Adial Pharmaceuticals (ADIL) 10-K 30 Mar 23 2022 FY Annual report Financial data

Document And Entity Information

Document And Entity Information - USD ($)	12 Months Ended
	Dec. 31, 2022	Mar. 30, 2023	Jun. 30, 2022
Document Information Line Items
Entity Registrant Name	ADIAL PHARMACEUTICALS, INC.
Trading Symbol	ADIL
Document Type	10-K
Current Fiscal Year End Date	--12-31
Entity Common Stock, Shares Outstanding		28,516,564
Entity Public Float			$ 31,265,353
Amendment Flag	false
Entity Central Index Key	0001513525
Entity Current Reporting Status	Yes
Entity Voluntary Filers	No
Entity Filer Category	Non-accelerated Filer
Entity Well-known Seasoned Issuer	No
Document Period End Date	Dec. 31, 2022
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	FY
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Shell Company	false
Entity Ex Transition Period	false
ICFR Auditor Attestation Flag	false
Document Annual Report	true
Document Transition Report	false
Entity File Number	001-38323
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	82-3074668
Entity Address, Address Line One	1180 Seminole Trail
Entity Address, Address Line Two	Suite 495
Entity Address, City or Town	Charlottesville
Entity Address, State or Province	VA
Entity Address, Postal Zip Code	22901
City Area Code	(434)
Local Phone Number	422-9800
Title of 12(b) Security	Common Stock, par value $0.001 per share
Security Exchange Name	NASDAQ
Entity Interactive Data Current	Yes
Auditor Firm ID	711
Auditor Name	Friedman LLP
Auditor Location	Marlton, New Jersey

Consolidated Balance Sheets

Consolidated Balance Sheets - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Current Assets:
Cash and cash equivalents	$ 4,001,794	$ 6,062,173
Prepaid research and development	428,700	9,931
Prepaid expenses and other current assets	349,441	389,501
Total Current Assets	4,779,935	6,461,605
Fixed Assets, net	50,424	58,149
Intangible assets, net	4,477	5,041
Acquired in-process research and development	455,000	455,000
Right-to-use Asset	193,997	246,209
Goodwill	248,971	248,971
Total Assets	5,732,804	7,474,975
Current Liabilities:
Accounts payable	393,834	286,192
Accrued expenses	1,154,817	2,376,930
Accrued expenses, related party	175,000
Lease liability, current	56,828	49,585
Other current liabilities	10,387	9,683
Total Current Liabilities	1,790,866	2,722,390
Long-term Liabilities:
Contingent liabilities	492,000	1,014,000
Lease liability, non-current	150,547	207,375
Deferred tax liability	22,897	23,399
Total Liabilities	2,456,310	3,967,164
Commitments and contingencies – see Note 12
Stockholders’ Equity
Preferred Stock, 5,000,000 shares authorized with a par value of $0.001 per share, 0 shares outstanding at December 31, 2022 and 2021
Common Stock, 50,000,000 shares authorized with a par value of $0.001 per share, 26,687,295 and 20,946,712 shares issued and outstanding at December 31, 2022 and 2021, respectively	26,687	20,947
Additional paid in capital	66,924,338	54,429,979
Accumulated deficit	(63,674,531)	(50,943,115)
Total Stockholders’ Equity	3,276,494	3,507,811
Total Liabilities and Stockholders’ Equity	$ 5,732,804	$ 7,474,975

Consolidated Balance Sheets (Pa

Consolidated Balance Sheets (Parentheticals) - $ / shares	Dec. 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	26,687,295	20,946,712
Common stock, shares outstanding	26,687,295	20,946,712

Consolidated Statements of Oper

Consolidated Statements of Operations - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Operating Expenses:
Research and development	$ 4,176,998	$ 8,395,648
General and administrative	9,140,129	9,344,678
Impairment expenses		1,548,397
Total Operating Expenses	13,317,127	19,288,723
Loss From Operations	(13,317,127)	(19,288,723)
Other Income (Expense)
Interest income	63,209	6,539
Change in fair value of contingent liability	522,000	(281,713)
Other income		46,494
Total other income (expense)	585,209	(228,680)
Loss Before Provision For Income Taxes	(12,731,918)	(19,517,403)
Income tax benefit	502	94,077
Net Loss	$ (12,731,416)	$ (19,423,326)
Net loss per share, basic and diluted (in Dollars per share)	$ (0.51)	$ (1.04)
Weighted average shares, basic and diluted (in Shares)	25,037,637	18,588,748

Consolidated Statements of Op_2

Consolidated Statements of Operations (Parentheticals) - $ / shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Income Statement [Abstract]
Net loss per share, diluted	$ (0.51)	$ (1.04)
Weighted average shares, basic and diluted	25,037,637	18,588,748

Consolidated Statements of Chan

Consolidated Statements of Changes in Stockholders’ Equity - 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
Stock-based compensation		2,259,517		2,259,517
Stock-based compensation (in Shares)
Stock-based compensation, common stock issued for services	$ 713	1,980,187		1,980,900
Stock-based compensation, common stock issued for services (in Shares)	713,000
Options exercised	$ 216	469,285		469,501
Options exercised (in Shares)	215,556
Warrant exercises	$ 712	1,424,286		1,424,998
Warrant exercises (in Shares)	712,500
Stock issued in consideration of purchase of subsidiary	$ 700	1,059,450		1,060,150
Stock issued in consideration of purchase of subsidiary (in Shares)	699,980
Sale of common stock	$ 4,213	11,745,792		11,750,005
Sale of common stock (in Shares)	4,212,576
Net loss			(19,423,326)	(19,423,326)
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
Stock-based compensation		2,101,210		2,101,210
Stock-based compensation (in Shares)
Stock-based compensation, common stock issued for services	$ 1,553	1,271,730		1,273,283
Stock-based compensation, common stock issued for services (in Shares)	1,553,333
Warrant exercises	$ 1,865			1,865
Warrant exercises (in Shares)	1,865,000
Sale of common stock	$ 2,322	9,121,419		9,123,741
Sale of common stock (in Shares)	2,322,250
Net loss			(12,731,416)	(12,731,416)
Balance at Dec. 31, 2022	$ 26,687	$ 66,924,338	$ (63,674,531)	$ 3,276,494
Balance (in Shares) at Dec. 31, 2022	26,687,295

Consolidated Statements of Cash

Consolidated Statements of Cash Flows - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (12,731,416)	$ (19,423,326)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	3,374,493	4,240,417
Gain on forgiveness of loan		(29,088)
Depreciation of fixed assets	7,725	6,456
Fixed asset disposal		6,954
Impairment expenses		1,548,397
Amortization of intangible assets	564	565
Amortization of right to use asset	52,212	48,085
Change in fair value of contingent liability	(522,000)	281,713
Deferred Taxes	(502)	(94,077)
Changes in operating assets and liabilities:
Prepaid research and development	(418,769)	223,104
Prepaid expenses and other current assets	40,060	112,188
Accrued expenses	(1,222,113)	1,520,291
Accrued expenses, related party	175,000
Change in operating lease liability	(49,585)	(37,337)
Accounts payable and other current liabilities	108,346	(353,771)
Net cash used in operating activities	(11,185,985)	(11,949,429)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of fixed assets		(64,605)
Purchase consideration paid for acquisition, net of cash acquired		30,589
Net cash used in investing activities		(34,016)
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from equity offerings	9,123,741	11,750,005
Proceeds from warrant exercises	1,865	1,424,998
Proceeds of options exercises		469,501
Net cash provided by financing activities	9,125,606	13,644,504
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	(2,060,379)	1,661,059
CASH AND CASH EQUIVALENTS-BEGINNING OF YEAR	6,062,173	4,401,114
CASH AND CASH EQUIVALENTS-END OF YEAR	4,001,794	6,062,173
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	12 Months Ended
	Dec. 31, 2022
Description of Business [Abstract]
DESCRIPTION OF BUSINESS	1 — DESCRIPTION OF BUSINESS Adial Pharmaceuticals, Inc. ( “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. Adial’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. These consolidated financial statements include the accounts of both Adial and Purnovate for the year ended December 31, 2022 and 2021. In June of 2022, the Company released data from its 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. The Company has obtained meetings with the FDA and national medicines authorities in Europe to determine the path toward approval. 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 has the potential to be used for the treatment of other addictive disorders, such as Opioid Use Disorder, obesity, smoking, and other drug addictions.

Going Concern and Other Uncerta

Going Concern and Other Uncertainties	12 Months Ended
	Dec. 31, 2022
Going Concern and Other Uncertainties [Abstract]
GOING CONCERN AND OTHER UNCERTAINTIES	2 — GOING CONCERN AND OTHER UNCERTAINTIES The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“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. Based on the current development plans for AD04 in both the U.S. and international markets, planned R&D activities to develop Purnovate drug candidates, and other operating requirements, the Company does not believe that the existing cash and cash equivalents are sufficient to fund operations for the next twelve months following the filing of these consolidated financial statements. These factors raise substantial doubt about the Company’s ability to continue as a going concern. Based on the recently announced results of its ONWARD Phase 3 trial, the Company has scheduled meetings with the FDA and various European national authorities to discuss the appropriate next steps towards the expeditious development of AD04 and to seek product approval. The results of these meetings may materially change the Company’s expectations concerning the expected development cost of AD04. The Company has also initiated a number of research and development projects associated with Purnovate, including Purnovate’s lead compound, PNV5030, for treatment of pain and potentially for treatment of cancer. The Company has entered into an option agreement for the sale and support of the Purnovate programs by an independent company formed for that purpose. Should this option agreement be exercised, the exercise fee and cash reimbursement of previous Purnovate expenses would generate a modest amount of operating capital, and would eliminate the Company’s Purnovate-related operating expenses. However, there is no guarantee that the option holder will be able to raise sufficient capital in its own right to exercise the option. Neither is there any certainty that the Company will be able to access additional capital on acceptable terms, if at all, with or without the option having been exercised. If unable to access sufficient capital, the Company would be required to delay, scale back or eliminate some or all of its research and development programs or delay its approach to regulators concerning AD04, 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. With the results of the ONWARD trial having been released and regulatory approaches underway, the risk of delays to the Company’s development programs from COVID-19 are reduced. However, the ongoing effects of the ongoing coronavirus pandemic, such as supply chain disruptions and post-stimulus inflation, may 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 other key vendors and suppliers. The full extent to which the COVID-19 pandemic impacts the clinical development of AD04 and 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	12 Months Ended
	Dec. 31, 2022
Summary of Significant Accounting Policies [Abstract]
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation and Principals of Consolidation The accompanying consolidated financial statements have been prepared in accordance with GAAP. The 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 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 and pre-clinical activities, estimated fair values of long-lived assets used to assess the value of 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. 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, restricted stock, and warrants to the extent dilutive. Basic net loss per share was the same as diluted net loss per share for the years ended December 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 years ended December 31, 2022 and 2021 were as follows: Potentially 2022 2021 Warrants to purchase common shares 12,095,870 7,917,982 Common Shares issuable on exercise of options 4,316,977 3,585,310 Restricted shares subject to repurchase 1,083,333 – Total potentially dilutive Common Shares excluded 17,496,180 11,503,292 Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less to be cash equivalents. At times, the Company’s cash balances may exceed the current insured amounts under the Federal Deposit Insurance Corporation. At December 31, 2022, the Company did not exceed FDIC insurance limits but held approximately $3.8 million in non-FDIC insured cash equivalent accounts. Included in cash equivalents are money market investments with maturity dates less than ninety days and are carried at fair value. Unrealized gain or loss are included in the interest income and are immaterial to the financial statements. At December 31, 2021, the Company did not exceed FDIC insurance limits but held approximately $3.7 million in non-FDIC insured cash equivalent investments. 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 and accounts payable approximate their carrying value due to their short-term maturities. 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 December 31, 2022, the resulting probability-weighted cash flows were discounted using a weighted average cost of capital of 44% for regulatory and sales-based milestones. December 31, Opening balance $ – Additions (732,287 ) Total losses recorded (281,713 ) Balance as of December 31, 2021 $ (1,014,000 ) Total gains recorded 522,000 Balance as of December 31, 2022 $ (492,000 ) Business Combinations The Company accounts for its business combinations under the provisions of Accounting Standards Codification (“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. At each reporting date, the Company revalues these obligations and record increases or decreases in their fair value as an adjustment to other income and expenses. Changes to contingent consideration obligations can result from adjustments to discount rates, accretion of the liability due to the passage of time, changes in our 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. Having assessed the assets qualitatively, the Company did not recognize any impairment to IPR&D in the years ended December 31, 2022 and 2021. 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. Having assessed the assets qualitatively, the Company recognized no impairment of goodwill for the years ended December 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, 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 contract research organizations (“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; where fees earned are greater than milestone payments, an accrued expense liability is recorded as expense. 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.

Acquisition

Acquisition	12 Months Ended
	Dec. 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”), pursuant to the Equity Purchase Agreement, dated December 7, 2020, as amended. Mr. Stilley, Adial’s then CEO, owned 28.73% of the membership interests in Purnovate and, therefore, the acquisition of Purnovate is considered a related party transaction. The acquisition of Purnovate included an in-place workforce comprised of four employees, ongoing research and development projects and pending patents, certain net working capital assets and an assumed operating lease for laboratory and office space (“Assumed Lease”). Purnovate began occupying the premises of the Assumed Lease in January, 2020 and, as a term of its lease, gained access and use to a significant library of chemical compounds and certain laboratory equipment had been abandoned by a prior tenant. On January 19, 2021, Purnovate, modified and agreed to amend the lease agreement with the landlord (a third party) of the Assumed Lease, which transferred legal title to Purnovate for all assets on the premises of the Assumed Lease while simultaneously extending its term. The Company concluded that the Purnovate Lease Amendment was completed for the benefit of the Company and therefore the acquisition of the assets were considered a separate transaction and apart from the acquisition of Purnovate in accordance with ASC 805-10-25-21. The purchase price of Purnovate consisted of cash consideration of $350,000 (excluding a $350,000 initial working capital loan to Purnovate, which was assumed by Adial at acquisition through its ownership of Purnovate, Purnovate’s liability and Adial’s asset being eliminated in consolidation), the issuance 699,980 shares of Adial common stock ($2.34 at date of closing, less a discount of 35% for a discount for lack of marketability related to the restrictions on the stock-based consideration) and contingent consideration for (i) certain development milestones in an aggregate amount of up to $2,100,000 for the first time any product or compound has achieved the relevant milestone within forty five (45) days after such occurrence (ii) milestones in an aggregate amount of up to $20,000,000 for each compound commercialized, and (iii) royalties of 3.0% of Net Sales (as defined in the Purchase Agreement). The equity consideration was placed into escrow to secure certain indemnification and other obligations of Purnovate and the Members and will be released, subject to certain terms. The Company utilized a relative fair value approach to allocate the fair value of the assets acquired in connection with the Purnovate Lease Amendment and the fair value of Purnovate’s business to the purchase price of Purnovate. Assets acquired and liabilities assumed are recorded at the date of acquisition at their respective fair values. 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. The estimated fair value of the acquired IPR&D was determined using a method which reflects the present value of the operating cash flows generated by this asset after taking into account the cost to realize the revenue, and an appropriate discount rate to reflect the time value and risk associated with the invested capital. These assets are subject to impairment testing until completion or abandonment of each project. The estimated fair value of the acquired research and development supplies (library of chemical compounds and certain laboratory equipment) was determined by discounting the replacement cost of the supplies for probability of use and salvage value if unused. Book value was determined by assigning a portion of the value of consideration paid to the supplies according to the relative fair value of the supplies compared to the fair value of Purnovate’s business. Certain adjustments to the assessed fair values of the assets and liabilities made subsequent to the acquisition date, but within the measurement period, which is up to one year, are recorded as adjustments to goodwill. Any adjustments subsequent to the measurement period are recorded in income. In connection with the business acquisition, the Company incurred acquisition costs of approximately $46,000 that were recognized in selling, general and administrative expense. Total consideration paid Cash consideration $ 350,000 Stock consideration 1,060,150 Contingent consideration 732,287 Total 2,142,437 Less: Assets acquired through Purnovate Lease Amendment Research and development supplies (1,548,397 ) Remaining consideration $ 594,040 The table below sets forth the allocation of the fair value of the Purnovate Net Acquired Assets and the corresponding line item in the Company’s consolidated balance sheet at the date of acquisition. Cash $ 380,589 Property and equipment 6,954 Lease right of use assets 294,294 In-process research and development 455,000 Total identifiable assets acquired 1,136,837 Accounts payable and accrued liabilities 910 Notes payable 350,000 Lease liability 294,294 Paycheck protection program loan 29,088 Deferred tax liability 117,476 Total liabilities assumed 791,768 Total identifiable net assets acquired 345,069 Goodwill 248,971 Net assets acquired $ 594,040 The Company’s consolidated financial statements for the year ended December 31, 2022 and 2021 include the results of operations of Purnovate since January 26, 2021. During the year ended December 31, 2021, Purnovate contributed a net loss of approximately $1,923,000. On an unaudited pro forma basis, the revenues and net income of the Company assuming the acquisition had occurred on January 1, 2020, 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, 2020, nor is the financial information indicative of the results of future operations. Year Net revenue $ – Net loss $ (19,434,447 ) Net loss per share, basic and diluted $ (1.05 )

Note Payable

Note Payable	12 Months Ended
	Dec. 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 (“SBA”). 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	12 Months Ended
	Dec. 31, 2022
Acquired in-Process Research & 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. The changes in the carrying value of these acquired in-process research and development assets for the year ended are as noted in the table below: Carrying Balance at December 31, 2020 $ — In-process research and development acquired during the period 455,000 Balance at December 31, 2021 $ 455,000 In-process research and development acquired during the period — Balance at December 31, 2022 $ 455,000

Goodwill

Goodwill	12 Months Ended
	Dec. 31, 2022
Goodwill [Abstract]
GOODWILL	7 — GOODWILL The Company recorded goodwill in connection with the acquisition of Purnovate. The changes in the carrying value of goodwill for the year ended are as noted in the table below: Carrying Balance at December 31, 2020 $ — Goodwill acquired during the period 248,971 Balance at December 31, 2021 $ 248,971 Goodwill acquired during the period — Balance at December 31, 2022 $ 248,971

Accrued Expenses

Accrued Expenses	12 Months Ended
	Dec. 31, 2022
Accrued Expenses [Abstract]
ACCRUED EXPENSES	8 — ACCRUED EXPENSES Accrued expenses consist of the following: December 31, December 31, Clinical research organization services and expenses $ 123,386 $ 1,826,479 Employee compensation 761,509 520,795 Pre-clinical and manufacturing expenses 197,306 – Legal and consulting services 72,616 29,656 Total accrued expenses $ 1,154,817 $ 2,376,930

Related Party Transactions

Related Party Transactions	12 Months Ended
	Dec. 31, 2022
Related Party Transactions [Abstract]
RELATED PARTY TRANSACTIONS	9 — RELATED PARTY TRANSACTIONS In January 2011, the Company entered into an exclusive, worldwide license agreement with The University of Virginia Patent Foundation d/b/a the University of Virginia Licensing and Ventures Group (the “UVA LVG”) for rights to make, use or sell licensed products in the United States based upon patents and patent applications made and held by UVA LVG (the “UVA LVG License”). The Company is required to pay compensation to the UVA LVG, as described Note 12. 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. 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 became a wholly owned subsidiary of Adial. The Company’s then Chief Executive Officer and board member, William B. Stilley, and another Adial board member, James W. Newman, were, directly or indirectly, members of Purnovate. 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 and the other members of Purnovate 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 “SPAs”) with each of Bespoke, three entities controlled by James W. Newman, Jr., a member of the Company’s Board of Directors (“Newman”), and Keystone Capital Partners, LLC (“Keystone”), pursuant to which: (i) Bespoke 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) 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. In 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 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 “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. SPAs were entered with each of Bespoke Growth Partners, Inc. (“Bespoke”), a company controlled by Mark Peikin, the Chief Strategy Officer of the Company at that time, Keystone Capital Partners, LLC (“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. Under the terms of the SPAs, on July 7, 2021: (i) Bespoke purchased 83,334 shares of the Company’s common stock and agreed to purchase an additional 750,000 shares of the Company’s common stock upon the effectiveness of the Registration Statement; (ii) Keystone purchased 50,000 shares of the Company’s common stock and agreed to purchase an additional 450,000 shares of the Company’s common stock upon the effectiveness of the Registration Statement; and (iii) Gilliam purchased 33,334 shares of the Company’s common stock and agreed to purchase an additional 300,000 shares of the Company’s common stock upon the effectiveness of the Registration Statement. Under the terms of the SPAs, on August 2, 2021, Bespoke purchased 750,000 shares of the Company’s common stock for proceeds of $2,250,000; and on August 4, 2021, Keystone purchased 450,000 shares of the Company’s common stock for proceeds of $1,350,000 and Gilliam purchased 300,000 shares of the Company’s common stock for proceeds of $900,000. 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 with Bespoke Growth Partners, Inc. Pursuant to the terms of the agreement, 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. Bespoke has a pre-existing relationship with the Company and is controlled by Mark Peikin, the Company’s Chief Strategy Officer. Pursuant to the terms of the stock purchase agreement, Bespoke purchased an initial 20,000 shares of the Company’s common stock on November 9, 2021 and agreed to purchase an additional 180,000 shares of the Company’s common stock upon the effectiveness of a registration statement. On December 17, 2021, after the effectiveness of a registration statement on form S-3, the additional 180,000 were sold. See Note 12 for related party vendor, consulting, and lease agreements. See Note 13 for a related party option agreement.

Shareholders' Equity

Shareholders' Equity	12 Months Ended
	Dec. 31, 2022
Shareholders Equity [Abstract]
SHAREHOLDERS' EQUITY	10 — SHAREHOLDERS’ EQUITY Common Stock Issuances On January 26, 2021, 669,980 unregistered shares of common stock were issued to the shareholders of Purnovate, Inc., including William B. Stilley, the Company’s then CEO and entities controlled by James Newman, a Director, in consideration of purchase of Purnovate, Inc., at a total cost of $1,060,150 (See Note 4.) On February 8, 2021, an option to purchase 10,000 shares of common stock at an exercise price of $1.45 per share was exercised for total proceeds of $14,500. On February 25, 2021, previously registered warrants to purchase 712,500 shares at an exercise fee of $2.00 per share were exercised for a total of $1,425,000. During the year ended December 31, 2021, the Company issued 1,645,907 shares of common stock under the Keystone equity purchase agreement for total proceeds of $3,850,000. During the year ended December 31, 2021, the Company issued 2,566,669 shares of common stock for total proceeds of $7,900,007 under securities purchase agreements. During the year ended December 31, 2021, the Company issued 713,000 shares of common stock to consultants for services rendered and to employees at a total cost of $1,980,900. On February 10, 2022, the Company, entered into a securities purchase agreement with an accredited institutional investor (“the 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. On June 8, 2022, all of the pre-funded warrants issued on February 10, 2022 were exercised for proceeds of $1,865, resulting in issuance of 1,865,000 shares common stock. During the year ended December 31, 2022, the Company issued 470,000 shares of common stock at a cost of $818,350 to consultants for services rendered. During the year ended December 31, 2022, the Company issued employees 1,250,000 shares of common stock as bonuses, of which 1,083,333 remain outstanding. The first issuance of 250,000 shares were subject to forfeiture for nominal consideration to Company on termination of the employee, the shares no longer being liable to forfeiture (“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 December 30, 2022, the 166,667 shares vesting over 24 months were canceled by the recipient at the recipient’s will, at which time the Company recognized the remaining $191,325 cost of the unvested shares cancelled. The second issuance of 1,000,000 shares are subject to forfeiture on the same conditions, but on the following schedule: 1/6 of the issued shares vesting six months from date of issue, then 1/12 vesting at the end of each subsequent three month period, the entire grant being vested three years from date of issue. On December 31, 2022, none of the uncancelled shares were vested and 1,083,333 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 October 13, 2022, by a vote of the shareholders, the number of shares issuable under the 2017 Equity Incentive Plan was increased to 9,500,000. At December 31, 2022, the Company had issued 2,248,326 shares and had outstanding 4,177,291 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 3,074,383 available for issue. Stock Options The following table provides the stock option activity for the years ended December, 2022 and 2021: Total Weighted Weighted Weighted Outstanding December 31, 2020 2,668,866 8.09 $ 2.48 $ 1.13 Issued 1,132,000 2.47 2.37 Exercised (215,556 ) 2.18 0.89 Outstanding December 31, 2021 3,585,310 7.80 $ 2.64 $ 2.02 Issued 731,667 1.70 1.39 Exercised – Outstanding December 31, 2022 4,316,977 7.21 $ 2.48 $ 1.91 Outstanding December 31, 2022, vested and exercisable 3,237,778 6.79 $ 2.59 $ 1.96 At December 31, 2022, the total intrinsic value of the outstanding options was zero dollars. The Company used the Black Scholes valuation model to determine the fair value of the options issued, using the following key assumptions for the years ended December 31, 2022 and 2021: December 31, December 31, Fair Value per Share $ 0.59-2.00 $ 2.21-4.52 Expected Term 6.0 years 1.00-5.75 years Expected Dividend $ — $ — Expected Volatility 107.88-116.54% 108.35-110.69% Risk free rate 1.89-3.26% 0.07-1.26% During the year ended December 31, 2022, 731,667 options to purchase shares of common stock were granted at a fair value of $1,017,095, an approximate weighted average fair value of $1.39 per option, to be amortized over a service a weighted average period of 2.89 years. As of December 31, 2022, $1,939,438 in unrecognized compensation expense will be recognized over a remaining service period of 1.52 years. The components of stock-based compensation expense included in the Company’s Statements of Operations for the years ended December 31, 2022 and 2021 are as follows: Year ended December 31, 2022 2021 Research and development options expense 230,627 304,421 Total research and development expenses 230,627 304,421 General and administrative options expense 1,870,583 1,955,096 Stock issued to consultants and employees 1,273,283 1,980,900 Total general and administrative expenses 3,143,866 3,935,996 Total stock-based compensation expense $ 3,374,493 $ 4,240,417 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, 2020 8,649,625 3.46 $ 4.60 0.02 Issued 53,146 2.26 Exercised (712,500 ) $ 2.00 Outstanding December 31, 2021 7,990,271 2.63 $ 4.82 0.14 Issued 6,042,888 1.74 Exercised (1,865,000 ) $ 0.001 Outstanding December 31, 2022 12,168,159 3.04 $ 4.03 0.01 This table includes warrants to purchase 344,851 shares of common stock issued to consultants, including the 200,000 issued during the year ended December 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. During the year ended December 31, 2022, the Company recognized $305,230 in expense associated with these warrants with no additional expense remaining to be recognized. During the years ended December 31, 2022 and 2021, 1,865,000 and 712,500 warrants to purchase shares of common stock were exercised for total proceeds of $1,865 and $1,424,998, respectively.

Income Taxes

Income Taxes	12 Months Ended
	Dec. 31, 2022
Income Tax Disclosure [Abstract]
INCOME TAXES	11 — INCOME TAXES A reconciliation of the statutory Federal income tax rate and effective rate of the provision for income taxes is as follows: Year ended December 31, December 31, Federal statutory rate 21.00 % 21.00 % Stock Options (4.11 )% (2.43 )% Impairment charges (0.00 )% (1.67 )% Other Permanent Items 0.51 % (0.60 )% State Taxes 4.02 % 2.78 % Increase in VA (21.42 )% (18.61 )% Other 0.00 % 0.00 % Effective tax rate 0.00 % 0.48 % Tax expense (benefit) for the year ended December 31, 2022 is shown on the table below: Current Deferred Total Federal — (24,473 ) (24,473 ) State and Local — 23,971 23,971 Total — (502 ) (502 ) Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities recognized for financial reporting, and the amounts recognized for income tax purposes. The significant components of deferred tax assets and liabilities as of December 31, 2022 and 2021, respectively, are as follows: Deferred Tax Assets & Liabilities (rounded) Deferred Tax Asset 2022 2021 Net operating loss carry-forward 11,378,190 9,670,286 Accrued Expenses 171,902 116,147 Lease Liability 52,180 64,623 Restricted stock 15,982 — Section 174 R&D 946,624 — Less: valuation allowance (12,418,870 ) (9,692,143 ) Total tax assets $ 146,008 $ 158,913 Fixed Asset (5,221 ) (1,663 ) Intangible assets (114,871 ) (117,340 ) ROU Assets (48,813 ) (63,309 Total deferred tax labilities $ (168,905 ) $ (182,312 ) Net deferred tax asset (liability) $ (22,897 ) $ (23,399 ) The Company has a net operating loss carry-forward of $44.7 million for Federal and of $51.8 million state tax purposes at December 31,2022, that is potentially available to offset future taxable income. NOLS generated prior to 2018 will expire in 2037 and the 20- year carryover limitation was eliminated for losses generated after January 1, 2018, giving the taxpayer the ability to carry forward losses indefinitely. However, NOL carry forward arising after January 1, 2018, will now be limited to 80 percent of Taxable income. In assessing the realizability of the deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, net operating loss carryback potential and tax planning strategies in making these assessments. Based upon the above criteria, the Company believes that it is more likely than not that the remaining net deferred tax assets will not be realized. Accordingly, the Company has recorded a valuation allowance of $12.4M against the net deferred tax asset that is not realizable. Section 382 of the Internal Revenue Code (“Section 382”) imposes limitations on a corporation’s ability to utilize net operating losses if it experiences an “ownership change.” In general terms, an ownership change may result from transactions increasing the ownership of certain stockholders in the stock of a corporation by more than 50 percentage points over a three-year period. Any unused annual limitation may be carried over to later years, and the amount of the limitation may under certain circumstances be increased by the built-in gains in assets held by us at the time of the change that are recognized in the five-year period after the change. The company has not performed a study to assess whether an ownership change for purposes of Section 382 has occurred, or whether there have been multiple ownership change since the Company’s inception, due to the significant costs and complexities associated with such study. If the company has experienced a change in control, as defined by Section 382, at any time since its public offering, utilization of net operating loss carryforwards would be subject to an annual limitation under Section 382. Any limitation may result in expiration of a portion of the net operating losses before utilization. On August 16, 2022, the Inflation Reduction Act of 2022 (the “IR Act”) was signed into federal law. The IR Act provides for, among other things, a new U.S. federal 1% excise tax on certain repurchases of stock by publicly traded U.S. domestic corporations and certain U.S. domestic subsidiaries of publicly traded foreign corporations occurring on or after January 1, 2023. The excise tax is imposed on the repurchasing corporation itself, not its shareholders from which shares are repurchased. The amount of the excise tax is generally 1% of the fair market value of the shares repurchased at the time of the repurchase. However, for purposes of calculating the excise tax, repurchasing corporations are permitted to net the fair market value of certain new stock issuances against the fair market value of stock repurchases during the same taxable year. In addition, certain exceptions apply to the excise tax. The U.S. Department of Treasury has been given authority to provide regulations and other guidance to carry out and prevent the abuse or avoidance of the excise tax. The excise tax applies in cases where the total value of the stock repurchased during the taxable year exceeds $1,000,000. The Company does not anticipate that the IR Act will have an impact on the Company’s tax liability in the near term. The Company files tax returns as prescribed by the tax laws of the jurisdiction in which they operate. In the normal course of business, the Company is subject to examination of Federal and state jurisdiction where applicable based on the statute of limitations that apply in each jurisdiction. As of December 31, 2022, open years related to the federal and state Jurisdictions are 2021, 2020, & 2019. The company has no open tax audits with any taxing authority as of December 31, 2022. The Company had no uncertain tax positions at December 31, 2022.

Commitments and Contingencies

Commitments and Contingencies	12 Months Ended
	Dec. 31, 2022
Commitments and Contingencies Disclosure [Abstract]
COMMITMENTS AND CONTINGENCIES	12 — COMMITMENTS AND CONTINGENCIES License with University of Virginia Patent Foundation 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 years ended December 31, 2022 and 2021, the Company recognized $40,000 minimum license royalty expenses under this agreement. On May 13, 2022, the Company acknowledged that its Phase 3 trial was complete according to the terms of the UVA LVG license and recognized an accrued license royalty expense of $155,000, which payment was made on September 6, 2022. At December 31, 2022 and 2021, total accrued royalties and fees due to UVA LVG were $40,000 and $0, respectively, shown on balance sheet as accrued expenses, related party. 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 the Company’s lead compound, AD04 for fees, as amended, of $3,398,957 (€3,168,895 converted to dollars at the Euro/US Dollar exchange rate of 1.0726 as of December 31, 2022) milestone payments. On May 13, 2022, the Company acknowledged the milestone event of the last patient having made the last clinical visit and made a payment of $146,765, and on June 30, 2022 the Company acknowledged the additional milestone event of the trial database being locked at which time it recognized a payable of $137,375. On April 28, 2022, the Company and Crown settled 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 December 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 eTMF Transfer 5 % $ 144,768 During the year ended December 31, 2022, the Company recognized $209,689 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 December 31, 2022 there remained an accrued R&D expense of $123,386 related to direct expenses under this agreement, which expense is expected to be fully paid with the occurrence of the final milestone payment. (See Note 13 for the occurrence of the final milestone and recognition of this invoice.) Service Agreement 1 also estimated approximately $2.1 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. With clinical enrollment having ended, the Company has recorded approximately $3.5 million in site fees over the entire conduct of the trial, and does not expect to record material additional site expenses. Lease Commitments – Purnovate lease The Company has one operating lease which consists of office space with a remaining lease term of approximately four 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: Components of total lease cost: Year Year Operating lease expense $ 72,828 $ 75,116 Short-term lease expense — — Total lease cost $ 72,828 $ 75,116 Supplemental cash flow information related to leases are as follows: Year Year Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows for operating leases $ 70,202 $ 67,719 Supplemental non-cash amounts of lease liabilities arising from obtaining right of use assets $ — $ 294,294 Supplemental balance sheet information related to leases was as follows: As of As of Assets Lease right of use assets $ 193,997 $ 246,209 Total lease assets $ 193,997 $ 246,209 Liabilities Current liabilities: Lease liability - current portion $ 56,828 $ 49,585 Noncurrent liabilities: Lease liability, net of current portion 150,547 207,375 Total lease liability $ 207,375 $ 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 3.08 4.08 Weighted average discount rate - operating leases 9.00 % 9.00 % Future lease payments included in the measurement of lease liabilities on the balance sheet as of December 31, 2022, for the following four fiscal years and thereafter were as follows: Year ending December 31, Operating 2023 72,687 2024 75,231 2025 77,864 2026 and thereafter 6,508 Total Minimum Lease Payments $ 232,290 Less effects of discounting (24,915 ) Present value of future minimum lease payments $ 207,375 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 year ended December 31, 2021, 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. On September 8, 2022, Dr. Johnson’s consulting agreement was amended to increase his annual compensation to $430,000 annually and to pay him series of bonuses in cash and shares on the occurrence of certain milestones. The Company recognized $416,200 and $375,000 in compensation expense in the years ended December 31, 2022 and 2021, respectively. On July 5, 2019, the Company entered into a Master Services Agreement (the “MSA”) and attached 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 MSA will total approximately $300,000, of which shares of the Company’s common stock having a value equal to twenty percent (20%) of this total can be issued to Dr. Johnson in lieu of cash payment. As of December 31, 2022, the Company had recognized all expenses associated with this agreement. No further expenses associated with the PEPCO MSA work order are expected. Consulting Agreement – Related Party On October 24, 2022, the Company entered into a Master Services Agreement (the “MSA”) with Abuwala & Company, LLC, dba as Orbytel, for provision of strategic consulting services. Orbytel made it known that it intended to utilize the services of the Keswick Group, LLC as a subcontractor in the provision of these services. Tony Goodman, a director, is the founder and principal of Keswick Group, LLC, therefor Orbytel was considered a related party. Statement of work #1 (“SOW #1”), executed with the MSA, committed the Company to $209,250 in payments. During the year ended December 31, 2022, the Company recognized $151,500 in consulting expenses associated with this agreement, with $135,000 being recognized as related party accrued expenses on the balance sheet. The Company expected $57,750 in remaining expenses under SOW #1 at December 31, 2022. Preclinical Research Agreement On June 1, 2022, the Company entered into an agreement and scope-of-work (“SOW”) specification for research services with IIT Research Institute for a range of in vitro 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 30 months. These agreements, in aggregate, commit the Company to approximately $1.2 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 December 31, 2022, the Company did not have any pending legal actions.

Subsequent Events

Subsequent Events	12 Months Ended
	Dec. 31, 2022
Subsequent Events [Abstract]
SUBSEQUENT EVENTS	13 — SUBSEQUENT EVENTS Purnovate Option Agreement On January 27, 2023, the Company and Adenomed, LLC (the “Buyer”) entered into an Option Agreement (the “Option Agreement”) pursuant to which the Company granted to the Buyer an exclusive option for a period of one hundred twenty (120) days from the effective date of the Agreement (the “Option Term”) for Buyer or its designated affiliate to acquire all of the assets of Purnovate, the Company’s wholly owned subsidiary, in a related party transaction. William Stilley, a director and Executive Vice President of the Company and Chief Executive Officer of Purnovate, serves as the President of the Buyer and is the principal stockholder of the Buyer. The Buyer has the right to extend the Option Term for an additional thirty (30) consecutive day period by the payment of one hundred thousand dollars ($100,000) to the Company prior to the end of the original Option Term, and the Buyer may also extend the Option Term for another thirty (30) consecutive day period by the payment of fifty thousand dollars ($50,000) to the Company prior to the end of the extended Option Term. The Buyer has the right to exercise the Option by paying a cash exercise price of $150,000. Upon exercise of the Option, the Company will transfer to and Buyer will assume liabilities of Purnovate, including: (i) trade payables incurred for services or purchases by Purnovate exclusively for its research operations; (ii) any unpaid salaries of personnel on Purnovate’s payroll; and (iii) the lease for 1180 Seminole Trail, Suite 495, Charlottesville, VA 22901 (as modified). All other Purnovate liabilities, shall be retained by, or transferred to, the Company and any amounts owed by Purnovate to Company will be extinguished. The Company will be reimbursed by Buyer for any Purnovate expenditures incurred and paid commencing December 2022, to be paid within thirty (30) days of execution of the final acquisition agreement, and will hold a security interest in the assets of Buyer until the expense reimbursement is paid in full and the equity in Buyer described below is issued to Company. The Option Agreement sets forth the terms of the definitive acquisition agreement to be negotiated in good faith by the parties after exercise of the Option which include: (i) an upfront cash payment of $300,000 upon the completion of the definitive agreement (in addition to the option exercise payment) ; (ii) the issuance by Buyer to Company of 19.99% of the equity of Buyer within thirty (30) days of execution of the final acquisition agreement (such 19.99% to be subject to anti-dilution protection until the Buyer has raised $4,000,000); (iii) the assumption by Buyer of the obligations of Company under that certain Equity Purchase Agreement by and among Company, Purnovate, the members of Purnovate, and Robert D. Thompson as the member’s representative, dated December 7, 2020 and amended January 25, 2021 (the “PNV EPA”); (iv) the assumption by Buyer of the obligations of Company under that certain Employment Agreement, dated July 31, 2018, as amended, by and between Company and William Stilley; (v) a low, single digit royalty payments on net sales; (vi) cash payments of up to approximately $11 million in development and approval milestones for each compound after payments to the prior members of Purnovate pursuant to the PNV EPA; and (vii) cash payments of up to an aggregate of $50,000,000 upon the achievement of certain commercial milestones. Securities Purchase Agreement On February 23, 2023, the Company entered into a securities purchase agreement (the “2023 Purchase Agreement”) with an accredited institutional investor (the “Investor”) providing for the issuance of 1,829,269 shares of the Common Stock, par value $0.001 (the “Common Stock”). Pursuant to the 2023 Purchase Agreement, the Investor purchased the Shares for an aggregate purchase price of $750,000 with expected proceeds of $550,000, after placement agent fees and expenses. Pursuant to the Purchase Agreement, an aggregate of 1,829,269 Shares were issued to the Investor. The Company agreed to issue to the Placement Agent a warrant (the “Placement Agent Warrants”) to purchase up to an aggregate of 182,927 shares of common stock, representing 10% of the aggregate number of shares of Common Stock sold in the Registered Offering. The Placement Agent Warrants have an exercise price equal to $0.41 and are exercisable two months after the closing date and expire five years after the date of issuance. Crown CRO Final Milestone On March 1, 2023, the Company acknowledged that Crown CRO had transferred the completed trial master file to the control of the Company and thereby met the final milestone specified in Service Order 1, as amended. Accordingly, Crown CRO invoiced the final milestone payment of €134,969 ($143,685 at the exchange rate then prevailing). On receipt of this invoice (and with adjustment for intervening exchange rate fluctuations), there remained no accrued expense liabilities associated with the agreement and no expected material expenses. Consulting Agreement – Related Party Effective March 15, 2023, the Company entered in a master services agreement (the “Services Agreement”) with The Keswick Group, LLC, of which Tony Goodman, a director of the Company, is the founder and principal, pursuant to which The Keswick Group, LLC has agreed to serve as a business consultant to lead the Company’s partnering efforts for AD04 for nine months at a monthly fee of $22,000, with a performance bonus of 100,000 shares of the Company’s restricted common stock issuable upon the Company’s completion of a partnering agreement for AD04 through its efforts. The opportunity to earn the restricted stock performance bonus expires if a partnering agreement has not been completed before the termination of the agreement. The Services Agreement may be terminated by either party upon thirty (30) days’ notice.

Accounting Policies, by Policy

Accounting Policies, by Policy (Policies)	12 Months Ended
	Dec. 31, 2022
Accounting Policies [Abstract]
Basis of Presentation and Principals of Consolidation	Basis of Presentation and Principals of Consolidation The accompanying consolidated financial statements have been prepared in accordance with GAAP. The 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 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 and pre-clinical activities, estimated fair values of long-lived assets used to assess the value of 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.
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, restricted stock, and warrants to the extent dilutive. Basic net loss per share was the same as diluted net loss per share for the years ended December 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 years ended December 31, 2022 and 2021 were as follows: Potentially 2022 2021 Warrants to purchase common shares 12,095,870 7,917,982 Common Shares issuable on exercise of options 4,316,977 3,585,310 Restricted shares subject to repurchase 1,083,333 – Total potentially dilutive Common Shares excluded 17,496,180 11,503,292
Cash and Cash Equivalents	Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less to be cash equivalents. At times, the Company’s cash balances may exceed the current insured amounts under the Federal Deposit Insurance Corporation. At December 31, 2022, the Company did not exceed FDIC insurance limits but held approximately $3.8 million in non-FDIC insured cash equivalent accounts. Included in cash equivalents are money market investments with maturity dates less than ninety days and are carried at fair value. Unrealized gain or loss are included in the interest income and are immaterial to the financial statements. At December 31, 2021, the Company did not exceed FDIC insurance limits but held approximately $3.7 million in non-FDIC insured cash equivalent investments.
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 and accounts payable approximate their carrying value due to their short-term maturities. 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 December 31, 2022, the resulting probability-weighted cash flows were discounted using a weighted average cost of capital of 44% for regulatory and sales-based milestones. December 31, Opening balance $ – Additions (732,287 ) Total losses recorded (281,713 ) Balance as of December 31, 2021 $ (1,014,000 ) Total gains recorded 522,000 Balance as of December 31, 2022 $ (492,000 )
Business Combinations	Business Combinations The Company accounts for its business combinations under the provisions of Accounting Standards Codification (“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. At each reporting date, the Company revalues these obligations and record increases or decreases in their fair value as an adjustment to other income and expenses. Changes to contingent consideration obligations can result from adjustments to discount rates, accretion of the liability due to the passage of time, changes in our 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. Having assessed the assets qualitatively, the Company did not recognize any impairment to IPR&D in the years ended December 31, 2022 and 2021. 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. Having assessed the assets qualitatively, the Company recognized no impairment of goodwill for the years ended December 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, 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 contract research organizations (“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; where fees earned are greater than milestone payments, an accrued expense liability is recorded as expense.
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.

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Tables)	12 Months Ended
	Dec. 31, 2022
Schedule of Potentially Dilutive Common Shares [Abstract]
Schedule of potentially dilutive common shares	Potentially 2022 2021 Warrants to purchase common shares 12,095,870 7,917,982 Common Shares issuable on exercise of options 4,316,977 3,585,310 Restricted shares subject to repurchase 1,083,333 – Total potentially dilutive Common Shares excluded 17,496,180 11,503,292
Schedule of probability-weighted cash flows were discounted using a weighted average cost of capital	December 31, Opening balance $ – Additions (732,287 ) Total losses recorded (281,713 ) Balance as of December 31, 2021 $ (1,014,000 ) Total gains recorded 522,000 Balance as of December 31, 2022 $ (492,000 )

Acquisition (Tables)

Acquisition (Tables)	12 Months Ended
	Dec. 31, 2022
Schedule of Selling, General And Administrative Expense [Abstract]
Schedule of selling, general and administrative expense	Total consideration paid Cash consideration $ 350,000 Stock consideration 1,060,150 Contingent consideration 732,287 Total 2,142,437 Less: Assets acquired through Purnovate Lease Amendment Research and development supplies (1,548,397 ) Remaining consideration $ 594,040
Schedule of fair value of the purnovate net acquired assets and the corresponding	Cash $ 380,589 Property and equipment 6,954 Lease right of use assets 294,294 In-process research and development 455,000 Total identifiable assets acquired 1,136,837 Accounts payable and accrued liabilities 910 Notes payable 350,000 Lease liability 294,294 Paycheck protection program loan 29,088 Deferred tax liability 117,476 Total liabilities assumed 791,768 Total identifiable net assets acquired 345,069 Goodwill 248,971 Net assets acquired $ 594,040
Schedule of financial information indicative of the results of future operations	Year Net revenue $ – Net loss $ (19,434,447 ) Net loss per share, basic and diluted $ (1.05 )

Acquired in-Process Research _2

Acquired in-Process Research & Development (Tables)	12 Months Ended
	Dec. 31, 2022
Schedule of Carrying Value Acquired in-Process Research And Development Assets [Abstract]
Schedule of carrying value acquired in-process research and development assets	Carrying Balance at December 31, 2020 $ — In-process research and development acquired during the period 455,000 Balance at December 31, 2021 $ 455,000 In-process research and development acquired during the period — Balance at December 31, 2022 $ 455,000

Goodwill (Tables)

Goodwill (Tables)	12 Months Ended
	Dec. 31, 2022
Schedule of Goodwill in Connection with the Acquisition of Purnovate [Abstract]
Schedule of goodwill in connection with the acquisition of purnovate	Carrying Balance at December 31, 2020 $ — Goodwill acquired during the period 248,971 Balance at December 31, 2021 $ 248,971 Goodwill acquired during the period — Balance at December 31, 2022 $ 248,971

Accrued Expenses (Tables)

Accrued Expenses (Tables)	12 Months Ended
	Dec. 31, 2022
Schedule of Accrued Expenses [Abstract]
Schedule of accrued expenses	December 31, December 31, Clinical research organization services and expenses $ 123,386 $ 1,826,479 Employee compensation 761,509 520,795 Pre-clinical and manufacturing expenses 197,306 – Legal and consulting services 72,616 29,656 Total accrued expenses $ 1,154,817 $ 2,376,930

Shareholders' Equity (Tables)

Shareholders' Equity (Tables)	12 Months Ended
	Dec. 31, 2022
Schedule of Stock Option Activity [Abstrac]
Schedule of stock option activity	Total Weighted Weighted Weighted Outstanding December 31, 2020 2,668,866 8.09 $ 2.48 $ 1.13 Issued 1,132,000 2.47 2.37 Exercised (215,556 ) 2.18 0.89 Outstanding December 31, 2021 3,585,310 7.80 $ 2.64 $ 2.02 Issued 731,667 1.70 1.39 Exercised – Outstanding December 31, 2022 4,316,977 7.21 $ 2.48 $ 1.91 Outstanding December 31, 2022, vested and exercisable 3,237,778 6.79 $ 2.59 $ 1.96
Schedule of black scholes valuation model to determine the fair value of the options issued	December 31, December 31, Fair Value per Share $ 0.59-2.00 $ 2.21-4.52 Expected Term 6.0 years 1.00-5.75 years Expected Dividend $ — $ — Expected Volatility 107.88-116.54% 108.35-110.69% Risk free rate 1.89-3.26% 0.07-1.26%
Schedule of stock-based compensation expense	Year ended December 31, 2022 2021 Research and development options expense 230,627 304,421 Total research and development expenses 230,627 304,421 General and administrative options expense 1,870,583 1,955,096 Stock issued to consultants and employees 1,273,283 1,980,900 Total general and administrative expenses 3,143,866 3,935,996 Total stock-based compensation expense $ 3,374,493 $ 4,240,417
Schedule of activity in warrants	Total Warrants Weighted Weighted Average Exercise Price Average Outstanding December 31, 2020 8,649,625 3.46 $ 4.60 0.02 Issued 53,146 2.26 Exercised (712,500 ) $ 2.00 Outstanding December 31, 2021 7,990,271 2.63 $ 4.82 0.14 Issued 6,042,888 1.74 Exercised (1,865,000 ) $ 0.001 Outstanding December 31, 2022 12,168,159 3.04 $ 4.03 0.01

Income Taxes (Tables)

Income Taxes (Tables)	12 Months Ended
	Dec. 31, 2022
Income Tax Disclosure [Abstract]
Schedule of statutory federal income tax rate and effective rate	Year ended December 31, December 31, Federal statutory rate 21.00 % 21.00 % Stock Options (4.11 )% (2.43 )% Impairment charges (0.00 )% (1.67 )% Other Permanent Items 0.51 % (0.60 )% State Taxes 4.02 % 2.78 % Increase in VA (21.42 )% (18.61 )% Other 0.00 % 0.00 % Effective tax rate 0.00 % 0.48 %
Schedule of tax expense (benefit)	Current Deferred Total Federal — (24,473 ) (24,473 ) State and Local — 23,971 23,971 Total — (502 ) (502 )
Schedule of deferred tax assets & liabilities (rounded)	Deferred Tax Asset 2022 2021 Net operating loss carry-forward 11,378,190 9,670,286 Accrued Expenses 171,902 116,147 Lease Liability 52,180 64,623 Restricted stock 15,982 — Section 174 R&D 946,624 — Less: valuation allowance (12,418,870 ) (9,692,143 ) Total tax assets $ 146,008 $ 158,913 Fixed Asset (5,221 ) (1,663 ) Intangible assets (114,871 ) (117,340 ) ROU Assets (48,813 ) (63,309 Total deferred tax labilities $ (168,905 ) $ (182,312 ) Net deferred tax asset (liability) $ (22,897 ) $ (23,399 )

Commitments and Contingencies (

Commitments and Contingencies (Tables)	12 Months Ended
	Dec. 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 eTMF Transfer 5 % $ 144,768
Schedule of components of lease expense	Components of total lease cost: Year Year Operating lease expense $ 72,828 $ 75,116 Short-term lease expense — — Total lease cost $ 72,828 $ 75,116
Schedule of supplemental cash flow information related to leases	Year Year Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows for operating leases $ 70,202 $ 67,719 Supplemental non-cash amounts of lease liabilities arising from obtaining right of use assets $ — $ 294,294
Schedule of supplemental balance sheet information related to leases	As of As of Assets Lease right of use assets $ 193,997 $ 246,209 Total lease assets $ 193,997 $ 246,209 Liabilities Current liabilities: Lease liability - current portion $ 56,828 $ 49,585 Noncurrent liabilities: Lease liability, net of current portion 150,547 207,375 Total lease liability $ 207,375 $ 256,960
Schedule of weighted-average remaining lease term	As of As of Weighted average remaining lease term (in years) - operating leases 3.08 4.08 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 2023 72,687 2024 75,231 2025 77,864 2026 and thereafter 6,508 Total Minimum Lease Payments $ 232,290 Less effects of discounting (24,915 ) Present value of future minimum lease payments $ 207,375

Summary of Significant Accoun_3

Summary of Significant Accounting Policies (Details) $ in Millions	Dec. 31, 2022 USD ($)
Summary of Significant Accounting Policies (Details) [Line Items]
FDICFDIC Insured cash amount Insured cash amount	$ 3.8
Weighted average cost of capital, percentage	44%
Cash Equivalents [Member]
Summary of Significant Accounting Policies (Details) [Line Items]
FDICFDIC Insured cash amount Insured cash amount	$ 3.7

Summary of Significant Accoun_4

Summary of Significant Accounting Policies (Details) - Schedule of potentially dilutive common shares - shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Schedule Of Potentially Dilutive Common Shares [Abstract]
Warrants to purchase common shares	12,095,870	7,917,982
Common Shares issuable on exercise of options	4,316,977	3,585,310
Restricted shares subject to repurchase	1,083,333
Total potentially dilutive Common Shares excluded	17,496,180	11,503,292

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	12 Months Ended
	Dec. 31, 2022 USD ($)
Schedule Of Probability Weighted Cash Flows Were Discounted Using a Weighted Average Cost Of Capital [Abstract]
Opening balance
Additions	(732,287)
Total losses recorded	(281,713)
Opening balance	(1,014,000)
Total gains recorded	522,000
Ending balance	$ (492,000)

Acquisition (Details)

Acquisition (Details) - USD ($)	1 Months Ended	12 Months Ended
	Jan. 26, 2021	Dec. 31, 2022
Acquisition (Details) [Line Items]
Owned membership interests	28.73%
Purchase price, description		The purchase price of Purnovate consisted of cash consideration of $350,000 (excluding a $350,000 initial working capital loan to Purnovate, which was assumed by Adial at acquisition through its ownership of Purnovate, Purnovate’s liability and Adial’s asset being eliminated in consolidation), the issuance 699,980 shares of Adial common stock ($2.34 at date of closing, less a discount of 35% for a discount for lack of marketability related to the restrictions on the stock-based consideration) and contingent consideration for (i) certain development milestones in an aggregate amount of up to $2,100,000 for the first time any product or compound has achieved the relevant milestone within forty five (45) days after such occurrence (ii) milestones in an aggregate amount of up to $20,000,000 for each compound commercialized, and (iii) royalties of 3.0% of Net Sales (as defined in the Purchase Agreement). The equity consideration was placed into escrow to secure certain indemnification and other obligations of Purnovate and the Members and will be released, subject to certain terms.
Incurred acquisition costs (in Dollars)		$ 46,000
Net loss (in Shares)	1,923,000
Business Combination [Member]
Acquisition (Details) [Line Items]
Business acquisition shares percentage	100%

Acquisition (Details) - Schedu

Acquisition (Details) - Schedule of selling, general and administrative expense	12 Months Ended
	Dec. 31, 2022 USD ($)
Total consideration paid
Cash consideration	$ 350,000
Stock consideration	1,060,150
Contingent consideration	732,287
Total	2,142,437
Less: Assets acquired through Purnovate Lease Amendment
Research and development supplies	(1,548,397)
Remaining consideration	$ 594,040

Acquisition (Details) - Sche_2

Acquisition (Details) - Schedule of fair value of the purnovate net acquired assets and the corresponding - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Schedule Of Fair Value Of The Purnovate Net Acquired Assets And The Corresponding Abstract
Cash	$ 380,589
Property and equipment	6,954
Lease right of use assets	294,294
In-process research and development	455,000	$ 455,000
Total identifiable assets acquired	1,136,837
Accounts payable and accrued liabilities	910
Notes payable	350,000
Lease liability	294,294
Paycheck protection program loan	29,088
Deferred tax liability	117,476
Total liabilities assumed	791,768
Total identifiable net assets acquired	345,069
Goodwill	248,971	$ 248,971
Net assets acquired	$ 594,040

Acquisition (Details) - Sche_3

Acquisition (Details) - Schedule of financial information indicative of the results of future operations - Acquisition [Member]	12 Months Ended
	Dec. 31, 2021 USD ($) $ / shares
Acquisition (Details) - Schedule of financial information indicative of the results of future operations [Line Items]
Net revenue
Net loss	$ (19,434,447)
Net loss per share, basic and diluted (in Dollars per share) | $ / shares	$ (1.05)

Acquisition (Details) - Sche_4

Acquisition (Details) - Schedule of financial information indicative of the results of future operations (Parentheticals)	12 Months Ended
	Dec. 31, 2021 $ / shares
Schedule Of Financial Information Indicative Of The Results Of Future Operations Abstract
Net loss per share, basic and diluted (in Dollars per share)	$ (1.05)

Note Payable (Details)

Note Payable (Details) - USD ($)	12 Months Ended
	Dec. 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 _3

Acquired in-Process Research & Development (Details) - Schedule of carrying value acquired in-process research and development assets - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Schedule Of Carrying Value Acquired In Process Research And Development Assets Abstract
Balance at beginning	$ 455,000
In-process research and development acquired during the period	455,000	455,000
Balance at ending	$ 455,000	$ 455,000

Goodwill (Details) - Schedule o

Goodwill (Details) - Schedule of goodwill in connection with the acquisition of purnovate - Goodwill [Member] - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Goodwill [Line Items]
Balance at December 31, 2020	$ 248,971
Goodwill acquired during the period		248,971
Balance at December 31	$ 248,971	$ 248,971

Accrued Expenses (Details) - Sc

Accrued Expenses (Details) - Schedule of accrued expenses - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Schedule Of Accrued Expenses Abstract
Clinical research organization services and expenses	$ 123,386	$ 1,826,479
Employee compensation	761,509	520,795
Pre-clinical and manufacturing expenses	197,306
Legal and consulting services	72,616	29,656
Total accrued expenses	$ 1,154,817	$ 2,376,930

Related Party Transactions (Det

Related Party Transactions (Details) - USD ($)									1 Months Ended	12 Months Ended
	Nov. 09, 2021	Oct. 05, 2021	Aug. 04, 2021	Aug. 02, 2021	Jul. 07, 2021	Jul. 06, 2021	Mar. 11, 2021	Dec. 07, 2020	Dec. 17, 2021	Dec. 31, 2022	Dec. 31, 2021
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 “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. SPAs were entered with each of Bespoke Growth Partners, Inc. (“Bespoke”), a company controlled by Mark Peikin, the Chief Strategy Officer of the Company at that time, Keystone Capital Partners, LLC (“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 “SPAs”) with each of Bespoke, three entities controlled by James W. Newman, Jr., a member of the Company’s Board of Directors (“Newman”), and Keystone Capital Partners, LLC (“Keystone”), pursuant to which: (i) Bespoke 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) 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. In 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 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.
Purchase an additional shares	180,000
Common stock for proceeds (in Dollars)										$ 9,123,741	$ 11,750,005
Shares of common stock	20,000	200,000
Warrants shares		150,000
Expiring date		Jul. 31, 2023
Exercisable per share (in Dollars per share)		$ 6.25
Sale of additional shares									180,000
Bespoke [Member]
Related Party Transactions (Details) [Line Items]
Purchase shares					83,334
Purchase an additional shares					750,000
Purchase shares				750,000
Common stock for proceeds (in Dollars)				$ 2,250,000
Shares of common stock	200,000
Price per share (in Dollars per share)	$ 4
Aggregate investment (in Dollars)	$ 800,000
Keystone [Member]
Related Party Transactions (Details) [Line Items]
Purchase shares					50,000
Purchase an additional shares					450,000
Purchase shares			450,000
Common stock for proceeds (in Dollars)			$ 1,350,000
Gilliam [Member]
Related Party Transactions (Details) [Line Items]
Purchase shares					33,334
Purchase an additional shares					300,000
Purchase shares			300,000
Common stock for proceeds (in Dollars)			$ 900,000

Shareholders' Equity (Details)

Shareholders' Equity (Details) - USD ($)					1 Months Ended		12 Months Ended
	Oct. 13, 2022	Feb. 10, 2022	Feb. 08, 2021	Oct. 09, 2017	Feb. 25, 2021	Jan. 26, 2021	Dec. 31, 2022	Dec. 31, 2021
Shareholders' Equity (Details) [Line Items]
Unregistered shares of common stock						669,980
Stock consideration (in Dollars)						$ 1,060,150
Options to purchase shares of common stock			10,000				731,667
Exercise price (in Dollars per share)			$ 1.45
Total exercised (in Dollars)			$ 14,500		$ 1,425,000
Warrants for purchase					712,500
Warrant exercise fee (in Dollars per share)					$ 2
Total proceeds (in Dollars)							$ 1,865	$ 1,424,998
Shares issued							470,000
Common Stock Issuances, description		the Company, entered into a securities purchase agreement with an accredited institutional investor (“the 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.
Net proceeds from the offering (in Dollars)		$ 9,123,741
Exercised for proceeds (in Dollars)		$ 1,865
Common stock available for issuance		1,865,000
Cost of common stock (in Dollars)							$ 818,350
Employee vesting shares, description							During the year ended December 31, 2022, the Company issued employees 1,250,000 shares of common stock as bonuses, of which 1,083,333 remain outstanding. The first issuance of 250,000 shares were subject to forfeiture for nominal consideration to Company on termination of the employee, the shares no longer being liable to forfeiture (“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 December 30, 2022, the 166,667 shares vesting over 24 months were canceled by the recipient at the recipient’s will, at which time the Company recognized the remaining $191,325 cost of the unvested shares cancelled. The second issuance of 1,000,000 shares are subject to forfeiture on the same conditions, but on the following schedule: 1/6 of the issued shares vesting six months from date of issue, then 1/12 vesting at the end of each subsequent three month period, the entire grant being vested three years from date of issue. On December 31, 2022, none of the uncancelled shares were vested and 1,083,333 shares remained subject to repurchase.
Outstanding options intrinsic value (in Dollars)							$ 0
Weighted average fair value (in Dollars)							$ 1,017,095
weighted average fair value per share (in Dollars per share)							$ 1.39
Weighted average remaining vesting period							1 year 6 months 7 days
Unrecognized compensation expense (in Dollars)							$ 1,939,438
Warrants to purchase shares of common stock							1,865,000	712,500
2017 Equity Incentive Plan [Member]
Shareholders' Equity (Details) [Line Items]
Common shares issued	9,500,000			1,750,000			2,248,326
Consultants Services [Member]
Shareholders' Equity (Details) [Line Items]
Total proceeds (in Dollars)					$ 1,980,900
Keystone Equity Purchase Agreement [Member]
Shareholders' Equity (Details) [Line Items]
Share issued					1,645,907
Total proceeds (in Dollars)					$ 3,850,000
Securities Purchase Agreements [Member]
Shareholders' Equity (Details) [Line Items]
Total proceeds (in Dollars)					$ 7,900,007
Shares issued					2,566,669
Consultants Services [Member]
Shareholders' Equity (Details) [Line Items]
Shares issued					713,000
Stock Options [Member]
Shareholders' Equity (Details) [Line Items]
Common stock available for issuance							139,686
Common stock, shares outstanding							4,177,291
Weighted average remaining vesting period							2 years 10 months 20 days
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 during the year ended December 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. During the year ended December 31, 2022, the Company recognized $305,230 in expense associated with these warrants with no additional expense remaining to be recognized.

Shareholders' Equity (Details)

Shareholders' Equity (Details) - Schedule of stock option activity - Share-Based Payment Arrangement, Option [Member] - $ / shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Shareholders' Equity (Details) - Schedule of stock option activity [Line Items]
Total Options Outstanding, Beginning Balance (in Shares)	3,585,310	2,668,866
Weighted Average Remaining Term (Years), Beginning Balance		8 years 1 month 2 days
Weighted Average Exercise Price, Beginning Balance	$ 2.64	$ 2.48
Weighted Average Fair Value at Issue, Beginning Balance		$ 1.13
Total Options Outstanding, Issued (in Shares)	731,667	1,132,000
Weighted Average Remaining Term (Years), Issued	$ 1.7	$ 2.47
Weighted Average Fair Value at Issue, Issued	$ 1.39	$ 2.37
Total Options Outstanding, Exercised (in Shares)		(215,556)
Weighted Average Remaining Term (Years), Exercised		$ 2.18
Weighted Average Fair Value at Issue, Exercised		$ 0.89
Total Options Outstanding, Ending Balance (in Shares)	4,316,977	3,585,310
Weighted Average Remaining Term (Years), Ending Balance	7 years 2 months 15 days	7 years 9 months 18 days
Weighted Average Exercise Price, Ending Balance	$ 2.48	$ 2.64
Weighted Average Fair Value at Issue, Ending Balance	$ 1.91	$ 2.02
Total Options Outstanding, vested and exercisable (in Shares)	3,237,778
Weighted Average Remaining Term (Years),Outstanding, vested and exercisable	6 years 9 months 14 days
Weighted Average Exercise Price, Outstanding, vested and exercisable	$ 2.59
Weighted Average Fair Value at Issue ,Outstanding, vested and exercisable	$ 1.96

Shareholders' Equity (Details_2

Shareholders' Equity (Details) - Schedule of black scholes valuation model to determine the fair value of the options issued - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Shareholders' Equity (Details) - Schedule of black scholes valuation model to determine the fair value of the options issued [Line Items]
Expected Term	6 years
Expected Dividend (in Dollars)
Minimum [Member]
Shareholders' Equity (Details) - Schedule of black scholes valuation model to determine the fair value of the options issued [Line Items]
Fair Value per Share (in Dollars per share)	$ 0.59	$ 2.21
Expected Term		1 year
Expected Volatility	107.88%	108.35%
Risk free rate	1.89%	0.07%
Maximum [Member]
Shareholders' Equity (Details) - Schedule of black scholes valuation model to determine the fair value of the options issued [Line Items]
Fair Value per Share (in Dollars per share)	$ 2	$ 4.52
Expected Term		5 years 9 months
Expected Volatility	116.54%	110.69%
Risk free rate	3.26%	1.26%

Shareholders' Equity (Details_3

Shareholders' Equity (Details) - Schedule of stock-based compensation expense - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Shareholders' Equity (Details) - Schedule of stock-based compensation expense [Line Items]
Total stock-based compensation expense	$ 3,374,493	$ 4,240,417
Research and Development Options Expense [Member]
Shareholders' Equity (Details) - Schedule of stock-based compensation expense [Line Items]
Total stock-based compensation expense	230,627	304,421
Total research and development expenses [Member]
Shareholders' Equity (Details) - Schedule of stock-based compensation expense [Line Items]
Total stock-based compensation expense	230,627	304,421
General and Administrative Options Expense [Member]
Shareholders' Equity (Details) - Schedule of stock-based compensation expense [Line Items]
Total stock-based compensation expense	1,870,583	1,955,096
Stock and Warrants Issued to Consultants and Employees [Member]
Shareholders' Equity (Details) - Schedule of stock-based compensation expense [Line Items]
Total stock-based compensation expense	1,273,283	1,980,900
Total General and Administrative Expenses [Member]
Shareholders' Equity (Details) - Schedule of stock-based compensation expense [Line Items]
Total stock-based compensation expense	$ 3,143,866	$ 3,935,996

Shareholders' Equity (Details_4

Shareholders' Equity (Details) - Schedule of activity in warrants - $ / shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Schedule Of Activity In Warrants Abstract
Warrants, Outstanding Beginning Balance (in Shares)	7,990,271	8,649,625
Weighted Average Remaining Term, Outstanding Beginning Balance		3 years 5 months 15 days
Weighted Average Exercise Price, Outstanding Beginning Balance		$ 4.6
Average Intrinsic Value, Outstanding Beginning Balance	$ 0.14	$ 0.02
Warrants, Issued (in Shares)	6,042,888	53,146
Weighted Average Exercise Price, Issued	$ 1.74	$ 2.26
Warrants, Exercised (in Shares)	(1,865,000)	(712,500)
Weighted Average Exercise Price, Exercised	$ 0.001	$ 2
Total Warrants, Outstanding Ending Balance (in Shares)	12,168,159	7,990,271
Weighted Average Remaining Term (Years), Outstanding Ending Balance	3 years 14 days	2 years 7 months 17 days
Weighted Average Exercise Price, Outstanding Ending Balance	$ 4.03	$ 4.82
Average Intrinsic Value, Outstanding Ending Balance	$ 0.01	$ 0.14

Income Taxes (Details)

Income Taxes (Details) - USD ($)	1 Months Ended	12 Months Ended
	Apr. 16, 2022	Dec. 31, 2022
Income Taxes (Details) [Line Items]
Net operating loss carry-forward, description		NOLS generated prior to 2018 will expire in 2037 and the 20- year carryover limitation was eliminated for losses generated after January 1, 2018, giving the taxpayer the ability to carry forward losses indefinitely. However, NOL carry forward arising after January 1, 2018, will now be limited to 80 percent of Taxable income.
Valuation allowance		$ 12,400,000
U.S. federal excise tax	1%
Excise tax rate percentage	1%
Stock repurchased	$ 1,000,000
Federal [Member]
Income Taxes (Details) [Line Items]
Net operating loss carry-forward		44,700,000
State [Member]
Income Taxes (Details) [Line Items]
Net operating loss carry-forward		$ 51,800,000

Income Taxes (Details) - Schedu

Income Taxes (Details) - Schedule of statutory federal income tax rate and effective rate	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Schedule Of Statutory Federal Income Tax Rate And Effective Rate Abstract
Federal statutory rate	21%	21%
Stock Options	(4.11%)	(2.43%)
Impairment charges	0%	(1.67%)
Other Permanent Items	0.51%	(0.60%)
State Taxes	4.02%	2.78%
Increase in VA	(21.42%)	(18.61%)
Other	0%	0%
Effective tax rate	0%	0.48%

Income Taxes (Details) - Sche_2

Income Taxes (Details) - Schedule of tax expense (benefit)	12 Months Ended
	Dec. 31, 2022 USD ($)
Schedule Of Tax Expense Benefit Abstract
Current, Federal
Deferred, Federal	(24,473)
Federal	(24,473)
Current, State and Local
Deferred, State and Local	23,971
State and Local	23,971
Current
Deferred	(502)
Total	$ (502)

Income Taxes (Details) - Sche_3

Income Taxes (Details) - Schedule of deferred tax assets & liabilities (rounded) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Schedule Of Deferred Tax Assets Liabilities Rounded Abstract
Net operating loss carry-forward	$ 11,378,190	$ 9,670,286
Accrued Expenses	171,902	116,147
Lease Liability	52,180	64,623
Restricted stock	15,982
Section 174 R&D	946,624
Less: valuation allowance	(12,418,870)	(9,692,143)
Total tax assets	146,008	158,913
Fixed Asset	(5,221)	(1,663)
Intangible assets	(114,871)	(117,340)
ROU Assets	(48,813)	63,309
Total deferred tax labilities	(168,905)	(182,312)
Net deferred tax asset (liability)	$ (22,897)	$ (23,399)

Commitments and Contingencies_2

Commitments and Contingencies (Details)

1 Months Ended

12 Months Ended

May 13, 2022 USD ($)

May 13, 2022 USD ($)

Jul. 05, 2019 USD ($)

Nov. 16, 2018 USD ($)

Nov. 16, 2018 EUR (€)

Jan. 26, 2021

Oct. 31, 2018

Dec. 31, 2022 USD ($) $ / shares

Dec. 31, 2022 EUR (€)

Dec. 31, 2021 USD ($)

Apr. 28, 2022 USD ($)

Apr. 28, 2022 EUR (€)

Mar. 01, 2020

Commitments and Contingencies (Details) [Line Items]

License fees and milestone payments, description

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.

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.

License royalty expenses

$ 40,000

$ 40,000

Accrued license royalty expense

$ 155,000

Accrued expenses, related party

$ 40,000

0

Master services agreement, description

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.

Amended fees

$ 3,398,957

€ 3,168,895

Exchange rate (in Dollars per share) | $ / shares

$ 1.0726

Amount paid

$ 146,765

Revenue Recognition, Milestone Method, Revenue Recognized

$ 137,375

$ 143,685

€ 134,969

Settlement amount

$ 454,034

€ 410,000

Non cash income

$ 209,689

Remaining lease term

4 years

Estimated incremental borrowing rate

9%

Monthly rent

$ 1,400

Operating Leases, Rent Expense, Sublease Rentals

1,400

Compensation expense

416,200

$ 375,000

Compensation to be paid

$ 300,000

Common stock percentage

20%

Committed payment

209,250

Consulting expenses

151,500

Related party accrued expenses

135,000

Other expenses

$ 398,600

Agreement payments

$1,409,000

$1,409,000

Advance payment

$ 579,000

Advanced payment

150,300

Paid in cash

64,200

Accrued amount

184,100

Prepaid expense asset

428,700

Future cash

1.2

Purnovate, LLC [Member]

Commitments and Contingencies (Details) [Line Items]

Equity interest

28.70%

Minimum [Member]

Commitments and Contingencies (Details) [Line Items]

Annual fee

$ 375,000

Ranging terms

12 months

12 months

Maximum [Member]

Commitments and Contingencies (Details) [Line Items]

Annual fee

$ 430,000

Ranging terms

30 months

30 months

Consulting Agreement [Member]

Commitments and Contingencies (Details) [Line Items]

Other expenses

$ 57,750

Service Agreement 1 [Member]

Commitments and Contingencies (Details) [Line Items]

Accrued R&D expenses

123,386

Estimated cost

2,100,000

€ 2,200,000

Estimated future site costs

$ 3,500,000

Commitments and Contingencies_3

Commitments and Contingencies (Details) - Schedule of future milestone payments are shown in the table below, converted to dollars from euros - eTMF transfer [Member] $ in Millions	12 Months Ended
	Dec. 31, 2022 USD ($)
Commitments and Contingencies (Details) - Schedule of future milestone payments are shown in the table below, converted to dollars from euros [Line Items]
Percent Milestone Fees	5%
Amount	$ 144,768

Commitments and Contingencies_4

Commitments and Contingencies (Details) - Schedule of components of lease expense - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Schedule Of Components Of Lease Expense [Abstract]
Operating lease expense	$ 72,828	$ 75,116
Short-term lease expense
Total lease cost	$ 72,828	$ 75,116

Commitments and Contingencies_5

Commitments and Contingencies (Details) - Schedule of supplemental cash flow information related to leases - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Schedule Of Supplemental Cash Flow Information Related To Leases [Abstract]
Operating cash flows for operating leases	$ 70,202	$ 67,719
Supplemental non-cash amounts of lease liabilities arising from obtaining right of use assets		$ 294,294

Commitments and Contingencies_6

Commitments and Contingencies (Details) - Schedule of supplemental balance sheet information related to leases - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Assets
Lease right of use assets	$ 193,997	$ 246,209
Total lease assets	193,997	246,209
Liabilities
Lease liability - current portion	56,828	49,585
Lease liability, net of current portion	150,547	207,375
Total lease liability	$ 207,375	$ 256,960

Commitments and Contingencies_7

Commitments and Contingencies (Details) - Schedule of weighted-average remaining lease term	Dec. 31, 2022	Dec. 31, 2021
Schedule Of Weighted Average Remaining Lease Term [Abstract]
Weighted average remaining lease term (in years) - operating leases	3 years 29 days	4 years 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	Dec. 31, 2022 USD ($)
Schedule Of Future Lease Payments Included In The Measurement Of Lease Liabilities [Abstract]
2023	$ 72,687
2024	75,231
2025	77,864
2026 and thereafter	6,508
Total Minimum Lease Payments	232,290
Less effects of discounting	(24,915)
Present value of future minimum lease payments	$ 207,375

Subsequent Events (Details)

Subsequent Events (Details)		12 Months Ended
	May 13, 2022 USD ($)	Dec. 31, 2022 USD ($) $ / shares shares	Dec. 31, 2022 EUR (€) shares	Dec. 31, 2021 $ / shares
Subsequent Events (Details) [Line Items]
Cash payment		$11	$11
Exercise price | $ / shares		$ 150,000
Buyer raised amount | $		$ 4,000,000
Cash payment of aggregate amount | $		$ 50,000,000
Common Stock par value | $ / shares		$ 0.001		$ 0.001
Aggregate purchase price | $		$ 750,000
Fees and expenses | $		$ 550,000
Aggregate shares | shares		1,829,269	1,829,269
Percentage of common stock		10%	10%
Exercise price per share | $ / shares		$ 0.41
Cash payment	$ 137,375	$ 143,685	€ 134,969
Fee amount		$22,000	$22,000
Option Agreement [Member]
Subsequent Events (Details) [Line Items]
Cash payment		$300,000	$300,000
Percentage of equity		19.99%
Original Option Term [Member]
Subsequent Events (Details) [Line Items]
Cash payment		($100,000)	($100,000)
Extended Option Term [Member]
Subsequent Events (Details) [Line Items]
Cash payment		($50,000)	($50,000)
Purnovate Option Agreement [Member] | Option Agreement [Member]
Subsequent Events (Details) [Line Items]
Percentage of equity		19.99%
Securities Purchase Agreement [Member]
Subsequent Events (Details) [Line Items]
Share issuance | shares		1,829,269
Purchase Agreement [Member]
Subsequent Events (Details) [Line Items]
Common Stock par value | $ / shares		$ 0.001
Aggregate shares | shares		182,927	182,927
Consulting Agreement [Member]
Subsequent Events (Details) [Line Items]
Shares bonus amount | shares		100,000