding during the period. Diluted loss per share is based upon the weighted average number of common stock and of common stock equivalents outstanding when dilutive. Common stock equivalents include outstanding stock options and warrants which are included under the treasury stock method when dilutive. The following number of stock options and warrants were excluded from the calculation of diluted loss per share because their effect would have been anti-dilutive for the periods presented (share data): SCHEDULE OF ANTI-DILUTIVE SECURITIES For the year ended December 31, 2023 2022 Outstanding stock options 1,979,196 1,600,830 Warrants 3,090,787 3,090,787 |
Cash and cash equivalents | Cash and cash equivalents The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. As of December 31, 2023, and 2022, cash and cash equivalents consist primarily of checking and money market deposits. The Company’s cash balances exceed those that are federally insured; however, the Company believes it is not exposed to significant credit risk due to the financial strength of the depository institutions in which the cash and cash equivalents are held. To date, the Company has not recognized any losses caused by uninsured balances. |
Marketable securities | Marketable securities The Company’s investments in marketable securities included U.S. treasury bonds that were classified as available-for-sale securities pursuant to Accounting Standards Codification (“ASC”) 320 “Investments — Debt Securities |
Property and equipment | Property and equipment Property and equipment assets are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. The Company uses an estimated useful life of three years five years |
Patents | Patents The Company expenses patent costs, including related legal costs, as incurred and records such costs within general and administrative expense in the accompanying consolidated statements of operations. |
Research and development expenses | Research and development expenses Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, stock-based compensation expenses, payroll taxes and other employee benefits, subcontractors and materials used for research and development activities, including clinical trials and professional services. All costs associated with research and development are expensed as incurred. The Company accrues for expenses resulting from obligations under agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and other outside service providers for which payment flows do not match the periods over which services or materials are provided to the Company. Accruals are recorded based on estimates of services received and efforts expended pursuant to agreements with CROs, CMOs, and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through analysis with internal personnel and external service providers as to the progress or stage of completion of the services. In the event advance payments are made to a CRO, CMO, or other outside service provider, the payments will be recorded as a prepaid expense or other asset, which will be amortized or expensed as the contracted services are performed. |
General and administrative expenses | General and administrative expenses General and administrative expenses include compensation, employee benefits, and stock-based compensation for executive management, finance administration and human resources, facility costs (including rent), professional service fees, and other general overhead costs, including depreciation, to support the Company’s operations. |
Income taxes | Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded for deferred tax assets if it is more likely than not that some portion or all of the deferred tax assets will not be realized in the foreseeable future. As of December 31, 2023, and 2022, the Company has recorded a full valuation allowance against its deferred tax assets. The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that is greater than 50% likely of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. The Company records interest related to unrecognized tax benefits in interest expense and penalties in general and administrative expenses. |
Stock-based compensation | Stock-based compensation The Company measures and records the expense related to stock-based payment awards based on the fair value of those awards as determined using the Black-Scholes-Merton (“Black-Scholes”) model as of the date of grant. The Company recognizes stock-based compensation expense over the requisite service period of the individual grant, generally equal to the vesting period, on a straight-line basis. The Black-Scholes model requires the use of highly subjective and complex assumptions, which determine the fair value of stock-based payment awards, including the option’s expected term and the price volatility of the underlying stock. The Company estimates the fair value of options granted by using the Black-Scholes model with the following assumptions: Expected Volatility Expected Term Risk-Free Interest Rate Dividend Yield The Company has elected to recognize forfeitures as they occur. |
Fair value measurements | Fair value measurements Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company follows the established framework for measuring fair value and providing disclosures about fair value measurements. The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. ASC 820, Fair Value Measurement The following financial assets are measured and recorded at fair value on the Company’s consolidated balance sheet as of December 31, 2022. As of December 31, 2023, there were no such assets on the Company’s consolidated balance sheet. SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE MEASUREMENT December 31, 2022 Total Level 1 Level 2 Level 3 Marketable securities $ 16,806,009 $ - $ 16,806,009 $ - Total $ 16,806,009 $ - $ 16,806,009 $ - |
Segment information | Segment information Operating segments are defined as components of an entity for which discrete financial information is available that is regularly reviewed by the Chief Operating Decision Maker (“CODM”). The Company’s Chief Executive Officer is the CODM. The CODM reviews financial information presented on a consolidated basis for purposes of making operating decisions, allocating resources, and evaluating financial performance. The Company currently operates in one business segment, which is biotechnology. The Company is not organized by market and is managed and operated as one business. |
Recently adopted accounting pronouncements | Recently adopted accounting pronouncements On January 1, 2023, the Company adopted ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments . Recently issued accounting pronouncements In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
SCHEDULE OF ANTI-DILUTIVE SECURITIES | The following number of stock options and warrants were excluded from the calculation of diluted loss per share because their effect would have been anti-dilutive for the periods presented (share data): SCHEDULE OF ANTI-DILUTIVE SECURITIES For the year ended December 31, 2023 2022 Outstanding stock options 1,979,196 1,600,830 Warrants 3,090,787 3,090,787 |
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE MEASUREMENT | The following financial assets are measured and recorded at fair value on the Company’s consolidated balance sheet as of December 31, 2022. As of December 31, 2023, there were no such assets on the Company’s consolidated balance sheet. SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE MEASUREMENT December 31, 2022 Total Level 1 Level 2 Level 3 Marketable securities $ 16,806,009 $ - $ 16,806,009 $ - Total $ 16,806,009 $ - $ 16,806,009 $ - |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid Expenses And Other Current Assets | |
SCHEDULE OF PREPAID EXPENSE AND OTHER CURRENT ASSETS | Prepaid expenses and other current assets are comprised of the following: SCHEDULE OF PREPAID EXPENSE AND OTHER CURRENT ASSETS For the year ended December 31, 2023 2022 Prepaid insurance $ 554,097 $ 610,208 Prepaid research and development 17,309 80,910 Other prepaid expenses 61,750 120,315 Total prepaid expenses and other current assets $ 633,156 $ 811,433 Prepaid expenses and other current assets $ 633,156 $ 811,433 |
ACCOUNTS PAYABLE AND OTHER CU_2
ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES | Accounts payable and other current liabilities are comprised of the following: SCHEDULE OF ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES For the year ended December 31, 2023 2022 Accounts payable $ 806,004 $ 1,378,316 Accrued employee costs 1,213,054 1,216,242 Accrued professional fees 39,165 172,356 Accrued research and development 439,024 311,036 Accrued board fees 117,750 116,000 Delaware franchise taxes payable 40,000 128,929 Other accrued expenses 17,330 29,968 Total accounts payable and other current liabilities $ 2,672,327 $ 3,352,847 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
SCHEDULE OF SHARE BASED COMPENSATION | A summary of the stock option activity during the year ended December 31, 2023, is presented in the table below: SCHEDULE OF SHARE BASED COMPENSATION Weighted average Number of Exercise Remaining Intrinsic value Outstanding as of January 1, 2023 1,672,873 $ 13.01 8.5 $ - Granted 425,750 $ 1.70 - $ - Forfeited and cancelled (48,426 ) $ 4.34 - $ - Outstanding as of December 31, 2023 2,050,197 $ 10.90 7.9 $ 36,363 Exercisable as of December 31, 2023 1,184,749 $ 15.59 7.4 $ - Vested and expected to vest as of December 31, 2023 2,050,197 $ 10.90 7.9 $ 36,363 |
SCHEDULE OF STOCK BASED COMPENSATION EXPENSES | SCHEDULE OF STOCK BASED COMPENSATION EXPENSES 2023 2022 For the year ended December 31, 2023 2022 Research and development $ 792,273 $ 709,527 General and administrative 2,173,665 2,247,722 Total stock-based compensation expense $ 2,965,938 $ 2,957,249 |
SCHEDULE OF WEIGHTED AVERAGE INPUTS USED TO MEASURE VALUE OF OPTIONS GRANTED | SCHEDULE OF WEIGHTED AVERAGE INPUTS USED TO MEASURE VALUE OF OPTIONS GRANTED 2023 2022 Exercise price $ 1.70 $ 4.04 Expected term (in years) 5.8 5.8 Volatility 110.9 % 106.6 % Risk free rate 3.7 % 2.2 % Dividend yield 0.0 % 0.0 % |
SCHEDULE OF EXERCISE PRICE OF OUTSTANDING STOCK OPTIONS | The following table presents the exercise price of outstanding stock options as of December 31, 2023: SCHEDULE OF EXERCISE PRICE OF OUTSTANDING STOCK OPTIONS Exercise price Options $0.01 - $8.00 1,023,249 $ 0.01 8.00 1,023,249 $ 8.01 16.00 992,250 $ 16.01 34,698 Total 2,050,197 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
SUMMARY OF MINIMUM LEASE PAYMENTS | Future minimum annual lease payments and a reconciliation to the Company’s operating lease liability under the Company’s noncancelable operating lease as of December 31, 2023 are as follows: SUMMARY OF MINIMUM LEASE PAYMENTS 2024 $ 101,705 2025 86,862 Total minimum lease payments 188,567 Less: amount representing interest (13,514 ) Present value of operating lease liability 175,053 Less: current portion (101,705 ) Operating lease liability, net of current portion $ 73,348 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
SCHEDULE OF PROVISION FOR INCOME TAXES | The Company’s provision for income taxes consisted of the following: SCHEDULE OF PROVISION FOR INCOME TAXES For the year ended December 31, 2023 2022 Computed “expected” tax benefit $ (3,238,593 ) $ (3,007,284 ) State taxes, net of federal benefit 1,304 (8,797 ) Non-deductible items 61,842 86,955 Change in deferred tax asset valuation allowance 2,509,496 (1,351,029 ) Stock-based compensation 613,167 544,640 Return-to-provision adjustments 41,316 3,662,174 Other 13,918 73,371 Income tax expense $ 2,450 $ 30 |
SCHEDULE OF NET DEFERRED TAX ASSETS | The Company’s net deferred tax assets were comprised of the following as of December 31, 2023 and 2022: SCHEDULE OF NET DEFERRED TAX ASSETS 2023 2022 Deferred tax assets: Net operating losses $ 51,846,000 $ 50,244,447 Capitalized research and development 2,162,872 1,054,824 Stock-based compensation 261,052 234,350 Accruals 220,923 447,973 Operating lease liabilities 36,761 16,960 Other 559 451 Total gross deferred tax assets 54,528,167 51,999,005 Deferred tax liabilities: Right-of-use asset (36,373 ) (16,707 ) Gross deferred tax liabilities (36,373 ) (16,707 ) Less: Deferred tax asset valuation allowance (54,491,794 ) (51,982,298 ) Total net deferred tax assets $ - $ - |
GENERAL (Details Narrative)
GENERAL (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Net loss | $ 15,423,471 | $ 14,322,798 |
Accumulated deficit | 45,417,156 | 29,993,685 |
Cash in operations | $ 13,405,315 | $ 13,078,347 |
SCHEDULE OF ANTI-DILUTIVE SECUR
SCHEDULE OF ANTI-DILUTIVE SECURITIES (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Equity Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 1,979,196 | 1,600,830 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 3,090,787 | 3,090,787 |
SCHEDULE OF ASSETS AND LIABILIT
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE MEASUREMENT (Details) | Dec. 31, 2022 USD ($) |
Platform Operator, Crypto-Asset [Line Items] | |
Marketable securities | $ 16,806,009 |
Total | 16,806,009 |
Fair Value, Inputs, Level 1 [Member] | |
Platform Operator, Crypto-Asset [Line Items] | |
Marketable securities | |
Total | |
Fair Value, Inputs, Level 2 [Member] | |
Platform Operator, Crypto-Asset [Line Items] | |
Marketable securities | 16,806,009 |
Total | 16,806,009 |
Fair Value, Inputs, Level 3 [Member] | |
Platform Operator, Crypto-Asset [Line Items] | |
Marketable securities | |
Total |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - Property, Plant and Equipment [Member] | Dec. 31, 2023 |
Computers and Other Office Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 3 years |
Furniture [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 5 years |
MARKETABLE SECURITIES (Details
MARKETABLE SECURITIES (Details Narrative) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Investments, Debt and Equity Securities [Abstract] | ||
Marketable securities | $ 16,806,009 |
SCHEDULE OF PREPAID EXPENSE AND
SCHEDULE OF PREPAID EXPENSE AND OTHER CURRENT ASSETS (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Prepaid Expenses And Other Current Assets | ||
Prepaid insurance | $ 554,097 | $ 610,208 |
Prepaid research and development | 17,309 | 80,910 |
Other prepaid expenses | 61,750 | 120,315 |
Prepaid expenses and other current assets | $ 633,156 | $ 811,433 |
SCHEDULE OF ACCOUNTS PAYABLE AN
SCHEDULE OF ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 806,004 | $ 1,378,316 |
Accrued employee costs | 1,213,054 | 1,216,242 |
Accrued professional fees | 39,165 | 172,356 |
Accrued research and development | 439,024 | 311,036 |
Accrued board fees | 117,750 | 116,000 |
Delaware franchise taxes payable | 40,000 | 128,929 |
Other accrued expenses | 17,330 | 29,968 |
Total accounts payable and other current liabilities | $ 2,672,327 | $ 3,352,847 |
SCHEDULE OF SHARE BASED COMPENS
SCHEDULE OF SHARE BASED COMPENSATION (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Number of options, Outstanding, Beginning balance | 1,672,873 | |
Weighted average exercise price, Outstanding, Beginning balance | $ 13.01 | |
Weighted average remaining contractual life, Outstanding, Ending balance | 7 years 10 months 24 days | 8 years 6 months |
Intrinsic value, Outstanding, Beginning balance | ||
Number of options, Granted | 425,750 | |
Weighted average exercise price, Granted | $ 1.70 | |
Number of options, Forfeited and cancelled | (48,426) | |
Weighted average exercise price, Forfeited and cancelled | $ 4.34 | |
Number of options, Outstanding, Ending balance | 2,050,197 | 1,672,873 |
Weighted average exercise price, Ending balance | $ 10.90 | $ 13.01 |
Intrinsic value, Outstanding, Ending balance | $ 36,363 | |
Number of options, Exercisable | 1,184,749 | |
Weighted average exercise price, Exercisable | $ 15.59 | |
Exercisable at end of period, Weighted average remaining contractual life | 7 years 4 months 24 days | |
Intrinsic value, Exercisable, Ending balance | ||
Number of options, Vested and expected to vest | 2,050,197 | |
Weighted average exercise price, Vested and expected to vest | $ 10.90 | |
Vested and expected to vest, Weighted average remaining contractual life | 7 years 10 months 24 days | |
Intrinsic value, Vested and expected to vest | $ 36,363 |
SCHEDULE OF STOCK BASED COMPENS
SCHEDULE OF STOCK BASED COMPENSATION EXPENSES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 2,965,938 | $ 2,957,249 |
Research and Development Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 792,273 | 709,527 |
General and Administrative Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 2,173,665 | $ 2,247,722 |
SCHEDULE OF WEIGHTED AVERAGE IN
SCHEDULE OF WEIGHTED AVERAGE INPUTS USED TO MEASURE VALUE OF OPTIONS GRANTED (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Exercise price | $ 1.70 | $ 4.04 |
Expected term (in years) | 5 years 9 months 18 days | 5 years 9 months 18 days |
Volatility | 110.90% | 106.60% |
Risk free rate | 3.70% | 2.20% |
Dividend yield | 0% | 0% |
SCHEDULE OF EXERCISE PRICE OF O
SCHEDULE OF EXERCISE PRICE OF OUTSTANDING STOCK OPTIONS (Details) | Dec. 31, 2023 shares |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Options outstanding | 2,050,197 |
Exercise Price Range One [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Options outstanding | 1,023,249 |
Exercise Price Range Two [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Options outstanding | 992,250 |
Exercise Price Range Three [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Options outstanding | 34,698 |
SCHEDULE OF EXERCISE PRICE OF_2
SCHEDULE OF EXERCISE PRICE OF OUTSTANDING STOCK OPTIONS (Details) (Parenthetical) | 12 Months Ended |
Dec. 31, 2023 $ / shares | |
Exercise Price Range One [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price range lower range limit | $ 0.01 |
Exercise price range upper range limit | 8 |
Exercise Price Range Two [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price range lower range limit | 8.01 |
Exercise price range upper range limit | 16 |
Exercise Price Range Three [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price range lower range limit | $ 16.01 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details Narrative) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||||
Dec. 31, 2023 | Jan. 01, 2024 | Jan. 01, 2023 | Dec. 31, 2022 | Jan. 01, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Share-based compensation, not yet recognized | $ 2.2 | ||||
Share-based compensation, not yet recognized, term | 8 months 12 days | ||||
Weighted average grant date fair value of options granted | $ 1.43 | $ 3.27 | |||
2021 Plan [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Number of shares available for grant,shares | 252,031 | 247,758 | |||
Share based Compensation description | the Pool will increase on January 1 of each calendar year beginning on January 1, 2022 and ending on and including January 1, 2024 (each, an “Evergreen Date”), in an amount equal to the lesser of (i) 3% of the total number of shares of common stock outstanding on the December 31st immediately preceding the applicable Evergreen Date and (ii) such lesser number of shares of common stock as determined to be appropriate by the Committee (as defined in the 2021 Plan) in its sole discretion. On January 1, 2022, January 1, 2023 and January 1, 2024 the Pool was increased by 247,758 shares, 252,031 shares and 252,031 shares, respectively. In no event shall more than 1,864,963 shares be available for issuance for Incentive Stock Options (as defined in the 2021 Plan) under the 2021 Plan. | ||||
2021 Plan [Member] | Subsequent Event [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Number of shares available for grant,shares | 252,031 | ||||
2021 Plan [Member] | Employees Officers Consultants Directors [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Number of shares available for grant,shares | 1,864,963 |
CAPITALIZATION (Details Narrati
CAPITALIZATION (Details Narrative) - USD ($) | 1 Months Ended | 2 Months Ended | 12 Months Ended | ||||
Dec. 23, 2022 | Dec. 22, 2022 | Sep. 01, 2022 | Mar. 31, 2024 | Mar. 13, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | |
Common stock, shares authorized | 200,000,000 | 200,000,000 | |||||
Common stock, shares issued | 8,401,047 | 8,401,047 | |||||
Common stock, shares outstanding | 8,401,047 | 8,401,047 | |||||
Common stock, par value | $ 0.01 | $ 0.01 | |||||
Purchase ordinary shares | |||||||
Subsequent Event [Member] | |||||||
Common stock gross proceeds | $ 300,000 | ||||||
Commitment shares issued | 137,836 | ||||||
At The Market Offering Agreement [Member] | HC Wainwright And Co LLC [Member] | |||||||
Common stock, par value | $ 0.01 | ||||||
Common stock gross proceeds | $ 3,700,000 | ||||||
At The Market Offering Agreement [Member] | HC Wainwright And Co LLC [Member] | Subsequent Event [Member] | |||||||
Common stock gross proceeds | $ 300,000 | ||||||
Commitment shares issued | 137,836 | ||||||
Purchase Agreements [Member] | Lincoln Park Capital Fund LLC [Member] | |||||||
Commitment shares issued | 142,450 | 142,450 | |||||
Purchase ordinary shares | $ 20,000,000 | ||||||
Commitments shares description | (i) issued to Lincoln Park 142,450 shares of common stock, as the initial commitment shares, and (ii) will issue additional commitment shares, of common stock equal to $125,000 divided by the arithmetic average of the ten (10) Nasdaq Official Closing Prices (as defined in the Purchase Agreement) for the common stock immediately preceding the date that the Company has sold over $10,000,000 of shares to Lincoln Park, (to be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction) provided that the additional commitment shares number shall be no greater than 76,220. On December 23, 2022, the Company filed a Form S-1 covering the resale of up to 4,000,000 shares of common stock comprised of (i) 142,450 initial commitment shares, (ii) up to a maximum of 76,220 additional commitment shares, and (iii) up to 3,781,330 shares of common stock reserved for issuance and sale to Lincoln Park under the Purchase Agreement. | ||||||
Additional commitment shares as dividend | $ 125,000 | ||||||
Sale of stock consideration received | $ 10,000,000 | ||||||
Commitment shares to be issued upon certain conditions | 76,220 | 76,220 | |||||
Number of resale common stock comprised | 4,000,000 | ||||||
Purchase Agreements [Member] | Lincoln Park Capital Fund LLC [Member] | Maximum [Member] | |||||||
Commitment shares to be issued upon certain conditions | 3,781,330 | ||||||
Warrant [Member] | |||||||
Weighted average exercise price | $ 12.50 | ||||||
Weighted average, remaining contractual life | 3 years | ||||||
Warrant [Member] | |||||||
Warrants outstanding to purchase | 3,090,787 | 3,090,787 |
SUMMARY OF MINIMUM LEASE PAYMEN
SUMMARY OF MINIMUM LEASE PAYMENTS (Details) - USD ($) | Dec. 31, 2023 | Apr. 19, 2023 | Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] | |||
2024 | $ 101,705 | ||
2025 | 86,862 | ||
Total minimum lease payments | 188,567 | ||
Less: amount representing interest | (13,514) | ||
Present value of operating lease liability | 175,053 | $ 236,506 | |
Less: current portion | (101,705) | $ (80,494) | |
Operating lease liability, net of current portion | $ 73,348 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) | 12 Months Ended | |||||||
Apr. 19, 2023 USD ($) | Feb. 07, 2023 USD ($) | Feb. 07, 2023 EUR (€) | Jul. 13, 2022 EUR (€) | Oct. 01, 2021 USD ($) ft² | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2022 EUR (€) | |
Product Liability Contingency [Line Items] | ||||||||
Operating lease, extend description | lease agreement to extend the lease through October 31, 2025. | |||||||
Operating lease liability | $ 236,506 | $ 175,053 | ||||||
Incremental borrowing rate | 9% | |||||||
Rental expense | 100,742 | $ 97,425 | ||||||
Operating lease payments | $ 99,254 | 96,465 | ||||||
CALIFORNIA | Two Year Lease Agreement [Member] | ||||||||
Product Liability Contingency [Line Items] | ||||||||
Area of land | ft² | 2,000 | |||||||
Base rent | $ 7,999 | |||||||
Rate of increase in lease rent | 3% | |||||||
Lohmann Therapie System AG [Member] | ||||||||
Product Liability Contingency [Line Items] | ||||||||
Payments for legal settlements | € | € 2,000,000 | |||||||
Litigation settlement, expense | $ 860,000 | € 800,000 | 1,000,000 | € 1,000,000 | ||||
Other income | $ 365,000 | € 345,000 |
SCHEDULE OF PROVISION FOR INCOM
SCHEDULE OF PROVISION FOR INCOME TAXES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Computed “expected” tax benefit | $ (3,238,593) | $ (3,007,284) |
State taxes, net of federal benefit | 1,304 | (8,797) |
Non-deductible items | 61,842 | 86,955 |
Change in deferred tax asset valuation allowance | 2,509,496 | (1,351,029) |
Stock-based compensation | 613,167 | 544,640 |
Return-to-provision adjustments | 41,316 | 3,662,174 |
Other | 13,918 | 73,371 |
Income tax expense | $ 2,450 | $ 30 |
SCHEDULE OF NET DEFERRED TAX AS
SCHEDULE OF NET DEFERRED TAX ASSETS (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Income Tax Disclosure [Abstract] | ||
Net operating losses | $ 51,846,000 | $ 50,244,447 |
Capitalized research and development | 2,162,872 | 1,054,824 |
Stock-based compensation | 261,052 | 234,350 |
Accruals | 220,923 | 447,973 |
Operating lease liabilities | 36,761 | 16,960 |
Other | 559 | 451 |
Total gross deferred tax assets | 54,528,167 | 51,999,005 |
Right-of-use asset | (36,373) | (16,707) |
Gross deferred tax liabilities | (36,373) | (16,707) |
Less: Deferred tax asset valuation allowance | (54,491,794) | (51,982,298) |
Total net deferred tax assets |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | ||
Valuation allowance change amount | $ 2,500,000 | $ 1,500,000 |
Income tax examination description | greater than 50% likely of being realized upon settlement. | |
Unrecognized tax benefits, income tax penalties and interest accrued | $ 0 | $ 0 |
ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 198,600,000 | |
Federal [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 26,900,000 | |
Federal [Member] | Expire In 2036 [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 800,000 | |
Federal [Member] | Indefinite Period [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 26,100,000 | |
State [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 7,400,000 | |
State [Member] | Expire In 2035 [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 7,400,000 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - Subsequent Event [Member] $ in Millions | 2 Months Ended |
Mar. 13, 2024 USD ($) shares | |
Subsequent Event [Line Items] | |
Number of shares issued | shares | 137,836 |
Common stock gross proceeds | $ | $ 0.3 |