Item 1. Financial Statements
Item
1. Financial Statements.
Ensysce
Biosciences, Inc.
Consolidated
Balance Sheets
(Unaudited)
June 30, 2023
December 31, 2022
Assets
Current assets:
Cash and cash equivalents
$ 3,829,482
$ 3,147,702
Unbilled receivable
107,578
276,821
Right-of-use asset
10,866
27,165
Prepaid expenses and other current assets
1,907,147
1,847,481
Total current assets
5,855,073
5,299,169
Other assets
502,550
585,883
Total assets
$ 6,357,623
$ 5,885,052
Liabilities and stockholders’ deficit
Current liabilities:
Accounts payable
$ 1,274,629
$ 2,943,791
Accrued expenses and other liabilities
785,827
2,226,494
Lease liability
10,926
27,315
Notes payable and accrued interest
445,738
4,266,610
Total current liabilities
2,517,120
9,464,210
Long-term liabilities:
Notes payable, net of current portion
-
140,148
Liability classified warrants
47,696
310,346
Total long-term liabilities
47,696
450,494
Total liabilities
$ 2,564,816
$ 9,914,704
Commitments and contingencies (Note 6)
Stockholders’ equity deficit
Preferred stock, $ 0.0001 par value, 1,500,000 shares authorized, no shares issued and outstanding at June 30, 2023 and December 31, 2022
-
-
Common stock, $ 0.0001 par value, 250,000,000 shares authorized at June 30, 2023 and December 31, 2022; 2,669,873 and 534,571 shares issued at June 30, 2023 and December 31, 2022, respectively; 2,669,792 and 534,490 shares outstanding at June 30, 2023 and December 31, 2022, respectively
267
53
Additional paid-in capital
119,481,957
107,216,566
Accumulated deficit
( 115,363,208 )
( 110,931,063 )
Total Ensysce Biosciences, Inc. stockholders’ equity (deficit)
4,119,016
( 3,714,444 )
Noncontrolling interests in stockholders’ equity (deficit)
( 326,209 )
( 315,208 )
Total stockholders’ equity (deficit)
3,792,807
( 4,029,652 )
Total liabilities and stockholders’ equity (deficit)
$ 6,357,623
$ 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
2023
2022
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Federal grants
$ 490,472
$ 207,471
$ 1,280,107
$ 810,569
Operating expenses:
Research and development
1,643,726
5,311,298
3,439,742
8,451,394
General and administrative
1,140,700
1,951,356
2,695,553
4,217,161
Total operating expenses
2,784,426
7,262,654
6,135,295
12,668,555
Loss from operations
( 2,293,954 )
( 7,055,183 )
( 4,855,188 )
( 11,857,986 )
Other income (expense):
Change in fair value of convertible notes
-
( 88,763 )
146,479
2,678,415
Change in fair value of liability classified warrants
43,622
148,393
262,650
2,942,791
Loss on debt conversions
-
( 892,636 )
-
( 2,595,278 )
Interest expense, net
-
( 37,781 )
( 1,497 )
( 52,802 )
Other income, net
11,030
2,850
16,448
10,816
Total other income (expense), net
54,652
( 867,937 )
424,080
2,983,942
Net loss
$ ( 2,239,302 )
$ ( 7,923,120 )
$ ( 4,431,108 )
$ ( 8,874,044 )
Net loss attributable to noncontrolling interests
( 7,060 )
( 26,309 )
( 11,001 )
( 26,127 )
Deemed dividend related to warrants down round provision
3,729
102,479
12,038
818,059
Net loss attributable to common stockholders
$ ( 2,235,971 )
$ ( 7,999,290 )
$ ( 4,432,145 )
$ ( 9,665,976 )
Net loss per basic and diluted share:
Net loss per share attributable to common stockholders, basic and diluted
$ ( 0.98 )
$ ( 56.49 )
$ ( 2.66 )
$ ( 75.67 )
Weighted average common shares outstanding, basic and diluted
2,274,113
141,615
1,667,527
127,732
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 March 31, 2022
124,784
$ 12
$ 88,903,147
$ ( 87,512,253 )
$ ( 279,633 )
$ 1,111,273
Conversion of convertible notes
22,837
2
5,718,687
-
-
5,718,689
Stock-based compensation
-
-
295,580
-
-
295,580
Settlement of restricted stock units
416
-
-
-
-
-
Deemed dividend related to warrants down round provision
-
-
102,479
( 102,479 )
-
-
Net loss
( 7,896,811 )
( 26,309 )
( 7,923,120 )
Balance on June 30, 2022
148,037
$ 14
$ 95,019,893
$ ( 95,511,543 )
$ ( 305,942 )
$ ( 797,578 )
Balance on March 31, 2023
1,284,583
$ 128
$ 113,293,834
$ ( 113,127,237 )
$ ( 319,149 )
$ ( 152,424 )
Settlement of restricted stock units
312
-
-
-
-
-
Public offering, net
1,084,000
109
6,360,843
-
-
6,360,952
Transaction costs associated with public offering
-
-
( 253,836 )
-
-
( 253,836 )
Issuance of common stock upon exercise of warrants
300,897
30
( 30 )
Stock-based compensation
-
-
77,417
-
-
77,417
Deemed dividend related to warrants down round provision
-
-
3,729
( 3,729 )
-
-
Net loss
-
-
( 2,232,242 )
( 7,060 )
( 2,239,302 )
Balance on June 30, 2023
2,669,792
$ 267
$ 119,481,957
$ ( 115,363,208 )
$ ( 326,209 )
$ 3,792,807
Balance on December 31, 2021
102,678
$ 10
$ 77,967,314
$ ( 85,845,567 )
$ ( 279,815 )
$ ( 8,158,058 )
Consultant Compensation
208
-
54,250
-
-
54,250
Conversion of convertible notes
42,455
4
13,794,028
-
-
13,794,032
Settlement of restricted stock units
2,696
-
-
-
-
-
Stock-based compensation
-
-
2,386,242
-
-
2,386,242
Deemed dividend related to warrants down round provision
-
-
818,059
( 818,059 )
-
-
Net loss
-
-
-
( 8,847,917 )
( 26,127 )
( 8,874,044 )
Balance on June 30, 2022
148,037
$ 14
$ 95,019,893
$ ( 95,511,543 )
$ ( 305,942 )
$ ( 797,578 )
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
624
-
-
-
-
-
Settlement of commitment fee
44,444
4
399,996
-
-
400,000
Conversion of convertible notes
408,580
41
3,056,851
-
-
3,056,892
Public offerings, net
1,381,619
139
9,049,865
-
-
9,050,004
Transaction costs associated with public offerings
-
-
( 447,879 )
-
-
( 447,879 )
Issuance of common stock upon exercise of warrants
300,897
30
( 30 )
-
-
-
Stock-based compensation
-
-
194,550
-
194,550
Reverse split fractional shares
( 862 )
-
-
-
-
-
Deemed dividend related to warrants down round provision
-
-
12,038
( 12,038 )
-
-
Net loss
-
-
-
( 4,420,107 )
( 11,001 )
( 4,431,108 )
Balance on June 30, 2023
2,669,792
$ 267
$ 119,481,957
$ ( 115,363,208 )
$ ( 326,209 )
$ 3,792,807
Balance
2,669,792
$ 267
$ 119,481,957
$ ( 115,363,208 )
$ ( 326,209 )
$ 3,792,807
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
Six Months Ended June 30,
2023
2022
Cash flows from operating activities:
Net loss
$ ( 4,431,108 )
$ ( 8,874,044 )
Adjustments to reconcile net loss to net cash used in operating activities:
Gain on sale of asset
-
( 4,500 )
Accrued interest
1,497
28,677
Change in fair value of convertible notes
( 146,479 )
( 2,678,415 )
Change in fair value of liability classified warrants
( 262,650 )
( 2,942,791 )
Loss on debt conversions
-
2,595,278
Stock-based compensation
194,550
698,013
Lease cost
( 90 )
( 91 )
Changes in operating assets and liabilities:
Unbilled receivable
169,243
165,090
Prepaid expenses and other assets
469,404
( 158,499 )
Accounts payable
( 1,669,162 )
2,746,933
Accrued expenses and other liabilities
( 1,040,666 )
546,841
Net cash used in operating activities
( 6,715,461 )
( 7,877,508 )
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 from public offerings, net of placement fees and costs
9,050,004
-
Transaction costs associated with public offerings
( 447,879 )
-
Repayment of convertible notes
( 1,000,208 )
( 265,812 )
Repayment of financed insurance premiums
( 204,676 )
( 391,270 )
Net cash provided by (used in) financing activities
7,397,241
( 657,082 )
Increase (decrease) in cash and cash equivalents
681,780
( 8,530,090 )
Cash and cash equivalents beginning of period
3,147,702
12,264,736
Cash and cash equivalents end of period
$ 3,829,482
$ 3,734,646
Supplemental cash flow information:
Income tax payments
$ -
$ 1,600
Supplemental disclosure of non-cash investing and financing activities:
Deferred transaction costs for convertible notes
$ -
$ 82,819
Stock-based compensation
$ -
$ 1,742,479
Conversions of convertible notes into common stock
$ 3,056,892
$ 11,198,754
Financed insurance premiums
$ 445,737
$ -
Settlement of commitment fee in shares
$ 400,000
$ -
Deemed dividend related to warrants down round provision
$ 12,038
$ 818,059
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 ® (Multi-Pill
Abuse Resistance) technology for overdose protection which will be applied to the PF614 program. The Company is also applying its TAAP
and MPAR ® 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 these unaudited consolidated
financial statements. Operating results for the three and six months ended June 30, 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 unaudited 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 unaudited 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 $ 115.4 million at June 30, 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 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.
These
unaudited 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. There was no depreciation expense recognized during the three and six month periods ended June 30, 2023.
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. As of June 30, 2023 and
December 31, 2022, the Company did not have any bifurcated embedded derivatives in the
Company’s consolidated balance sheets.
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 June 30, 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 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
The
Company issued liability-classified warrants in connection with the issuance of the 2021 and 2022 Notes. The warrants were liability-classified
due to certain cash settlement features and are 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 at each balance sheet date. 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 June
30, 2023, and December 31, 2022.
SCHEDULE
OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE
Total
Level 1
Level 2
Level 3
June 30, 2023
Total
Level 1
Level 2
Level 3
Fair value of convertible note
$ -
$ -
$ -
$ -
Liability classified warrants
$ 47,696
$ -
$ -
$ 47,696
Total
$ 47,696
$ -
$ -
$ 47,696
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 six months ended June
30, 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
( 409,129 )
( 146,479 )
( 262,650 )
Fair value, June 30, 2023
$ 47,696
$ -
$ 47,696
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 ® 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 ®
abuse deterrent technology for Opioid Use Disorder (the “OUD Grant”). The total approved budget was approximately $ 5.4
million, and the current grant period ends in August of 2024.
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:
SCHEDULE
OF REVENUE RECOGNIZATION UNDER GRANTS
2023
2022
2023
2022
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
MPAR
$ 437,263
$ -
$ 918,542
$ 504,471
TAAP/OUD
53,209
207,471
361,565
306,098
Total
$ 490,472
$ 207,471
$ 1,280,107
$ 810,569
Revenue
$ 490,472
$ 207,471
$ 1,280,107
$ 810,569
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 sheets. As all amounts are expected to be remitted in a timely
manner, 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. 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.
Net
loss per share
The
basic net loss per share is calculated by dividing the Company’s net loss attributable to common stockholders by the weighted average
number of common shares outstanding during the period. Basic shares outstanding include the weighted average effect of the Company’s
outstanding pre-funded warrants, the exercise of which requires little or no consideration for the delivery of shares of common stock.
The diluted net loss per share is calculated by dividing the Company’s net loss 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
2023
2022
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Stock options
26,354
28,688
26,354
26,421
RSUs
377
3,863
377
2,837
Warrants
3,017,026
87,878
1,938,542
87,878
Convertible notes
-
14,193
-
14,193
Total
3,043,757
134,622
1,965,273
131,329
Anti-dilutive weighted average shares
3,043,757
134,622
1,965,273
131,329
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
June 30,
2023
December 31,
2022
Prepaid research and development
$ 1,176,874
$ 1,300,473
Prepaid insurance
678,285
445,583
Other prepaid expenses
51,988
101,425
Total prepaid expenses and other current assets
$ 1,907,147
$ 1,847,481
NOTE
5 – ACCRUED EXPENSES AND OTHER LIABILITIES
SCHEDULE OF ACCRUED EXPENSES AND OTHER LIABILITIES
June 30,
2023
December 31,
2022
Accrued research and development
$ 568,452
$ 1,332,713
Share subscription facility commitment fees
-
400,000
Professional fees
83,586
421,530
Other accrued liabilities
133,789
72,251
Total accrued expenses and other liabilities
$ 785,827
$ 2,226,494
12
NOTE
6 – COMMITMENTS AND CONTINGENCIES
Purchase
Commitments
As
of June 30, 2023, the Company’s commitments included an estimated $ 18.5 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 June 30, 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
June 30, 2023, the future lease payments totaled $ 10,926 . The Company recognized total rent expense of $ 8,375 and $ 16,749 in the three
and six months ended June 30, 2023 and $ 7,834 and $ 15,667 in the three and six months ended June 30, 2022.
NOTE
7 – NOTES PAYABLE
The
Company’s outstanding notes payable balance was $ 445,738 as of June 30, 2023 consisting solely of the principal balance on the
Company’s financing of their current Directors’ and Officers’ insurance premiums.
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
Interest
expense
The
interest expense recognized for financed insurance was $ 0 and $ 1,497 for the three and six month periods ended June 30, 2023 and $ 0
and $ 2,004 for the three and six month periods ended June 30, 2022.
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 second closing for $ 10.6 million (resulting in net proceeds of $ 9.4 million) which closed on November 5, 2021.
The
2021 Notes included a stated rate of interest 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 the related interest expense is not presented as a separate amount on
the consolidated statements of operations.
The
2021 Notes were settled on October 11, 2022 and were not outstanding during the quarter ended June 30, 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 per closing). 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 fair value on its
issuance date and remeasured as of each reporting date with the change in fair value recorded as a component of other income
(expense) in the Company’s consolidated statements of operations.
The
Company initially recorded the 2022 Notes at a 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 .
In connection with 2023 May Offering, and in exchange for $ 0.125
per outstanding warrant, the exercise prices of the 2022 Notes warrants and 2021 Notes warrants were reduced to $ 3.64
per share.
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
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 were due to be paid within 120 days from January 12, 2023 in accordance with the Letter
Agreement. On May 12, 2023, the Company paid $ 0.6 million of cash true-up payments to the holders of the 2022 Notes.
Financed
insurance premiums
In
June 2023, the Company renewed and financed its directors’ and officers’ liability insurance in the amount of $ 0.4 million.
Monthly payments commence in July 2023 and are scheduled through March 2024. During the year ended December 31, 2022, the Company financed
its directors’ and officers’ liability insurance in the amount of $ 0.4 million and 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 was paid in full. The Company
expensed $ 1,497 of interest for the six months ended June 30, 2023. The Company incurred no interest expense during the three months
ended June 30, 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 June 30, 2023 and December 31, 2022,
there were no shares of preferred stock issued and outstanding.
2023
February Offering
On
February 2, 2023, the Company agreed to issue and sell in a registered direct offering an aggregate of 297,619
shares of common stock of the Company, par value $ 0.0001
per share, at an offering price of $ 10.08
per share, for gross proceeds of approximately $ 3.0
million before the deduction of placement agent fees and related costs of $ 0.3
million. The closing occurred on February 6, 2023. The warrants issued in connection with the 2023 February Offering are described
further below.
2023
May Offering
On
May 12, 2023, the Company completed a public offering of an aggregate of 1,800,876
shares of its common stock at par value $ 0.0001
per share (including pre-funded warrants in lieu thereof) at a combined offering price of $ 3.887
per share, gross proceeds from this offering were approximately $ 7.0
million before the deduction of placement agent fees and related costs of $ 0.7
million. The warrants issued in connection with the 2023 May Offering are described further below.
In
connection with the offering, the Company also agreed to amend certain existing warrants to purchase up to an aggregate of 210,085 shares
of the Company’s common stock that were previously issued in September 2021 through December 2022 to purchasers in the offering
at exercise prices ranging from $ 16.80 to $ 187.20 per share, such that effective upon the closing of the offering, the amended warrants
had a reduced exercise price of $ 3.64 per share at an additional offering price of $ 0.125 per amended warrant.
Warrants
On
June 30, 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
$ 3.64
Share subscription facility
Equity
(c)
4,512
$ 3.64
2021 Notes
Liability
(d)
38,894
$ 3.64
2022 Notes
Liability
(e)
549,987
$ 3.64 - 16.80
Public offering
Equity
(f)
318,451
$ 8.58 – 12.60
Public offering
Equity
(g)
3,727,813
$ 3.64 - 4.86
Public offering
Equity
(h)
415,974
$ 0.0001
Public offering
Equity
5,131,208
a)
On
June 30, 2021, as a result of the Business Combination, 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 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 three-year warrants to purchase common
stock pursuant to the share subscription facility. 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. The adjustments have progressed from the original exercise
price of $ 2,402.40 per share to the current exercise price at June 30, 2023 of $ 3.64 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 exercise 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 . On
May 12, 2023, in exchange for $ 0.125 per outstanding warrant, the Company amended the warrants to reduce their exercise price to
$ 3.64 .
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 . On May 12, 2023, in exchange for $ 0.125 per outstanding warrant, the Company amended the warrants to
reduce their exercise price to $ 3.64 .
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 and expire on December 9, 2027 . On May 12, 2023, in exchange for $ 0.125 per applicable
warrant, the Company amended 166,667 of these warrants to reduce their exercise price to $ 3.64 .
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 and expire on February 2, 2028 , and August 7, 2028 .
(g)
On
May 12, 2023, the Company issued 3,727,813 equity classified warrants (series A-1, A-2 and
placement agent warrants) in connection with a public offering. The warrants were immediately
exercisable with an exercise price of $ 3.64 - $ 4.86 and expire on November 12, 2024 , May
10, 2028 , and May 12, 2028 .
(h)
On
May 12, 2023 the Company also issued 1,451,876 pre-funded warrants in connection with a public offering, 885,000 pre-funded warrants
were exercised in connection with the closing of the public offering, 300,902 were exercised between the closing date and June 30,
2023. As of June 30, 2023, 415,974 pre-funded warrants remain outstanding. The pre-funded warrants are immediately exercisable with
an exercise price of $ 0.0001 .
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)
$ 3.53 -
116.64
$ 3.64
- 201.60
1.15 - 1.47
91.25 % - 96.0 %
3.9 %- 4.12 %
(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 6/30/23)
$ 1.80
$ 3.64
3.25 - 3.35
96.9 %- 98.5 %
4.5 %
(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 6/30/23)
$ 1.80
$ 3.64
4.00 - 4.11
103.5 - 104.4 %
4.1 %
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 of
Directors 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 $ 60,394 and $ 156,663 for the three and
six months ended June 30, 2023 and $ 228,823 and $ 602,767 for the three and six months ended June 30, 2022. The Company recognized stock-based
compensation expense within research and development of $ 17,023 and $ 37,887 for the three and six months ended June 30, 2023 and $ 66,756
and $ 95,246 for the three and six months ended June 30, 2022.
Option
Activity
There
were no stock options granted during the six months ended June 30, 2023. During the six months ended June 30, 2022, the Company granted
stock options to purchase an aggregate of 9,545 shares of common stock to employees, consultants, and members of the board of directors.
The options vest over periods between zero and four years and have an exercise price of between $ 103.20 and $ 1,507.20 per share.
16
The
following table summarizes the Company’s stock option activity during the six months ended June 30, 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 June 30, 2023
26,334
$ 707.63
4.93
-
Exercisable at June 30, 2023
24,282
724.56
-
-
Vested and expected to vest
26,334
$ 707.63
4.93
-
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
Six Months Ended June 30, 2022
Exercise price
$ 103.20 - 1,507.20
Expected stock price volatility
76.61 - 95.87 %
Expected term (years)
5.19 - 10.00
Risk-free interest rate
1.52 % - 3.14 %
Expected dividend yield
0.00 %
●
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 six months ended June 30, 2022 was $ 0.96 .
As
of June 30, 2023, the Company had an aggregate of $ 219,428 of unrecognized share-based compensation cost, which is expected to be recognized
over the weighted average period of 1.42 years.
17
Restricted
Stock Units
The
following table summarizes the Company’s restricted stock units activity during the six months ended June 30, 2023:
SCHEDULE OF RESTRICTED STOCK UNITS
Restricted Stock Units
Weighted average fair value
Outstanding at December 31, 2022
1,003
$ 120.02
Released
( 624 )
101.40
Cancelled
( 2 )
-
Outstanding at June 30, 2023
377
$ 149.43
There
were no restricted stock units granted or forfeited during the six months ended June 30, 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 restricted stock
units 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
June 30, 2023
Awards outstanding under the 2021 Omnibus Incentive Plan
26,711
Awards available for future grant under 2021 Omnibus Incentive Plan
31,296
Warrants outstanding
5,131,208
Total shares of common stock reserved for future issuance
5,189,215
NOTE
10 – SUBSEQUENT EVENTS
The
Company has evaluated subsequent events through the filing of this Quarterly Report on Form 10-Q and determined that there have been
no events that have occurred that would require adjustments to our disclosures in the unaudited consolidated financial statements.
18
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.