Indaptus Therapeutics (INDP) 10-Q 11 May 23 2023 Q1 Quarterly report Financial data

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