Ensysce Biosciences, Inc. 10-Q

Item 1. Financial Statements. Ensysce Biosciences, Inc. Consolidated Balance Sheets (Unaudited) March 31, 2023 December 31, 2022 Assets Current assets: Cash and cash equivalents $ 1,415,765 $ 3,147,702 Unbilled receivable 289,312 276,821 Right-of-use asset 19,015 27,165 Prepaid expenses and other current assets 1,646,553 1,847,481 Total current assets 3,370,645 5,299,169 Other assets 544,217 585,883 Total assets $ 3,914,862 $ 5,885,052 Liabilities and stockholders’ deficit Current liabilities: Accounts payable $ 1,598,166 $ 2,943,791 Accrued expenses and other liabilities 2,358,682 2,226,494 Lease liability 19,120 27,315 Notes payable and accrued interest ($ 0 and $ 4,063,431 at fair value at March 31, 2023 and December 31, 2022, respectively) - 4,266,610 Total current liabilities 3,975,968 9,464,210 Long-term liabilities: Notes payable, net of current portion (at fair value) - 140,148 Liability classified warrants 91,318 310,346 Total long-term liabilities 91,318 450,494 Total liabilities $ 4,067,286 $ 9,914,704 Commitments and contingencies (Note 6) Stockholders’ deficit Preferred stock, $ 0.0001 par value, 1,500,000 shares authorized, no shares issued and outstanding at March 31, 2023 (unaudited) and December 31, 2022 - - Common stock, $ 0.0001 par value, 250,000,000 shares authorized at March 31, 2023 (unaudited) and December 31, 2022; 1,284,664 and 534,571 shares issued at March 31, 2023 (unaudited) and December 31, 2022, respectively; 1,284,583 and 534,490 shares outstanding at March 31, 2023 (unaudited) and December 31, 2022, respectively 128 53 Additional paid-in capital 113,293,834 107,216,566 Accumulated deficit ( 113,127,237 ) ( 110,931,063 ) Total Ensysce Biosciences, Inc. stockholders’ equity (deficit) 166,725 ( 3,714,444 ) Noncontrolling interests in stockholders’ deficit ( 319,149 ) ( 315,208 ) Total stockholders’ deficit ( 152,424 ) ( 4,029,652 ) Total liabilities and stockholders’ deficit $ 3,914,862 $ 5,885,052 The accompanying notes are an integral part of these consolidated financial statements. 1 Ensysce Biosciences, Inc. Consolidated Statements of Operations (Unaudited) 2023 2022 Three Months Ended March 31, 2023 2022 Federal grants $ 789,635 $ 603,098 Operating expenses: Research and development 1,796,015 3,140,096 General and administrative 1,554,855 2,265,806 Total operating expenses 3,350,870 5,405,902 Loss from operations ( 2,561,235 ) ( 4,802,804 ) Other income (expense): Change in fair value of convertible notes 146,479 2,767,178 Change in fair value of liability classified warrants 219,028 2,794,398 Loss on debt conversions - ( 1,702,642 ) Interest expense, net ( 1,497 ) ( 15,021 ) Other income and expense, net 5,419 7,966 Total other income, net 369,429 3,851,879 Net loss $ ( 2,191,806 ) $ ( 950,925 ) Net loss attributable to noncontrolling interests ( 3,941 ) 182 Deemed dividend related to warrants down round provision 8,309 715,579 Net loss attributable to common stockholders $ ( 2,196,174 ) $ ( 1,666,686 ) Net loss per basic and diluted share: Net loss per share attributable to common stockholders, basic and diluted $ ( 2.08 ) $ ( 14.66 ) Weighted average common shares outstanding, basic and diluted 1,054,202 113,696 The accompanying notes are an integral part of these consolidated financial statements. 2 Ensysce Biosciences, Inc. Consolidated Statements of Changes in Stockholders’ EQUITY (Deficit) (Unaudited) Number of Shares Amount Paid-In Capital Accumulated Deficit Noncontrolling interests Total Stockholders’ Equity (Deficit) Common Stock Additional Number of Shares Amount Paid-In Capital Accumulated Deficit Noncontrolling interests Total Balance on December 31, 2021 102,678 $ 10 $ 77,967,314 $ ( 85,845,567 ) $ ( 279,815 ) $ ( 8,158,058 ) Consultant compensation 208 0 54,250 - - 54,250 Conversion of convertible notes 19,618 2 8,075,341 - - 8,075,343 Settlement of restricted stock units 2,280 0 ( 0 ) - - - Stock-based compensation - - 2,090,663 - - 2,090,663 Deemed dividend related to warrants down round provision - - 715,579 ( 715,579 ) - - Net loss - - - ( 951,107 ) 182 ( 950,925 ) Balance on March 31, 2022 124,784 $ 12 $ 88,903,147 $ ( 87,512,253 ) $ ( 279,633 ) $ 1,111,273 Balance on December 31, 2022 534,490 $ 53 $ 107,216,566 $ ( 110,931,063 ) $ ( 315,208 ) $ ( 4,029,652 ) Balance 534,490 $ 53 $ 107,216,566 $ ( 110,931,063 ) $ ( 315,208 ) $ ( 4,029,652 ) Settlement of restricted stock units 312 - - - - - Conversion of convertible notes 408,582 41 3,056,851 - - 3,056,892 Settlement of commitment fee 44,444 4 399,996 - - 400,000 Public offering, net 297,619 30 2,689,022 2,689,052 Transaction costs associated with public offering - - ( 194,043 ) - - ( 194,043 ) Stock-based compensation - - 117,133 - - 117,133 Reverse split fractional shares ( 864 ) - - - - - Deemed dividend related to warrants down round provision - - 8,309 ( 8,309 ) - - Net loss - - - ( 2,187,865 ) ( 3,941 ) ( 2,191,806 ) Balance on March 31, 2023 1,284,583 $ 128 $ 113,293,834 $ ( 113,127,237 ) $ ( 319,149 ) $ ( 152,424 ) Balance 1,284,583 $ 128 $ 113,293,834 $ ( 113,127,237 ) $ ( 319,149 ) $ ( 152,424 ) The accompanying notes are an integral part of these consolidated financial statements. 3 Ensysce Biosciences, Inc. Consolidated Statements of Cash Flows (U naudited ) 2023 2022 Three Months Ended March 31, 2023 2022 Cash flows from operating activities: Net loss $ ( 2,191,806 ) $ ( 950,925 ) Adjustments to reconcile net loss to net cash used in operating activities: Gain on sale of asset - ( 4,500 ) Accrued interest 1,497 15,021 Change in fair value of convertible notes ( 146,479 ) ( 2,767,178 ) Change in fair value of liability classified warrants ( 219,028 ) ( 2,794,398 ) Loss on debt conversions - 1,702,642 Stock-based compensation 117,133 402,434 Lease cost ( 46 ) ( 46 ) Changes in operating assets and liabilities: Unbilled receivable ( 12,491 ) ( 366,880 ) Prepaid expenses and other assets 242,594 581,840 Accounts payable ( 1,345,624 ) 658,526 Accrued expenses and other liabilities ( 52,669 ) 86,450 Net cash used in operating activities ( 3,606,919 ) ( 3,437,014 ) Cash flows from investing activities: Proceeds from sale of assets - 4,500 Net cash provided by investing activities - 4,500 Cash flows from financing activities: Proceeds public offering, net 2,689,052 - Transaction costs associated with public offering ( 194,043 ) - Repayment of convertible notes ( 415,351 ) - Repayment of financed insurance premiums ( 204,676 ) ( 391,270 ) Net cash provided by (used in) financing activities 1,874,982 ( 391,270 ) Decrease in cash and cash equivalents ( 1,731,937 ) ( 3,823,784 ) Cash and cash equivalents beginning of period 3,147,702 12,264,736 Cash and cash equivalents end of period $ 1,415,765 $ 8,440,952 Supplemental cash flow information: Income tax payments $ - $ - Supplemental disclosure of non-cash investing and financing activities: Stock-based compensation $ - $ 1,742,479 Conversions of convertible notes into common stock $ 3,056,892 $ 6,372,701 Cash true-up liability $ 584,857 $ - Settlement of commitment fee in shares $ 400,000 $ - Deemed dividend related to warrants down round provision $ 8,309 $ 715,579 The accompanying notes are an integral part of these consolidated financial statements. 4 ENSYSCE BIOSCIENCES, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) NOTE 1 – ORGANIZATION AND PRINCIPAL ACTIVITIES Ensysce Biosciences, Inc. (“Ensysce”), along with its 79.2 %-owned subsidiary, EBIR, Inc. (“EBIR”, formerly known as Covistat, Inc.) and its wholly-owned subsidiaries EBI Operating, Inc. and EBI OpCo, Inc. (collectively, the “Company”), is a clinical-stage biotech company using its proprietary technology platforms to develop safer prescription drugs. The primary focus of the Company is its program developing abuse and overdose resistant pain technology with a clinical stage program being the abuse resistant, TAAP (Trypsin Activated Abuse Protection) opioid product candidate, PF614. In addition, the Company is developing its MPAR TM (Multi-Pill Abuse Resistant) technology for overdose protection which will be applied to the PF614 program. The Company is also applying its TAAP and MPAR TM technology to a methadone prodrug for use in the treatment of Opioid Use Disorder. In 2020, the Company commenced an initiative to develop a therapeutic for the treatment of certain coronavirus infections through the formation of a separate entity, EBIR, a Delaware corporation. Pursuant to the certificate of incorporation, EBIR was authorized to issue 1,000,000 shares of common stock, $ 0.001 par value per share, and 100,000 shares of preferred stock, $ 0.001 par value per share. Ensysce is a 79.2 % stockholder in EBIR, with 19.8 % and 1.0 % of the shares held by certain key personnel of the Company and an unrelated party, respectively. The non-Ensysce owned shares and the activity are reflected on the financial statements as Noncontrolling interests. The Company currently operates in one business segment, which is pharmaceuticals. The Company is not organized by market and is managed and operated as one business. A single management team reports to the chief operating decision maker, the Chief Executive Officer. NOTE 2 - BASIS OF PRESENTATION The consolidated financial statements have been prepared in accordance with GAAP and pursuant to the rules and regulations of the SEC. The consolidated financial statements include the accounts of Ensysce Biosciences, Inc. and its subsidiaries. All intercompany balances and transactions have been eliminated in the consolidation. 5 In the opinion of management, all adjustments considered necessary for a fair presentation have been included in the consolidated financial statements. Operating results for the three months ended March 31, 2023, are not necessarily indicative of the results that may be expected for the year ending December 31, 2023. The interim unaudited consolidated financial statements have been prepared under the presumption that users of the interim financial information have either read or have access to the audited consolidated financial statements for the fiscal year ended December 31, 2022, which may be found in the Company’s Form 10-K filed with the SEC on March 30, 2023. Reverse stock split In March 2023, the Company completed a 1-for-12 reverse split of its outstanding common stock. All references in these consolidated financial statements to shares and per share amounts in all periods have been retroactively restated to reflect the split. The number of authorized shares and the par value of the shares did not change as a result of the reverse stock split. Going concern The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. The Company has not generated any product revenue and had an accumulated deficit of $ 113.1 million at March 31, 2023. There is no assurance that profitable operations will ever be achieved, and, if achieved, could be sustained on a continuing basis. Product development activities, clinical and pre-clinical testing, and commercialization of the Company’s product candidates are necessary to develop the Company’s products and will require significant additional financing. There can be no assurance the Company will be able to obtain such funds. These matters, among others, raise substantial doubt about the Company’s ability to continue as a going concern. In December 2020, the Company executed the GEM Agreement. Under the agreement, the investor agreed to provide the Company with a share subscription facility of up to $ 60.0 million for a 36-month term following the public listing of the Company’s common stock. The Company controls the timing and maximum amount of drawdown under this facility and has no minimum drawdown obligation. The investor will pay, in cash, a per-share amount equal to 90% of the average daily closing price of the Company’s stock during the 30 consecutive trading days prior to the issuance of a draw notice, which shall not exceed 400% of the average trading volume for the 30 trading days immediately preceding the draw down date. On June 30, 2021, the Company consummated the Business Combination, resulting in the Company’s shares becoming publicly listed on Nasdaq on July 2, 2021. Concurrent with the public listing of the Company’s shares, the Company issued to the investor 4,608 warrants with a five-year term to purchase common stock of Ensysce at an exercise price of $ 2,402.40 per share (Note 8). The Company was required to pay a commitment fee to the investor of $ 1.2 million with $ 0.8 million due on the first anniversary of the public listing date and $ 0.4 million due on the 18-month anniversary of the public listing date. The first $ 0.8 million of the commitment fee was paid in July 2022 in common stock of the Company (Note 10) and the remaining $ 0.4 million was paid in January 2023 in common stock of the Company. Usage of the GEM facility is limited by other agreements of the Company. The Company has not raised any capital to date pursuant to the GEM facility and may not raise any capital pursuant to it prior to its expiration. 6 While the Company believes in the viability of its strategy to ultimately realize revenues and in its ability to raise additional funds, management cannot be certain that additional funding will be available on acceptable terms, or at all. The Company’s ability to continue as a going concern is dependent upon its ability to obtain adequate financing and achieve profitable operations. As a result, these plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern for a period of 12 months following the date these consolidated financial statements were issued. The consolidated financial statements do not include any adjustments that might be necessary should the Company be unable to continue as a going concern. NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of estimates and assumptions Preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and disclosed in the accompanying notes. Actual results may differ from those estimates and such differences may be material to the consolidated financial statements. The more significant estimates and assumptions by management include, but are not limited to, the expense recognition for certain accrued research and development services, the valuation allowance of deferred tax assets resulting from net operating losses, and the fair value of warrants and options to purchase the Company’s common stock and convertible notes payable. Cash and cash equivalents For purposes of the consolidated balance sheets and consolidated statements of cash flows, the Company considers all highly liquid instruments with maturity of three months or less at the time of issuance to be cash equivalents. Concentrations of credit risk and off-balance sheet risk Cash and cash equivalents are financial instruments that are potentially subject to concentrations of credit risk. The Company’s cash and cash equivalents are deposited in accounts at large financial institutions and amounts currently exceed federally insured limits. The Company has no financial instruments with off-balance sheet risk of loss. Property and equipment Property and equipment include office and laboratory equipment that is recorded at cost and depreciated using the straight-line method over the estimated useful lives of five to six years . Property and equipment are fully depreciated as such there is no depreciation recognized in the periods presented. Depreciation expense is classified in general and administrative expense in the accompanying consolidated statements of operations. 7 Derivative financial instruments The Company does not use derivative instruments to hedge exposures to interest rate, market, or foreign currency risks. The Company evaluates all of its financial instruments, including notes payable, to determine whether such instruments are derivatives or contain features that qualify as embedded derivatives. Embedded derivatives must be separately measured from the host contract if all the requirements for bifurcation are met. The assessment of the conditions surrounding the bifurcation of embedded derivatives depends on the nature of the host contract and the features of the derivatives. Bifurcated embedded derivatives are recognized at fair value, with changes in fair value recognized in the consolidated statement of operations each period. Bifurcated embedded derivatives are classified with the related host contract in the Company’s consolidated balance sheet. Fair Value Measurement ASC 820, Fair Value Measurements , (“ASC 820”) provides guidance on the development and disclosure of fair value measurements. Pursuant to ASC 820, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little, or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. The Company evaluates assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them for each reporting period. This determination requires significant judgments to be made by the Company. As of March 31, 2023 and December 31, 2022, the recorded values of cash and cash equivalents, prepaid expenses, accounts payable, and accrued expenses and other liabilities approximate their fair values due to the short-term nature of these items. 2021 Notes In 2021 the Company issued convertible notes and elected the fair value option to account for the convertible notes as it believes the fair value option provides users of the financial statements with greater ability to estimate the outcome of future events as facts and circumstances change, particularly with respect to changes in the fair value of the common stock underlying the conversion option and redemption feature. The fair value estimate of the 2021 Notes was based on a discounted cash flow model and a Monte Carlo simulation, which represent Level 3 measurements. Significant assumptions include the discount rate used in the discounted cash flow model and the expected premium for conversion used in the Monte Carlo simulation. Changes in the fair value of the notes are recognized in other income (expense) for each reporting period. Refer to Note 7 for details of the terms and conditions of the 2021 Notes. 2022 Notes In July 2022 the Company issued convertible notes and the 2022 Notes are accounted for under ASC 480 – Distinguishing Liabilities from Equity, due to share settlement features contained within the notes. As a result, the 2022 Notes are recorded as liabilities at fair value at the balance sheet date with changes in the fair value of the notes recognized in other income (expense) for each reporting period. The fair value estimate of the 2022 Notes was based on a discounted cash flow model and a Monte Carlo simulation, which represent Level 3 measurements. Significant assumptions include the discount rate used in the discounted cash flow model and the expected premium for conversion used in the Monte Carlo simulation. Refer to Note 7 for details of the terms and conditions of the 2022 Notes. 8 Warrants In 2021 the Company issued liability classified warrants in connection with the issuance of the 2021 Notes. In 2022 the Company issued liability classified warrants in connection with the issuance of the 2022 Notes. The warrants were liability classified due to certain cash settlement features and included in “Other long-term liabilities” on the consolidated balance sheets. The Company uses a Black Scholes model to estimate the fair value of the warrants. Changes in the fair value of the warrants are recognized in other income (expense) for each reporting period. Refer to Note 8 for details of the warrants. The following tables present liabilities measured and recorded at fair value on the Company’s consolidated balance sheets as of March 31, 2023 and December 31, 2022. SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE Total Level 1 Level 2 Level 3 March 31, 2023 Total Level 1 Level 2 Level 3 Liability classified warrants $ 91,318 $ - $ - $ 91,318 Total $ 91,318 $ - $ - $ 91,318 Total Level 1 Level 2 Level 3 December 31, 2022 Total Level 1 Level 2 Level 3 Fair value of convertible note $ 4,203,579 $ - $ - $ 4,203,579 Liability classified warrants 310,346 - - 310,346 Total $ 4,513,925 $ - $ - $ 4,513,925 The following table summarizes the change in fair value of the Company’s Level 3 assets and liabilities for the quarter ended March 31, 2023: SCHEDULE OF CHANGE IN FAIR VALUE OF COMPANY’S LEVEL 3 Total Convertible note Liability classified warrants Fair value, December 31, 2022 $ 4,513,925 $ 4,203,579 $ 310,346 Conversions ( 3,056,892 ) ( 3,056,892 ) - Cash payments ( 415,351 ) ( 415,351 ) - Cash true-up liability ( 584,857 ) ( 584,857 ) - Change in fair value ( 365,507 ) ( 146,479 ) ( 219,028 ) Fair value, March 31, 2023 $ 91,318 $ - $ 91,318 Federal Grants In September 2018, the National Institutes of Health (“NIH”) through the National Institute on Drug Abuse (“NIDA”) awarded the Company a research and development grant related to the development of its MPAR TM overdose prevention technology (the “MPAR Grant”). The total approved budget for the initial two-year period was approximately $ 5.4 million ($ 3.2 million and $ 2.2 million in years 1 and 2, respectively) of which the Company must contribute $ 1.1 million in the first year of the grant. In August 2019, the grant was amended such that the approved budget for the two-year period decreased to approximately $ 5.1 million ($ 2.1 million and $ 3.0 million in years 1 and 2, respectively). In June 2021, the Company received a Notice of Award for an additional $ 2.8 million of funding in year 3 under the MPAR Grant beginning July 1, 2021. In June 2022, the Company received a Notice of Award for an additional $ 2.8 million of funding in year 4 under the MPAR Grant from July 1, 2022 through June 30, 2023. This brings total funding under this grant to approximately $ 10.7 million. 9 In September 2019, the NIH/NIDA awarded the Company a second research and development grant related to the development of its TAAP/MPAR TM abuse deterrent technology for Opioid Use Disorder (the “OUD Grant”). The total approved budget was approximately $ 5.4 million. The Company recognizes revenue when costs related to the grants are incurred and assessed as reimbursable. The Company believes this policy is consistent with the overarching premise in Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“ASC 606”), applied by analogy, to ensure that it recognizes revenues to reflect the transfer of promised goods or services to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services, even though there is no “exchange” as defined in ASC 606. The Company believes the recognition of revenue as costs are incurred and reimbursable amounts become due is analogous to the concept of transfer of control of a service over time under ASC 606. The revenue recognized under the MPAR Grant and OUD Grant was as follows: SCHEDULE OF REVENUE RECOGNIZATION UNDER GRANTS 2023 2022 Three Months Ended March 31, 2023 2022 MPAR $ 481,279 $ 504,470 TAAP/OUD 308,356 98,628 Total $ 789,635 $ 603,098 Revenue $ 789,635 $ 603,098 Amounts requested or eligible to be requested through the NIH payment management system, but for which cash has not been received, are presented as an unbilled receivable on the Company’s consolidated balance sheet. As all amounts are expected to be remitted timely, no valuation allowances are recorded. Research and development costs The Company’s research and development expenses consist primarily of third-party research and development expenses, consulting expenses, animal and clinical studies, and any allocable direct overhead, including facilities and depreciation costs, as well as salaries, payroll taxes, and employee benefits for those individuals directly involved in ongoing research and development efforts. Research and development expenses are charged to expense as incurred. Payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received. General and administrative expenses General and administrative expenses consist primarily of personnel costs associated with the Company’s executive, finance, human resources, compliance, and other administrative personnel, as well as accounting and legal professional services fees. Stock-based compensation The Company expenses stock-based compensation over the requisite service period based on the estimated grant-date fair value of the awards using a graded amortization approach. The Company accounts for forfeitures as they occur. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. For the three months ended March 31, 2023, stock-based compensation costs are recorded in general and administrative expenses and research and development expenses in the consolidated statements of operations. From time-to-time equity classified awards may be modified. On the modification date, the Company estimates the fair value of the awards immediately before and immediately after modification. The incremental increase in fair value is recognized as expense immediately to the extent the underlying equity awards are vested and over the same remaining amortization schedule as the unvested underlying equity awards. 10 Income taxes Income taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit would more likely than not be realized assuming examination by the taxing authority. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. The Company recognizes any interest and penalties accrued related to unrecognized tax benefits as income tax expense. Earnings per share The basic earnings per share is calculated by dividing the Company’s net income or loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. The diluted earnings per share is calculated by dividing the Company’s net earnings attributable to common stockholders by the diluted weighted average number of common shares outstanding during the period, determined using the treasury stock method and the average stock price during the period. The following weighted average shares have been excluded from the calculations of diluted weighted average common shares outstanding because they would have been anti-dilutive: SCHEDULE OF WEIGHTED AVERAGE SHARES OF ANTI-DILUTIVE SECURITIES 2023 2022 Three Months Ended March 31, 2023 2022 Stock options 26,354 24,111 RSUs 691 1,788 Warrants 858,609 87,878 Convertible notes - 5,437 Total 885,654 119,214 Anti-dilutive weighted average shares 885,654 119,214 11 Recently Issued Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other Options (Topic 470) to address issues identified as a result of the complexity with applying GAAP for certain financial instruments with characteristics of liabilities and equity. The FASB decided to reduce the number of accounting models for convertible debt instruments and convertible preferred stock, resulting in fewer embedded conversion features being separately recognized from the host contract as compared with current GAAP. Certain types of convertible instruments will continue to be subject to separation models: (a) those with embedded conversion features that are not clearly and closely related to the host contract, that meet the definition of a derivative, and that do not qualify for a scope exception from derivative accounting and (b) convertible debt instruments issued with substantial premiums for which the premiums are recorded as paid-in capital. For convertible instruments, the contracts primarily affected are those with beneficial conversions or cash conversion features as the accounting models for those specific features have been removed. For contracts in an entity’s own equity, the contracts primarily affected are freestanding instruments and embedded features that are accounted for as derivatives due to a failure to meet the settlement conditions of the derivatives scope exceptions. The FASB simplified the settlement assessment by removing the requirements to (a) consider whether the contract would be settled in registered shares, (b) to consider whether collateral is required to be posted, and (c) assess shareholder rights. The FASB also decided to enhance information transparency by making targeted improvements to the disclosures for convertible instruments and earnings-per-share guidance. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023 and early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. Entities must adopt the guidance as of the beginning of its annual fiscal year and a modified retrospective or fully retrospective transition approach is permitted. The Company adopted the standard with an effective date of January 1, 2023 and the adoption did not have a significant impact on the consolidated financial statements. NOTE 4 – PREPAID EXPENSES AND OTHER CURRENT ASSETS SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS March 31, 2023 December 31, 2022 Prepaid research and development $ 1,180,547 $ 1,300,473 Prepaid insurance 314,990 445,583 Other prepaid expenses 151,016 101,425 Total prepaid expenses and other current assets $ 1,646,553 $ 1,847,481 NOTE 5 – ACCRUED EXPENSES AND OTHER LIABILITIES SCHEDULE OF ACCRUED EXPENSES AND OTHER LIABILITIES March 31, 2023 December 31, 2022 Accrued research and development $ 1,293,348 $ 1,332,713 Share subscription facility commitment fees - 400,000 Professional fees 393,077 421,530 Other accrued liabilities 672,257 72,251 Total accrued expenses and other liabilities $ 2,358,682 $ 2,226,494 12 NOTE 6 – COMMITMENTS AND CONTINGENCIES Purchase Commitments As of March 31, 2023, the Company’s commitments included an estimated $ 20.4 million related to the Company’s open purchase orders and contractual obligations that occurred in the ordinary course of business, including commitments with contract research organizations for multi-year pre-clinical and clinical research studies. Although open purchase orders are considered enforceable and legally binding, the terms generally allow the Company the option to cancel, reschedule, and adjust its requirements based on its business needs prior to the delivery of goods or the performance of services. Litigation As of March 31, 2023 and December 31, 2022, there were no pending legal proceedings against the Company that are expected to have a material adverse effect on cash flows, financial condition or results of operations. From time to time, the Company could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. Periodically, the Company reviews the status of significant matters, if any exist, and assesses its potential financial exposure. If the potential loss from any claim or legal claim is considered probable and the amount can be estimated, the Company accrues a liability for the estimated loss. Legal proceedings are subject to uncertainties, and the outcomes are difficult to predict. Because of such uncertainties, accruals are based on the best information available at the time. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation. Lease The Company’s current lease agreement (as amended) has a term that extends through October 31, 2023 with no option to renew. As of March 31, 2023, the future lease payments totaled $ 19,120 . The Company recognized total rent expense of $ 8,375 in the three months ended March 31, 2023 and $ 7,834 in the three months ended March 31, 2022. NOTE 7 – NOTES PAYABLE The Company’s outstanding debt balance was zero as of March 31, 2023. The following table provides a summary of the Company’s outstanding debt as of December 31, 2022: SCHEDULE OF DEBT Principal balance Accrued interest Fair value adjustment Net debt balance 2022 Notes $ 3,905,264 $ 10,544 $ 287,771 $ 4,203,579 Financed insurance 195,273 7,906 - 203,179 Total $ 4,100,537 $ 18,450 $ 287,771 $ 4,406,758 13 The interest expense recognized for financed insurance was as follows: SCHEDULE OF INTEREST EXPENSE DEBT 2023 2022 Three months ended March 31, 2023 2022 Stated interest accrual $ 1,497 $ 2,004 Total $ 1,497 $ 2,004 2021 Notes On September 24, 2021, the Company entered into an agreement with institutional investors to issue the 2021 Notes. The agreement provides for two closings: the first closing for $ 5.3 million (resulting in net proceeds of $ 4.6 million) which closed on September 24, 2021 (the “First Closing”). The second closing for $ 10.6 million (resulting in net proceeds of $ 9.4 million) which closed on November 5, 2021 (the “Second Closing”). The notes included interest at a rate of 5 % per annum, in addition to an original issue discount of 6 % . The interest could be settled in cash or shares at the option of the Company and was payable together with monthly redemptions of the outstanding principal amount of the debt. The Company elected to apply the fair value option to the measurement of the 2021 Notes. The total initial fair value of the debt at issuance was $ 15.9 million. The Company recorded total issuance costs of $ 1.9 million representing investment banking and legal fees of $ 1.0 million and original issue discounts of $ 0.9 million. The fair value measurement includes the assumption of accrued interest and interest expense (at the stated rate plus an 8 % cash settlement premium) and thus a separate amount is not reflected on the consolidated statements of operations. The 2021 Notes were settled on October 11, 2022 and were not outstanding during the quarter ending March 31, 2023. 2022 Notes On June 30, 2022, the Company entered into an $ 8.0 million convertible financing agreement with institutional investors. The agreement provided for two closings, each for notes payable of $ 4.24 million (resulting in gross cash proceeds of $ 4.0 million). Funds were received for the first closing on July 1, 2022 and for the second closing on August 9, 2022. On the issuance date, the Company assessed the probability of the potential settlement scenarios under the terms of the 2022 Notes and determined that the predominant settlement feature of the 2022 Notes was the redemption feature into shares of the Company’s common stock issuable at the lower of the conversion price or 92 % of the average of the three lowest VWAPs in the 10 trading days immediately preceding the redemption date. As the predominant settlement feature of the 2022 Notes is to settle a fixed monetary amount into a variable number of shares, the 2022 Notes fell within the scope of ASC 480. Accordingly, the Company determined that the 2022 Notes should be recorded at estimated fair value on its issuance date and adjusted to its estimated fair value as of each reporting date with the change in estimated fair value recorded as a component other income (expense) in the Company’s consolidated statements of operations. The Company recorded the 2022 Notes at an initial fair value of $ 12.09 million which included a loss upon issuance of $ 3.6 million due to the current share price at issuance exceeding the conversion price. Additionally, the Company recorded issuance costs of $ 1.1 million representing a 6 % original issue discount of $ 0.5 million and $ 0.6 million of legal and investment banking fees, which were immediately expensed. In connection with each of the first and second closings of the 2022 Notes the Company also issued warrants to purchase 38,894 shares of the Company’s common stock. The warrants had an original exercise price of $ 170.04 and are exercisable for five years following issuance of the 2022 Notes. The issuance of these warrants required the Company to reduce the conversion price of the 2021 Notes and the exercise price of the outstanding warrants associated with the 2021 Notes to $ 187.20 . The proceeds of the 2022 Notes were used for working capital purposes subject to certain customary restrictions are secured by the Company’s rights to its patents and licenses. The Company is restricted from issuing certain additional debt or equity without the prior written consent of the holders for certain specified periods set forth in the 2022 Notes. If, at any time while the 2022 Notes are outstanding, the Company carries out one or more capital raises in excess of $ 5.0 million, the holder has the right to require the Company to use up to 20 % of the gross proceeds of such transaction to redeem all or a portion of the convertible notes for an amount in cash equal to the cash Mandatory Redemption Amount (i.e., 108% of outstanding principal and unpaid interest). The Company triggered this provision in connection with the public offering of securities in December of 2022, the resulting principal payments and interest were reflected as a reduction to the outstanding balance of the 2022 Notes. The 8 % premium was paid in cash and was reflected as interest expense within the consolidated statement of operations. The 2022 Notes were scheduled to mature on December 29, 2023 and February 7, 2024 , for the first and second closings, respectively. The notes bear interest at a rate of 6 % per annum, in addition to an original issue discount of 6 % . The interest may be settled in cash or shares at the option of the Company and is payable together with monthly redemptions of the outstanding principal amount of the debt. The outstanding principal and interest balances were satisfied in March 2023. 14 The following table provides a summary of the Company’s 2022 Notes conversions during the quarter ended March 31, 2023: SCHEDULE OF CONVERSION DEBT Shares Weighted Average Conversion Price Conversion Value During the quarter ended March 31, 2023 408,582 $ 7.48 $ 3,056,892 In January 2023, the Company entered into a letter agreement to reduce the conversion price for the remaining balance of the Company’s outstanding 2022 Notes from $ 24.07 to $ 9.01 for the period from January 12, 2023 until May 12, 2023. Cash true-up payments totaling $ 0.6 million for conversions below the adjusted price are due to be paid within 120 days from January 12, 2023 in accordance with the Letter Agreement. Such payments due are recorded as Accrued Expenses and Other Liabilities (Note 5). Financed insurance premiums During the year ended December 31, 2022, the Company financed its directors’ and officers’ liability insurance in the amount of $ 399,949 , the liability was paid in full by March 31, 2023. The Company paid a total of $ 9,402 in interest from inception through March 2023 when the note will be paid in full. The Company expensed $ 1,497 of interest for the three months ended March 31, 2023. NOTE 8 - STOCKHOLDERS’ EQUITY In June 2021, the Company amended and restated its Certificate of Incorporation to authorize 150,000,000 shares of common stock and 1,500,000 shares of preferred stock, both with par value equal to $ 0.0001 . In September 2022, the Company amended and restated its Certificate of Incorporation to authorize shares up to a total of 250,000,000 shares of common stock. As of March 31, 2023 and December 31, 2022, there were no shares of preferred stock issued and outstanding. Preferred Stock On January 31, 2023, the Board of Directors declared a dividend of 0.001 of a share of Series A Preferred Stock, par value $ 0.0001 per share, for each outstanding share of the Company’s common stock to stockholders of record on February 13, 2023. Each full share of the Series A Preferred Stock entitled holders to 1,000,000 votes per share with respect to the reverse stock split proposal and the adjournment proposal at the Company’s special meeting of stockholders on March 23, 2023. The Series A Preferred Stock had no dividend rights and was fully redeemed following the effectiveness of a reverse stock split on March 31, 2023. Warrants On March 31, 2023, outstanding warrants to purchase shares of common stock are as follows: SCHEDULE OF OUTSTANDING WARRANT Reference Shares Underlying Outstanding Warrants Exercise Price Description Classification (a) 70,969 $ 2,400.00 - 2,760.00 LACQ warrants Equity (b) 4,608 $ 8.58 Share subscription facility Equity (c) 4,512 $ 187.20 2021 Notes Liability (d) 38,894 $ 24.07 2022 Notes Liability (e) 549,987 $ 16.80 Public offering Equity (f) 318,451 $ 8.84 Public offering Equity 987,421 a) On June 30, 2021, as a result of the Closing, the Company assumed a total of 78,751 warrants previously issued by LACQ (subsequently in December 2022, 7,782 warrants were cancelled). The warrants provide holders the right to purchase common stock at a strike price of between $ 2,400.00 and $ 2,760.00 per share and expire June 30, 2026 , five years following the completion of the Business Combination. A total of 41,666 of the outstanding warrants are public warrants which trade on the OTC Pink Open Market under the ticker symbol ENSCW. The remaining 29,303 warrants are private warrants with restrictions on transfer and which have the right to a cashless exercise at the option of the holder. On August 3, 2021, the Company entered into an agreement with an existing warrant holder to reduce the price of 2,083 warrants issued on June 30, 2021 from $ 2,760.00 to $ 2,400.00 . b) On July 2, 2021, upon public listing of the Company’s shares, the Company issued 4,608 warrants to purchase common stock pursuant to the share subscription facility. The warrants have a three -year life. The grant date fair value of the warrants, based on the $ 3,477.60 stock price on the date of issuance, was $ 11.6 million, and was recognized in general and administrative expense due to the uncertainty of future issuance of shares under the share subscription facility. 15 The warrants have been subject to multiple exercise price reductions as required by a down round adjustment feature of the warrant, due to common stock issued at a price below the then current exercise price (primarily the result of the conversions of the 2021 Notes and the 2022 Notes). The adjustments have progressed from the original exercise price of $ 2,402.40 per share to the current exercise price at March 31, 2023 of $ 8.58 per share. The difference in fair value of the existing warrant prior to the adjustment and the value of the warrant after (utilizing a Black-Scholes model) is reflected on the consolidated statement of operations as a deemed dividend. c) On September 24, 2021 and November 5, 2021, the Company issued 1,504 and 3,008 warrants in connection with the issuance of the 2021 Notes. The warrants were immediately exercisable with an exercise price of $ 1,831.20 (subject to downward revision protection in the event the Company makes certain issuances of common stock at prices below the conversion price) and expire on September 23, 2026 . As a result of the issuance of the 2022 Notes in July 2022, the exercise price of these warrants was adjusted down to $ 187.20 . d) On July 1, 2022 and August 9, 2022, the Company issued 19,447 warrants each in connection with the issuance of the 2022 Notes. The warrants were immediately exercisable with an exercise price of $ 170.04 (subject to downward revision protection in the event the Company makes certain issuance of common stock at prices below the conversion price) and expire on June 29, 2027 and August 8, 2027 , respectively. As a result of the issuance of shares and warrants in connection with the December public offering, the exercise price of these warrants was adjusted down to $ 24.07 . e) On December 9, 2022, the Company issued 549,987 equity classified warrants in connection with a public offering. The warrants were immediately exercisable with an exercise price of $ 16.80 (subject to downward revision protection in the event the Company makes certain issuance of common stock at prices below the exercise price) and expire on December 9, 2027 . f) On February 6, 2023, the Company issued 318,451 equity classified warrants in connection with a public offering. The warrants were immediately exercisable with an exercise price of $ 8.58 - $ 12.60 (subject to downward revision protection in the event the Company makes certain issuance of common stock at prices below the exercise price) and expire on February 2, 2028 , and August 7, 2028 . The fair value of each warrant issued has been determined using the Black-Scholes option-pricing model. The material assumptions used in the Black-Scholes model in estimating the fair value of the warrants issued for the periods presented were as follows: SCHEDULE OF WARRANTS FAIR VALUE ESTIMATION ASSUMPTIONS Stock price Exercise price Expected term (years) Volatility Risk free rate (a) LACQ warrants (grant date varies) $ 3,477.60 $ 2,400.00 - 2,760.00 3.00 110.0 % 0.5 % (b) Share subscription facility (grant date 7/2/21) $ 3,477.60 $ 2,402.40 3.00 110.0 % 0.5 % (b) Share subscription facility (remeasurement date varies) $ 7.01 - 1,029.60 $ 8.58 - 1,080.00 1.41 - 2.49 92.6 % - 125.3 % 1.0 % - 4.9 % (c) Liability classified warrants (grant date 9/24/21) $ 1,077.60 $ 1,831.20 5.00 94.1 % 1.0 % (c) Liability classified warrants (grant date 11/5/21) $ 540.00 $ 1,831.20 5.00 94.1 % 1.0 % (c) Liability classified warrants (remeasured at 3/31/23) $ 4.86 $ 187.20 3.50 - 3.60 102.9 % - 103.4 % 3.8 % (d) Liability classified warrants (grant date 7/1/22) $ 136.80 $ 170.04 5.00 98.9 % 2.9 % (d) Liability classified warrants (grant date 8/9/22) $ 127.20 $ 170.04 5.00 102.8 % 3.0 % (d) Liability classified warrants (remeasured at 3/31/23) $ 4.86 $ 24.07 4.25 - 4.36 101.2 % - 102.1 % 3.6 % NOTE 9 - STOCK-BASED COMPENSATION In connection with the Business Combination, the Company assumed the 2021 Omnibus Incentive Plan (the “2021 Omnibus Plan”), which was approved by LACQ’s board and subsequently LACQ’s stockholders at a special stockholder meeting on June 28, 2021. The 2021 Omnibus Plan provides for the conversion with existing terms of the 18,432 options outstanding under Former Ensysce stock plans and reserves for issuance an additional 4,166 shares for future awards under the 2021 Omnibus Plan. No further awards may be made under the Former Ensysce stock plans. In January 2022, the 2021 Omnibus Plan was amended and restated to include an additional 12,500 shares available for future grant and to provide for future annual increases. In February 2023, the Company’s Board approved an annual increase of 26,725 shares available for future grant. The Company recognized within general and administrative expense stock-based compensation expense of $ 96,270 and $ 373,944 for the three months ended March 31, 2023 and 2022, respectively. During the three months ended March 31, 2023 and 2022, the Company recognized stock-based compensation expense of $ 20,863 and $ 28,490 , respectively, within research and development expense. Option Activity There were no stock options granted during the three months ended March 31, 2023. During the three months ended March 31, 2022, the Company granted stock options to purchase an aggregate of 8,275 shares of common stock to employees, consultants and members of the Board. The options vest over periods between zero and four years and have an exercise price of between $ 259.20 and $ 1,507.20 per share. 16 The following table summarizes the Company’s stock option activity during the three months ended March 31, 2023: SCHEDULE OF STOCK OPTION ACTIVITY Weighted average Options Exercise price Remaining contractual life Intrinsic value Outstanding at December 31, 2022 26,334 $ 707.63 6.53 $ - Granted - - - - Exercised - - - - Expired / Forfeited - - - - Outstanding at March 31, 2023 26,334 $ 707.63 6.29 - Exercisable at March 31, 2023 23,922 729.16 - - Vested and expected to vest 26,334 $ 707.63 6.29 - Option Valuation The fair value of each stock option granted has been determined using the Black-Scholes option-pricing model. The material assumptions used in the Black-Scholes model in estimating the fair value of the options granted for the periods presented were as follows (there were no grants issued in 2023): SCHEDULE OF SHARE-BASED PAYMENT AWARD, STOCK OPTIONS, VALUATION ASSUMPTIONS Three Months Ended March 31, 2022 Exercise price $ 259.20 - 1,507.20 Expected stock price volatility 76.12 % - 95.87 % Expected term (years) 5.19 - 10.00 Risk-free interest rate 1.52 % - 2.20 % Expected dividend yield 0 % ● Expected stock-price volatility. The expected volatility is derived from the historical volatilities of publicly traded companies within the Company’s industry that the Company considers to be comparable to the Company’s business over a period approximately equal to the expected term. ● Expected term. The expected term represents the period that the stock-based awards are expected to be outstanding. The Company’s historical share option exercise experience does not provide a reasonable basis upon which to estimate an expected term due to a lack of sufficient data. Therefore, the Company estimates the expected term for employees by using the simplified method provided by the Securities and Exchange Commission. The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life of the options. ● Risk-free interest rate. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities approximately equal to the expected term. ● Expected dividend yield. The expected dividend is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on the Company’s common stock. The weighted-average grant date fair value of options granted during the three months ended March 30, 2022 was $ 1.01 . As of March 31, 2023, the Company had an aggregate of $ 296,845 of unrecognized share-based compensation cost, which is expected to be recognized over the weighted average period of 1.48 years. 17 Restricted Stock Units The following table summarizes the Company’s restricted stock units activity during the three months ended March 31, 2023: SCHEDULE OF RESTRICTED STOCK UNITS Restricted Stock Units Weighted average fair value Outstanding at December 31, 2022 1,003 $ 120.02 Released ( 312 ) 101.40 Outstanding at March 31, 2023 691 $ 128.43 There were no restricted stock units granted or forfeited during the three months ended March 31, 2023. The remaining awards outstanding are subject to time-based vesting conditions and are scheduled to vest by December 2023. The estimated fair value of each of the Company’s was determined on the date of grant based on the closing price of the Company’s common stock on the previous trading date. Shares Reserved for Future Issuance The following shares of common stock are reserved for future issuance: SCHEDULE OF COMMON STOCK FUTURE ISSUANCE March 31, 2023 Awards outstanding under the 2021 Omnibus Incentive Plan 27,025 Awards available for future grant under 2021 Omnibus Incentive Plan 31,294 Warrants outstanding 987,421 Total shares of common stock reserved for future issuance 1,045,740 NOTE 10 - RELATED PARTIES On December 9, 2022, the Company completed a public offering for the sale of 241,666 shares of common stock at $ 16.80 per share and issued 550,000 warrants with an exercise price of $ 16.80 per share that expire five years following the date of issuance. A Board member purchased 29,761 shares of common stock and was issued 59,523 warrants exercisable for common stock in the public offering. In July 2022, the Chief Executive Officer and a Board member transferred 3,838 shares of registered common stock to GYBL to settle $ 0.8 million of Company obligations related to the GEM Agreement (Note 2). In October 2022, 3,838 shares of unregistered and restricted common stock were subsequently issued by the Company to the related parties as reimbursement and recognized under the consolidated statement of changes in stockholders’ deficit. NOTE 11 – SUBSEQUENT EVENTS On May 12, 2023, the Company completed a public offering of an aggregate of 1,800,876 shares of its common stock (or pre-funded warrants in lieu thereof), Series A-1 warrants to purchase up to 1,800,876 shares of common stock and Series A-2 warrants to purchase 1,800,876 shares of common stock, at a combined public offering price of $3.887 per share (or pre-funded warrant in lieu thereof) and accompanying warrants. The Series A-1 warrants have an exercise price of $ 3.637 per share and expire five years from the date of issuance, and the Series A-2 warrants have an exercise price of $ 3.637 per share and expire eighteen months from the date of issuance. The Company received gross proceeds of approximately $ 7.0 million before the deduction of placement agent fees and offering expenses. On May 12, 2023, the Company paid $ 0.6 million of cash true-up payments to holders of the 2022 Notes (Note 7). 18