Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2023 | May 11, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Period Focus | Q1 | |
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 $0.01 per share | |
Trading Symbol | INDP | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 8,401,047 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 6,805,146 | $ 9,626,800 |
Marketable securities | 14,875,693 | 16,806,009 |
Prepaid expenses and other current assets | 470,751 | 811,433 |
Total current assets | 22,151,590 | 27,244,242 |
Non-current assets: | ||
Property and equipment, net | 1,698 | 2,019 |
Right-of-use asset | 236,506 | 79,294 |
Other assets | 754,728 | 738,251 |
Total non-current assets | 992,932 | 819,564 |
Total assets | 23,144,522 | 28,063,806 |
Current liabilities: | ||
Accounts payable and other current liabilities | 1,722,622 | 3,352,847 |
Operating lease liability, current portion | 99,837 | 80,494 |
Total current liabilities | 1,822,459 | 3,433,341 |
Non-current liabilities: | ||
Operating lease liability, net of current portion | 136,669 | |
Total non-current liabilities | 136,669 | |
Total liabilities | 1,959,128 | 3,433,341 |
Commitments and contingent liabilities (Note 7) | ||
Stockholders’ equity: | ||
Common stock: $0.01 par value, 200,000,000 shares authorized as of March 31, 2023 and December 31, 2022; 8,401,047 shares issued and outstanding as of March 31, 2023 and December 31, 2022 | 84,011 | 84,011 |
Additional paid in capital | 55,170,849 | 54,443,705 |
Accumulated deficit | (34,246,923) | (29,993,685) |
Accumulated other comprehensive income | 177,457 | 96,434 |
Total stockholders’ equity | 21,185,394 | 24,630,465 |
Total liabilities and stockholders’ equity | $ 23,144,522 | $ 28,063,806 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 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 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating expenses: | ||
Research and development | $ 1,879,900 | $ 1,297,098 |
General and administrative | 2,575,266 | 2,104,975 |
Total operating expenses | 4,455,166 | 3,402,073 |
Loss from operations | (4,455,166) | (3,402,073) |
Other income, net | 201,928 | 36,919 |
Net loss | $ (4,253,238) | $ (3,365,154) |
Net loss available to common stockholders per share of common stock, basic and diluted | $ (0.51) | $ (0.41) |
Weighted average number of shares used in calculating net loss per share, basic and diluted | 8,401,047 | 8,258,597 |
Other comprehensive income (loss): | ||
Reclassification adjustment for realized gain on marketable securities included in net loss | $ (129,229) | |
Unrealized gain (loss) on marketable securities | 210,252 | (9,221) |
Comprehensive loss | $ (4,172,215) | $ (3,374,375) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - 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 | 831,183 | 831,183 | |||
Change in unrealized gain on marketable securities | (9,221) | (9,221) | |||
Net loss | (3,365,154) | (3,365,154) | |||
Balance at Mar. 31, 2022 | $ 82,586 | 52,319,064 | (19,036,041) | (9,221) | 33,356,388 |
Balance, shares at Mar. 31, 2022 | 8,258,597 | ||||
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 | 727,144 | 727,144 | |||
Change in unrealized gain on marketable securities | 210,252 | 210,252 | |||
Net loss | (4,253,238) | (4,253,238) | |||
Reclassification adjustment for realized gain on marketable securities included in net loss | (129,229) | (129,229) | |||
Balance at Mar. 31, 2023 | $ 84,011 | $ 55,170,849 | $ (34,246,923) | $ 177,457 | $ 21,185,394 |
Balance, shares at Mar. 31, 2023 | 8,401,047 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (4,253,238) | $ (3,365,154) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 321 | 534 |
Stock-based compensation | 727,144 | 831,183 |
Realized gain on marketable securities | (129,229) | |
Realized gain on assets held for sale | (24,155) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 324,205 | 364,708 |
Accounts payable and other current liabilities | (1,630,225) | (925,204) |
Operating lease right-of-use asset and liability, net | (1,200) | 360 |
Net cash used in operating activities | (4,962,222) | (3,117,728) |
Cash flows from investing activities: | ||
Proceeds received for assets held for sale | 172,555 | |
Maturity of marketable securities | 9,000,000 | |
Purchase of marketable securities | (6,859,432) | (2,970,681) |
Net cash provided by (used in) investing activities | 2,140,568 | (2,798,126) |
Net decrease in cash and cash equivalents | (2,821,654) | (5,915,854) |
Cash and cash equivalents at beginning of period | 9,626,800 | 39,132,165 |
Cash and cash equivalents at end of period | 6,805,146 | 33,216,311 |
Noncash investing and financing activities | ||
Change in unrealized gain/loss on marketable securities | 81,023 | |
ASC 842 lease renewal option exercise | 236,506 | |
Reclassification of security deposit | 16,477 | |
Supplemental Disclosures | ||
Cash received for interest earned on deposits | $ 36,123 | $ 1,318 |
GENERAL
GENERAL | 3 Months Ended |
Mar. 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 operating losses (see below), competition from substitute products and services from larger companies, protection of proprietary technology, patent litigation, and dependence on key individuals. The Company is subject to general conditions and macroeconomic factors in the global economy including increasing concerns over banking failures and bailouts and their potential broader effect on the banking sector generally and on the biotechnology industry. Additionally, inflation, rising interest rates, overall economic conditions and uncertainties, and the risk of a severe or prolonged economic downturn could result in a variety of risks, including the Company’s ability to raise additional funding on a timely basis or on acceptable terms and may additionally impact third parties upon which the Company relies to carry out its operations. Going concern and management’s plans The Company has incurred net losses and utilized cash in operations since inception, has an accumulated deficit as of March 31, 2023 of $ 34.2 Management plans to raise additional capital through equity and/or debt financings, or other capital sources, including potential collaborations, licenses, and other similar arrangements. However, these plans are not entirely within its control and cannot be assessed as being probable of occurring. The Company’s ability to raise additional capital may be adversely impacted by potential worsening of global economic conditions and the recent disruptions to, and volatility in, financial markets in the United States and worldwide resulting from the recent events in the banking sector, ongoing conflict between Russia and Ukraine, and the lingering impact from the COVID-19 pandemic. If the Company is unable to raise capital when needed or on attractive terms, it would be forced to delay, reduce, or eliminate its research and development programs or other operations. If any of these events occur, the Company’s ability to achieve its development and commercialization goals would be adversely affected. These condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2: SIGNIFICANT ACCOUNTING POLICIES Basis of presentation The unaudited interim condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) and S-X Article 10 for interim financial statements. Accordingly, they do not contain all information and notes required by US GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated interim financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of March 31, 2023, and the consolidated results of operations, changes in stockholders’ equity, and cash flows for the three-month periods ended March 31, 2023, and 2022. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the SEC on March 17, 2023 The results for the three-month period ended March 31, 2023, are not necessarily indicative of the results expected for the year ending December 31, 2023. 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 the unaudited condensed consolidated 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 condensed 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, 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 three months ended 2023 2022 Outstanding stock options 1,873,929 1,580,623 Warrants 3,090,787 3,090,787 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, share-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 developments 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 outside service provider, the payments will be recorded as a prepaid expense, which will be amortized or expensed as the contracted services are performed. Recently adopted accounting standard On January 1, 2023, the Company adopted ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 3 Months Ended |
Mar. 31, 2023 | |
Prepaid Expenses And Other Current Assets | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | NOTE 3: 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 March 31, December 31, 2023 2022 Prepaid insurance $ 363,478 $ 610,208 Prepaid research and development 12,689 80,910 Other receivables 19,062 - Other prepaid expenses 75,522 120,315 Total prepaid expenses and other current assets $ 470,751 $ 811,433 |
ACCOUNTS PAYABLE AND OTHER CURR
ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES | NOTE 4: 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 2023 2022 March 31, December 31, 2023 2022 Accounts payable $ 382,099 $ 1,378,316 Accrued employee costs 430,006 1,216,242 Accrued professional fees 246,295 172,356 Accrued research and development 472,155 311,036 Accrued board fees 122,583 116,000 Delaware franchise taxes payable 50,000 128,929 Other accrued expenses 19,484 29,968 Total accounts payable and other current liabilities $ 1,722,622 $ 3,352,847 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | NOTE 5: 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 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 and January 1, 2023, the Pool was increased by 247,758 252,031 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 three months ended March 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 255,750 $ 1.62 - $ - Outstanding as of March 31, 2023 1,928,623 $ 11.50 8.5 $ - Exercisable as of March 31, 2023 791,345 $ 20.12 7.8 $ - Vested and expected to vest March 31, 2023 1,928,623 $ 11.50 8.5 $ 59,380 The following table summarizes the total stock-based compensation expense included in the condensed consolidated statements of operations for the periods presented: SCHEDULE OF STOCK BASED COMPENSATION EXPENSES 2023 2022 For the three months ended 2023 2022 Research and development $ 192,544 $ 170,163 General and administrative 534,600 661,020 Total stock-based compensation expense $ 727,144 $ 831,183 As of March 31, 2023, total compensation cost not yet recognized related to unvested stock options was approximately $ 4.2 1.4 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 three months ended March 31, 2023 are presented in the table below. The weighted average fair value of stock options issued during the three months ended March 31, 2023 was $ 1.35 SCHEDULE OF WEIGHTED AVERAGE INPUTS USED TO MEASURE VALUE OF OPTIONS GRANTED 2023 Stock price $ 1.62 Exercise price $ 1.62 Expected term (in years) 5.9 Volatility 109.7 % Risk free rate 3.5 % Dividend yield 0 % The following table presents the exercise price of outstanding stock options as of March 31, 2023: SCHEDULE OF EXERCISE PRICE OF OUTSTANDING STOCK OPTIONS Exercise price Options $ 0.01 8.00 887,925 $ 8.01 16.00 1,006,000 $ 16.00 34,698 Total 1,928,623 |
CAPITALIZATION
CAPITALIZATION | 3 Months Ended |
Mar. 31, 2023 | |
Capitalization | |
CAPITALIZATION | NOTE 6: CAPITALIZATION a. As of March 31, 2023 and December 31, 2022, the Company had 200,000,000 8,401,047 b. As of March 31, 2023 and December 31, 2022, there were warrants outstanding to purchase an aggregate of 3,090,787 of common stock of Indaptus exercisable at a weighted average price of $ 12.50 and their weighted average remaining contractual term is 3.7 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 7: 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 Israel. 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 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 lease payments for the years ending December 31, under the Company’s noncancelable operating lease as of March 31, 2023 are as follows: SUMMARY OF MINIMUM LEASE PAYMENTS 2023 $ 74,537 2024 101,705 2025 86,862 Total minimum lease payments 263,104 Less: amount representing interest (26,598 ) Present value of operating lease liability 236,506 Less: current portion (99,837 ) Operating lease liability, net of current portion $ 136,669 The Company recognized rent expense of $ 24,356 26,542 24,716 26,182 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 8: SUBSEQUENT EVENTS The Company evaluated subsequent events from March 31, 2023, the date of these unaudited condensed consolidated financial statements, through May XX, 2023, which represents the date the condensed consolidated financial statements were issued, for events requiring recognition or disclosure in the condensed |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation The unaudited interim condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) and S-X Article 10 for interim financial statements. Accordingly, they do not contain all information and notes required by US GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated interim financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of March 31, 2023, and the consolidated results of operations, changes in stockholders’ equity, and cash flows for the three-month periods ended March 31, 2023, and 2022. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the SEC on March 17, 2023 The results for the three-month period ended March 31, 2023, are not necessarily indicative of the results expected for the year ending December 31, 2023. |
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 the unaudited condensed consolidated 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 condensed 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, 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 three months ended 2023 2022 Outstanding stock options 1,873,929 1,580,623 Warrants 3,090,787 3,090,787 |
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, share-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 developments 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 outside service provider, the payments will be recorded as a prepaid expense, which will be amortized or expensed as the contracted services are performed. |
Recently adopted accounting standard | Recently adopted accounting standard On January 1, 2023, the Company adopted ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
SCHEDULE OF ANTI-DILUTIVE SECURITIES | The following number of stock options, 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 three months ended 2023 2022 Outstanding stock options 1,873,929 1,580,623 Warrants 3,090,787 3,090,787 |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 3 Months Ended |
Mar. 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 March 31, December 31, 2023 2022 Prepaid insurance $ 363,478 $ 610,208 Prepaid research and development 12,689 80,910 Other receivables 19,062 - Other prepaid expenses 75,522 120,315 Total prepaid expenses and other current assets $ 470,751 $ 811,433 |
ACCOUNTS PAYABLE AND OTHER CU_2
ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES (Tables) | 3 Months Ended |
Mar. 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 2023 2022 March 31, December 31, 2023 2022 Accounts payable $ 382,099 $ 1,378,316 Accrued employee costs 430,006 1,216,242 Accrued professional fees 246,295 172,356 Accrued research and development 472,155 311,036 Accrued board fees 122,583 116,000 Delaware franchise taxes payable 50,000 128,929 Other accrued expenses 19,484 29,968 Total accounts payable and other current liabilities $ 1,722,622 $ 3,352,847 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
SCHEDULE OF SHARE BASED COMPENSATION | A summary of the stock option activity during the three months ended March 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 255,750 $ 1.62 - $ - Outstanding as of March 31, 2023 1,928,623 $ 11.50 8.5 $ - Exercisable as of March 31, 2023 791,345 $ 20.12 7.8 $ - Vested and expected to vest March 31, 2023 1,928,623 $ 11.50 8.5 $ 59,380 |
SCHEDULE OF STOCK BASED COMPENSATION EXPENSES | SCHEDULE OF STOCK BASED COMPENSATION EXPENSES 2023 2022 For the three months ended 2023 2022 Research and development $ 192,544 $ 170,163 General and administrative 534,600 661,020 Total stock-based compensation expense $ 727,144 $ 831,183 |
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 Stock price $ 1.62 Exercise price $ 1.62 Expected term (in years) 5.9 Volatility 109.7 % Risk free rate 3.5 % Dividend yield 0 % |
SCHEDULE OF EXERCISE PRICE OF OUTSTANDING STOCK OPTIONS | The following table presents the exercise price of outstanding stock options as of March 31, 2023: SCHEDULE OF EXERCISE PRICE OF OUTSTANDING STOCK OPTIONS Exercise price Options $ 0.01 8.00 887,925 $ 8.01 16.00 1,006,000 $ 16.00 34,698 Total 1,928,623 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
SUMMARY OF MINIMUM LEASE PAYMENTS | Future minimum lease payments for the years ending December 31, under the Company’s noncancelable operating lease as of March 31, 2023 are as follows: SUMMARY OF MINIMUM LEASE PAYMENTS 2023 $ 74,537 2024 101,705 2025 86,862 Total minimum lease payments 263,104 Less: amount representing interest (26,598 ) Present value of operating lease liability 236,506 Less: current portion (99,837 ) Operating lease liability, net of current portion $ 136,669 |
GENERAL (Details Narrative)
GENERAL (Details Narrative) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accumulated deficit | $ 34,246,923 | $ 29,993,685 |
SCHEDULE OF ANTI-DILUTIVE SECUR
SCHEDULE OF ANTI-DILUTIVE SECURITIES (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Equity Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 1,873,929 | 1,580,623 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 3,090,787 | 3,090,787 |
SCHEDULE OF PREPAID EXPENSE AND
SCHEDULE OF PREPAID EXPENSE AND OTHER CURRENT ASSETS (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Prepaid Expenses And Other Current Assets | ||
Prepaid insurance | $ 363,478 | $ 610,208 |
Prepaid research and development | 12,689 | 80,910 |
Other receivables | 19,062 | |
Other prepaid expenses | 75,522 | 120,315 |
Total prepaid expenses and other current assets | $ 470,751 | $ 811,433 |
SCHEDULE OF ACCOUNTS PAYABLE AN
SCHEDULE OF ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 382,099 | $ 1,378,316 |
Accrued employee costs | 430,006 | 1,216,242 |
Accrued professional fees | 246,295 | 172,356 |
Accrued research and development | 472,155 | 311,036 |
Accrued board fees | 122,583 | 116,000 |
Delaware franchise taxes payable | 50,000 | 128,929 |
Other accrued expenses | 19,484 | 29,968 |
Total accounts payable and other current liabilities | $ 1,722,622 | $ 3,352,847 |
SCHEDULE OF SHARE BASED COMPENS
SCHEDULE OF SHARE BASED COMPENSATION (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 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 | 8 years 6 months | 8 years 6 months |
Intrinsic value, Outstanding, Beginning balance | ||
Number of options, Granted | 255,750 | |
Weighted average exercise price, Granted | $ 1.62 | |
Number of options, Outstanding, Ending balance | 1,928,623 | |
Weighted average exercise price, Ending balance | $ 11.50 | |
Intrinsic value, Outstanding, Ending balance | ||
Number of options, Exercisable | 791,345 | |
Weighted average exercise price, Exercisable | $ 20.12 | |
Exercisable at end of period, Weighted average remaining contractual life | 7 years 9 months 18 days | |
Intrinsic value, Exercisable, Ending balance | ||
Number of options, Vested and expected to vest | 1,928,623 | |
Weighted average exercise price, Vested and expected to vest | $ 11.50 | |
Vested and expected to vest, Weighted average remaining contractual life | 8 years 6 months | |
Intrinsic value, Vested and expected to vest | $ 59,380 |
SCHEDULE OF STOCK BASED COMPENS
SCHEDULE OF STOCK BASED COMPENSATION EXPENSES (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 727,144 | $ 831,183 |
Research and Development Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 192,544 | 170,163 |
General and Administrative Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 534,600 | $ 661,020 |
SCHEDULE OF WEIGHTED AVERAGE IN
SCHEDULE OF WEIGHTED AVERAGE INPUTS USED TO MEASURE VALUE OF OPTIONS GRANTED (Details) | 3 Months Ended |
Mar. 31, 2023 $ / shares | |
Share-Based Payment Arrangement [Abstract] | |
Stock price | $ 1.62 |
Exercise price | $ 1.62 |
Expected term | 5 years 10 months 24 days |
Volatility rate | 109.70% |
Risk free rate | 3.50% |
Dividend yield | 0% |
SCHEDULE OF EXERCISE PRICE OF O
SCHEDULE OF EXERCISE PRICE OF OUTSTANDING STOCK OPTIONS (Details) (Parenthetical) | 3 Months Ended |
Mar. 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 |
SCHEDULE OF EXERCISE PRICE OF_2
SCHEDULE OF EXERCISE PRICE OF OUTSTANDING STOCK OPTIONS (Details) | Mar. 31, 2023 shares |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Outstanding options, number of outstanding options at the end of period | 1,928,623 |
Exercise Price Range One [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Outstanding options, number of outstanding options at the end of period | 887,925 |
Exercise Price Range Two [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Outstanding options, number of outstanding options at the end of period | 1,006,000 |
Exercise Price Range Three [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Outstanding options, number of outstanding options at the end of period | 34,698 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details Narrative) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | ||
Mar. 31, 2023 | Jan. 01, 2023 | Jan. 01, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Share-based compensation, not yet recognized | $ 4.2 | ||
Share-based compensation, not yet recognized, term | 1 year 4 months 24 days | ||
Weighted average grant date fair value of options granted | $ 1.35 | ||
2021 Plan [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Share based compensation arrangement by share based payment award, number of shares available for grant | 252,031 | 247,758 | |
Share based Compensation arrangement by share based payment award, 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 and January 1, 2023, the Pool was increased by 247,758 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] | Employees Officers Consultants Directors [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Share based compensation arrangement by share based payment award, number of shares available for grant | 1,864,963 |
CAPITALIZATION (Details Narrati
CAPITALIZATION (Details Narrative) - $ / shares | 3 Months Ended | |
Mar. 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 |
Warrant [Member] | ||
Warrant outstanding | 3,090,787 | 3,090,787 |
Weighted average exercise price | $ 12.50 | |
Weighted average, remaining contractual life | 3 years 8 months 12 days |
SUMMARY OF MINIMUM LEASE PAYMEN
SUMMARY OF MINIMUM LEASE PAYMENTS (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
2023 | $ 74,537 | |
2024 | 101,705 | |
2025 | 86,862 | |
Total minimum lease payments | 263,104 | |
Less: amount representing interest | (26,598) | |
Present value of operating lease liability | 236,506 | |
Less: current portion | (99,837) | $ (80,494) |
Operating lease liability, net of current portion | $ 136,669 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) | 3 Months Ended | 12 Months Ended | |||||||
Apr. 19, 2023 | Feb. 07, 2023 USD ($) | Feb. 07, 2023 EUR (€) | Jul. 13, 2022 EUR (€) | Oct. 01, 2021 USD ($) ft² | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2022 EUR (€) | |
Product Liability Contingency [Line Items] | |||||||||
Operating lease liability | $ 236,506 | ||||||||
Right of use assets | 236,506 | $ 79,294 | |||||||
Incremental borrowing rate | 9% | ||||||||
Rental expense | 24,356 | $ 26,542 | |||||||
Operating lease payments | $ 24,716 | $ 26,182 | |||||||
Subsequent Event [Member] | |||||||||
Product Liability Contingency [Line Items] | |||||||||
Operating lease, extend description | lease agreement to extend the lease through October 31, 2025. | ||||||||
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 |