Adial Pharmaceuticals (ADIL) POS AM 24 Jun 22 Prospectus update (post-effective amendment) Financial data

Document And Entity Information

Document And Entity Information	3 Months Ended
	Mar. 31, 2022
Document Information Line Items
Entity Registrant Name	ADIAL PHARMACEUTICALS, INC.
Document Type	POS AM
Amendment Flag	true
Amendment Description	This Post-Effective Amendment No. 4 (this “Amendment”) to the Registration Statement on Form S-1, as amended by Amendment No. 1, Amendment No. 2 and Amendment No. 3 thereto (Commission File No. 333-220368) (the “Original Registration Statement”), of Adial Pharmaceuticals, Inc. (the “Company”) is being filed pursuant to the undertakings in the Original Registration Statement to update and supplement the information contained in the Original Registration Statement, which was originally declared effective by the Securities and Exchange Commission on July 26, 2018.The Original Registration Statement, as amended by this Amendment, pertains solely to the registration of an aggregate of 1,575,112 shares of common stock, par value $0.001 per share, consisting of: 1,516,552 shares of common stock, par value $0.001 per share, underlying warrants (the “Investor Warrants”) previously issued by the Company to investors in its initial public offering and warrants to purchase 58,560 shares of common stock previously issued to the underwriters (the “Underwriters Warrants” and together with the Investor Warrants, the “Warrant”). The shares of Common Stock issuable upon exercise of the Warrants (the “Warrant Shares”) were initially registered on the Original Registration Statement.For the convenience of the reader, this Amendment sets forth the Original Registration Statement in its entirety, as amended by this Amendment. This Amendment is being filed to incorporate certain information from the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 28, 2022 and the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 filed with the SEC on May 16, 2022.No additional securities are being registered under this Amendment.  All applicable registration fees were paid at the time of the filing of the Original Registration Statement.  Accordingly, the Company hereby amends the Original Registration Statement, as amended and supplemented through the date hereof, by filing this Amendment.
Entity Central Index Key	0001513525
Entity Filer Category	Non-accelerated Filer
Document Period End Date	Mar. 31, 2022
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Incorporation, State or Country Code	DE

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets (Unaudited) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Current Assets:
Cash and cash equivalents	$ 12,689,161	$ 6,062,173
Prepaid research and development	9,931	9,931
Prepaid expenses and other current assets	265,897	389,501
Total Current Assets	12,964,989	6,461,605
Other Assets:
Fixed Assets, net	56,218	58,149
Intangible assets, net	4,900	5,041
Acquired in-process research and development	455,000	455,000
Right-to-use Asset	233,570	246,209
Goodwill	248,971	248,971
Total Assets	13,963,648	7,474,975
Current Liabilities:
Accounts payable	415,086	286,192
Accrued expenses	1,694,831	2,376,930
Lease liability, current	51,351	49,585
Other current liabilities	9,859	9,683
Total Current Liabilities	2,171,127	2,722,390
Contingent liabilities	868,000	1,014,000
Lease liability, non-current	193,797	207,375
Deferred tax liability	23,399	23,399
Total Liabilities	3,256,323	3,967,164
Commitments and contingencies
Shareholders’ Equity
Preferred Stock, 5,000,000 shares authorized with a par value of $0.001 per share, 0 shares outstanding at March 31, 2022 and December 31, 2021
Common Stock, 50,000,000 shares authorized with a par value of $0.001 per share, 23,482,850 and 20,946,712 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively	23,719	20,947
Additional paid in capital	64,534,560	54,429,979
Accumulated deficit	(53,850,954)	(50,943,115)
Total Shareholders’ Equity	10,707,325	3,507,811
Total Liabilities and Shareholders’ Equity	$ 13,963,648	$ 7,474,975

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares	Mar. 31, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Preferred stock, par value (in Dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized	5,000,000	5,000,000
Preferred stock, shares outstanding	0	0
Common stock, par value (in Dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized	50,000,000	50,000,000
Common stock, shares issued	23,718,962	20,946,712
Common stock, shares outstanding	23,718,962	20,946,712

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Operating Expenses:
Research and development expenses	$ 596,341	$ 2,051,623
General and administrative expenses	2,462,613	2,788,711
Total Operating Expenses	3,058,954	4,840,334
Loss From Operations	(3,058,954)	(4,840,334)
Other Income
Gain on change in value of contingent liability	146,000	6,275
Interest income	5,115	295
Total Other Income	151,115	6,570
Loss Before Provision For Income Taxes	(2,907,839)	(4,833,764)
Benefit from income taxes
Net Loss	$ (2,907,839)	$ (4,833,764)
Net loss per share, basic and diluted (in Dollars per share)	$ (0.13)	$ (0.3)
Weighted average shares, basic and diluted (in Shares)	23,151,193	15,911,897

Condensed Consolidated Statem_2

Condensed Consolidated Statements of Shareholders’ Equity (Unaudited) - USD ($)	Common Stock	Additional Paid In Capital	Accumulated Deficit	Total
Balance at Dec. 31, 2020	$ 14,393	$ 35,491,462	$ (31,519,789)	$ 3,986,066
Balance (in Shares) at Dec. 31, 2020	14,393,100
Equity-based compensation - stock option expense		473,787		473,787
Equity-based compensation - stock issuances to consultants and employees	$ 350	850,550		850,900
Equity-based compensation - stock issuances to consultants and employees (in Shares)	350,000
Warrants exercised	$ 712	1,424,288		1,425,000
Warrants exercised (in Shares)	712,500
Stock options exercised	$ 10	14,490		14,500
Stock options exercised (in Shares)	10,000
Stock issued as consideration for acquisition	$ 700	1,059,450		1,060,150
Stock issued as consideration for acquisition (in Shares)	699,980
Sale of common stock and warrants, net of transaction costs	$ 1,105	2,639,898		2,641,003
Sale of common stock and warrants, net of transaction costs (in Shares)	1,104,297
Net loss			(4,833,764)	(4,833,764)
Balance at Mar. 31, 2021	$ 17,270	41,953,925	(36,353,553)	5,617,642
Balance (in Shares) at Mar. 31, 2021	17,269,877
Balance at Dec. 31, 2021	$ 20,947	54,429,979	(50,943,115)	3,507,811
Balance (in Shares) at Dec. 31, 2021	20,946,712
Equity-based compensation - stock option expense		567,189		567,189
Equity-based compensation - stock issuances to consultants and employees	$ 450	415,973		416,423
Equity-based compensation - stock issuances to consultants and employees (in Shares)	450,000
Sale of common stock and warrants, net of transaction costs	$ 2,322	9,121,419		9,123,741
Sale of common stock and warrants, net of transaction costs (in Shares)	2,322,250
Net loss			(2,907,839)	(2,907,839)
Balance at Mar. 31, 2022	$ 23,719	$ 64,534,560	$ (53,850,954)	$ 10,707,325
Balance (in Shares) at Mar. 31, 2022	23,718,962

Condensed Consolidated Statem_3

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (2,907,839)	$ (4,833,764)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	983,612	1,324,687
Depreciation of fixed assets	1,931	662
Fixed asset disposal		6,954
Amortization of intangible assets	141	141
Amortization of right-to-use asset	12,639	11,663
Change in fair value of contingent liability	(146,000)	(6,275)
Changes in operating assets and liabilities:
Prepaid research and development expenses		(3,847)
Prepaid expenses and other current assets	123,604	204,179
Accrued expenses	(682,099)	474,810
Accounts payable	129,070	(12,246)
Change in operating lease liability	(11,812)	(10,388)
Net cash used in operating activities	(2,496,753)	(2,843,424)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of fixed assets		(30,875)
Purchase consideration paid for acquisition, net of cash acquired		30,589
Net cash used in investing activities		(286)
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from sale of common stock and warrants	9,123,741	2,641,003
Proceeds from warrant exercise		1,425,000
Proceeds from options exercise		14,500
Net cash provided by financing activities	9,123,741	4,080,503
NET INCREASE IN CASH AND CASH EQUIVALENTS	6,626,988	1,236,793
CASH AND CASH EQUIVALENTS-BEGINNING OF PERIOD	6,062,173	4,401,114
CASH AND CASH EQUIVALENTS-END OF PERIOD	12,689,161	5,637,907
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Interest paid
Income taxes paid
Issuance of common stock for acquisition		1,060,150
Contingent consideration for acquisition		$ 732,287

Description of Business

Description of Business	3 Months Ended
	Mar. 31, 2022
Description of Business [Abstract]
DESCRIPTION OF BUSINESS	1 — DESCRIPTION OF BUSINESS Adial Pharmaceuticals, Inc. (the “Company” or “Adial”) was converted from a limited liability company formed under the name Adial Pharmaceuticals, LLC, formed on November 23, 2010 in the Commonwealth of Virginia to a corporation and reincorporated in Delaware on October 1, 2017. Adial is presently engaged in the development of medications for the treatment or prevention of addictions and related disorders. The Company’s wholly owned subsidiary, Purnovate, Inc., was acquired on January 26, 2021, having been formed as Purnovate, LLC in December of 2019. Purnovate is a drug development company with a platform focused on developing drug candidates for non-opioid pain reduction and other diseases and disorders potentially targeted with adenosine analogs that are selective, potent, stable, and soluble. The Company is nearing completion of the ONWARD™ Phase 3 pivotal trial of its lead compound AD04 (“AD04”) for the treatment of Alcohol Use Disorder. Both the U.S. Food and Drug Administration (“FDA”) and the European Medicines Authority (“EMA”) have indicated they will accept heavy-drinking-based endpoints as a basis for approval for the treatment of Alcohol Use Disorder rather than the previously required abstinence-based endpoints. Key patents have been issued in the United States, the European Union, and other jurisdictions for which the Company has exclusive license rights. The active ingredient in AD04 is ondansetron, a serotonin-3 antagonist. Due to its mechanism of action, AD04 is believed to have the potential to be used for the treatment of other addictive disorders, such as Opioid Use Disorder, obesity, smoking, and other drug addictions.

Liquidity and Other Uncertainti

Liquidity and Other Uncertainties	3 Months Ended
	Mar. 31, 2022
Liquidity, Going Concern and Other Uncertainties [Abstract]
LIQUIDITY AND OTHER UNCERTAINTIES	2 — LIQUIDITY AND OTHER UNCERTAINTIES The unaudited condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States (“GAAP”), which contemplate continuation of the Company as a going concern. The Company is in a development stage and has incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception and has an accumulated deficit of approximately $53.9 million as of March 31, 2022. Based on the current development plans for AD04 in both the U.S. and international markets and other operating requirements, the Company believes that the existing cash and cash equivalents are sufficient to fund operations, including the Company’s ongoing trial of AD04 as well as a number of additional, discretionary research and development projects associated with the Company’s Purnovate subsidiary, for at least the next twelve months following the filing of these unaudited condensed consolidated financial statements. The Company’s cash on hand at the filing date is estimated to be sufficient to fund operations through the year subsequent to the date of this report, while completing the Company’s ONWARD trial of AD04 and releasing data. The Company has also initiated a number of research and development projects associated with its Purnovate subsidiary, including Purnovate’s lead compound for treatment of pain. The Company believes funds on hand to be sufficient to bring that program to the point of filing an IND. However, there can be no guarantee that conditions will not change, due to the COVID-19 pandemic or for other reason and that the Company will require additional funding in order to fund these additional projects, which may not be available on acceptable terms or at all, in which case significant delays or cost increases may result in material disruption to the Company’s operations. In such case, the Company would be required to delay, scale back or eliminate some or all of its research and development programs, which would likely have a material adverse effect on the Company and its financial statements. The Company’s continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, grant funding, strategic relationships, or out-licensing in order to complete its subsequent clinical trial requirements for AD04. Management is actively pursuing financing and other strategic plans but can provide no assurances that such financing or other strategic plans will be available on acceptable terms, or at all. Without additional funding, the Company would be required to delay, scale back or eliminate some or all of its research and development programs, which would likely have a material adverse effect on the Company and its financial statements. Other Uncertainties Generally, the industry in which the Company operates subjects the Company to a number of other risks and uncertainties that can affect its operating results and financial condition. Such factors include, but are not limited to: the timing, costs and results of clinical trials and other development activities versus expectations; the ability to obtain regulatory approval to market product candidates; the ability to manufacture products successfully; competition from products sold or being developed by other companies; the price of, and demand for, Company products once approved; the ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products. The Company also faces the ongoing risk that the coronavirus pandemic may further slow, for an unforeseeable period, the conduct of the Company’s trial. The effects of the ongoing coronavirus pandemic may also increase non-trial costs such as insurance premiums, increase the demand for and cost of capital, increase loss of work time from key personnel, and negatively impact our key clinical trial vendors and supplier of our active pharmaceutical ingredient. The full extent to which the COVID-19 pandemic impacts the clinical development of AD04, the Company’s suppliers and other commercial partners, will depend on future developments that are still highly uncertain and cannot be predicted with confidence at this time, all of which could have a material adverse effect on our business, financial condition, and results of operations.

Summary of Significant Accounti

Summary of Significant Accounting Policies	3 Months Ended
	Mar. 31, 2022
Accounting Policies [Abstract]
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation and Principals of Consolidation The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with GAAP as determined by the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results of operations for the periods presented. The interim operating results are not necessarily indicative of results that may be expected for any subsequent period. These unaudited condensed financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2021, included in the 2021 Form 10-K. The unaudited condensed consolidated financial statements represent the consolidation of the Company and its subsidiary in conformity with GAAP. All intercompany transactions have been eliminated in consolidation. Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include the valuation of stock-based compensation, accruals associated with third party providers supporting clinical trials, estimated fair values of long-lived assets used to record impairment charges related to intangible assets, acquired in-process research and development (“IPR&D”) and goodwill, allocation of purchase price in business acquisitions, measurement of contingent liabilities, and income tax asset realization. In particular, the recognition of clinical trial costs is dependent on the Company’s own judgement, as well as the judgment of our contractors and subcontractors in their reporting of information to us. Basic and Diluted Loss per Share Basic and diluted loss per share are computed based on the weighted-average outstanding shares of common stock, which are all voting shares. Diluted net loss per share is computed giving effect to all proportional shares of common stock, including stock options and warrants to the extent dilutive. Basic net loss per share was the same as diluted net loss per share for the three months ended March 31, 2022 and 2021 as the inclusion of all potential common shares outstanding would have an anti-dilutive effect. The total potentially dilutive common shares that were excluded for the three month periods ended March 31, 2022 and 2021 were as follows: Potentially Dilutive Common 2022 2021 Warrants to purchase common shares 12,095,870 7,884,936 Common Shares issuable on exercise of options 4,146,977 3,576,866 Unvested restricted stock awards 236,112 — Total potentially dilutive Common Shares excluded 16,478,959 11,461,802 Fair Value Measurements FASB ASC 820, Fair Value Measurement, (“ASC 820”) defines fair value as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The methodology establishes consistency and comparability by providing a fair value hierarchy that prioritizes the inputs to valuation techniques into three broad levels, which are described below: ● Level 1 inputs are quoted market prices in active markets for identical assets or liabilities (these are observable market inputs). ● Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability (includes quoted market prices for similar assets or identical or similar assets in markets in which there are few transactions, prices that are not current or prices that vary substantially). ● Level 3 inputs are unobservable inputs that reflect the entity’s own assumptions in pricing the asset or liability (used when little or no market data is available). The fair value of cash and cash equivalents, prepaid and other current assets, accounts payable and accrued liabilities approximate their carrying value due to their short-term maturities. The lease liability are presented at their carrying value, which based on borrowing rates currently available to the Company for leases with similar terms, approximate their fair values. Non-financial assets, such as IPR&D and goodwill, are accounted for at fair value on a nonrecurring basis. Acquisition-Related Contingent Consideration In connection with the Purnovate business combination, the Company may be required to pay future consideration that is contingent upon the achievement of specified development, regulatory approvals or sales-based milestone events. The Company determines the fair value of these obligations using various estimates that are not observable in the market and represent a Level 3 measurement within the fair value hierarchy. As of March 31, 2022, the resulting probability-weighted cash flows were discounted using a weighted average cost of capital of 45.5% for regulatory and sales-based milestones. March 31, Balance, December 31, 2021 $ (1,014,000 ) Additions — Total gains recognized 146,000 Balance as of March 31, 2022 $ (868,000 ) Business Combinations The Company accounts for its business combinations under the provisions of ASC Topic 805-10, Business Combinations (“ASC 805-10”), which requires that the purchase method of accounting be used for all business combinations. Assets acquired and liabilities assumed are recorded at the date of acquisition at their respective fair values. For transactions that are business combinations, the Company evaluates the existence of goodwill. Goodwill represents the excess purchase price over the fair value of the tangible net assets and intangible assets acquired in a business combination. ASC 805-10 also specifies criteria that intangible assets acquired in a business combination must meet to be recognized and reported apart from goodwill. Acquisition-related expenses are recognized separately from the business combinations and are expensed as incurred. The estimated fair value of net assets acquired, including the allocation of the fair value to identifiable assets and liabilities, was determined using established valuation techniques. A fair value measurement is determined as the price the Company would receive to sell an asset or pay to transfer a liability in an orderly transaction between market participants at the measurement date. In the context of purchase accounting, the determination of fair value often involves significant judgments and estimates by management, including the selection of valuation methodologies, estimates of future revenues, costs and cash flows, discount rates, and selection of comparable companies. The estimated fair values reflected in the purchase accounting are subject to management’s judgment. Contingent Consideration The Company records contingent consideration resulting from a business combination at fair value on the acquisition date. On a quarterly basis, the Company revalues these obligations and records increases or decreases in their fair value as an adjustment to other income. Changes to contingent consideration obligations can result from adjustments to discount rates, accretion of the liability due to the passage of time, changes in the Company’s estimates of the likelihood or timing of achieving development or commercial milestones, changes in the probability of certain clinical events or changes in the assumed probability associated with regulatory approval. Intangible Assets Intangible assets generally consist of patents, purchased technology, acquired IPR&D and other intangibles. Intangible assets with definite lives are amortized based on their pattern of economic benefit over their estimated useful lives and reviewed periodically for impairment. Intangible assets related to acquired IPR&D projects are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. During the period the assets are considered indefinite-lived, they will not be amortized but will be tested for impairment. Impairment testing is performed at least annually or when a triggering event occurs that could indicate a potential impairment. If and when development is complete, which generally occurs when regulatory approval to market a product is obtained, the associated assets are deemed finite-lived and are amortized over a period that best reflects the economic benefits provided by these assets. Goodwill Goodwill, which represents the excess of purchase price over the fair value of net assets acquired, is carried at cost. Goodwill is not amortized; rather, it is subject to a periodic assessment for impairment by applying a fair value-based test. The Company is organized in one reporting unit and evaluates the goodwill for the Company as a whole. The Company reviews goodwill for impairment on a reporting unit basis annually during the fourth quarter of each year and whenever events or changes in circumstances indicate the carrying value of goodwill might not be recoverable. Under the authoritative guidance issued by the FASB, the Company has the option to first assess the qualitative factors to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount as a basis for determining whether it is necessary to perform a quantitative goodwill impairment test. If the Company determines that it is more likely than not that the fair value of a reporting unit is less than its carrying amount, then the goodwill impairment test is performed. The goodwill impairment test requires the Company to estimate the fair value of the reporting unit and to compare the fair value of the reporting unit with its carrying amount. If the fair value exceeds the carrying amount, then no impairment is recognized. If the carrying amount recorded exceeds the fair value calculated, then an impairment charge is recognized for the difference. The judgments made in determining the projected cash flows used to estimate the fair value can materially impact the Company’s financial condition and results of operations. There was no impairment of goodwill for the three months ended March 31, 2022 and 2021. Leases The Company determines if an arrangement is a lease at inception and on the lease commencement date, the Company recognizes an asset for the right to use a leased asset and a liability based on the present value of remaining lease payments over the lease term. As the Company’s leases do not provide an implicit interest rate, the Company uses its incremental borrowing rate based on a third-party analysis, which is updated periodically. The incremental borrowing rate is determined using the remaining lease term as of the lease commencement date. The Company elected the package of practical expedients included in this guidance, which allows it (i) to not reassess whether any expired or existing contracts contain leases; (ii) to not reassess the lease classification for any expired or existing leases; (iii) to account for a lease and non-lease component as a single component for both its real estate and non-real estate leases; and (iv) to not reassess the initial direct costs for existing leases. Amortization and interest expense related to lease right-of-use assets and liabilities are generally calculated on a straight-line basis over the lease term. Amortization and interest expense related to previously impaired lease right-of-use assets are calculated on a front-loaded amortization pattern resulting in higher single lease expense in earlier periods. The Company’s lease agreements do not contain any material residual value guarantees or material restrictive covenants. In addition, the Company does not have any finance leases, any material sublease arrangements or any material leases where the Company is considered the lessor. Research and Development Research and development costs are charged to expense as incurred and include supplies and other direct trial expenses such as fees due to contract research organizations (“CROs”), consultants which support the Company’s research and development endeavors, the acquisition of technology rights without an alternative use, and compensation and benefits of clinical research and development personnel. Certain research and development costs, in particular fees to CROs, are structured with milestone payments due on the occurrence of certain key events. Where such milestone payments are greater than those earned through the provision of such services, the Company recognizes a prepaid asset which is recorded as expense as services are incurred. Stock-Based Compensation The Company measures the cost of option awards based on the grant date fair value of the awards. That cost is recognized on a straight-line basis over the period during which the awardee was required to provide service in exchange for the entire award. The fair value of options is calculated using the Black-Scholes option pricing model, based on key assumptions such as the expected volatility of the Company’s common stock, the risk-free rate of return, and expected term of the options. The Company’s estimates of these assumptions are primarily based on historical data, peer company data, government data, and the judgment of management regarding future trends. Common shares issued are valued based on the fair value of the Company’s common shares as determined by the market closing price of a share of our common stock on the date of the commitment to make the issuance. Income Taxes The Company accounts for income taxes using 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 basis and tax 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 established to reduce net deferred tax assets to the amount expected to be realized. The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Changes in recognition and measurement are reflected in the period in which the change in judgment occurs. Interest and penalties related to unrecognized tax benefits are included in income tax expense. The Company has generally recorded a full valuation allowance for its tax carryforwards, reflecting the judgment of Company management that they are more likely than not to expire unused. Adoption of Recent Accounting Pronouncements In December 2019, the FASB issued Accounting Standards Update (“ASU”) No. 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes. This guidance removes certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period, and the recognition of deferred tax liabilities for outside basis differences. This guidance also clarifies and simplifies other areas of ASC 740. This ASU is effective for fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022. Adoption of this guidance did not have any material impact on the Company’s financial statements. In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings per share calculation in certain areas. The ASU is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020 and adoption must be as of the beginning of the Company’s annual fiscal year. The Company adopted ASU 2020-06 on January 1, 2021, with no material impact on our financial statements.

Acquisition

Acquisition	3 Months Ended
	Mar. 31, 2022
Acquisition [Abstract]
ACQUISITION	4 — ACQUISITION Purnovate, Inc. Acquisition – Related Party On January 26, 2021 the Company completed its business acquisition of 100% of the equity interests of Purnovate, Inc. (“Purnovate”), in a related party transaction. The purchase price of Purnovate totaled $2,142,437 in cash, stock, and contingent consideration. As a result of this purchase, the Company recognized an intangible in-process research and development asset of $455,000 and goodwill of $248,971. At March 31, 2022, the value of the intangible in-process research and development asset and goodwill remained $455,000 and $248,971, respectively. The Company’s unaudited condensed consolidated financial statements for the three months ended March 31, 2021 include the results of operations of Purnovate since January 26, 2021 during which period Purnovate contributed an approximately $82,000 net loss. On an unaudited pro forma basis, the revenues and net income of the Company assuming the acquisition had occurred on January 1, 2021, are shown below. The unaudited pro forma information does not purport to present what the Company’s actual results would have been had the acquisition occurred on January 1, 2021, nor is the financial information indicative of the results of future operations. Three months ended Net revenue $ – Net loss $ (4,844,435 ) Net loss per share, basic and diluted $ (0.30 )

Note Payable

Note Payable	3 Months Ended
	Mar. 31, 2022
Note Payable [Abstract]
NOTE PAYABLE	5 – NOTE PAYABLE Note Payable – Paycheck Protection Program Loan In connection with the acquisition of Purnovate (See Note 4), the Company assumed $29,088 in loan funding from the Paycheck Protection Program (the “PPP”), established pursuant to the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) and administered by the U.S. Small Business Administration. Under the terms of the PPP Note and the PPP Loan, interest accrued on the outstanding principal at the rate of 1% per annum, and there is a deferment period until installment payments of principal and interest are due. The term of the PPP Note was two years. In April of 2021, the PPP Loan was forgiven in accordance with the terms established for such loans under the CARES Act, on which forgiveness the Company recognized a gain of $29,088, classified as other income.

Acquired in-Process Research &

Acquired in-Process Research & Development	3 Months Ended
	Mar. 31, 2022
Research and Development [Abstract]
ACQUIRED IN-PROCESS RESEARCH & DEVELOPMENT	6 — ACQUIRED IN-PROCESS RESEARCH & DEVELOPMENT The Company booked intangible assets associated with a number of ongoing research and development projects at the time of the acquisition of Purnovate. Carrying value of acquired in-process research and development wat $455,000 and both March 31, 2022 and December 31, 2021.

Goodwill

Goodwill	3 Months Ended
	Mar. 31, 2022
Goodwill [Abstract]
GOODWILL	7 — GOODWILL The Company recorded goodwill in connection with the acquisition of Purnovate. Carrying value of goodwill at both March 31, 2022 and December 31, 2021 was $248,971.

Accrued Expenses

Accrued Expenses	3 Months Ended
	Mar. 31, 2022
Accrued Expenses [Abstract]
ACCRUED EXPENSES	8 — ACCRUED EXPENSES Accrued expenses consist of the following: March 31, 2022 December 31, Clinical research organization services and expenses $ 995,088 $ 1,826,479 Employee compensation 357,535 520,795 Preclinical and manufacturing expenses 293,150 – Legal and consulting services 39,058 29,656 Minimum license royalties 10,000 – Total accrued expenses $ 1,694,831 $ 2,376,930

Related Party Transactions

Related Party Transactions	3 Months Ended
	Mar. 31, 2022
Related Party Transactions [Abstract]
RELATED PARTY TRANSACTIONS	9 — RELATED PARTY TRANSACTIONS On December 7, 2020, the Company entered into an Equity Purchase Agreement with Purnovate, LLC to purchase all of the outstanding membership interests of Purnovate from the members of Purnovate (the “Members”), such that after the acquisition, Purnovate would be a wholly owned subsidiary of Adial. The Company’s Chief Executive Officer and board member, William B. Stilley, and another Adial board member, James W. Newman, Jr. were, directly or indirectly, The Members. Messrs. Stilley and Newman agreed to sell their membership interests on the same terms as the other Members, except that Mr. Stilley is subject to a two (2) year lock up with respect to the sale and transfer of the stock consideration that he receives so long as his employment has not been terminated by the Company without cause prior to the end of such period. Mr. Stilley owned approximately 28.7% of the membership interest of Purnovate and Mr. Newman controlled two entities that, together, own less than 1% of the membership interests of Purnovate. As a result of the foregoing, the Company formed a Special Committee of independent members of its Board of Directors to review and negotiate the acquisition terms. On January 26, 2021 the acquisition was consummated, and Messrs. Stilley and Newman sold all of their membership interests in Purnovate to the Company (see Note 4). On March 11, 2021, the Company entered into Securities Purchase Agreements (the “March 2021 SPAs”) with each of Bespoke, three entities controlled by Mr. Newman, and Keystone Capital Partners, LLC (“Keystone”), pursuant to which: (i) Bespoke Growth Partners, Inc. (“Bespoke”) a company controlled by Mark Peikin, the Company’s Chief Strategy Officer who is not an executive officer, agreed to purchase an aggregate of 336,667 shares of the Company’s common stock at a purchase price of $3.00 per share for aggregate gross proceeds of $1,010,001; (ii) Mr. Newman agreed to purchase an aggregate of 30,000 shares of the Company’s common stock at a purchase price of $3.00 per share for aggregate gross proceeds of $90,000; and (iii) Keystone agreed to purchase an aggregate of 333,334 shares of the Company’s common stock at a purchase price of $3.00 per share for aggregate gross proceeds of $1,000,002. During the year ended December 31, 2021, the Company issued 700,001 shares of common stock for total proceeds of $2,100,003. The shares sold pursuant to the March 2021 SPAs were registered though a registration statement on Form S-3 that was filed with the SEC on April 20, 2021 and declared effective on May 26, 2021. On July 6, 2021, the Company entered into Securities Purchase Agreements, dated July 6, 2021 (the “June 2021 SPAs”), with three pre-existing investors for an aggregate investment of $5,000,004 in consideration of the purchase by such investors of an aggregate of 1,666,667 shares of the Company’s common stock at a purchase price of $3.00 per share. June 2021 SPAs were entered with each of Bespoke , Keystone, and Richard Gilliam, a private investor (“Gilliam”) (collectively, the “Investors,” and each an “Investor”), pursuant to which: (i) Bespoke agreed to purchase an aggregate of 833,334 shares of the Company’s common stock at a purchase price of $3.00 per share for aggregate gross proceeds of $2,500,002; (ii) Keystone agreed to purchase an aggregate of 500,000 shares of the Company’s common stock at a purchase price of $3.00 per share for aggregate gross proceeds of $1,500,000; and (iii) Gilliam agreed to purchase an aggregate of 333,334 shares of the Company’s common stock at a purchase price of $3.00 per share for gross proceeds of $1,000,002. The shares sold pursuant to the SPAs were registered though a registration statement on Form S-3 that was filed with the SEC on July 20, 2021 and declared effective on July 29, 2021. On October 5, 2021, the Company released 200,000 shares of its common stock and 150,000 warrants, expiring July 31, 2023 and exercisable at $6.25 per share, beneficially owned by Dr. Bankole Johnson, the Company’s Chief Medical Officer, from the Lock-Up Agreement by and between the Company and Dr. Johnson, dated December 12, 2019, as amended, and the related Pledge and Security Agreement, by and between the Company and Dr. Johnson, dated December 12, 2019, to permit the sale of such shares and warrants to Bespoke Growth Partners, Inc. in a private transaction. On November 9, 2021, the Company entered into a Securities Purchase Agreement (the “November 2021 SPA”) with Bespoke. Pursuant to the terms of the November 2021 SPA, Bespoke agreed to purchase up to 200,000 shares of common stock of the Company at a price of $4.00 per share for an aggregate investment of $800,000. The shares sold pursuant to the were registered though a registration statement on Form S-3 that was filed with the SEC and was declared effective on December 17, 2021. See Note 11 for related party vendor, consulting, and lease agreements.

Shareholders' Equity

Shareholders' Equity	3 Months Ended
	Mar. 31, 2022
Stockholders' Equity Note [Abstract]
SHAREHOLDERS' EQUITY	10 — SHAREHOLDERS’ EQUITY Common Stock Issuances On February 10, 2022, the Company, entered into a securities purchase agreement with an accredited institutional investor providing for the issuance of (i) 2,322,250 shares of the Company’s common stock, par value $0.001, (ii) pre-funded warrants to purchase up to 1,865,000 shares of Common Stock with an exercise price of $0.001 per share, which Pre-Funded Warrants are to be issued in lieu of shares of Common Stock to ensure that the Investor does not exceed certain beneficial ownership limitations, and (iii) warrants, with a term of five years and six months from the date of issuance, to purchase an aggregate of up to 3,977,888 shares of Common Stock at an exercise price of $2.52 per share. The Company received net proceeds from the offering of $9,123,741 after deducting fees due to the placement agent and the Company’s transaction expenses. In the three months ended March 31, 2022, the Company issued 200,000 shares of common stock to employees and consultants for services rendered. In the three months ended March 31, 2022, the Company issued an employee 250,000 shares common stock as a bonus on salary. The shares are subject to repurchase by the Company on termination of the employee, the shares no longer being liable to repurchase (“vesting”) on the following schedule: 1/24 of 166,667 shares vesting on the date of issue and the first of each of the next twenty-three subsequent months, and 83,333 shares vesting on the third anniversary of the date of issue. On March 31, 2022, 13,888 shares were vested and 236,112 shares remained subject to repurchase. 2017 Equity Incentive Plan On October 9, 2017, the Company adopted the Adial Pharmaceuticals, Inc. 2017 Equity Incentive Plan (the “2017 Equity Incentive Plan”); which became effective on July 31, 2018. Initially, the aggregate number of shares of our common stock that may be issued pursuant to stock awards under the 2017 Equity Incentive Plan was 1,750,000 shares. On September 27, 2021, by a vote of the shareholders, the number of shares issuable under the 2017 Equity Incentive Plan was increased to 7,500,000. At March 31, 2022, the Company had issued 1,144,993 shares under the 2017 Equity Incentive Plan and had outstanding 4,007,291 options to purchase shares of our common stock under the 2017 Equity Incentive Plan, as well as 139,686 options to purchase shares of common stock that were issued before the 2017 Equity Incentive Plan was adopted, leaving 2,347,716 available for issue. Stock Options The following table provides the stock option activity for the three months ended March 31, 2022: Total Weighted Weighted Weighted Outstanding December 31, 2021 3,585,310 7.80 $ 2.64 $ 2.02 Issued 561,667 2.00 1.63 Cancelled – Outstanding March 31, 2022 4,146,977 7.87 $ 2.56 $ 1.97 Outstanding March 31, 2022, vested and exercisable 2,465,264 7.25 $ 2.73 $ 2.06 At March 31, 2022, the intrinsic value totals of the outstanding options were $713,933. The Company used the Black Scholes valuation model to determine the fair value of the options issued, using the following key assumptions for the three months ended March 31, 2022: March 31, Fair Value per Share $ 2.00 Expected Term 6.5 Expected Dividend $ — Expected Volatility 107.88 % Risk free rate 1.89 % During the three months ended March 31, 2022, 561,667 options to purchase shares of common stock were granted at a fair value of $915,066, an approximate weighted average fair value of $1.63 per option, to be amortized over a service a weighted average period of 3 years. As of March 31, 2022, $3,146,919 in unrecognized compensation expense will be recognized over a weighted average remaining service period of 2.02 years. The components of stock-based compensation expense included in the Company’s Statements of Operations for the three months ended March 31, 2022 and 2021 are as follows: Three months ended 2022 2021 Research and development options expense $ 76,390 $ 66,631 Total research and development expenses 76,390 66,631 General and administrative options and warrants expense 490,799 407,156 Stock issued to consultants and employees 416,423 850,900 Total general and administrative expenses 907,222 1,258,056 Total stock-based compensation expense $ 983,612 $ 1,324,687 Stock Warrants The following table provides the activity in warrants for the respective periods. Total Warrants Weighted Weighted Average Exercise Price Average Outstanding December 31, 2021 7,990,271 2.63 $ 4.82 0.14 Issued 6,042,888 $ 1.74 Outstanding March 31, 2022 14,033,159 3.07 $ 3.49 0.27 This table includes warrants to purchase 344,851 shares of common stock issued to consultants, including the 200,000 issued in the three months ended March 31, 2022, with a total fair value of $263,195 at time of issue, calculated using the Black Scholes model assuming an underlying security values of $2.06, volatility rate of 107.88% risk-free rate of 1.71%, and an expected term of 6.5 years. In the three months ended March 31, 2022, the Company recognized $33,457 in expense associated with these warrants with $240,841 remaining to be recognized.

Commitments and Contingencies

Commitments and Contingencies	3 Months Ended
	Mar. 31, 2022
Commitments and Contingencies Disclosure [Abstract]
COMMITMENTS AND CONTINGENCIES	11 — COMMITMENTS AND CONTINGENCIES License with University of Virginia Patent Foundation – Related Party In January 2011, the Company entered into an exclusive, worldwide license agreement with the University of Virginia Patent Foundation, dba UVA Licensing and Ventures Group (“UVA LVG”) for rights to make, use or sell licensed products in the United States based upon the ten separate patents and patent applications made and held by UVA LVG. As consideration for the rights granted in the UVA LVG License, the Company is obligated to pay UVA LVG yearly license fees and milestone payments, as well as a royalty based on net sales of products covered by the patent-related rights. More specifically, the Company paid UVA LVG a license issue fee and is obligated to pay UVA LVG (i) annual minimum royalties of $40,000 commencing in 2017; (ii) a $20,000 milestone payments upon dosing the first patient under a Phase 3 human clinical trial of a licensed product, $155,000 upon the earlier of the completion of a Phase 3 trial of a licensed product, partnering of a licensed product, or sale of the Company, $275,000 upon acceptance of an NDA by the FDA, and $1,000,000 upon approval for sale of AD04 in the U.S., Europe or Japan; as well as (iii) royalties equal to a 2% and 1% of net sales of licensed products in countries in which a valid patent exists or does not exist, respectively, with royalties paid quarterly. In the event of a sublicense to a third party, the Company is obligated to pay royalties to UVA LVG equal to a percentage of what the Company would have been required to pay to UVA LVG had it sold the products under sublicense ourselves. In addition, the Company is required to pay to UVA LVG 15% of any sublicensing income. A certain percentage of these payments by the Company to the UVA LVG may then be distributed to the Company’s former Chairman of the Board who currently serves as the Company’s Chief Medical Officer in his capacity as inventor of the patents by the UVA LVG in accordance with their policies at the time. The license agreement may be terminated by UVA LVG upon sixty (60) days written notice if the Company breaches its obligations thereunder, including failing to make any milestone, failure to make required payments, or the failure to exercise diligence to bring licensed products to market. In the event of a termination, the Company will be obligated to pay all amounts that accrued prior to such termination. The Company is required to use commercially reasonable efforts to achieve the goals of submitting a New Drug Application to the FDA for a licensed product by December 31, 2024 and commencing commercialization of an FDA approved product by December 31, 2025. If the Company were to fail to use commercially reasonable effort and fail to meet either goal, the licensor would have the right to terminate the license. The term of the license continues until the expiration, abandonment or invalidation of all licensed patents and patent applications, and following any such expiration, abandonment or invalidation will continue in perpetuity on a royalty-free, fully paid basis. During both the three months ended March 31, 2022 and 2021, the Company recognized $10,000 minimum license royalty expenses under this agreement. Clinical Research Organization (CRO) On October 31, 2018, the Company entered into a master services agreement (“MSA”) with Crown CRO Oy (“Crown”) for contract clinical research and consulting services. The MSA has a term of five years, automatically renewed for two-year periods, unless either party gives written notice of a decision not to renew the agreement six months prior to automatic renewal. The MSA or a service agreement under it may be terminated by the Company, without penalty, on fourteen days written notice for scientific, administrative, or financial reasons, or if the purpose of the study becomes obsolete. In the event that the MSA or Service Order are terminated, Crown’s actual costs up the date of termination will be payable by the Company, but any unrealized milestones would not be owed. On November 16, 2018, the Company and Crown entered into Service Agreement 1 under the MSA for a 24 week, multi-centered, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 clinical study of AD04 for fees, as amended, of $3,509,234 (€3,168,895 converted to dollars at the Euro/US Dollar exchange rate of 1.1074 as of March 31, 2022) milestone payments. On March 22, 2022, the Company acknowledged the occurrence of the milestone event of 90% of trial case report forms having been monitored, and made a payment of $148,875. On April 28, 2022, the Company and Crown entered into a settlement of a previous dispute concerning a putative change order. As part of this agreement, the Company agreed to pay Crown a total of $454,034 (€410,000) for changes to the services described in Service Order 1. The settlement also altered the schedule of remaining milestones to be as described in the table below. At March 31, 2022, the remaining future milestone payments are shown in the table below, converted to dollars from euros at the exchange rate then prevailing. Milestone Event Percent Amount Last patient last visit 5 % $ 149,465 Database Lock 5 % $ 149,465 eTMF Transfer 5 % $ 149,465 During the three months ended March 31, 2022, the Company recognized $311,727 in non-cash income associated with the Service Agreement 1 and the settlement described above, classified as a negative R&D expense. The negative expense was a result of the value of the settlement and total, fully earned value of milestones being less than the expense previously accrued. On March 31, 2022 there remained an accrued R&D expense of $803,591 related to direct expenses under this agreement, which expense is expected to be fully paid with the occurrence of the settlement payment and three remaining milestone payments. Service Agreement 1 also estimated approximately $2.4 million (€2.2 million) in pass-through costs, mostly fees to clinical investigators and sites, which are billed as incurred and the total contingent upon individual site rate and enrollment rates. Based on current enrollment rates and the various active clinical sites, the Company has increased its total estimated future site costs to a total of approximately $3.1 million. During the three months ended March 31, 2022, the Company recognized non-cash income of $75,991 associated with fees to investigators and sites, classified as a negative R&D expense, resulting from earned site fees in the quarter being lower than the those previously accrued. Lease Commitments – Purnovate lease The Company has one operating lease which consists of office space with a remaining lease term of approximately five years. Leases with an initial term of twelve months or less are not recorded on the balance sheet, and the Company does not separate lease and non-lease components of contracts. The Company’s lease agreement does not provide for determination of the interest rate implicit in the lease. Therefore, the Company used a benchmark approach to derive an appropriate incremental borrowing rate. The Company’s incremental borrowing rate is the rate of interest that the lessee would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The Company benchmarked itself against other companies of similar credit ratings and comparable quality and derived an incremental borrowing rate, which was used to discount its lease liabilities. The Company used an estimated incremental borrowing rate of 9% on January 26, 2021 for its lease contract. The Company’s lease agreement does not contain any material residual value guarantees or material restrictive covenants. In addition, the Company does not have any finance leases, any sublease arrangements, or any leases where the Company is considered the lessor. The components of lease expense, which are included in general and administrative expense, based on the underlying use of the ROU asset, were as follows: Three months Three months Components of total lease cost: Operating lease expense $ 19,376 $ 18,207 Short-term lease expense — — Total lease cost $ 19,376 $ 18,207 Supplemental cash flow information related to leases are as follows: Three months Three months Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows for operating leases $ 17,606 $ 10,388 Supplemental non-cash amounts of lease liabilities arising from obtaining right of use assets $ 1,770 $ 294,294 Supplemental balance sheet information related to leases was as follows: As of As of December 31, Assets Lease right of use assets $ 233,570 $ 246,209 Total lease assets $ 233,570 $ 246,209 Liabilities Current liabilities: Lease liability - current portion $ 51,351 $ 49,585 Noncurrent liabilities: Lease liability, net of current portion 193,797 207,375 Total lease liability $ 245,148 $ 256,960 The weighted-average remaining lease term of the Company’s operating leases and the weighted-average discount rates used to calculate the Company’s operating lease liabilities are as follows: As of As of Weighted average remaining lease term (in years) - operating leases 3.83 4.83 Weighted average discount rate - operating leases 9.00 % 9.00 % Future lease payments included in the measurement of lease liabilities on the condensed balance sheet as of March 31, 2022, for the following five fiscal years and thereafter were as follows: Year ending December 31, Operating 2022 (remaining) 52,597 2023 72,687 2024 75,231 2025 77,864 2026 and thereafter 6,507 Total Minimum Lease Payments $ 284,886 Less effects of discounting (39,738 ) Present value of future minimum lease payments $ 245,148 Lease Commitments – Related Party On March 1, 2020, the Company entered into a sublease with Purnovate, LLC, a private company in which the Company’s CEO had a 28.7% equity interest, for the lease of three offices at 1180 Seminole Trail, Suite 495, Charlottesville, VA 22901. The lease had a term of two years, and the monthly rent was $1,400. During the three months ended March 31, 2022, the rent expense associated with this lease was $1,400. On acquisition of Purnovate, the sublease was terminated and the Company assumed the obligations of Purnovate’s lease. Consulting Agreements – Related Party On March 24, 2019, the Company entered into a consulting agreement (the “Consulting Agreement”) with Dr. Bankole A. Johnson, who at the time of the agreement was serving as the Chairman of the Board of Directors, for his service as Chief Medical Officer of the Company. The Consulting Agreement has a term of three years, unless terminated by mutual consent or by the Company for cause. Dr. Johnson resigned as Chairman of the Board of Directors at the time of execution of the consulting agreement. Under the terms of the Consulting Agreement, Dr. Johnson’s annual fee of $375,000 per year is paid twice per month. The Consulting Agreement had an expiration date of March 31, 2022, which was extended on March 22, 2022 for an additional three years commencing as of March 24, 2022. The Company recognized $93,750 in compensation expense in the both the three months ended March 31, 2022 and 2021 as a result of this agreement. On July 5, 2019, the Company entered into a Master Services Agreement (the “PEPCO MSA”) and statement of work with Psychological Education Publishing Company (“PEPCO”) to administer a behavioral therapy program during the Company’s upcoming Phase 3 clinical trial. PEPCO is owned by a related party, Dr. Bankole Johnson. It is anticipated that the compensation to be paid to PEPCO for services under the PEPCO MSA will total approximately $300,000. As of March 31, 2022, the Company had recognized all expenses associated with this agreement. No further expenses associated with the PEPCO MSA work order are expected. On April 5, 2021, the Company entered into another Lock-Up Agreement Extension, which amended the Lock-Up Extension and extended the term of Dr. Johnson’s Lock-Up from April 1, 2021 until such date as the Company shall have publicly released the data from its ONWARD™ Phase 3 pivotal trial of AD04, in genetically identified subjects for the treatment of Alcohol Use Disorder. See Note 9 for a release of this lockup with respect to certain shares and warrants beneficially owned by Dr. Johnson. Other Consulting and Vendor Agreements The Company has entered into a number of agreements and work orders for future consulting, clinical trial support, and testing services, with terms ranging between 12 and 36 months. These agreements, in aggregate, commit the Company to approximately $1.6 million in future cash. Litigation The Company is subject, from time to time, to claims by third parties under various legal disputes. The defense of such claims, or any adverse outcome relating to any such claims, could have a material adverse effect on the Company’s liquidity, financial condition and cash flows. As of March 31, 2022, the Company did not have any pending legal actions.

Subsequent Events

Subsequent Events	3 Months Ended
	Mar. 31, 2022
Subsequent Events [Abstract]
SUBSEQUENT EVENTS	12 — SUBSEQUENT EVENTS On April 4, 2022, the Company acknowledged the occurrence of the milestone event in its agreement with Crown CRO of the last patient having made a last clinical site visit, and as a result made a milestone payment of $147,182 (€134,969). On April 8, 2022, the Company issued 25,000 shares of common stock to a vendor for services rendered at a market cost of $1.62 per share, for total cost of $40,500.

Accounting Policies, by Policy

Accounting Policies, by Policy (Policies)	3 Months Ended
	Mar. 31, 2022
Accounting Policies [Abstract]
Basis of Presentation and Principals of Consolidation	Basis of Presentation and Principals of Consolidation The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with GAAP as determined by the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results of operations for the periods presented. The interim operating results are not necessarily indicative of results that may be expected for any subsequent period. These unaudited condensed financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2021, included in the 2021 Form 10-K. The unaudited condensed consolidated financial statements represent the consolidation of the Company and its subsidiary in conformity with GAAP. All intercompany transactions have been eliminated in consolidation.
Use of Estimates	Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include the valuation of stock-based compensation, accruals associated with third party providers supporting clinical trials, estimated fair values of long-lived assets used to record impairment charges related to intangible assets, acquired in-process research and development (“IPR&D”) and goodwill, allocation of purchase price in business acquisitions, measurement of contingent liabilities, and income tax asset realization. In particular, the recognition of clinical trial costs is dependent on the Company’s own judgement, as well as the judgment of our contractors and subcontractors in their reporting of information to us.
Basic and Diluted Loss per Share	Basic and Diluted Loss per Share Basic and diluted loss per share are computed based on the weighted-average outstanding shares of common stock, which are all voting shares. Diluted net loss per share is computed giving effect to all proportional shares of common stock, including stock options and warrants to the extent dilutive. Basic net loss per share was the same as diluted net loss per share for the three months ended March 31, 2022 and 2021 as the inclusion of all potential common shares outstanding would have an anti-dilutive effect. The total potentially dilutive common shares that were excluded for the three month periods ended March 31, 2022 and 2021 were as follows: Potentially Dilutive Common 2022 2021 Warrants to purchase common shares 12,095,870 7,884,936 Common Shares issuable on exercise of options 4,146,977 3,576,866 Unvested restricted stock awards 236,112 — Total potentially dilutive Common Shares excluded 16,478,959 11,461,802
Fair Value Measurements	Fair Value Measurements FASB ASC 820, Fair Value Measurement, (“ASC 820”) defines fair value as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The methodology establishes consistency and comparability by providing a fair value hierarchy that prioritizes the inputs to valuation techniques into three broad levels, which are described below: ● Level 1 inputs are quoted market prices in active markets for identical assets or liabilities (these are observable market inputs). ● Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability (includes quoted market prices for similar assets or identical or similar assets in markets in which there are few transactions, prices that are not current or prices that vary substantially). ● Level 3 inputs are unobservable inputs that reflect the entity’s own assumptions in pricing the asset or liability (used when little or no market data is available). The fair value of cash and cash equivalents, prepaid and other current assets, accounts payable and accrued liabilities approximate their carrying value due to their short-term maturities. The lease liability are presented at their carrying value, which based on borrowing rates currently available to the Company for leases with similar terms, approximate their fair values. Non-financial assets, such as IPR&D and goodwill, are accounted for at fair value on a nonrecurring basis. Acquisition-Related Contingent Consideration In connection with the Purnovate business combination, the Company may be required to pay future consideration that is contingent upon the achievement of specified development, regulatory approvals or sales-based milestone events. The Company determines the fair value of these obligations using various estimates that are not observable in the market and represent a Level 3 measurement within the fair value hierarchy. As of March 31, 2022, the resulting probability-weighted cash flows were discounted using a weighted average cost of capital of 45.5% for regulatory and sales-based milestones. March 31, Balance, December 31, 2021 $ (1,014,000 ) Additions — Total gains recognized 146,000 Balance as of March 31, 2022 $ (868,000 )
Business Combinations	Business Combinations The Company accounts for its business combinations under the provisions of ASC Topic 805-10, Business Combinations (“ASC 805-10”), which requires that the purchase method of accounting be used for all business combinations. Assets acquired and liabilities assumed are recorded at the date of acquisition at their respective fair values. For transactions that are business combinations, the Company evaluates the existence of goodwill. Goodwill represents the excess purchase price over the fair value of the tangible net assets and intangible assets acquired in a business combination. ASC 805-10 also specifies criteria that intangible assets acquired in a business combination must meet to be recognized and reported apart from goodwill. Acquisition-related expenses are recognized separately from the business combinations and are expensed as incurred. The estimated fair value of net assets acquired, including the allocation of the fair value to identifiable assets and liabilities, was determined using established valuation techniques. A fair value measurement is determined as the price the Company would receive to sell an asset or pay to transfer a liability in an orderly transaction between market participants at the measurement date. In the context of purchase accounting, the determination of fair value often involves significant judgments and estimates by management, including the selection of valuation methodologies, estimates of future revenues, costs and cash flows, discount rates, and selection of comparable companies. The estimated fair values reflected in the purchase accounting are subject to management’s judgment.
Contingent Consideration	Contingent Consideration The Company records contingent consideration resulting from a business combination at fair value on the acquisition date. On a quarterly basis, the Company revalues these obligations and records increases or decreases in their fair value as an adjustment to other income. Changes to contingent consideration obligations can result from adjustments to discount rates, accretion of the liability due to the passage of time, changes in the Company’s estimates of the likelihood or timing of achieving development or commercial milestones, changes in the probability of certain clinical events or changes in the assumed probability associated with regulatory approval.
Intangible Assets	Intangible Assets Intangible assets generally consist of patents, purchased technology, acquired IPR&D and other intangibles. Intangible assets with definite lives are amortized based on their pattern of economic benefit over their estimated useful lives and reviewed periodically for impairment. Intangible assets related to acquired IPR&D projects are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. During the period the assets are considered indefinite-lived, they will not be amortized but will be tested for impairment. Impairment testing is performed at least annually or when a triggering event occurs that could indicate a potential impairment. If and when development is complete, which generally occurs when regulatory approval to market a product is obtained, the associated assets are deemed finite-lived and are amortized over a period that best reflects the economic benefits provided by these assets.
Goodwill	Goodwill Goodwill, which represents the excess of purchase price over the fair value of net assets acquired, is carried at cost. Goodwill is not amortized; rather, it is subject to a periodic assessment for impairment by applying a fair value-based test. The Company is organized in one reporting unit and evaluates the goodwill for the Company as a whole. The Company reviews goodwill for impairment on a reporting unit basis annually during the fourth quarter of each year and whenever events or changes in circumstances indicate the carrying value of goodwill might not be recoverable. Under the authoritative guidance issued by the FASB, the Company has the option to first assess the qualitative factors to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount as a basis for determining whether it is necessary to perform a quantitative goodwill impairment test. If the Company determines that it is more likely than not that the fair value of a reporting unit is less than its carrying amount, then the goodwill impairment test is performed. The goodwill impairment test requires the Company to estimate the fair value of the reporting unit and to compare the fair value of the reporting unit with its carrying amount. If the fair value exceeds the carrying amount, then no impairment is recognized. If the carrying amount recorded exceeds the fair value calculated, then an impairment charge is recognized for the difference. The judgments made in determining the projected cash flows used to estimate the fair value can materially impact the Company’s financial condition and results of operations. There was no impairment of goodwill for the three months ended March 31, 2022 and 2021.
Leases	Leases The Company determines if an arrangement is a lease at inception and on the lease commencement date, the Company recognizes an asset for the right to use a leased asset and a liability based on the present value of remaining lease payments over the lease term. As the Company’s leases do not provide an implicit interest rate, the Company uses its incremental borrowing rate based on a third-party analysis, which is updated periodically. The incremental borrowing rate is determined using the remaining lease term as of the lease commencement date. The Company elected the package of practical expedients included in this guidance, which allows it (i) to not reassess whether any expired or existing contracts contain leases; (ii) to not reassess the lease classification for any expired or existing leases; (iii) to account for a lease and non-lease component as a single component for both its real estate and non-real estate leases; and (iv) to not reassess the initial direct costs for existing leases. Amortization and interest expense related to lease right-of-use assets and liabilities are generally calculated on a straight-line basis over the lease term. Amortization and interest expense related to previously impaired lease right-of-use assets are calculated on a front-loaded amortization pattern resulting in higher single lease expense in earlier periods. The Company’s lease agreements do not contain any material residual value guarantees or material restrictive covenants. In addition, the Company does not have any finance leases, any material sublease arrangements or any material leases where the Company is considered the lessor.
Research and Development	Research and Development Research and development costs are charged to expense as incurred and include supplies and other direct trial expenses such as fees due to contract research organizations (“CROs”), consultants which support the Company’s research and development endeavors, the acquisition of technology rights without an alternative use, and compensation and benefits of clinical research and development personnel. Certain research and development costs, in particular fees to CROs, are structured with milestone payments due on the occurrence of certain key events. Where such milestone payments are greater than those earned through the provision of such services, the Company recognizes a prepaid asset which is recorded as expense as services are incurred.
Stock-Based Compensation	Stock-Based Compensation The Company measures the cost of option awards based on the grant date fair value of the awards. That cost is recognized on a straight-line basis over the period during which the awardee was required to provide service in exchange for the entire award. The fair value of options is calculated using the Black-Scholes option pricing model, based on key assumptions such as the expected volatility of the Company’s common stock, the risk-free rate of return, and expected term of the options. The Company’s estimates of these assumptions are primarily based on historical data, peer company data, government data, and the judgment of management regarding future trends. Common shares issued are valued based on the fair value of the Company’s common shares as determined by the market closing price of a share of our common stock on the date of the commitment to make the issuance.
Income Taxes	Income Taxes The Company accounts for income taxes using 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 basis and tax 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 established to reduce net deferred tax assets to the amount expected to be realized. The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Changes in recognition and measurement are reflected in the period in which the change in judgment occurs. Interest and penalties related to unrecognized tax benefits are included in income tax expense. The Company has generally recorded a full valuation allowance for its tax carryforwards, reflecting the judgment of Company management that they are more likely than not to expire unused.
Adoption of Recent Accounting Pronouncements	Adoption of Recent Accounting Pronouncements In December 2019, the FASB issued Accounting Standards Update (“ASU”) No. 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes. This guidance removes certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period, and the recognition of deferred tax liabilities for outside basis differences. This guidance also clarifies and simplifies other areas of ASC 740. This ASU is effective for fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022. Adoption of this guidance did not have any material impact on the Company’s financial statements. In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings per share calculation in certain areas. The ASU is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020 and adoption must be as of the beginning of the Company’s annual fiscal year. The Company adopted ASU 2020-06 on January 1, 2021, with no material impact on our financial statements.

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Tables)	3 Months Ended
	Mar. 31, 2022
Accounting Policies [Abstract]
Schedule of potentially dilutive common shares	Potentially Dilutive Common 2022 2021 Warrants to purchase common shares 12,095,870 7,884,936 Common Shares issuable on exercise of options 4,146,977 3,576,866 Unvested restricted stock awards 236,112 — Total potentially dilutive Common Shares excluded 16,478,959 11,461,802
Schedule of probability-weighted cash flows were discounted using a weighted average cost of capital	March 31, Balance, December 31, 2021 $ (1,014,000 ) Additions — Total gains recognized 146,000 Balance as of March 31, 2022 $ (868,000 )

Acquisition (Tables)

Acquisition (Tables)	3 Months Ended
	Mar. 31, 2022
Acquisition [Abstract]
Schedule of financial information indicative of the results of future operations	Three months ended Net revenue $ – Net loss $ (4,844,435 ) Net loss per share, basic and diluted $ (0.30 )

Accrued Expenses (Tables)

Accrued Expenses (Tables)	3 Months Ended
	Mar. 31, 2022
Payables and Accruals [Abstract]
Schedule of accrued expenses	March 31, 2022 December 31, Clinical research organization services and expenses $ 995,088 $ 1,826,479 Employee compensation 357,535 520,795 Preclinical and manufacturing expenses 293,150 – Legal and consulting services 39,058 29,656 Minimum license royalties 10,000 – Total accrued expenses $ 1,694,831 $ 2,376,930

Shareholders' Equity (Tables)

Shareholders' Equity (Tables)	3 Months Ended
	Mar. 31, 2022
Stockholders' Equity Note [Abstract]
Schedule of stock options activity	Total Weighted Weighted Weighted Outstanding December 31, 2021 3,585,310 7.80 $ 2.64 $ 2.02 Issued 561,667 2.00 1.63 Cancelled – Outstanding March 31, 2022 4,146,977 7.87 $ 2.56 $ 1.97 Outstanding March 31, 2022, vested and exercisable 2,465,264 7.25 $ 2.73 $ 2.06
Schedule of black scholes valuation model to determine the fair value of the options issued	March 31, Fair Value per Share $ 2.00 Expected Term 6.5 Expected Dividend $ — Expected Volatility 107.88 % Risk free rate 1.89 %
Schedule of stock-based compensation expense	Three months ended 2022 2021 Research and development options expense $ 76,390 $ 66,631 Total research and development expenses 76,390 66,631 General and administrative options and warrants expense 490,799 407,156 Stock issued to consultants and employees 416,423 850,900 Total general and administrative expenses 907,222 1,258,056 Total stock-based compensation expense $ 983,612 $ 1,324,687
Schedule of activity in warrants	Total Warrants Weighted Weighted Average Exercise Price Average Outstanding December 31, 2021 7,990,271 2.63 $ 4.82 0.14 Issued 6,042,888 $ 1.74 Outstanding March 31, 2022 14,033,159 3.07 $ 3.49 0.27

Commitments and Contingencies (

Commitments and Contingencies (Tables)	3 Months Ended
	Mar. 31, 2022
Commitments and Contingencies Disclosure [Abstract]
Schedule of future milestone payments are shown in the table below, converted to dollars from euros	Milestone Event Percent Amount Last patient last visit 5 % $ 149,465 Database Lock 5 % $ 149,465 eTMF Transfer 5 % $ 149,465
Schedule of components of lease expense	Three months Three months Components of total lease cost: Operating lease expense $ 19,376 $ 18,207 Short-term lease expense — — Total lease cost $ 19,376 $ 18,207
Schedule of supplemental cash flow information related to leases	Three months Three months Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows for operating leases $ 17,606 $ 10,388 Supplemental non-cash amounts of lease liabilities arising from obtaining right of use assets $ 1,770 $ 294,294
Schedule of supplemental balance sheet information related to leases	As of As of December 31, Assets Lease right of use assets $ 233,570 $ 246,209 Total lease assets $ 233,570 $ 246,209 Liabilities Current liabilities: Lease liability - current portion $ 51,351 $ 49,585 Noncurrent liabilities: Lease liability, net of current portion 193,797 207,375 Total lease liability $ 245,148 $ 256,960
Schedule of weighted-average remaining lease term	As of As of Weighted average remaining lease term (in years) - operating leases 3.83 4.83 Weighted average discount rate - operating leases 9.00 % 9.00 %
Schedule of future lease payments included in the measurement of lease liabilities	Year ending December 31, Operating 2022 (remaining) 52,597 2023 72,687 2024 75,231 2025 77,864 2026 and thereafter 6,507 Total Minimum Lease Payments $ 284,886 Less effects of discounting (39,738 ) Present value of future minimum lease payments $ 245,148

Liquidity and Other Uncertain_2

Liquidity and Other Uncertainties (Details) $ in Millions	Mar. 31, 2022 USD ($)
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Accumulated Deficit	$ (53.9)

Summary of Significant Accoun_3

Summary of Significant Accounting Policies (Details)	Mar. 31, 2022
Accounting Policies [Abstract]
Weighted average cost of capital, percentage	45.50%

Summary of Significant Accoun_4

Summary of Significant Accounting Policies (Details) - Schedule of potentially dilutive common shares - shares	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Schedule of potentially dilutive common shares [Abstract]
Warrants to purchase common shares	12,095,870	7,884,936
Common Shares issuable on exercise of options	4,146,977	3,576,866
Unvested restricted stock awards	236,112
Total potentially dilutive Common Shares excluded	16,478,959	11,461,802

Summary of Significant Accoun_5

Summary of Significant Accounting Policies (Details) - Schedule of probability-weighted cash flows were discounted using a weighted average cost of capital	3 Months Ended
	Mar. 31, 2022 USD ($)
Schedule of probability-weighted cash flows were discounted using a weighted average cost of capital [Abstract]
Opening balance	$ (1,014,000)
Additions
Total gains recognized	146,000
Ending balance	$ (868,000)

Acquisition (Details)

Acquisition (Details) - USD ($)	1 Months Ended	3 Months Ended
	Jan. 26, 2021	Mar. 31, 2022
Acquisition (Details) [Line Items]
Total purchase price		$ 2,142,437
Research and development asset		455,000
Goodwill		$ 248,971
Net loss (in Shares)	82,000
Business Combination [Member]
Acquisition (Details) [Line Items]
Business acquisition shares percentage	100%

Acquisition (Details) - Schedul

Acquisition (Details) - Schedule of financial information indicative of the results of future operations - Acquisition [Member]	3 Months Ended
	Mar. 31, 2021 USD ($) $ / shares
Acquisition (Details) - Schedule of financial information indicative of the results of future operations [Line Items]
Net revenue
Net loss	$ (4,844,435)
Net loss per share, basic and diluted (in Dollars per share) | $ / shares	$ (0.3)

Note Payable (Details)

Note Payable (Details) - USD ($)	3 Months Ended
	Mar. 31, 2022	Apr. 30, 2021
Debt Disclosure [Abstract]
Note payable	$ 29,088
Outstanding principal rate	1%
Paycheck protection program term	2 years
Other income		$ 29,088

Acquired in-Process Research _2

Acquired in-Process Research & Development (Details) - USD ($)	3 Months Ended	12 Months Ended
	Mar. 31, 2022	Dec. 31, 2021
Research and Development [Abstract]
Research and development	$ 455,000	$ 455,000

Goodwill (Details)

Goodwill (Details) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Goodwill [Abstract]
Carrying value of goodwill	$ 248,971	$ 248,971

Accrued Expenses (Details) - Sc

Accrued Expenses (Details) - Schedule of accrued expenses - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Schedule of accrued expenses [Abstract]
Clinical research organization services and expenses	$ 995,088	$ 1,826,479
Employee compensation	357,535	520,795
Preclinical and manufacturing expenses	293,150
Legal and consulting services	39,058	29,656
Minimum license royalties	10,000
Total accrued expenses	$ 1,694,831	$ 2,376,930

Related Party Transactions (Det

Related Party Transactions (Details) - USD ($)	Nov. 09, 2021	Oct. 05, 2021	Jul. 06, 2021	Mar. 11, 2021	Dec. 07, 2020
Related Party Transactions (Details) [Line Items]
Membership interest, description					Mr. Stilley owned approximately 28.7% of the membership interest of Purnovate and Mr. Newman controlled two entities that, together, own less than 1% of the membership interests of Purnovate. As a result of the foregoing, the Company formed a Special Committee of independent members of its Board of Directors to review and negotiate the acquisition terms.
Securities purchase agreements, description			the Company entered into Securities Purchase Agreements, dated July 6, 2021 (the “June 2021 SPAs”), with three pre-existing investors for an aggregate investment of $5,000,004 in consideration of the purchase by such investors of an aggregate of 1,666,667 shares of the Company’s common stock at a purchase price of $3.00 per share. June 2021 SPAs were entered with each of Bespoke , Keystone, and Richard Gilliam, a private investor (“Gilliam”) (collectively, the “Investors,” and each an “Investor”), pursuant to which: (i) Bespoke agreed to purchase an aggregate of 833,334 shares of the Company’s common stock at a purchase price of $3.00 per share for aggregate gross proceeds of $2,500,002; (ii) Keystone agreed to purchase an aggregate of 500,000 shares of the Company’s common stock at a purchase price of $3.00 per share for aggregate gross proceeds of $1,500,000; and (iii) Gilliam agreed to purchase an aggregate of 333,334 shares of the Company’s common stock at a purchase price of $3.00 per share for gross proceeds of $1,000,002.	the Company entered into Securities Purchase Agreements (the “March 2021 SPAs”) with each of Bespoke, three entities controlled by Mr. Newman, and Keystone Capital Partners, LLC (“Keystone”), pursuant to which: (i) Bespoke Growth Partners, Inc. (“Bespoke”) a company controlled by Mark Peikin, the Company’s Chief Strategy Officer who is not an executive officer, agreed to purchase an aggregate of 336,667 shares of the Company’s common stock at a purchase price of $3.00 per share for aggregate gross proceeds of $1,010,001; (ii) Mr. Newman agreed to purchase an aggregate of 30,000 shares of the Company’s common stock at a purchase price of $3.00 per share for aggregate gross proceeds of $90,000; and (iii) Keystone agreed to purchase an aggregate of 333,334 shares of the Company’s common stock at a purchase price of $3.00 per share for aggregate gross proceeds of $1,000,002. During the year ended December 31, 2021, the Company issued 700,001 shares of common stock for total proceeds of $2,100,003. The shares sold pursuant to the March 2021 SPAs were registered though a registration statement on Form S-3 that was filed with the SEC on April 20, 2021 and declared effective on May 26, 2021.
Shares of common stock		200,000
Warrants shares		150,000
Exercisable per share		$ 6.25
Bespoke [Member]
Related Party Transactions (Details) [Line Items]
Shares of common stock	200,000
Price per share	$ 4
Aggregate investment	$ 800,000

Shareholders' Equity (Details)

Shareholders' Equity (Details) - USD ($)			1 Months Ended	3 Months Ended
	Feb. 10, 2022	Oct. 09, 2017	Sep. 27, 2020	Mar. 31, 2022	Dec. 31, 2021
Shareholders' Equity (Details) [Line Items]
Common Stock Issuances, description	(i) 2,322,250 shares of the Company’s common stock, par value $0.001, (ii) pre-funded warrants to purchase up to 1,865,000 shares of Common Stock with an exercise price of $0.001 per share, which Pre-Funded Warrants are to be issued in lieu of shares of Common Stock to ensure that the Investor does not exceed certain beneficial ownership limitations, and (iii) warrants, with a term of five years and six months from the date of issuance, to purchase an aggregate of up to 3,977,888 shares of Common Stock at an exercise price of $2.52 per share. The Company received net proceeds from the offering of $9,123,741 after deducting fees due to the placement agent and the Company’s transaction expenses.
Employee vesting shares, description				the Company issued an employee 250,000 shares common stock as a bonus on salary. The shares are subject to repurchase by the Company on termination of the employee, the shares no longer being liable to repurchase (“vesting”) on the following schedule: 1/24 of 166,667 shares vesting on the date of issue and the first of each of the next twenty-three subsequent months, and 83,333 shares vesting on the third anniversary of the date of issue. On March 31, 2022, 13,888 shares were vested and 236,112 shares remained subject to repurchase.
Common stock, shares outstanding				23,718,962	20,946,712
Outstanding options intrinsic value (in Dollars)				$ 713,933
Option purchased (in Dollars)				561,667
Weighted average fair value (in Dollars)				$ 915,066
Weighted average fair value share price (in Dollars per share)				$ 1.63
Weighted average remaining vesting period				2 years 7 days
Unrecognized compensation expense (in Dollars)				$ 3,146,919
2017 Equity Incentive Plan [Member]
Shareholders' Equity (Details) [Line Items]
Common stock issued, shares		1,750,000	7,500,000	1,144,993
Stock Options [Member]
Shareholders' Equity (Details) [Line Items]
Weighted average remaining vesting period				3 years
Stock Options [Member]
Shareholders' Equity (Details) [Line Items]
Common stock, shares outstanding				4,007,291
Common stock shares available for issuance				139,686
Shares issued				2,347,716
Consultant [Member]
Shareholders' Equity (Details) [Line Items]
Fair value of assumptions, description				This table includes warrants to purchase 344,851 shares of common stock issued to consultants, including the 200,000 issued in the three months ended March 31, 2022, with a total fair value of $263,195 at time of issue, calculated using the Black Scholes model assuming an underlying security values of $2.06, volatility rate of 107.88% risk-free rate of 1.71%, and an expected term of 6.5 years. In the three months ended March 31, 2022, the Company recognized $33,457 in expense associated with these warrants with $240,841 remaining to be recognized.
Employees and consultants [Member]
Shareholders' Equity (Details) [Line Items]
Shares issued				200,000

Shareholders' Equity (Details)

Shareholders' Equity (Details) - Schedule of stock options activity	3 Months Ended
	Mar. 31, 2022 $ / shares shares
Schedule of stock options activity [Abstract]
Options Outstanding, Beginning Balance (in Shares) | shares	3,585,310
Weighted Average Remaining Term (Years) , Balance	7 years 9 months 18 days
Weighted Average Exercise Price, Balance	$ 2.64
Weighted Average Fair Value at Issue , Balance	$ 2.02
Options Outstanding, Issued (in Shares) | shares	561,667
Weighted Average Exercise Price, Issued	$ 2
Weighted Average Fair Value at Issue, Issued	$ 1.63
Options Outstanding, Cancelled (in Shares) | shares
Options Outstanding, Ending Balance (in Shares) | shares	4,146,977
Weighted Average Remaining Term (Years) , Balance	7 years 10 months 13 days
Weighted Average Exercise Price, Balance	$ 2.56
Weighted Average Fair Value at Issue , Balance	$ 1.97
Options Outstanding,Outstanding, vested and exercisable (in Shares) | shares	2,465,264
Weighted Average Remaining Term (Years),Outstanding, vested and exercisable	7 years 3 months
Weighted Average Exercise Price, Outstanding, vested and exercisable	$ 2.73
Weighted Average Fair Value at Issue ,Outstanding, vested and exercisable	$ 2.06

Shareholders' Equity (Details_2

Shareholders' Equity (Details) - Schedule of black scholes valuation model to determine the fair value of the options issued	3 Months Ended
	Mar. 31, 2022 USD ($) $ / shares
Schedule of black scholes valuation model to determine the fair value of the options issued [Abstract]
Fair Value per Share (in Dollars per share) | $ / shares	$ 2
Expected Term	6 years 6 months
Expected Dividend (in Dollars) | $
Expected Volatility	107.88%
Risk free rate	1.89%

Shareholders' Equity (Details_3

Shareholders' Equity (Details) - Schedule of stock-based compensation expense - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Schedule of stock-based compensation expense [Abstract]
Research and development options expense	$ 76,390	$ 66,631
Total research and development expenses	76,390	66,631
General and administrative options and warrants expense	490,799	407,156
Stock issued to consultants and employees	416,423	850,900
Total general and administrative expenses	907,222	1,258,056
Total stock-based compensation expense	$ 983,612	$ 1,324,687

Shareholders' Equity (Details_4

Shareholders' Equity (Details) - Schedule of activity in warrants	3 Months Ended
	Mar. 31, 2022 $ / shares shares
Schedule of activity in warrants [Abstract]
Warrants, Beginning Balance (in Shares) | shares	7,990,271
Weighted Average Remaining Term (Years), Outstanding	2 years 7 months 17 days
Weighted Average Exercise Price, Outstanding	$ 4.82
Average Intrinsic Value, Outstanding	$ 0.14
Warrants, Issued (in Shares) | shares	6,042,888
Weighted Average Exercise Price, Issued	$ 1.74
Warrants, Ending Balance (in Shares) | shares	14,033,159
Weighted Average Remaining Term (Years), Outstanding	3 years 25 days
Weighted Average Exercise Price, Outstanding	$ 3.49
Average Intrinsic Value, Outstanding	$ 0.27

Commitments and Contingencies_2

Commitments and Contingencies (Details)

1 Months Ended

3 Months Ended

Mar. 01, 2020

Jul. 05, 2019

Nov. 16, 2018

Mar. 22, 2022 USD ($)

Jan. 26, 2021

Mar. 24, 2019

Oct. 31, 2018

Mar. 31, 2022 USD ($)

Mar. 31, 2022 EUR (€)

Mar. 31, 2021 USD ($)

Apr. 28, 2022 USD ($)

Apr. 28, 2022 EUR (€)

Commitments and Contingencies (Details) [Line Items]

License fees and milestone payments, description

the Company paid UVA LVG a license issue fee and is obligated to pay UVA LVG (i) annual minimum royalties of $40,000 commencing in 2017; (ii) a $20,000 milestone payments upon dosing the first patient under a Phase 3 human clinical trial of a licensed product, $155,000 upon the earlier of the completion of a Phase 3 trial of a licensed product, partnering of a licensed product, or sale of the Company, $275,000 upon acceptance of an NDA by the FDA, and $1,000,000 upon approval for sale of AD04 in the U.S., Europe or Japan; as well as (iii) royalties equal to a 2% and 1% of net sales of licensed products in countries in which a valid patent exists or does not exist, respectively, with royalties paid quarterly. In the event of a sublicense to a third party, the Company is obligated to pay royalties to UVA LVG equal to a percentage of what the Company would have been required to pay to UVA LVG had it sold the products under sublicense ourselves. In addition, the Company is required to pay to UVA LVG 15% of any sublicensing income.

the Company paid UVA LVG a license issue fee and is obligated to pay UVA LVG (i) annual minimum royalties of $40,000 commencing in 2017; (ii) a $20,000 milestone payments upon dosing the first patient under a Phase 3 human clinical trial of a licensed product, $155,000 upon the earlier of the completion of a Phase 3 trial of a licensed product, partnering of a licensed product, or sale of the Company, $275,000 upon acceptance of an NDA by the FDA, and $1,000,000 upon approval for sale of AD04 in the U.S., Europe or Japan; as well as (iii) royalties equal to a 2% and 1% of net sales of licensed products in countries in which a valid patent exists or does not exist, respectively, with royalties paid quarterly. In the event of a sublicense to a third party, the Company is obligated to pay royalties to UVA LVG equal to a percentage of what the Company would have been required to pay to UVA LVG had it sold the products under sublicense ourselves. In addition, the Company is required to pay to UVA LVG 15% of any sublicensing income.

License royalty expenses

$ 10,000

$ 10,000

Master services agreement, description

It is anticipated that the compensation to be paid to PEPCO for services under the PEPCO MSA will total approximately $300,000.

The MSA has a term of five years, automatically renewed for two-year periods, unless either party gives written notice of a decision not to renew the agreement six months prior to automatic renewal.

Service agreement, description

On November 16, 2018, the Company and Crown entered into Service Agreement 1 under the MSA for a 24 week, multi-centered, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 clinical study of AD04 for fees, as amended, of $3,509,234 (€3,168,895 converted to dollars at the Euro/US Dollar exchange rate of 1.1074 as of March 31, 2022) milestone payments. On March 22, 2022, the Company acknowledged the occurrence of the milestone event of 90% of trial case report forms having been monitored, and made a payment of $148,875. On April 28, 2022, the Company and Crown entered into a settlement of a previous dispute concerning a putative change order. As part of this agreement, the Company agreed to pay Crown a total of $454,034 (€410,000) for changes to the services described in Service Order 1. The settlement also altered the schedule of remaining milestones to be as described in the table below. At March 31, 2022, the remaining future milestone payments are shown in the table below, converted to dollars from euros at the exchange rate then prevailing.  Milestone Event  Percent Milestone Fees   Amount  Last patient last visit               5%  $149,465  Database Lock   5%  $149,465  eTMF Transfer   5%  $149,465   During the three months ended March 31, 2022, the Company recognized $311,727 in non-cash income associated with the Service Agreement 1 and the settlement described above, classified as a negative R&D expense. The negative expense was a result of the value of the settlement and total, fully earned value of milestones being less than the expense previously accrued. On March 31, 2022 there remained an accrued R&D expense of $803,591 related to direct expenses under this agreement, which expense is expected to be fully paid with the occurrence of the settlement payment and three remaining milestone payments. Service Agreement 1 also estimated approximately $2.4 million (€2.2 million) in pass-through costs, mostly fees to clinical investigators and sites, which are billed as incurred and the total contingent upon individual site rate and enrollment rates. Based on current enrollment rates and the various active clinical sites, the Company has increased its total estimated future site costs to a total of approximately $3.1 million. During the three months ended March 31, 2022, the Company recognized non-cash income of $75,991 associated with fees to investigators and sites, classified as a negative R&D expense, resulting from earned site fees in the quarter being lower than the those previously accrued. Lease Commitments – Purnovate lease The Company has one operating lease which consists of office space with a remaining lease term of approximately five years. Leases with an initial term of twelve months or less are not recorded on the balance sheet, and the Company does not separate lease and non-lease components of contracts. The Company’s lease agreement does not provide for determination of the interest rate implicit in the lease. Therefore, the Company used a benchmark approach to derive an appropriate incremental borrowing rate. The Company’s incremental borrowing rate is the rate of interest that the lessee would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The Company benchmarked itself against other companies of similar credit ratings and comparable quality and derived an incremental borrowing rate, which was used to discount its lease liabilities. The Company used an estimated incremental borrowing rate of 9% on January 26, 2021 for its lease contract. The Company’s lease agreement does not contain any material residual value guarantees or material restrictive covenants. In addition, the Company does not have any finance leases, any sublease arrangements, or any leases where the Company is considered the lessor. The components of lease expense, which are included in general and administrative expense, based on the underlying use of the ROU asset, were as follows:     Three months ended March 31, 2022   Three months ended March 31, 2021  Components of total lease cost:         Operating lease expense  $19,376   $18,207  Short-term lease expense   —    —  Total lease cost  $19,376   $18,207   Supplemental cash flow information related to leases are as follows:     Three months ended March 31, 2022   Three months ended March 31, 2021  Cash paid for amounts included in the measurement of lease liabilities:         Operating cash flows for operating leases  $17,606   $10,388              Supplemental non-cash amounts of lease liabilities arising from obtaining right of use assets  $1,770   $294,294  Supplemental balance sheet information related to leases was as follows:     As of March 31, 2022   As of December 31, 2021  Assets         Lease right of use assets  $233,570   $246,209  Total lease assets  $233,570   $246,209              Liabilities           Current liabilities:           Lease liability - current portion  $51,351   $49,585  Noncurrent liabilities:           Lease liability, net of current portion   193,797    207,375  Total lease liability  $245,148   $256,960   The weighted-average remaining lease term of the Company’s operating leases and the weighted-average discount rates used to calculate the Company’s operating lease liabilities are as follows:     As of March 31, 2022   As of March 31, 2021  Weighted average remaining lease term (in years) - operating leases   3.83    4.83  Weighted average discount rate - operating leases   9.00%   9.00%  Future lease payments included in the measurement of lease liabilities on the condensed balance sheet as of March 31, 2022, for the following five fiscal years and thereafter were as follows:  Year ending December 31,  Operating Leases  2022 (remaining)   52,597  2023   72,687  2024   75,231  2025   77,864  2026 and thereafter   6,507  Total Minimum Lease Payments  $284,886  Less effects of discounting   (39,738) Present value of future minimum lease payments  $245,148   Lease Commitments – Related Party  On March 1, 2020, the Company entered into a sublease with Purnovate, LLC, a private company in which the Company’s CEO had a 28.7% equity interest, for the lease of three offices at 1180 Seminole Trail, Suite 495, Charlottesville, VA 22901. The lease had a term of two years, and the monthly rent was $1,400. During the three months ended March 31, 2022, the rent expense associated with this lease was $1,400. On acquisition of Purnovate, the sublease was terminated and the Company assumed the obligations of Purnovate’s lease. Consulting Agreements – Related Party On March 24, 2019, the Company entered into a consulting agreement (the “Consulting Agreement”) with Dr. Bankole A. Johnson, who at the time of the agreement was serving as the Chairman of the Board of Directors, for his service as Chief Medical Officer of the Company. The Consulting Agreement has a term of three years, unless terminated by mutual consent or by the Company for cause. Dr.

Milestone payment

$ 3,847

Non cash income

311,727

Non-cash income

75,991

Estimated incremental borrowing rate

9%

Lease commitments related party, description

the Company entered into a sublease with Purnovate, LLC, a private company in which the Company’s CEO had a 28.7% equity interest, for the lease of three offices at 1180 Seminole Trail, Suite 495, Charlottesville, VA 22901. The lease had a term of two years, and the monthly rent was $1,400. During the three months ended March 31, 2022, the rent expense associated with this lease was $1,400. On acquisition of Purnovate, the sublease was terminated and the Company assumed the obligations of Purnovate’s lease.

Consulting agreement term

3 years

Consulting agreement, description

Johnson’s annual fee of $375,000 per year is paid twice per month.

Consulting agreement term, description

The Consulting Agreement had an expiration date of March 31, 2022, which was extended on March 22, 2022 for an additional three years commencing as of March 24, 2022. The Company recognized $93,750 in compensation expense in the both the three months ended March 31, 2022 and 2021 as a result of this agreement.

Future cash

1,600,000

Milestone [Member]

Commitments and Contingencies (Details) [Line Items]

Milestone payment percentage

90%

Milestone payment

$ 148,875

Subsequent Event [Member]

Commitments and Contingencies (Details) [Line Items]

Settlement amount

$ 454,034

€ 410,000

Service Agreement 1 [Member]

Commitments and Contingencies (Details) [Line Items]

Accrued R&D expenses

803,591

Estimated cost

2,400,000

€ 2,200,000

Estimated future site costs

$ 3,100,000

Commitments and Contingencies_3

Commitments and Contingencies (Details) - Schedule of future milestone payments are shown in the table below, converted to dollars from euros	3 Months Ended
	Mar. 31, 2022 USD ($)
Last patient last visit [Member]
Commitments and Contingencies (Details) - Schedule of future milestone payments are shown in the table below, converted to dollars from euros [Line Items]
Milestone Event	Last patient last visit
Percent Milestone Fees	5%
Amount	$ 149,465
Database Lock [Member]
Commitments and Contingencies (Details) - Schedule of future milestone payments are shown in the table below, converted to dollars from euros [Line Items]
Milestone Event	Database Lock
Percent Milestone Fees	5%
Amount	$ 149,465
eTMF Transfer [Member]
Commitments and Contingencies (Details) - Schedule of future milestone payments are shown in the table below, converted to dollars from euros [Line Items]
Milestone Event	eTMF Transfer
Percent Milestone Fees	5%
Amount	$ 149,465

Commitments and Contingencies_4

Commitments and Contingencies (Details) - Schedule of components of lease expense - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Components of total lease cost:
Operating lease expense	$ 19,376	$ 18,207
Short-term lease expense
Total lease cost	$ 19,376	$ 18,207

Commitments and Contingencies_5

Commitments and Contingencies (Details) - Schedule of supplemental cash flow information related to leases - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Schedule of supplemental cash flow information related to leases [Abstract]
Operating cash flows for operating leases	$ 17,606	$ 10,388
Supplemental non-cash amounts of lease liabilities arising from obtaining right of use assets	$ 1,770	$ 294,294

Commitments and Contingencies_6

Commitments and Contingencies (Details) - Schedule of supplemental balance sheet information related to leases - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Assets
Lease right of use assets	$ 233,570	$ 246,209
Total lease assets		246,209
Liabilities
Lease liability - current portion	51,351	49,585
Lease liability, net of current portion		207,375
Total lease liability		$ 256,960
Supplemental Lease [Member]
Assets
Lease right of use assets	233,570
Total lease assets	233,570
Liabilities
Lease liability - current portion	51,351
Lease liability, net of current portion	193,797
Total lease liability	$ 245,148

Commitments and Contingencies_7

Commitments and Contingencies (Details) - Schedule of weighted-average remaining lease term	Mar. 31, 2022	Dec. 31, 2021
Schedule of weighted-average remaining lease term [Abstract]
Weighted average remaining lease term (in years) - operating leases	3 years 9 months 29 days	4 years 9 months 29 days
Weighted average discount rate - operating leases	9%	9%

Commitments and Contingencies_8

Commitments and Contingencies (Details) - Schedule of future lease payments included in the measurement of lease liabilities	Mar. 31, 2022 USD ($)
Schedule of future lease payments included in the measurement of lease liabilities [Abstract]
2022 (remaining)	$ 52,597
2023	72,687
2024	75,231
2025	77,864
2026 and thereafter	6,507
Total Minimum Lease Payments	284,886
Less effects of discounting	(39,738)
Present value of future minimum lease payments	$ 245,148

Subsequent Events (Details)

Subsequent Events (Details) - Subsequent Event [Member]	Apr. 04, 2022 USD ($)	Apr. 04, 2022 EUR (€)	Apr. 08, 2022 USD ($) $ / shares shares
Subsequent Events (Details) [Line Items]
Milestone payments	$ 147,182	€ 134,969
Common stock, shares issued (in Shares) | shares			25,000
Market cost, per share (in Dollars per share) | $ / shares			$ 1.62
Total cost | $			$ 40,500