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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
10-Q
(Mark
One)
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended June 30, 2024
OR
☐ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from ________ to ________
Commission
File Number: 001-38306
Ensysce
Biosciences, Inc.
(Exact
Name of Registrant as Specified in its Charter)
Delaware |
|
82-2755287 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(I.R.S.
Employer
Identification
No.) |
7946
Ivanhoe Avenue, Suite 201
La
Jolla, California |
|
92037 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (858) 263-4196
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, $0.0001 par value per share |
|
ENSC |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company,
or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller
reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
Emerging
growth company |
☐ |
|
|
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Indicate
by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities
Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☒ No ☐
As
of August 12, 2024, the registrant had 8,471,172 shares of common stock, $0.0001 par value per share, outstanding.
FORWARD-LOOKING
STATEMENTS
This
Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. In some cases, you
can identify forward-looking statements by terms such as “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “might,” “objective,”
“ongoing,” “plan,” “potential,” “predict,” “project,” “should,”
“will” and “would,” or the negative of these terms or other similar expressions intended to identify statements
about the future. We have based these forward-looking statements largely on our current expectations and projections about future events
and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements
include, without limitation, statements about:
|
● |
our
estimates regarding expenses, revenue, capital requirements and timing and availability of and the need for additional financing
will almost certainly not match actual amounts and timing; |
|
|
|
|
● |
our
ability to continue as a going concern for the next twelve months; |
|
|
|
|
● |
the
risk that our lead product candidate PF614 and PF614-MPAR may not be successful in limiting or impeding abuse, overdose, or misuse
or providing additional safety upon commercialization; |
|
|
|
|
● |
the
need for substantial additional funding to complete the development and commercialization of our product candidates; |
|
|
|
|
● |
the
risk that our clinical trials may fail to replicate positive results from earlier preclinical studies or clinical trials conducted
by us or third parties; |
|
|
|
|
● |
the
risk that the potential product candidates that we develop may not progress through clinical development or receive required regulatory
approvals within expected timelines or at all; |
|
|
|
|
● |
the
risk that clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this Quarterly
Report on Form 10-Q; |
|
|
|
|
● |
the
risk that we will be unable to successfully market or gain market acceptance of our product candidates; |
|
|
|
|
● |
the
risk that our product candidates may not be beneficial to patients or successfully commercialized; |
|
|
|
|
● |
the
risk that we have overestimated the size of the target market, patients’ willingness to try new therapies, and the willingness
of physicians to prescribe these therapies; |
|
|
|
|
● |
effects
of competition; |
|
● |
the
risk that third parties on which we depend for laboratory, clinical development, manufacturing, and other critical services will
fail to perform satisfactorily; |
|
|
|
|
● |
the
risk that we will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or
will infringe the intellectual property protection of others; |
|
|
|
|
● |
the
loss of key members of our management team; |
|
|
|
|
● |
changes
in our regulatory environment; |
|
|
|
|
● |
the
ability to attract and retain key scientific, medical, commercial, or management personnel; |
|
|
|
|
● |
changes
in our industry; |
|
|
|
|
● |
our
ability to remediate any material weaknesses or establish and maintain effective internal controls over financial reporting; |
|
|
|
|
● |
the
risk that our common stock will be delisted from Nasdaq; |
|
|
|
|
● |
The
risk that we may not be able to regain or maintain compliance with applicable listing standards of Nasdaq; |
|
|
|
|
● |
other
factors disclosed in this Quarterly Report on Form 10-Q; and |
|
|
|
|
● |
other
factors beyond our control. |
The
forward-looking statements contained in this Quarterly Report on Form 10-Q are based on Ensysce’s current expectations and beliefs
concerning future developments and their potential effects on Ensysce. There can be no assurance that future developments affecting Ensysce
will be those that Ensysce has anticipated. These forward-looking statements involve risks, uncertainties (some of which are beyond Ensysce’s
control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied
by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the
heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, and other filings with the
Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of the assumptions
prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Moreover, the
occurrence of the events described in the “Risk Factors” in our Annual Report on Form 10-K may adversely affect Ensysce.
Ensysce will not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information,
future events or otherwise, except as may be required under applicable securities laws.
GLOSSARY
Definitions: |
|
|
2021
Notes |
|
The
senior secured convertible promissory notes in the aggregate original principal amount of $15.9 million, sold in two closings on
September 24, 2021 and November 5, 2021, respectively, pursuant to the Securities Purchase Agreement entered into on September 24,
2021 |
2021
Omnibus Incentive Plan |
|
Ensysce
Biosciences, Inc. Amended and Restated 2021 Omnibus Incentive Plan |
2022
Notes |
|
The
senior secured convertible promissory notes in the aggregate original principal amount of $8.48 million, sold in two closings on
June 30, 2022 and August 8, 2022, respectively, pursuant to the Securities Purchase Agreement entered into on June 30, 2022 |
2023
Notes |
|
The
senior secured convertible promissory notes in the aggregate original principal amount of $1.8 million, sold in two closings on October
25, 2023 and November 28, 2023, respectively, pursuant to the Securities Purchase Agreement entered into on October 23, 2023 |
2022
December Offering |
|
The
Company’s December 2022 registered direct offering of common stock (including pre-funded warrants in lieu thereof). The Offering
closed on December 9, 2022 for aggregate consideration of $4.1 million |
2023
February Offering |
|
The
Company’s February 2023 registered direct offering of common stock and private placement warrants for aggregate consideration
of $3.0 million |
2023
May Offering |
|
The
Company’s May 2023 registered direct offering of common stock (including pre-funded warrants in lieu thereof) for aggregate
consideration of $7.0 million |
2024
Warrant Inducement |
|
The
Company’s February 2024 transaction including the cash exercise of certain existing warrants at a reduced price and the issuance
of new warrants |
Board |
|
Board
of directors of Ensysce, or a committee thereof, as applicable |
Business
Combination |
|
The
definitive merger agreement among LACQ, Merger Sub and Former Ensysce, dated January 31, 2021, providing for, among other things,
and subject to terms and conditions therein, the business combination between LACQ and Former Ensysce pursuant to the merger of Merger
Sub with and into Former Ensysce, with Former Ensysce continuing as the surviving entity and as a wholly-owned subsidiary of LACQ
|
CMOs |
|
Contract
manufacturing organizations |
Company |
|
Ensysce
Biosciences, Inc. and its consolidated subsidiaries |
COVID-19 |
|
Novel
coronavirus disease |
Covistat |
|
A
subsidiary renamed EBIR, Inc. |
CROs |
|
Contract
research organizations |
EBIR |
|
Previously
known as Covistat, Inc., EBIR, Inc. is a clinical stage pharmaceutical company that is developing a compound utilized in the Company’s
overdose protection program for the treatment of COVID-19 and 79.2%-owned subsidiary of the Company |
Ensysce |
|
Ensysce
Biosciences Inc. |
Exchange
Act |
|
Securities
Exchange Act of 1934, as amended |
FDA |
|
United
States Food and Drug Administration |
Former
Ensysce |
|
Ensysce
Biosciences, Inc., a Delaware corporation, prior to the consummation of the merger with and into Merger Sub |
GAAP
|
|
Generally
Accepted Accounting Principles in the United States of America |
GCP |
|
Good
Clinical Practices |
GEM
Agreement |
|
Share
Purchase Agreement between the Company, GEM Global, and GYBL, dated as of December 29, 2020, including a Registration Rights Agreement
between the same parties and dated as of the same date |
GEM
Global |
|
GEM
Global Yield LLC SCS |
GEM
Warrants |
|
4,608
shares of common stock that may be issued upon the exercise of warrants issued to GYBL under the terms of the GEM Agreement at an
exercise price of $1.06 per share |
GYBL |
|
GEM
Yield Bahamas Limited |
Inducement
Letter |
|
Inducement
offer letter entered into with certain holders of existing warrants to purchase 3,601,752 shares of the Company’s common stock
(issued on May 12, 2023) to reduce the exercise price from $3.637 per share to $1.31 per share. |
Investor
Notes |
|
The
2021 Notes, 2022 Notes and 2023 Notes, collectively |
LACQ |
|
Leisure
Acquisition Corp., a Delaware Corporation |
LACQ
Warrants |
|
Warrants
that relate to the Business Combination or were issued prior to it and are exercisable for 21,993 shares of our common stock at a
weighted average exercise price of $2,725.90 per share |
Merger
|
|
The
merger of Merger Sub with and into Former Ensysce, with Former Ensysce continuing as the surviving entity and a wholly owned subsidiary
of LACQ, which changed its name to Ensysce Biosciences, Inc. following consummation of the Merger. |
Merger
Agreement |
|
Agreement
and Plan of Merger, dated as of January 31, 2021, by and among LACQ, Merger Sub and Former Ensysce, providing for, among other things,
and subject to the terms and conditions therein, a business combination between Former Ensysce and LACQ pursuant to the proposed
merger of Merger Sub with and into Former Ensysce, with Former Ensysce surviving the transaction as a wholly-owned subsidiary of
LACQ, which changed its name to Ensysce Biosciences, Inc. following consummation of the Merger |
Merger
Sub |
|
EB
Merger Sub, Inc., a Delaware corporation, a wholly-owned subsidiary of LACQ prior to the consummation of the Merger |
MPAR
Grant |
|
Research
and development grant related to the development of its MPAR® overdose prevention technology awarded to the Company
by NIH through NIDA in September 2018 |
Nasdaq |
|
The
Nasdaq Stock Market LLC |
NIDA |
|
National
Institute of Drug Abuse |
NIH |
|
National
Institutes of Health |
OUD
Grant |
|
Research
and development grant related to the development of its TAAP/MPAR® abuse deterrent technology for Opioid Use Disorder
awarded to the Company by NIH/NIDA in September 2019 |
Prior
Warrants |
|
Warrants
issued pursuant to the Securities Purchase Agreement. The Prior Warrants issued in (i) 2021 are exercisable for an aggregate of 4,518
shares of our common stock at an exercise price of $3.64 per share and in (ii) 2022 are exercisable for an aggregate of 38,900 shares
of our common stock at an exercise price of $3.64 per share |
Public
Warrants |
|
The
redeemable warrants issued by us and sold as part of the units in the LACQ IPO (whether they were purchased in the LACQ IPO or thereafter
in the open market). The Public Warrants are exercisable for an aggregate of approximately 41,666 shares of our common stock at an
exercise price of $2,760.00 per share |
R&D |
|
Research
and Development |
SEC |
|
U.S.
Securities and Exchange Commission |
Securities
Act |
|
Securities
Act of 1933, as amended |
Securities
Purchase Agreement |
|
The
Securities Purchase Agreement, dated as of September 24, 2021, June 30, 2022, or October 23, 2023 as the context dictates, by and
between Ensysce and the institutional investors party thereto |
SPA |
|
A
Securities Purchase Agreement, dated as of September 24, 2021, June 30, 2022, or October 23, 2023 as the context dictates, by and
between Ensysce and the institutional investors party thereto |
TAAP |
|
Trypsin
Activated Abuse Protection |
Table
of Contents
PART
I—FINANCIAL INFORMATION
Item
1. Financial Statements.
Ensysce
Biosciences, Inc.
Consolidated
Balance Sheets
(Unaudited)
| |
June 30, 2024 | | |
December 31, 2023 | |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 1,043,231 | | |
$ | 1,123,604 | |
Unbilled receivable | |
| 224,223 | | |
| 97,561 | |
Prepaid expenses and other current assets | |
| 1,192,283 | | |
| 1,067,703 | |
Total current assets | |
| 2,459,737 | | |
| 2,288,868 | |
Other assets | |
| 335,883 | | |
| 419,217 | |
Total assets | |
$ | 2,795,620 | | |
$ | 2,708,085 | |
Liabilities and stockholders’ equity (deficit) | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 481,971 | | |
$ | 1,936,007 | |
Accrued expenses and other liabilities | |
| 370,186 | | |
| 542,260 | |
Notes payable and accrued interest | |
| 454,463 | | |
| 854,697 | |
Total current liabilities | |
| 1,306,620 | | |
| 3,332,964 | |
Long-term liabilities: | |
| | | |
| | |
Liability classified warrants | |
| 9,615 | | |
| 26,388 | |
Total long-term liabilities | |
| 9,615 | | |
| 26,388 | |
Total liabilities | |
$ | 1,316,235 | | |
$ | 3,359,352 | |
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, 2024 (unaudited) and December 31, 2023 | |
| - | | |
| - | |
Common stock, $0.0001 par value, 250,000,000 shares authorized at June 30, 2024 (unaudited) and December 31, 2023; 8,151,253 and 3,146,157 shares issued at June 30, 2024 (unaudited) and December 31, 2023, respectively; 8,151,172 and 3,146,076 shares outstanding at June 30, 2024 (unaudited) and December 31, 2023, respectively | |
| 815 | | |
| 315 | |
Additional paid-in capital | |
| 128,448,699 | | |
| 121,233,901 | |
Accumulated deficit | |
| (126,641,646 | ) | |
| (121,557,074 | ) |
Total Ensysce Biosciences, Inc. stockholders’ equity (deficit) | |
| 1,807,868 | | |
| (322,858 | ) |
Noncontrolling interests in stockholders’ deficit | |
| (328,483 | ) | |
| (328,409 | ) |
Total stockholders’ equity (deficit) | |
| 1,479,385 | | |
| (651,267 | ) |
Total liabilities and stockholders’ equity (deficit) | |
$ | 2,795,620 | | |
$ | 2,708,085 | |
The
accompanying notes are an integral part of these consolidated financial statements.
Ensysce
Biosciences, Inc.
Consolidated
Statements of Operations
(Unaudited)
| |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Federal grants | |
$ | 181,797 | | |
$ | 490,472 | | |
$ | 487,519 | | |
$ | 1,280,107 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 947,229 | | |
| 1,643,726 | | |
| 1,726,133 | | |
| 3,439,742 | |
General and administrative | |
| 1,190,010 | | |
| 1,140,700 | | |
| 2,559,791 | | |
| 2,695,553 | |
Total operating expenses | |
| 2,137,239 | | |
| 2,784,426 | | |
| 4,285,924 | | |
| 6,135,295 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (1,955,442 | ) | |
| (2,293,954 | ) | |
| (3,798,405 | ) | |
| (4,855,188 | ) |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Change in fair value of convertible notes | |
| - | | |
| - | | |
| - | | |
| 146,479 | |
Change in fair value of liability classified warrants | |
| 7,818 | | |
| 43,622 | | |
| 16,773 | | |
| 262,650 | |
Interest expense, net | |
| (27,563 | ) | |
| - | | |
| (1,275,628 | ) | |
| (1,497 | ) |
Other income, net | |
| 7,394 | | |
| 11,030 | | |
| (27,096 | ) | |
| 16,448 | |
Total other income (expense), net | |
| (12,351 | ) | |
| 54,652 | | |
| (1,285,951 | ) | |
| 424,080 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (1,967,793 | ) | |
$ | (2,239,302 | ) | |
$ | (5,084,356 | ) | |
$ | (4,431,108 | ) |
Net loss attributable to noncontrolling interests | |
| - | | |
| (7,060 | ) | |
| (74 | ) | |
| (11,001 | ) |
Deemed dividend related to warrants down round provision | |
| - | | |
| 3,729 | | |
| 290 | | |
| 12,038 | |
Net loss attributable to common stockholders | |
$ | (1,967,793 | ) | |
$ | (2,235,971 | ) | |
$ | (5,084,572 | ) | |
$ | (4,432,145 | ) |
Net loss per basic and diluted share: | |
| | | |
| | | |
| | | |
| | |
Net loss per share attributable to common stockholders, basic and diluted | |
$ | (0.22 | ) | |
$ | (0.98 | ) | |
$ | (0.67 | ) | |
$ | (2.66 | ) |
Weighted average common shares outstanding, basic and diluted | |
| 8,817,316 | | |
| 2,274,113 | | |
| 7,640,192 | | |
| 1,667,527 | |
The
accompanying notes are an integral part of these consolidated financial statements.
Ensysce
Biosciences, Inc.
Consolidated
Statements of Changes in Stockholders’ EQUITY (Deficit)
(Unaudited)
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
Stockholders’ Equity (Deficit) | |
| |
Common Stock | | |
Additional | | |
| | |
| | |
| |
| |
Number of
Shares | | |
Amount | | |
Paid-In
Capital | | |
Accumulated
Deficit | | |
Noncontrolling
interests | | |
Total | |
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 March 31, 2024 | |
| 7,329,172 | | |
$ | 733 | | |
$ | 128,422,232 | | |
$ | (124,673,853 | ) | |
$ | (328,483 | ) | |
$ | 3,420,629 | |
Issuance of common stock upon warrant inducement | |
| 822,000 | | |
| 82 | | |
| (82 | ) | |
| - | | |
| - | | |
| - | |
Stock-based compensation | |
| - | | |
| - | | |
| 26,549 | | |
| - | | |
| - | | |
| 26,549 | |
Net Loss | |
| - | | |
| - | | |
| - | | |
| (1,967,793 | ) | |
| - | | |
| (1,967,793 | ) |
Balance on June 30, 2024 | |
| 8,151,172 | | |
$ | 815 | | |
$ | 128,448,699 | | |
$ | (126,641,646 | ) | |
$ | (328,483 | ) | |
$ | 1,479,385 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance on December 31, 2022 | |
| 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 on December 31, 2023 | |
| 3,146,076 | | |
$ | 315 | | |
$ | 121,233,901 | | |
$ | (121,557,074 | ) | |
$ | (328,409 | ) | |
$ | (651,267 | ) |
Balance | |
| 3,146,076 | | |
$ | 315 | | |
$ | 121,233,901 | | |
$ | (121,557,074 | ) | |
$ | (328,409 | ) | |
$ | (651,267 | ) |
Settlement of restricted stock units | |
| 63 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Conversion of convertible notes | |
| 745,521 | | |
| 75 | | |
| 1,168,525 | | |
| - | | |
| - | | |
| 1,168,600 | |
Issuance of common stock upon exercise of warrants | |
| 1,323,904 | | |
| 132 | | |
| 2,075,087 | | |
| - | | |
| - | | |
| 2,075,219 | |
Issuance of common stock upon warrant inducement, net of issuance costs | |
| 2,935,608 | | |
| 293 | | |
| 4,718,002 | | |
| - | | |
| - | | |
| 4,718,295 | |
Transaction costs associated with warrant inducement | |
| - | | |
| - | | |
| (806,862 | ) | |
| - | | |
| - | | |
| (806,862 | ) |
Stock-based compensation | |
| - | | |
| - | | |
| 59,756 | | |
| - | | |
| - | | |
| 59,756 | |
Deemed dividend related to warrants down round provision | |
| - | | |
| - | | |
| 290 | | |
| (290 | ) | |
| - | | |
| - | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (5,084,282 | ) | |
| (74 | ) | |
| (5,084,356 | ) |
Balance on June 30, 2024 | |
| 8,151,172 | | |
$ | 815 | | |
$ | 128,448,699 | | |
$ | (126,641,646 | ) | |
$ | (328,483 | ) | |
$ | 1,479,385 | |
Balance | |
| 8,151,172 | | |
$ | 815 | | |
$ | 128,448,699 | | |
$ | (126,641,646 | ) | |
$ | (328,483 | ) | |
$ | 1,479,385 | |
The
accompanying notes are an integral part of these consolidated financial statements.
Ensysce
Biosciences, Inc.
Consolidated
Statements of Cash Flows
(Unaudited)
| |
| | | |
| | |
| |
Six
Months Ended June 30, | |
| |
2024 | | |
2023 | |
Cash flows from operating
activities: | |
| | | |
| | |
Net loss | |
$ | (5,084,356 | ) | |
$ | (4,431,108 | ) |
Adjustments to reconcile net loss to net cash
used in operating activities: | |
| | | |
| | |
Accrued interest and interest
expense related to note conversions | |
| 29,113 | | |
| 1,497 | |
Amortization of original
issue discount and debt issuance costs | |
| 1,197,200 | | |
| - | |
Change in fair value of
convertible notes | |
| - | | |
| (146,479 | ) |
Change in fair value of
liability classified warrants | |
| (16,773 | ) | |
| (262,650 | ) |
Stock-based compensation | |
| 59,756 | | |
| 194,550 | |
Lease cost | |
| - | | |
| (90 | ) |
Changes in operating assets and liabilities: | |
| | | |
| | |
Unbilled receivable | |
| (126,662 | ) | |
| 169,243 | |
Prepaid expenses and other
assets | |
| 190,909 | | |
| 469,404 | |
Accounts payable | |
| (1,795,404 | ) | |
| (1,669,162 | ) |
Accrued
expenses and other liabilities | |
| (172,077 | ) | |
| (1,040,666 | ) |
Net cash used in operating
activities | |
| (5,718,294 | ) | |
| (6,715,461 | ) |
Cash flows from financing
activities: | |
| | | |
| | |
Proceeds public offering,
net | |
| - | | |
| 9,050,004 | |
Proceeds from warrant exercises | |
| 2,075,219 | | |
| - | |
Proceeds from warrant inducement,
net of issuance costs | |
| 4,718,295 | | |
| - | |
Transaction costs associated
with public offering | |
| - | | |
| (447,879 | ) |
Transaction costs associated
with warrant inducement | |
| (465,494 | ) | |
| - | |
Repayment of convertible
notes | |
| (485,190 | ) | |
| (1,000,208 | ) |
Repayment
of financed insurance premiums | |
| (204,909 | ) | |
| (204,676 | ) |
Net cash provided by
financing activities | |
| 5,637,921 | | |
| 7,397,241 | |
Increase (decrease) in cash and cash equivalents | |
| (80,373 | ) | |
| 681,780 | |
Cash
and cash equivalents beginning of period | |
| 1,123,604 | | |
| 3,147,702 | |
Cash
and cash equivalents end of period | |
$ | 1,043,231 | | |
$ | 3,829,482 | |
| |
| | | |
| | |
Supplemental disclosure
of non-cash investing and financing activities: | |
| | | |
| | |
Incremental fair value of February 2024 warrant inducement | |
$ | 5,167,372 | | |
$ | - | |
Conversions of convertible
notes into common stock | |
$ | 1,168,600 | | |
$ | 3,056,892 | |
Transaction costs from
warrant inducement | |
$ | 341,368 | | |
$ | - | |
Deemed dividend related
to warrants down round provision | |
$ | 290 | | |
$ | 12,038 | |
Financed insurance premiums | |
$ | 235,155 | | |
$ | 445,737 | |
Settlement of commitment
fee in shares | |
$ | - | | |
$ | 400,000 | |
The
accompanying notes are an integral part of these consolidated financial statements.
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 Resistant) 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 9.9% and 10.9% of the shares held by a certain key person of the Company and two unrelated parties, 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.
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 six months ended June 30, 2024, are not necessarily indicative of the results that may be expected
for the year ending December 31, 2024. 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, 2023, which may be found in the Company’s Form 10-K filed with the SEC on March 15, 2024.
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. There is no assurance that profitable operations will ever be achieved, and, if achieved,
will 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.
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.
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. Additionally, the Company had concentration in accounts
payable, as two research and development vendors made up greater than 10% individually, and 31% and 38% in aggregate, of the outstanding
accounts payable balance as of June 30, 2024 and December 31, 2023, respectively.
Property
and equipment
Property
and equipment are fully depreciated and as such there is no depreciation expense recognized in the periods presented.
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, 2024, and December 31, 2023, 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.
Warrants
The
Company issued liability-classified warrants in connection with the issuance of the 2021 Notes and 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 June
30, 2024, and December 31, 2023.
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
June 30, 2024 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Liability classified warrants | |
$ | 9,615 | | |
$ | - | | |
$ | - | | |
$ | 9,615 | |
Total | |
$ | 9,615 | | |
$ | - | | |
$ | - | | |
$ | 9,615 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
December 31, 2023 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Liability classified warrants | |
| 26,388 | | |
| - | | |
| - | | |
| 26,388 | |
Total | |
$ | 26,388 | | |
$ | - | | |
$ | - | | |
$ | 26,388 | |
The
following table summarizes the change in fair value of the Company’s Level 3 liabilities for the six months ended June 30, 2024
(no level 3 assets as of the six months ended June 30, 2024):
SCHEDULE
OF CHANGE IN FAIR VALUE OF COMPANY’S LEVEL 3
| |
Liability
classified
warrants | |
Fair value, December 31, 2023 | |
$ | 26,388 | |
Change in fair value | |
| (16,773 | ) |
Fair value, June 30, 2024 | |
$ | 9,615 | |
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 initial grant was extended several times and cumulative funding under this grant of approximately
$10.7 million was completed in December 2023.
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 August 31, 2024. As of June 30, 2024, the remaining cash funding under the grant is $1.9 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 RECOGNITION UNDER GRANTS
| |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
MPAR | |
$ | - | | |
$ | 437,263 | | |
$ | - | | |
$ | 918,542 | |
TAAP/OUD | |
| 181,797 | | |
| 53,209 | | |
| 487,519 | | |
| 361,565 | |
Total | |
$ | 181,797 | | |
$ | 490,472 | | |
$ | 487,519 | | |
$ | 1,280,107 | |
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 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.
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 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. Basic shares outstanding include the weighted average effect
of the Company’s outstanding pre-funded warrants and abeyance shares, which require no consideration for the delivery of shares
of common stock. Diluted net loss per share is calculated by adjusting basic shares outstanding for the dilutive effect of common share
equivalents outstanding for 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 (the Company has utilized the principal balance outstanding and the end of period conversion price
for the Convertible Notes for the purposes of the weighted average share calculation below):
SCHEDULE
OF WEIGHTED AVERAGE SHARES OF ANTI-DILUTIVE SECURITIES
| |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Stock options | |
| 580,188 | | |
| 26,354 | | |
| 580,188 | | |
| 26,354 | |
RSUs | |
| - | | |
| 377 | | |
| - | | |
| 377 | |
Warrants | |
| 11,005,004 | | |
| 3,017,026 | | |
| 10,373,633 | | |
| 1,938,542 | |
Convertible notes | |
| 137,799 | | |
| - | | |
| 137,799 | | |
| - | |
Total | |
| 11,722,991 | | |
| 3,043,757 | | |
| 11,091,620 | | |
| 1,965,273 | |
Recently
Issued Accounting Pronouncements
In
November 2023, the FASB issued ASU 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures”,
which sets forth improvements to the current segment disclosure requirements in accordance with Topic 280 “Segment Reporting,”
including clarifying that entities with a single reportable segment are subject to both new and existing segment reporting requirements.
ASU 2023-07 will be effective retrospectively for fiscal years beginning after December 15, 2023, and interim periods beginning after
December 15, 2024. Adoption of this ASU is currently being evaluated by the Company.
In
December 2023, the FASB issued ASU No. 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” ASU 2023-09
requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income
taxes paid. ASU 2023-09 is effective for public entities with annual periods beginning after December 15, 2024, with early adoption permitted.
The Company is currently evaluating the impact of this guidance on its consolidated financial statements.
NOTE
4 – PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets consisted of the following:
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
June 30, 2024 | | |
December 31, 2023 | |
Prepaid research and development | |
$ | 539,208 | | |
$ | 535,474 | |
Prepaid insurance | |
| 418,215 | | |
| 441,871 | |
Other prepaid expenses | |
| 170,439 | | |
| 72,358 | |
Other current assets | |
| 64,421 | | |
| 18,000 | |
Total prepaid expenses and other current assets | |
$ | 1,192,283 | | |
$ | 1,067,703 | |
NOTE
5 – ACCRUED EXPENSES AND OTHER LIABILITIES
Accrued
expenses and other liabilities consisted of the following:
SCHEDULE
OF ACCRUED EXPENSES AND OTHER LIABILITIES
| |
June 30, 2024 | | |
December 31, 2023 | |
Accrued research and development | |
$ | 208,992 | | |
$ | 329,228 | |
Professional fees | |
| 26,950 | | |
| 110,202 | |
Other accrued liabilities | |
| 134,244 | | |
| 102,830 | |
Total accrued expenses and other liabilities | |
$ | 370,186 | | |
$ | 542,260 | |
NOTE
6 – COMMITMENTS AND CONTINGENCIES
Purchase
Commitments
As
of June 30, 2024, the Company’s commitments included approximately $16 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, 2024, and December 31, 2023, 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, 2024, with no contracted option to renew.
As of June 30, 2024, the future lease payments totaled $11,363. The Company recognized total rent expense of $8,747 and $17,495 in the
three and six months ended June 30, 2024 and $8,375 and $16,749 in the three and six-months ended June 30, 2023.
Share
Subscription Facility
In
December 2020, the Company executed the GEM Agreement, under which an 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. Concurrent with the public listing of the Company’s shares on July 2, 2021, the Company issued to
the investor 4,608 warrants with a three-year term to purchase common stock of Ensysce at an exercise price of $2,402.40 per share, subsequently
reduced to $1.06 at February 12, 2024 (Note 8). 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.
NOTE
7 – NOTES PAYABLE
The
following table provides a summary of the Company’s outstanding debt as of June 30, 2024:
SCHEDULE
OF DEBT
| |
Principal
balance | | |
Accrued
interest | | |
Net debt
balance | |
2023 Notes | |
$ | 216,000 | | |
| 6,308 | | - |
| 222,308 | |
Financed insurance | |
| 232,155 | | |
| - | | - |
| 232,155 | |
Total | |
$ | 448,155 | | |
$ | 6,308 | | - |
$ | 454,463 | |
The
following table provides a summary of the Company’s outstanding debt as of December 31, 2023:
| |
December 31, 2023 | |
| |
Principal
balance | | |
Accrued
interest | | |
Unamortized
Debt
Discount and
Issuance Costs | | |
Net debt
balance | |
2023 Notes | |
$ | 1,836,000 | | |
$ | 13,078 | | |
$ | (1,197,200 | ) | |
$ | 651,878 | |
Financed insurance | |
| 197,249 | | |
| 5,570 | | |
| - | | |
| 202,819 | |
Total | |
$ | 2,033,249 | | |
$ | 18,648 | | |
$ | (1,197,200 | ) | |
$ | 854,697 | |
Interest
Expense
The
interest expense recognized for financed insurance was $148 and $2,092 for the three and six months ended June 30, 2024 and $0 and $1,497
for the three and six months ended June 30, 2023. Interest expense recognized for the 2023 Notes was $27,563 and $1.3 million for the
three and six months ended June 30, 2024, which consists of amortization of the debt discount and debt issuance costs and incurred and
accrued interest.
2023
Notes
On
October 23, 2023, the Company entered into a Securities Purchase Agreement (“SPA”) for an aggregate financing of $1.8 million
with investors, including $0.2 million with a board member. At the first closing under the SPA, which occurred on October 25, 2023, the
Company issued to the investors (i) senior secured convertible promissory notes in the aggregate principal amount of $612,000 for an
aggregate purchase price of $566,667 and (ii) warrants to purchase 1,255,697 shares of the Company’s common stock, par value $0.0001
per share in the aggregate. At the second closing under the SPA, which occurred on November 29, 2023, the Company issued to the investors
referenced above, (i) additional notes in the aggregate principal amount of $1,224,000 for an aggregate purchase price of $1,133,333
and (ii) additional warrants to purchase 2,511,394 shares of the common stock in the aggregate. The notes were scheduled to mature on
April 25, 2024 and May 28, 2024, respectively.
The
combined notes are subject to an original issue discount of 8%, have an original term of six months from their respective date of issuance
and accrue interest at the rate of 6.0% per annum. The notes are convertible into common stock, at a per share conversion price equal
to $1.5675. Beginning ninety days following issuance of the respective notes, the Company was obligated to redeem monthly one third of
the original principal amount under the applicable note, plus accrued but unpaid interest, liquidated damages and any other amounts then
owing to the holder of such note. The Company is required to pay the redemption amount in cash with a premium of 10% or, at the election
of the purchaser at any time, some or all of the principal amount and interest may be paid by conversion of shares under the note into
common stock based on a conversion price equal to $1.5675. The Company determined the 2023 Notes are to be accounted for as conventional
convertible debt as they provide for the holder an option to convert the outstanding balances into a fixed number of shares (or an equivalent
amount of cash at the discretion of the Company) and the option to convert meets the definition of an exception from derivative accounting.
As a result, the Company reflected the outstanding principal amount, the remaining unamortized discount (both original issue discount
and the relative fair value discount associated with the warrants discussed below) and the remaining debt issuance costs as a net amount
on the face of the balance sheet. The amortization of the original debt discount (approximately $0.1 million) and issuance costs (approximately
$0.3 million) was recorded as interest expense within the consolidated statements of operations. As of June 30, 2024, the original debt
discount and issuance costs were fully amortized to interest expense.
The
warrants have an exercise price of $1.5675, the same as the conversion price, and are exercisable for five years following the issuance
date. The warrants were equity classified as they are indexed to the Company’s stock and only settleable in shares. The warrants
were initially measured at fair value using a Black-Scholes valuation model and were allocated along with the 2023 Notes using the relative
fair value method. The initial fair value of $1.1 million allocated to the warrants was considered a debt discount and will be amortized
to interest expense over the remaining term of the notes. As of June 30, 2024, the discount associated with the warrants was fully amortized
to interest expense.
During
2024, the Company converted 745,521 shares of common stock with a conversion value of $1.2 million related to the 2023 Notes. In addition,
in connection with the SPA, the Company incurred a $1.0 million waiver fee in connection to the 2024 Warrant Inducement (see Note 8)
to pay down $0.5 million of 2023 Notes and $0.5 million in transaction costs recorded as such in the consolidated statement of stockholders’
equity. As of June 30, 2024, the remaining amount of the 2023 Notes relates to senior secured convertible promissory notes held with
a Company board member (see Note 10).
Financed
insurance premiums
In
June 2024, the Company renewed and financed its directors’ and officers’ liability insurance in the amount of $0.2 million.
Monthly payments are scheduled from July 2024 through March 2025.
NOTE
8 - STOCKHOLDERS’ EQUITY
The
Company’s current Certificate of Incorporation authorizes 250,000,000 shares of common stock and 1,500,000 shares of preferred
stock, both with par value equal to $0.0001. As of June 30, 2024, and December 31, 2023, there were no shares of preferred stock issued
and outstanding.
2024
Warrant Inducement
On
February 12, 2024, the Company executed an Inducement Letter with certain holders of existing warrants to purchase up to an aggregate
of 3,601,752 shares of the Company’s common stock issued to the holders in connection with the 2023 May Offering. Pursuant to the
Inducement Letter, the holders agreed to exercise for cash their existing warrants to purchase an aggregate of 3,601,752 shares of Common
Stock at a reduced exercise price of $1.31 per share in consideration of the Company’s agreement to issue new unregistered Series
A Warrants (the “Series A Warrants”) to purchase up to 3,601,752 shares of Common Stock and new unregistered Series B Warrants
(the “Series B Warrants”) to purchase up to 3,601,752 shares of Common Stock (collectively, the “New Warrant Shares”).
The Series A Warrants have an exercise price of $1.06 per share and have a term equal to eighteen months from the date of issuance. The
Series B Warrants have an exercise price of $1.06 per share and will expire on May 12, 2028. The gross proceeds to the Company from the
exercise of the warrants were approximately $4.7 million, prior to deducting placement agent fees and estimated offering expenses. As
the existing warrants and the new warrants were equity classified before and after the exchange, and as the exchange is directly attributable
to an equity offering, the Company recognized the effect of the modification of approximately $5.2 million as an equity issuance cost.
In
connection with the execution of the Inducement Letter, the Company executed a waiver related to the 2023 Notes’ SPA it had entered
as of October 23, 2023. The SPA contained restrictions on the Company’s ability to undertake certain transactions, which included
the execution of the Inducement Letter. The Waiver permitted the Company to execute the Inducement Letter but required repayment of the
certain investor held notes issued under the SPA with a premium following closing of the transaction contemplated thereby. Refer to Note
7 for the details of the waiver fee and the application of the amounts to the outstanding notes and as a transaction cost of the warrant
inducement.
The
Company utilized an exclusive placement agent for the 2024 Warrant Inducement and incurred approximately $0.3 million in legal fees and
other closing costs. Additionally, the Company issued to the placement agent as compensation unregistered warrants to purchase up to
252,123 shares of Common Stock, equal to 7.0% of the aggregate number of shares of Common Stock (or warrants) placed in the transaction.
The placement agent warrants expire on May 12, 2028, and have an exercise price of $1.6375 per share of Common Stock (equal to 125% of
the reduced exercise price per Existing Warrant).
The
closing of the offering occurred on February 14, 2024.
Abeyance
Shares
Related
to the 2024 Warrant Inducement, a holder left 1,488,144 shares in abeyance at the Company’s transfer agent to be delivered to the
holder at their request. During the quarter ended June 30, 2024, 822,000 shares held in abeyance were delivered to the holder and the
remaining shares are held in abeyance. Accordingly, as of June 30, 2024, 666,144 shares were held in abeyance, have not been issued and
are not outstanding.
Warrants
The
following table provides a summary of outstanding warrants to purchase shares of common stock as of June 30, 2024:
SCHEDULE
OF OUTSTANDING WARRANT
Reference | |
Shares
Underlying
Outstanding
Warrants | | |
Exercise
Price | | |
Description | |
Classification |
(a) | |
| 63,659 | | |
$ | 2,400.00 - 2,760.00 | | |
LACQ warrants | |
Equity |
(b) | |
| 4,608 | | |
$ | 1.31 | | |
Share subscription facility | |
Equity |
(c) | |
| 4,518 | | |
$ | 3.64 | | |
2021 Notes | |
Liability |
(d) | |
| 38,900 | | |
$ | 3.64 | | |
2022 Notes | |
Liability |
(e) | |
| 549,993 | | |
$ | 3.64 - 16.80 | | |
Public offering | |
Equity |
(f) | |
| 318,451 | | |
$ | 8.58 - 12.60 | | |
Public offering | |
Equity |
(g) | |
| 126,061 | | |
$ | 4.86 | | |
Public offering | |
Equity |
(h) | |
| 2,443,187 | | |
$ | 1.57 | | |
2023 Notes | |
Equity |
(i) | |
| 7,455,627 | | |
$ | 1.06 - 1.64 | | |
2024 Warrants | |
Equity |
| |
| 11,005,004 | | |
| | | |
| |
|
(a) |
|
|
|
|
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 per share. |
|
|
(b) |
|
(c) |
|
|
|
(d) |
|
|
|
(e) |
|
|
|
(f) |
|
|
|
(g) |
|
|
|
(h) |
|
(i) |
|
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) | |
$ | 1.13 - $1,029.60 | | |
$ | 1.06- $680.23 | | |
| 0.38 - 2.58 | | |
| 91.3% - 140.5% | | |
| 1.04% - 5.43% | |
(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 | | |
$ | 1,831.20 | | |
| 5.00 | | |
| 94.1 | % | |
| 1.0 | % |
(c) Liability classified warrants (remeasured at 6/30/24) | |
$ | 0.50 | | |
$ | 3.64 | | |
| 2.25 - 2.35 | | |
| 133.7% - 135.4% | | |
| 4.6 | % |
(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 6/30/24) | |
$ | 0.50 | | |
$ | 3.64 | | |
| 3.00 - 3.11 | | |
| 126.7% - 128.6% | | |
| 4.4 | % |
NOTE
9 - STOCK-BASED COMPENSATION
In
connection with the Business Combination, the Company assumed the 2021 Omnibus Incentive Plan. In February 2023, the Company’s
Board approved an annual increase of 26,725 shares and in August 2023, the Company’s stockholders approved a proposal for an increase
of 585,796 shares available for future grant under the 2021 Omnibus Plan.
The
Company recognized stock-based compensation expense within general and administrative expense of $18,658 and $42,146 for the three and
six months ended June 30, 2024 and $60,394 and $156,663 for the three and six months ended June 30, 2023. The Company recognized stock-based
compensation expense within research and development expense of $7,891 and $17,610 for the three and six months ended June 30, 2024 and
$17,023 and $37,887 for the three and six months ended June 30, 2023.
Option
Activity
There
were no stock options granted during the six months ended June 30, 2024 and June 30, 2023.
The
following table summarizes the Company’s stock option activity during the six months ended June 30, 2024:
SCHEDULE OF STOCK OPTION ACTIVITY
| |
| | |
Weighted average | | |
| |
| |
Options | | |
Exercise price | | |
Remaining contractual life | | |
Intrinsic value | |
Outstanding at December 31, 2023 | |
| 581,314 | | |
$ | 33.15 | | |
| 9.57 | | |
$ | - | |
Granted | |
| - | | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | | |
| - | |
Expired / Forfeited | |
| - | | |
| - | | |
| - | | |
| - | |
Outstanding at June 30, 2024 | |
| 581,314 | | |
| 33.15 | | |
| 9.08 | | |
| - | |
Exercisable at June 30, 2024 | |
| 580,188 | | |
| 32.28 | | |
| - | | |
| - | |
Vested and expected to vest | |
| 581,314 | | |
| 33.15 | | |
| 9.08 | | |
| - | |
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 during the six months ended June 30, 2024 and 2023):
|
● |
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. |
As
of June 30, 2024, the Company had an aggregate of $60,092 of unrecognized share-based compensation cost, which is expected to be recognized
over the weighted average period of 0.95 years.
Shares
Reserved for Future Issuance
The
following shares of common stock are reserved for future issuance:
SCHEDULE OF COMMON STOCK FUTURE ISSUANCE
| |
June 30, 2024 | |
Awards outstanding under the 2021 Omnibus Incentive Plan | |
| 581,314 | |
Awards available for future grant under 2021 Omnibus Incentive Plan | |
| 2,112 | |
Warrants outstanding | |
| 11,005,004 | |
Total shares of common stock reserved for future issuance | |
| 11,588,430 | |
NOTE
10 - RELATED PARTIES
As
of June 30, 2024, the Company held a $0.2 million senior secured convertible promissory note plus accrued interest and 0.4 million warrants
exercisable for common stock at $1.5675 per share issued from a board member in connection to the issuance of the 2023 Notes. On April
25, 2024, the Company and the board member entered into a forbearance agreement that will expire on April 25, 2025. Upon termination
of the forbearance period, the Company will owe the remaining outstanding principal balance together with unpaid interest. The Company
may pay the notes in full at any time prior to the conclusion of the forbearance period.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion and analysis provide information which our management believes is relevant to an assessment and understanding of
our consolidated results of operations and financial condition. You should read the following discussion and analysis of our financial
condition and results of operations together with our consolidated financial statements and notes thereto included elsewhere in this
report. In addition to historical financial information, this discussion contains forward-looking statements based upon our current expectations
that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements
as a result of various factors, including those set forth in the section within Part II-Other Information - titled “Item 1A. Risk
Factors.”
References
in the following discussion to “we”, “us”, “our” and the “Company” refer to Ensysce Biosciences,
Inc. and its consolidated subsidiaries following the Closing of the Business Combination. Unless the context otherwise requires, references
to “LACQ” refer to Leisure Acquisition Corp., a Delaware corporation, prior to the Closing.
Overview
Ensysce
is a clinical stage pharmaceutical company seeking to develop innovative solutions for severe pain relief while reducing the fear of
and the potential for opioid misuse, abuse and overdose. Our lead product candidate, PF614, is an extended release TAAP prodrug of oxycodone.
TAAP modification of prescription drugs removed the ability to crush, chew or manipulate and inject to achieve the effect of the medication
more quickly than by swallowing. MPAR® adds a layer of overdose protection to each TAAP product.
Since
our inception in 2003, we devoted substantially all of our efforts and financial resources to organizing and staffing our company, business
planning, raising capital, discovering product candidates and securing related intellectual property rights and conducting research and
development activities for our product candidates. We do not have any products approved for sale and we have not generated any revenue
from product sales. We may never be able to develop or commercialize a marketable product.
Our
lead product candidate, PF614, is ready for Phase 3 clinical development, PF614-MPAR is in Phase 1b clinical development and nafamostat
has completed Phase 1 clinical development. Our other product candidates and our research initiatives are in preclinical or earlier stages
of development. Our ability to generate revenue from product sales sufficient to achieve profitability will depend heavily on the successful
development and eventual commercialization of one or more of our product candidates. We have not yet successfully completed any pivotal
clinical trials, nor have we obtained any regulatory approvals, manufactured a commercial-scale drug, or conducted sales and marketing
activities.
We
have incurred significant operating losses since inception and we expect to continue to incur net losses for the foreseeable future.
We expect that our expenses and capital requirements will increase substantially in connection with our ongoing development activities,
particularly if and as we:
|
● |
continue
preclinical studies and continues existing and initiates new clinical trials for PF614, PF614-MPAR and nafamostat, our lead product
candidates being tested for chronic pain and infectious disease; |
|
|
|
|
● |
advance
the development of our product candidate pipeline of other product candidates, including through business development efforts to
invest in or in-license other technologies or product candidates; |
|
|
|
|
● |
maintain,
expand and protect our intellectual property portfolio; |
|
|
|
|
● |
hire
additional clinical, quality control, medical, scientific and other technical personnel to support our clinical operations; |
|
|
|
|
● |
seek
regulatory approval for any product candidates that successfully complete clinical trials; |
|
|
|
|
● |
undertake
any pre-commercialization activities to establish sales, marketing and distribution capabilities for any product candidates for which
we may receive regulatory approval; |
|
|
|
|
● |
expand
our infrastructure and facilities to accommodate our growing employee base; and |
|
|
|
|
● |
add
operational, financial and management information systems and personnel, including personnel to support our research and development
programs and any future commercialization efforts. |
We
have incurred and expect to continue to incur costs associated with operating as a public company, including significant legal, accounting,
insurance, investor relations and other expenses. We may never become profitable.
We
require substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant
revenue from product sales, if ever, we expect to finance our operations through a combination of private and public equity offerings,
debt financings or other capital sources, which may include collaborations with other companies or other strategic transactions. To the
extent that we raise additional capital through the sale of private or public equity or convertible debt securities, existing ownership
interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights
of our equity holders.
Debt
financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability
to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we
raise additional funds through collaborations or other strategic transactions with third parties, we may have to relinquish valuable
rights to our technologies, future revenue streams, research programs or drug candidates, or grant licenses on terms that may not be
favorable to us. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable
terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale
back or discontinue the development and commercialization of one or more of our product candidates or delay our pursuit of potential
in-licenses or acquisitions.
Because
of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased
expenses or when or if we will be able to achieve or maintain profitability. Even if we generate product sales, we may not become profitable.
If we fail to become profitable or are unable to sustain profitability on a continuing basis, we may be unable to continue our operations
at planned levels and be forced to reduce or terminate our operations.
We
have generated limited revenues, have incurred significant operating losses since our inception and expect to continue to incur operating
losses for the foreseeable future. These factors raise substantial doubt about our ability to continue as a going concern. Our future
viability is dependent on our ability to raise additional capital to finance our operations.
We
expect to incur substantial expenses in the foreseeable future for the development and potential commercialization of our product candidates
and ongoing internal research and development programs. At this time, we cannot reasonably estimate the nature, timing, or aggregate
amount of costs for our development, potential commercialization, and internal research and development programs. However, in order to
complete our current and future preclinical studies and clinical trials, and to complete the process of obtaining regulatory approval
for our product candidates, as well as to build the sales, marketing and distribution infrastructure that we believe will be necessary
to commercialize our product candidates, if approved, we may require substantial additional funding in the future.
2024
Warrant Inducement
On
February 12, 2024, the Company entered into an Inducement Letter with certain holders of existing warrants to purchase up to an aggregate
of 3,601,752 shares of the Company’s common stock issued to the holders in connection with the 2023 May Offering. Pursuant to the
Inducement Letter, the holders agreed to exercise for cash their existing warrants to purchase an aggregate of 3,601,752 shares of Common
Stock at a reduced exercise price of $1.31 per share in consideration of the Company’s agreement to issue new unregistered Series
A Warrants (the “Series A Warrants”) to purchase up to 3,601,752 shares of Common Stock and new unregistered Series B Warrants
(the “Series B Warrants”) to purchase up to 3,601,752 shares of Common Stock (collectively, the “New Warrant Shares”).
The Series A Warrants have an exercise price of $1.06 per share and have a term equal to eighteen months from the date of issuance. The
Series B Warrants have an exercise price of $1.06 per share and will expire on May 12, 2028. The gross proceeds to the Company from the
exercise of the warrants were approximately $4.7 million, prior to deducting placement agent fees and estimated offering expenses. The
closing of the offering occurred on February 14, 2024.
In
connection with the execution of the Inducement Letter, the Company entered into a waiver related to the 2023 Notes’ SPA it had
entered into as of October 23, 2023. The SPA contained restrictions on the Company’s ability to undertake certain transactions,
which included entering into the Inducement Letter. The Waiver permitted the Company to enter into the Inducement Letter but required
repayment of the remaining $0.5 million of investor held notes issued under the SPA with a premium of $0.5 million following closing
of the transaction contemplated thereby.
The
Company utilized an exclusive placement agent for the 2024 Warrant Inducement and incurred approximately $0.5 million in legal fees and
other closing costs. Additionally, the Company issued to the placement agent as compensation unregistered warrants to purchase up to
252,123 shares of Common Stock, equal to 7.0% of the aggregate number of shares of Common Stock (or warrants) placed in the transaction.
The placement agent warrants expire on May 12, 2028, and have an exercise price of $1.6375 per share of Common Stock (equal to 125% of
the reduced exercise price per Existing Warrant).
Components
of Our Operating Results
Revenue
We
have generated limited revenue since our inception and we do not expect to generate any revenue from the sale of products in the near
future, if at all. If our development efforts are successful and we commercialize our products, or if we enter into collaboration or
license agreements with third parties, we may generate revenue in the future from product sales, as well as upfront, milestone and royalty
payments from such collaboration or license agreements, or a combination thereof.
We
have received funding under federal grants from the NIH through NIDA. In September 2018, we were awarded a research and development grant
related to the development of our MPAR® overdose prevention technology (the “MPAR Grant”). In September 2019, we were
awarded a second research and development grant related to the development of our TAAP/MPAR abuse deterrent technology for Opioid Use
Disorder (“OUD”) (the “OUD Grant”). Grant funds are awarded annually through a Notice of Award which contains
certain terms and conditions including, but not limited to, complying with the grant program legislation, regulation and policy requirements,
complying with conditions on expenditures of funds with respect to other applicable statutory requirements such as the federal appropriations
acts, periodic reporting requirements, and budget requirements.
Operating
Expenses
Research
and Development Expenses
Research
and development expenses consist primarily of costs incurred for research activities, including drug discovery efforts and the development
of our product candidates. We expense research and development costs as incurred, which include:
|
● |
expenses
incurred to conduct the necessary preclinical studies and clinical trials required to obtain regulatory approval; |
|
|
|
|
● |
expenses
incurred under agreements with CROs that are primarily engaged in the oversight and conduct of our drug discovery efforts and preclinical
studies, clinical trials and CMOs that are primarily engaged to provide preclinical and clinical drug substance and product for our
research and development programs; |
|
|
|
|
● |
other
costs related to acquiring and manufacturing materials in connection with our drug discovery efforts and preclinical studies and
clinical trial materials, including manufacturing validation batches, as well as investigative sites and consultants that conduct
our clinical trials, preclinical studies and other scientific development services; |
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|
● |
payments
made in cash or equity securities under third-party licensing, acquisition and option agreements; |
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|
● |
employee-related
expenses, including salaries and benefits, travel and stock-based compensation expense for employees engaged in research and development
functions; |
|
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|
● |
costs
related to compliance with regulatory requirements; and |
|
|
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|
● |
allocated
facilities-related costs, depreciation and other expenses, which include rent and utilities. |
We
recognize external development costs as incurred. Any advance payments we make for goods or services to be received in the future for
use in research and development activities are recorded as prepaid expenses. Such amounts are expensed as the related goods are delivered
or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered. We
estimate and accrue for the value of goods and services received from CROs and certain other third parties each reporting period based
on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers. This process
involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed
on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been
invoiced or otherwise notified of actual costs.
We
do not track our research and development expenses on a program-by-program basis. Our direct external research and development expenses
consist primarily of external costs, such as fees paid to outside consultants, CROs, CMOs and research laboratories in connection with
our preclinical development, process development, manufacturing and clinical development activities. We do not allocate employee costs,
costs associated with our discovery efforts, laboratory supplies, and facilities, including depreciation or other indirect costs, to
specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We use internal
resources primarily to manage our preclinical development, process development, manufacturing and clinical development activities. These
employees work across multiple programs and, therefore, we do not track our costs by program and cannot state precisely the total costs
incurred for each of our clinical and preclinical programs on a project-by-project basis.
Research
and development activities are central to our business model. Product candidates in later stages of clinical development generally have
higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage
clinical trials. As a result, we expect that our research and development expenses will remain elevated as we continue our existing,
and commence additional, planned clinical trials for PF614, PF614-MPAR and nafamostat, as well as conduct other preclinical and clinical
development, including submitting regulatory filings for our other product candidates, subject to our ability to obtain financing. We
also expect our related personnel costs to increase and, as a result, we expect our research and development expenses, including costs
associated with stock-based compensation, to remain elevated. In addition, we may incur additional expenses related to milestone and
royalty payments payable to third parties with whom we may enter license, acquisition and option agreements to acquire the rights to
future product candidates.
At
this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical
and clinical development of any of our product candidates or when, if ever, material net cash inflows may commence from any of our product
candidates. The successful development and commercialization of our product candidates are highly uncertain. This uncertainty is due
to the numerous risks and uncertainties associated with product development and commercialization, including the uncertainty of the following:
|
● |
the
scope, progress, outcome and costs of our preclinical development activities, clinical trials and other research and development
activities; |
|
|
|
|
● |
establishing
an appropriate safety and efficacy profile with investigational new drug (“IND”) enabling studies; |
|
|
|
|
● |
successful
patient enrollment in and the initiation and completion of clinical trials; |
|
|
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|
● |
the
timing, receipt and terms of any marketing approvals from applicable regulatory authorities including the FDA and non-U.S. regulators; |
|
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|
● |
the
extent of any required post-marketing approval commitments to applicable regulatory authorities; |
|
|
|
|
● |
establishing
clinical and commercial manufacturing capabilities or making arrangements with third-party manufacturers in order to ensure that
we or our third-party manufacturers are able to make product successfully; |
|
● |
development
and timely delivery of clinical-grade and commercial-grade drug formulations that can be used in our clinical trials and for commercial
launch; |
|
|
|
|
● |
obtaining,
maintaining, defending and enforcing patent claims and other intellectual property rights; |
|
|
|
|
● |
significant
and changing government regulation; |
|
|
|
|
● |
launching
commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others; and |
|
|
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|
● |
maintaining
a continued acceptable safety profile of our product candidates following approval, if any, of our product candidates. |
Any
changes in the outcome of any of these variables with respect to the development of our product candidates in preclinical and clinical
development could mean a significant change in the costs and timing associated with the development of these product candidates. For
example, if the FDA or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical
trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned
clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development
of that product candidate.
General
and Administrative Expenses
General
and administrative expenses consist primarily of employee-related expenses, including salaries and related benefits, travel and stock-based
compensation for personnel in executive, business development, finance, human resources, legal, information technology, and administrative
functions. General and administrative expenses also include direct and allocated facility-related costs as well as insurance costs and
professional fees for legal, patent, consulting, investor and public relations, accounting and audit services. We expense general and
administrative costs as incurred.
We
anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support the continued
development of our product candidates, subject to our ability to obtain financing. We also anticipate that we will continue to incur
significant accounting, audit, legal, regulatory, compliance and director and officer insurance costs as well as investor and public
relations expenses. Additionally, if and when we believe a regulatory approval of a product candidate appears likely, we anticipate an
increase in payroll and other employee-related expenses as a result of our preparation for commercial operations, especially as it relates
to the sales and marketing of that product candidate.
Other
Income (Expense)
Change
in fair value of convertible notes
The
2022 Notes were accounted for under ASC 480 – Distinguishing Liabilities from Equity, due to share settlement features contained
within the notes. We used a discounted cash flow model and a Monte Carlo simulation to estimate the fair value of the notes, both of
which rely on unobservable Level 3 inputs. Changes in the fair value of the notes are recognized through earnings for each reporting
period.
Change
in fair value of liability classified warrants
We
use a Black-Scholes option pricing model to estimate the fair value of the liability classified warrants. Changes in the fair value of
the warrants are recognized through earnings for each reporting period.
Interest
Expense
Interest
expense consists of interest accrued on our financed directors’ and officers’ insurance, and accumulated interest from the
2023 Notes based on the stated interest rate. In addition, the 2023 Notes balances reflect amortization of the debt discount from the
original issuance and a discount associated with the warrant issuances and amortization of the associated debt issuance costs that are
all recorded as interest expense. Interest expense related to the 2021 Notes and 2022 Notes was included in the estimate of fair value
of the convertible notes.
Provision
for Income Taxes
We
have not recorded any significant amounts related to income tax expense, we have not recognized any reserves related to uncertain tax
positions, nor have we recorded any income tax benefits for the majority of our net losses we have incurred to date or for our research
and development tax credits.
We
account for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities
for the expected future tax consequences of events that have been included in the financial statements or our tax returns. Deferred tax
assets and liabilities are determined based on difference between the financial statement carrying amounts and tax bases of existing
assets and liabilities and for loss and credit carryforwards, which are measured using the enacted tax rates and laws in effect in the
years in which the differences are expected to reverse. The realization of our deferred tax assets is dependent upon the generation of
future taxable income, the amount and timing of which are uncertain. 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. As of June 30, 2024
and December 31, 2023, we continue to maintain a full valuation allowance against all of our deferred tax assets based on our evaluation
of all available evidence.
Beginning
in 2022, the Tax Cuts and Jobs Act, or the Tax Act, eliminated the option to deduct research and development expenditures currently and
requires taxpayers to capitalize and amortize them over five or fifteen years pursuant to Internal Revenue Code Section 174. This has
not impacted our effective tax rate or our cash tax payable in 2024; however, if the requirement to capitalize Section 174 expenditures
is not modified, it may also impact our effective tax rate and our cash tax liability in future years.
We
file income tax returns in the United States federal tax jurisdiction and state jurisdictions and may become subject to income tax audit
and adjustments by related tax authorities. Our tax return period for United States federal income taxes for the tax years since 2020
remain open to examination under the statute of limitations by the Internal Revenue Service and state jurisdictions. We record reserves
for potential tax payments to various tax authorities related to uncertain tax positions, if any. The nature of uncertain tax positions
is subject to significant judgment by management and subject to change, which may be substantial. These reserves are based on a determination
of whether and how much a tax benefit taken by us in our tax filings or whether our position is more likely than not to be realized following
the resolution of any potential contingencies related to the tax benefit. We develop our assessment of uncertain tax positions, and the
associated cumulative probabilities, using internal expertise and assistance from third-party experts. As additional information becomes
available, estimates are revised and refined. Differences between estimates and final settlement may occur resulting in additional tax
expense. Potential interest and penalties associated with such uncertain tax positions is recorded as a component of our provision for
income taxes. To date, no amounts are being presented as an uncertain tax position.
Results
of Operations
Comparison
of the three months ended June 30, 2024 and 2023:
| |
Three Months Ended June 30, | | |
| |
| |
2024 | | |
2023 | | |
Change | |
Federal grants | |
$ | 181,797 | | |
$ | 490,472 | | |
$ | (308,675 | ) |
Operating expenses: | |
| | | |
| | | |
| | |
Research and development | |
| 947,229 | | |
| 1,643,726 | | |
| (696,497 | ) |
General and administrative | |
| 1,190,010 | | |
| 1,140,700 | | |
| 49,310 | |
Total operating expenses | |
| 2,137,239 | | |
| 2,784,426 | | |
| (647,187 | ) |
Loss from operations | |
| (1,955,442 | ) | |
| (2,293,954 | ) | |
| 338,512 | |
Other income (expense): | |
| | | |
| | | |
| | |
Change in fair value of liability classified warrants | |
| 7,818 | | |
| 43,622 | | |
| (35,804 | ) |
Interest expense | |
| (27,563 | ) | |
| - | | |
| (27,563 | ) |
Other income, net | |
| 7,394 | | |
| 11,030 | | |
| (3,636 | ) |
Total other income (expenses), net | |
| (12,351 | ) | |
| 54,652 | | |
| (67,003 | ) |
Net loss | |
| (1,967,793 | ) | |
| (2,239,302 | ) | |
| 271,509 | |
Net loss attributable to noncontrolling interests | |
| - | | |
| (7,060 | ) | |
| 7,060 | |
Deemed dividend related to warrants down round provision | |
| - | | |
| 3,729 | | |
| (3,729 | ) |
Net loss attributable to common stockholders | |
$ | (1,967,793 | ) | |
$ | (2,235,971 | ) | |
$ | 268,178 | |
Federal
grant funding
Funding
from federal grants for the three months ended June 30, 2024 and 2023 totaled $0.2 million and $0.5 million, respectively. The difference
is due to the timing of research activities eligible for funding, as current funding under the MPAR grant was completed in December 2023.
We expect funding from federal grants to increase in the third quarter due to increased preclinical activities under the OUD grant following
the recent selection of a lead drug candidate.
Research
and development expenses
Research
and development expenses for the three months ended June 30, 2024 and 2023 were $0.9 million and $1.6 million, respectively, representing
a decrease of $0.7 million. The decrease was primarily the result of reduced external research and development costs related to clinical
and pre-clinical programs for PF614 and PF614-MPAR. We do not currently track expenses on a program-by-program basis. We expect future
research and development expenses to approximate current levels but may need to adjust the timing of research and development based on
our ability to raise capital sufficient to fund these expenses.
General
and administrative expenses
General
and administrative expenses for the three months ended June 30, 2024 and 2023 were $1.2 million and $1.1 million, respectively, representing
an increase of $0.1 million. We expect future general and administrative expenses to approximate current levels.
Other
income and expense
Other
income and expense for the three months ended June 30, 2024, consisted primarily of interest expenses associated with the amortization
of the original issue discount and the debt issuance costs associated with the 2023 Notes. The comparative period for 2023 consisted
primarily of changes in fair value associated with the Company’s liability-classified warrants.
Results
of Operations
Comparison
of the six months ended June 30, 2024 and 2023:
| |
Six Months Ended June 30 | | |
| |
| |
2024 | | |
2023 | | |
Change | |
Federal grants | |
$ | 487,519 | | |
$ | 1,280,107 | | |
$ | (792,588 | ) |
Operating expenses: | |
| | | |
| | | |
| | |
Research and development | |
| 1,726,133 | | |
| 3,439,742 | | |
| (1,713,609 | ) |
General and administrative | |
| 2,559,791 | | |
| 2,695,553 | | |
| (135,762 | ) |
Total operating expenses | |
| 4,285,924 | | |
| 6,135,295 | | |
| (1,849,371 | ) |
Loss from operations | |
| (3,798,405 | ) | |
| (4,855,188 | ) | |
| 1,056,783 | |
Other income (expense): | |
| | | |
| | | |
| | |
Change in fair value of convertible notes | |
| - | | |
| 146,479 | | |
| (146,479 | ) |
Change in fair value of liability classified warrants | |
| 16,773 | | |
| 262,650 | | |
| (245,877 | ) |
Interest expense | |
| (1,275,628 | ) | |
| (1,497 | ) | |
| (1,274,131 | ) |
Other income, net | |
| (27,096 | ) | |
| 16,448 | | |
| (43,544 | ) |
Total other income, net | |
| (1,285,951 | ) | |
| 424,080 | | |
| (1,710,031 | ) |
Net loss | |
| (5,084,356 | ) | |
| (4,431,108 | ) | |
| (653,248 | ) |
Net loss attributable to noncontrolling interests | |
| (74 | ) | |
| (11,001 | ) | |
| 10,927 | |
Deemed dividend related to warrants down round provision | |
| 290 | | |
| 12,038 | | |
| (11,748 | ) |
Net loss attributable to common stockholders | |
$ | (5,084,572 | ) | |
$ | (4,432,145 | ) | |
$ | (652,427 | ) |
Federal
grant funding
Funding
from federal grants for the six months ended June 30, 2024 and 2023 totaled $0.5 million and $1.3 million, respectively. The difference
is due to the timing of research activities eligible for funding, as current funding under the MPAR grant was completed in December 2023.
We expect funding from federal grants to increase in the second half of 2024 due to increased preclinical activities under the OUD grant
following the recent selection of a lead drug candidate.
Research
and development expenses
Research
and development expenses for the six months ended June 30, 2024 and 2023 were $1.7 million and $3.4 million, respectively, representing
a decrease of $1.7 million. The decrease was primarily the result of reduced external research and development costs related to clinical
and pre-clinical programs for PF614 and PF614-MPAR. We do not currently track expenses on a program-by-program basis. We expect future
research and development expenses to approximate current levels but may need to be adjusted based on our ability to raise capital sufficient
to fund these expenses.
General
and administrative expenses
General
and administrative expenses for the six months ended June 30, 2024 and 2023 were $2.6 million and $2.7 million, respectively, representing
a decrease of $0.1 million. We expect future general and administrative expenses to approximate current levels.
Other
income and expense
Other
income and expense for the six months ended June 30, 2024, consisted primarily of interest expense associated with the amortization of
the original issue discount and the debt issuance costs associated with the 2023 Notes and represented a net change in other income and
expense of $1.3 million compared to the six months ended June 30, 2023. The comparative period for 2023 consisted primarily of changes
in fair value associated with the 2022 Notes and the Company’s liability-classified warrants.
Liquidity
and capital resources
Sources
of liquidity and capital
As
of June 30, 2024, we had $1.0 million of cash and cash equivalents. Since inception, we have generated limited revenues and have incurred
significant operating losses and negative cash flows from our operations, and we anticipate that we will continue to incur losses for
the foreseeable future. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales
of any product candidates for several years, if at all.
We
have funded our operations to date primarily with proceeds from the sale of common equity, funding under federal research grants and
borrowings under convertible promissory notes. To fund future operations, we will need to raise additional capital. The amount and timing
of future funding requirements will depend on many factors, including the timing and results of our ongoing research and development
efforts and related general and administrative support. We anticipate that we will fund our operations through public or private equity
or debt financings or other sources, such as potential collaboration agreements. We cannot make assurances that anticipated additional
financing will be available to us on favorable terms, if at all.
Remaining
cash funding under two approved federal research grants totaled $1.9 million at June 30, 2024 and is expected to be utilized by August
31, 2024. Pursuant to the terms and conditions of the two grants, we are required to submit progress reports to NIDA on an annual basis
and a final research performance progress report within 120 days of the performance period end date.
Going
Concern
We
have generated limited revenues and have incurred significant operating losses since our inception. We expect to continue to incur significant
expenses and operating losses for the foreseeable future. Without capital raised through financing transactions, existing cash resources
are sufficient to allow us to fund current planned operations into the third quarter of 2024, which raises substantial doubt about the
Company’s ability to continue as a going concern.
Cash
flows
The
following table summarizes our cash flows for each of the periods presented:
| |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
Net cash used in operating activities | |
$ | (5,718,294 | ) | |
$ | (6,715,461 | ) |
Net cash provided by (used in) financing activities | |
| 5,637,921 | | |
| 7,397,241 | |
Net increase (decrease) in cash and cash equivalents | |
$ | (80,373 | ) | |
$ | 681,780 | |
Operating
activities
During
the six months ended June 30, 2024 and 2023, we used cash in operating activities of $5.7 million and $6.7 million, respectively. The
decrease primarily resulted from the timing of vendor invoicing and payments and a reduction in research and development activities in
the 2024 period.
Financing
activities
During
the six months ended June 30, 2024, net cash provided by financing activities was $5.6 million, primarily consisting of net proceeds
from warrant exercises and the warrant inducement, less repayment of convertible notes and financed insurance premiums. During the six
months ended June 30, 2023, net cash provided by financing activities was $7.4 million, primarily consisting of net proceeds from the
2023 February and 2023 May Offerings, less repayment of convertible notes and financed insurance premiums.
Funding
requirements
Our
primary use of cash is to fund operating expenses, primarily related to our research and development activities. Cash used to fund operating
expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued
expenses and prepaid expenses.
We
expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities
and clinical trials of our product candidates. In addition, we have incurred, and will continue to incur, additional costs associated
with operating as a public company, including significant legal, accounting, insurance, investor relations and other expenses. The timing
and amount of our operating expenditures will depend largely on our ability to:
|
● |
advance
preclinical development of our early-stage programs and clinical trials of our product candidates; |
|
|
|
|
● |
manufacture,
or have manufactured on our behalf, preclinical and clinical drug material and develop processes for late state and commercial manufacturing; |
|
|
|
|
● |
seek
regulatory approvals for any product candidates that successfully complete clinical trials; |
|
|
|
|
● |
establish
a sales, marketing, medical affairs and distribution infrastructure to commercialize any product candidates for which we may obtain
marketing approval and intend to commercialize on our own; |
|
|
|
|
● |
hire
additional clinical, quality control and scientific personnel; |
|
|
|
|
● |
expand
our operational, financial and management systems and increase personnel, including personnel to support our clinical development,
manufacturing and commercialization efforts and our operations as a public company; |
|
|
|
|
● |
obtain,
maintain, expand and protect our intellectual property portfolio; |
|
|
|
|
● |
manage
the costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights,
including enforcing and defending intellectual property related claims; and |
|
|
|
|
● |
manage
the costs of operating as a public company. |
Commitments
Our
commitments as of June 30, 2024, included approximately $16 million related to 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 us
the option to cancel, reschedule, and adjust requirements based on our business needs prior to the delivery of goods or the performance
of services.
Working
capital
Because
of the numerous risks and uncertainties associated with research, development and commercialization of biologic product candidates, we
are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could
increase significantly because of many factors, including:
|
● |
the
scope, progress, results and costs of researching and developing our product candidates, and conducting preclinical and clinical
trials; |
|
|
|
|
● |
the
costs, timing and outcome of regulatory review of our product candidates; |
|
|
|
|
● |
the
costs, timing and ability to manufacture our product candidates to supply our clinical and preclinical development efforts and our
clinical trials; |
|
|
|
|
● |
the
costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product
candidates for which we receive marketing approval; |
|
|
|
|
● |
the
costs of manufacturing commercial-grade product and necessary inventory to support commercial launch; |
|
|
|
|
● |
the
ability to receive additional non-dilutive funding, including grants from organizations and foundations; |
|
|
|
|
● |
the
revenue, if any, received from commercial sale of our products, should any of our product candidates receive marketing approval; |
|
|
|
|
● |
the
costs of preparing, filing and prosecuting patent applications, obtaining, maintaining, expanding and enforcing our intellectual
property rights and defending intellectual property-related claims; |
|
|
|
|
● |
our
ability to establish and maintain collaborations on favorable terms, if at all; and |
|
|
|
|
● |
the
extent to which we acquire or in-license other product candidates and technologies. |
Critical
Accounting Policies and Significant Judgments and Estimates
Our
consolidated financial statements are prepared in accordance with GAAP. The preparation of our consolidated financial statements and
related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses.
We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under
the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that
are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ
from these estimates under different assumptions or conditions.
While
our significant accounting policies are described in more detail in Note 3 to our audited consolidated financial statements included
in our 2023 Annual Report on Form 10-K, we believe that the following accounting policy is the most critical to the judgments and estimates
used in the preparation of our consolidated financial statements.
Accrued
Research and Development Expenses
As
part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development
expenses. This process involves reviewing open contracts and purchase orders, communicating with our applicable personnel to identify
services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the
service when it has not yet been invoiced or otherwise notified of actual costs. Many of our service providers invoice us in arrears
for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments.
We make estimates of our accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances
known to us at that time. We periodically confirm the accuracy of the estimates with the service providers and adjust if necessary. Examples
of estimated accrued research and development expenses include fees paid to:
|
● |
vendors,
including research laboratories, in connection with preclinical development activities; |
|
|
|
|
● |
CROs
and investigative sites in connection with preclinical studies and clinical trials; and |
|
|
|
|
● |
CMOs
in connection with drug substance and drug product formulation of preclinical studies and clinical trial materials. |
We
base our expenses related to preclinical studies and clinical trials on our estimates of the services received and efforts expended pursuant
to quotes and contracts with multiple research institutions and CROs that supply, conduct and manage preclinical studies and clinical
trials on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result
in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and
result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful enrollment of
patients and the completion of clinical trial milestones. In accruing service fees, we estimate the time period over which services will
be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level
of effort varies from the estimate, we adjust the accrual or the prepaid expense accordingly. Although we do not expect our estimates
to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative
to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any
particular period.
Off-Balance
Sheet Arrangements
We
do not have during the periods presented, and do not currently have, any off-balance sheet arrangements, as defined in the rules and
regulations of the SEC.
Recently
issued accounting pronouncements
A
description of recently issued accounting pronouncements that may potentially impact Ensysce’s financial position and results of
operations is disclosed in Note 3 to our consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Smaller
reporting company status
We
are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage
of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We
will remain a smaller reporting company until the last day of the fiscal year in which (i) the market value of our common stock held
by non-affiliates exceeds $250 million as of the prior June 30, or (ii) our annual revenues exceeded $100 million during such completed
fiscal year and the market value of our common stock held by non-affiliates exceeds $700 million as of the prior June 30.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
We
are exposed to market risk in the ordinary course of our business, primarily related to changes in interest rates and inflation.
Interest
Rate Risk
Our
cash and cash equivalents as of June 30, 2024, consisted of cash and a money market fund account. Because of the short-term nature of
our money market fund, a sudden change in market interest rates would not be expected to have a material impact on our financial position
or results of operations.
Inflation
Risk
We
do not believe that inflation and changing prices had a significant impact on our results of operations for any periods presented herein.
Item
4. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
Our
disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports that we file or submit
under the Securities Exchange Act of 1934 as amended (the “Exchange Act”) is recorded, processed, summarized and reported
within the time periods specified in the rules and forms of the SEC, and that such information is accumulated and communicated to our
management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required
disclosure. Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness
of our disclosure controls and procedures (as defined in Exchange Act Rule 13a–15(e) and 15d-15(e)) as of June 30, 2024. Based
on that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and
procedures were effective as of June 30, 2024. Management has concluded that our financial statements included in this Quarterly Report
on Form 10-Q are fairly stated in all material respects in accordance with GAAP for each of the periods presented therein.
Changes
in Internal Control Over Financial Reporting
There
were no changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the
Exchange Act) during the fiscal quarter to which this report relates that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
PART
II—OTHER INFORMATION
Item
1. Legal Proceedings.
From
time to time, we 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,
we review 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, we accrue 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, we reassess the potential liability related
to pending claims and litigation.
Item
1A. Risk Factors.
While
we attempt to identify, manage and mitigate risks and uncertainties associated with our business to the extent practical, under the circumstances,
some level of risk and uncertainty will always be present. Part I, Item 1A. Risk Factors of our 2023 Annual Report on Form 10-K includes
a detailed discussion of our risk factors. Those risks and uncertainties have the potential to materially affect our financial condition
and results of operations.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item
3. Defaults Upon Senior Securities.
Not
applicable.
Item
4. Mine Safety Disclosures.
Not
applicable.
Item
5. Other Information
None.
Item
6. Exhibits.
The
following exhibits are filed as part of this report:
*
Filed herewith.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
ENSYSCE
BIOSCIENCES, INC. |
|
|
Date:
August 14, 2024 |
/s/
David Humphrey |
|
David
Humphrey |
|
Chief
Financial Officer, Secretary and Treasurer |
Exhibit
31.1
CERTIFICATION
PURSUANT TO
RULES
13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS
ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Lynn Kirkpatrick, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of Ensysce Biosciences, Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: |
|
a. |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
(Paragraph
omitted pursuant to SEC Release Nos. 33-8238/34-47986 and 33-8392/34-49313); |
|
|
|
|
c. |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures, and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d. |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
a. |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b. |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
August 14, 2024 |
|
|
|
|
/s/
Lynn Kirkpatrick |
|
Name: |
Lynn
Kirkpatrick |
|
Title: |
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
Exhibit
31.2
CERTIFICATION
PURSUANT TO
RULES
13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS
ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
David Humphrey, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of Ensysce Biosciences, Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: |
|
a. |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
(Paragraph
omitted pursuant to SEC Release Nos. 33-8238/34-47986 and 33-8392/34-49313); |
|
|
|
|
c. |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures, and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d. |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
a. |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b. |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
August 14, 2024 |
|
|
|
|
/s/
David Humphrey |
|
Name: |
David
Humphrey |
|
Title: |
Chief
Financial Officer |
|
|
(Principal
Financial Officer) |
Exhibit
32.1
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Ensysce Biosciences, Inc. (the “Company”) on Form 10-Q for the period ended June
30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Lynn Kirkpatrick, Chief
Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002, that to my knowledge:
|
(1) |
The
Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
|
|
(2) |
The
information contained in the Report fairly presents, in all material respects, the financial condition of the Company at the end
of the period covered by the Report and results of operations of the Company for the period covered by the Report. |
Date:
August 14, 2024 |
/s/
Lynn Kirkpatrick |
|
Lynn
Kirkpatrick |
|
Chief
Executive Officer |
|
(Principal
Executive Officer) |
This
certification accompanies the Report and shall not be deemed “filed” by the Company with the Securities and Exchange Commission
and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities
Exchange Act of 1934, as amended (whether made before or after the date of the Report), irrespective of any general incorporation language
contained in such filing.
Exhibit
32.2
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Ensysce Biosciences, Inc. (the “Company”) on Form 10-Q for the period ended June
30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, David Humphrey, Chief
Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002, that to my knowledge:
|
1) |
The
Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
|
|
2) |
The
information contained in the Report fairly presents, in all material respects, the financial condition of the Company at the end
of the period covered by the Report and results of operations of the Company for the period covered by the Report. |
Dated:
August 14, 2024 |
/s/
David Humphrey |
|
David
Humphrey |
|
Chief
Financial Officer |
|
(Principal
Financial Officer) |
This
certification accompanies the Report and shall not be deemed “filed” by the Company with the Securities and Exchange Commission
and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities
Exchange Act of 1934, as amended (whether made before or after the date of the Report), irrespective of any general incorporation language
contained in such filing.
v3.24.2.u1
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v3.24.2.u1
Consolidated Balance Sheets (Unaudited) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 1,043,231
|
$ 1,123,604
|
Unbilled receivable |
224,223
|
97,561
|
Prepaid expenses and other current assets |
1,192,283
|
1,067,703
|
Total current assets |
2,459,737
|
2,288,868
|
Other assets |
335,883
|
419,217
|
Total assets |
2,795,620
|
2,708,085
|
Current liabilities: |
|
|
Accounts payable |
481,971
|
1,936,007
|
Accrued expenses and other liabilities |
370,186
|
542,260
|
Notes payable and accrued interest |
454,463
|
854,697
|
Total current liabilities |
1,306,620
|
3,332,964
|
Long-term liabilities: |
|
|
Liability classified warrants |
9,615
|
26,388
|
Total long-term liabilities |
9,615
|
26,388
|
Total liabilities |
1,316,235
|
3,359,352
|
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, 2024 (unaudited) and December 31, 2023 |
|
|
Common stock, $0.0001 par value, 250,000,000 shares authorized at June 30, 2024 (unaudited) and December 31, 2023; 8,151,253 and 3,146,157 shares issued at June 30, 2024 (unaudited) and December 31, 2023, respectively; 8,151,172 and 3,146,076 shares outstanding at June 30, 2024 (unaudited) and December 31, 2023, respectively |
815
|
315
|
Additional paid-in capital |
128,448,699
|
121,233,901
|
Accumulated deficit |
(126,641,646)
|
(121,557,074)
|
Total Ensysce Biosciences, Inc. stockholders’ equity (deficit) |
1,807,868
|
(322,858)
|
Noncontrolling interests in stockholders’ deficit |
(328,483)
|
(328,409)
|
Total stockholders’ equity (deficit) |
1,479,385
|
(651,267)
|
Total liabilities and stockholders’ equity (deficit) |
$ 2,795,620
|
$ 2,708,085
|
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v3.24.2.u1
Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
1,500,000
|
1,500,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
250,000,000
|
250,000,000
|
Common stock, shares issued |
8,151,253
|
3,146,157
|
Common stock, shares outstanding |
8,151,172
|
3,146,076
|
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v3.24.2.u1
Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Federal grants |
$ 181,797
|
$ 490,472
|
$ 487,519
|
$ 1,280,107
|
Operating expenses: |
|
|
|
|
Research and development |
947,229
|
1,643,726
|
1,726,133
|
3,439,742
|
General and administrative |
1,190,010
|
1,140,700
|
2,559,791
|
2,695,553
|
Total operating expenses |
2,137,239
|
2,784,426
|
4,285,924
|
6,135,295
|
Loss from operations |
(1,955,442)
|
(2,293,954)
|
(3,798,405)
|
(4,855,188)
|
Other income (expense): |
|
|
|
|
Change in fair value of convertible notes |
|
|
|
146,479
|
Change in fair value of liability classified warrants |
7,818
|
43,622
|
16,773
|
262,650
|
Interest expense, net |
(27,563)
|
|
(1,275,628)
|
(1,497)
|
Other income, net |
7,394
|
11,030
|
(27,096)
|
16,448
|
Total other income (expense), net |
(12,351)
|
54,652
|
(1,285,951)
|
424,080
|
Net loss |
(1,967,793)
|
(2,239,302)
|
(5,084,356)
|
(4,431,108)
|
Net loss attributable to noncontrolling interests |
|
(7,060)
|
(74)
|
(11,001)
|
Deemed dividend related to warrants down round provision |
|
3,729
|
290
|
12,038
|
Net loss attributable to common stockholders |
$ (1,967,793)
|
$ (2,235,971)
|
$ (5,084,572)
|
$ (4,432,145)
|
Net loss per basic and diluted share: |
|
|
|
|
Net loss per share attributable to common stockholders, basic |
$ (0.22)
|
$ (0.98)
|
$ (0.67)
|
$ (2.66)
|
Net loss per share attributable to common stockholders, diluted |
$ (0.22)
|
$ (0.98)
|
$ (0.67)
|
$ (2.66)
|
Weighted average common shares outstanding, basic |
8,817,316
|
2,274,113
|
7,640,192
|
1,667,527
|
Weighted average common shares outstanding, diluted |
8,817,316
|
2,274,113
|
7,640,192
|
1,667,527
|
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v3.24.2.u1
Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Noncontrolling Interest [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 53
|
$ 107,216,566
|
$ (110,931,063)
|
$ (315,208)
|
$ (4,029,652)
|
Balance, shares at Dec. 31, 2022 |
534,490
|
|
|
|
|
Settlement of restricted stock units |
|
|
|
|
|
Settlement of restricted stock units, shares |
624
|
|
|
|
|
Public offerings, net |
$ 139
|
9,049,865
|
|
|
9,050,004
|
Public offerings, net, shares |
1,381,619
|
|
|
|
|
Transaction costs associated with public offerings |
|
(447,879)
|
|
|
(447,879)
|
Issuance of common stock upon exercise of warrants |
$ 30
|
(30)
|
|
|
|
Issuance of common stock upon exercise of warrants, shares |
300,897
|
|
|
|
|
Stock-based compensation |
|
194,550
|
|
|
194,550
|
Deemed dividend related to warrants down round provision |
|
12,038
|
(12,038)
|
|
|
Net loss |
|
|
(4,420,107)
|
(11,001)
|
(4,431,108)
|
Settlement of commitment fee |
$ 4
|
399,996
|
|
|
400,000
|
Settlement of commitment fee, shares |
44,444
|
|
|
|
|
Conversion of convertible notes |
$ 41
|
3,056,851
|
|
|
3,056,892
|
Conversion of convertible notes, shares |
408,580
|
|
|
|
|
Reverse split fractional shares |
|
|
|
|
|
Reverse split fractional shares, shares |
(862)
|
|
|
|
|
Balance at Jun. 30, 2023 |
$ 267
|
119,481,957
|
(115,363,208)
|
(326,209)
|
3,792,807
|
Balance, shares at Jun. 30, 2023 |
2,669,792
|
|
|
|
|
Balance at Mar. 31, 2023 |
$ 128
|
113,293,834
|
(113,127,237)
|
(319,149)
|
(152,424)
|
Balance, shares at Mar. 31, 2023 |
1,284,583
|
|
|
|
|
Settlement of restricted stock units |
|
|
|
|
|
Settlement of restricted stock units, shares |
312
|
|
|
|
|
Public offerings, net |
$ 109
|
6,360,843
|
|
|
6,360,952
|
Public offerings, net, shares |
1,084,000
|
|
|
|
|
Transaction costs associated with public offerings |
|
(253,836)
|
|
|
(253,836)
|
Issuance of common stock upon exercise of warrants |
$ 30
|
(30)
|
|
|
|
Issuance of common stock upon exercise of warrants, shares |
300,897
|
|
|
|
|
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 at Jun. 30, 2023 |
$ 267
|
119,481,957
|
(115,363,208)
|
(326,209)
|
3,792,807
|
Balance, shares at Jun. 30, 2023 |
2,669,792
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 315
|
121,233,901
|
(121,557,074)
|
(328,409)
|
(651,267)
|
Balance, shares at Dec. 31, 2023 |
3,146,076
|
|
|
|
|
Settlement of restricted stock units |
|
|
|
|
|
Settlement of restricted stock units, shares |
63
|
|
|
|
|
Issuance of common stock upon exercise of warrants |
$ 132
|
2,075,087
|
|
|
2,075,219
|
Issuance of common stock upon exercise of warrants, shares |
1,323,904
|
|
|
|
|
Stock-based compensation |
|
59,756
|
|
|
59,756
|
Deemed dividend related to warrants down round provision |
|
290
|
(290)
|
|
|
Net loss |
|
|
(5,084,282)
|
(74)
|
(5,084,356)
|
Issuance of common stock upon warrant inducement, net of issuance costs |
$ 293
|
4,718,002
|
|
|
4,718,295
|
Issuance of common stock upon warrant inducement, net of issuance costs, shares |
2,935,608
|
|
|
|
|
Conversion of convertible notes |
$ 75
|
1,168,525
|
|
|
$ 1,168,600
|
Conversion of convertible notes, shares |
745,521
|
|
|
|
745,521
|
Transaction costs associated with warrant inducement |
|
(806,862)
|
|
|
$ (806,862)
|
Balance at Jun. 30, 2024 |
$ 815
|
128,448,699
|
(126,641,646)
|
(328,483)
|
1,479,385
|
Balance, shares at Jun. 30, 2024 |
8,151,172
|
|
|
|
|
Balance at Mar. 31, 2024 |
$ 733
|
128,422,232
|
(124,673,853)
|
(328,483)
|
3,420,629
|
Balance, shares at Mar. 31, 2024 |
7,329,172
|
|
|
|
|
Stock-based compensation |
|
26,549
|
|
|
26,549
|
Net loss |
|
|
(1,967,793)
|
|
(1,967,793)
|
Issuance of common stock upon warrant inducement, net of issuance costs |
$ 82
|
(82)
|
|
|
|
Issuance of common stock upon warrant inducement, net of issuance costs, shares |
822,000
|
|
|
|
|
Balance at Jun. 30, 2024 |
$ 815
|
$ 128,448,699
|
$ (126,641,646)
|
$ (328,483)
|
$ 1,479,385
|
Balance, shares at Jun. 30, 2024 |
8,151,172
|
|
|
|
|
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v3.24.2.u1
Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Cash flows from operating activities: |
|
|
Net loss |
$ (5,084,356)
|
$ (4,431,108)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Accrued interest and interest expense related to note conversions |
29,113
|
1,497
|
Amortization of original issue discount and debt issuance costs |
1,197,200
|
|
Change in fair value of convertible notes |
|
(146,479)
|
Change in fair value of liability classified warrants |
(16,773)
|
(262,650)
|
Stock-based compensation |
59,756
|
194,550
|
Lease cost |
|
(90)
|
Changes in operating assets and liabilities: |
|
|
Unbilled receivable |
(126,662)
|
169,243
|
Prepaid expenses and other assets |
190,909
|
469,404
|
Accounts payable |
(1,795,404)
|
(1,669,162)
|
Accrued expenses and other liabilities |
(172,077)
|
(1,040,666)
|
Net cash used in operating activities |
(5,718,294)
|
(6,715,461)
|
Cash flows from financing activities: |
|
|
Proceeds public offering, net |
|
9,050,004
|
Proceeds from warrant exercises |
2,075,219
|
|
Proceeds from warrant inducement, net of issuance costs |
4,718,295
|
|
Transaction costs associated with public offering |
|
(447,879)
|
Transaction costs associated with warrant inducement |
(465,494)
|
|
Repayment of convertible notes |
(485,190)
|
(1,000,208)
|
Repayment of financed insurance premiums |
(204,909)
|
(204,676)
|
Net cash provided by financing activities |
5,637,921
|
7,397,241
|
Increase (decrease) in cash and cash equivalents |
(80,373)
|
681,780
|
Cash and cash equivalents beginning of period |
1,123,604
|
3,147,702
|
Cash and cash equivalents end of period |
1,043,231
|
3,829,482
|
Supplemental disclosure of non-cash investing and financing activities: |
|
|
Incremental fair value of February 2024 warrant inducement |
5,167,372
|
|
Conversions of convertible notes into common stock |
1,168,600
|
3,056,892
|
Transaction costs from warrant inducement |
341,368
|
|
Deemed dividend related to warrants down round provision |
290
|
12,038
|
Financed insurance premiums |
235,155
|
445,737
|
Settlement of commitment fee in shares |
|
$ 400,000
|
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v3.24.2.u1
ORGANIZATION AND PRINCIPAL ACTIVITIES
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
ORGANIZATION AND PRINCIPAL ACTIVITIES |
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 Resistant) 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 9.9% and 10.9% of the shares held by a certain key person of the Company and two unrelated parties, 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.
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- DefinitionThe entire disclosure for the business description and basis of presentation concepts. Business description describes the nature and type of organization including but not limited to organizational structure as may be applicable to holding companies, parent and subsidiary relationships, business divisions, business units, business segments, affiliates and information about significant ownership of the reporting entity. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.24.2.u1
BASIS OF PRESENTATION
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
BASIS OF PRESENTATION |
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.
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 six months ended June 30, 2024, are not necessarily indicative of the results that may be expected
for the year ending December 31, 2024. 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, 2023, which may be found in the Company’s Form 10-K filed with the SEC on March 15, 2024.
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. There is no assurance that profitable operations will ever be achieved, and, if achieved,
will 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.
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.
|
X |
- DefinitionThe entire disclosure for the basis of accounting, or basis of presentation, used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
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.
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. Additionally, the Company had concentration in accounts
payable, as two research and development vendors made up greater than 10% individually, and 31% and 38% in aggregate, of the outstanding
accounts payable balance as of June 30, 2024 and December 31, 2023, respectively.
Property
and equipment
Property
and equipment are fully depreciated and as such there is no depreciation expense recognized in the periods presented.
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, 2024, and December 31, 2023, 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.
Warrants
The
Company issued liability-classified warrants in connection with the issuance of the 2021 Notes and 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 June
30, 2024, and December 31, 2023.
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
June 30, 2024 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Liability classified warrants | |
$ | 9,615 | | |
$ | - | | |
$ | - | | |
$ | 9,615 | |
Total | |
$ | 9,615 | | |
$ | - | | |
$ | - | | |
$ | 9,615 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
December 31, 2023 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Liability classified warrants | |
| 26,388 | | |
| - | | |
| - | | |
| 26,388 | |
Total | |
$ | 26,388 | | |
$ | - | | |
$ | - | | |
$ | 26,388 | |
The
following table summarizes the change in fair value of the Company’s Level 3 liabilities for the six months ended June 30, 2024
(no level 3 assets as of the six months ended June 30, 2024):
SCHEDULE
OF CHANGE IN FAIR VALUE OF COMPANY’S LEVEL 3
| |
Liability
classified
warrants | |
Fair value, December 31, 2023 | |
$ | 26,388 | |
Change in fair value | |
| (16,773 | ) |
Fair value, June 30, 2024 | |
$ | 9,615 | |
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 initial grant was extended several times and cumulative funding under this grant of approximately
$10.7 million was completed in December 2023.
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 August 31, 2024. As of June 30, 2024, the remaining cash funding under the grant is $1.9 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 RECOGNITION UNDER GRANTS
| |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
MPAR | |
$ | - | | |
$ | 437,263 | | |
$ | - | | |
$ | 918,542 | |
TAAP/OUD | |
| 181,797 | | |
| 53,209 | | |
| 487,519 | | |
| 361,565 | |
Total | |
$ | 181,797 | | |
$ | 490,472 | | |
$ | 487,519 | | |
$ | 1,280,107 | |
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 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.
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 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. Basic shares outstanding include the weighted average effect
of the Company’s outstanding pre-funded warrants and abeyance shares, which require no consideration for the delivery of shares
of common stock. Diluted net loss per share is calculated by adjusting basic shares outstanding for the dilutive effect of common share
equivalents outstanding for 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 (the Company has utilized the principal balance outstanding and the end of period conversion price
for the Convertible Notes for the purposes of the weighted average share calculation below):
SCHEDULE
OF WEIGHTED AVERAGE SHARES OF ANTI-DILUTIVE SECURITIES
| |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Stock options | |
| 580,188 | | |
| 26,354 | | |
| 580,188 | | |
| 26,354 | |
RSUs | |
| - | | |
| 377 | | |
| - | | |
| 377 | |
Warrants | |
| 11,005,004 | | |
| 3,017,026 | | |
| 10,373,633 | | |
| 1,938,542 | |
Convertible notes | |
| 137,799 | | |
| - | | |
| 137,799 | | |
| - | |
Total | |
| 11,722,991 | | |
| 3,043,757 | | |
| 11,091,620 | | |
| 1,965,273 | |
Recently
Issued Accounting Pronouncements
In
November 2023, the FASB issued ASU 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures”,
which sets forth improvements to the current segment disclosure requirements in accordance with Topic 280 “Segment Reporting,”
including clarifying that entities with a single reportable segment are subject to both new and existing segment reporting requirements.
ASU 2023-07 will be effective retrospectively for fiscal years beginning after December 15, 2023, and interim periods beginning after
December 15, 2024. Adoption of this ASU is currently being evaluated by the Company.
In
December 2023, the FASB issued ASU No. 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” ASU 2023-09
requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income
taxes paid. ASU 2023-09 is effective for public entities with annual periods beginning after December 15, 2024, with early adoption permitted.
The Company is currently evaluating the impact of this guidance on its consolidated financial statements.
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v3.24.2.u1
PREPAID EXPENSES AND OTHER CURRENT ASSETS
|
6 Months Ended |
Jun. 30, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
PREPAID EXPENSES AND OTHER CURRENT ASSETS |
NOTE
4 – PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets consisted of the following:
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
June 30, 2024 | | |
December 31, 2023 | |
Prepaid research and development | |
$ | 539,208 | | |
$ | 535,474 | |
Prepaid insurance | |
| 418,215 | | |
| 441,871 | |
Other prepaid expenses | |
| 170,439 | | |
| 72,358 | |
Other current assets | |
| 64,421 | | |
| 18,000 | |
Total prepaid expenses and other current assets | |
$ | 1,192,283 | | |
$ | 1,067,703 | |
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v3.24.2.u1
ACCRUED EXPENSES AND OTHER LIABILITIES
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
ACCRUED EXPENSES AND OTHER LIABILITIES |
NOTE
5 – ACCRUED EXPENSES AND OTHER LIABILITIES
Accrued
expenses and other liabilities consisted of the following:
SCHEDULE
OF ACCRUED EXPENSES AND OTHER LIABILITIES
| |
June 30, 2024 | | |
December 31, 2023 | |
Accrued research and development | |
$ | 208,992 | | |
$ | 329,228 | |
Professional fees | |
| 26,950 | | |
| 110,202 | |
Other accrued liabilities | |
| 134,244 | | |
| 102,830 | |
Total accrued expenses and other liabilities | |
$ | 370,186 | | |
$ | 542,260 | |
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENCIES |
NOTE
6 – COMMITMENTS AND CONTINGENCIES
Purchase
Commitments
As
of June 30, 2024, the Company’s commitments included approximately $16 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, 2024, and December 31, 2023, 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, 2024, with no contracted option to renew.
As of June 30, 2024, the future lease payments totaled $11,363. The Company recognized total rent expense of $8,747 and $17,495 in the
three and six months ended June 30, 2024 and $8,375 and $16,749 in the three and six-months ended June 30, 2023.
Share
Subscription Facility
In
December 2020, the Company executed the GEM Agreement, under which an 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. Concurrent with the public listing of the Company’s shares on July 2, 2021, the Company issued to
the investor 4,608 warrants with a three-year term to purchase common stock of Ensysce at an exercise price of $2,402.40 per share, subsequently
reduced to $1.06 at February 12, 2024 (Note 8). 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.
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v3.24.2.u1
NOTES PAYABLE
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
NOTES PAYABLE |
NOTE
7 – NOTES PAYABLE
The
following table provides a summary of the Company’s outstanding debt as of June 30, 2024:
SCHEDULE
OF DEBT
| |
Principal
balance | | |
Accrued
interest | | |
Net debt
balance | |
2023 Notes | |
$ | 216,000 | | |
| 6,308 | | - |
| 222,308 | |
Financed insurance | |
| 232,155 | | |
| - | | - |
| 232,155 | |
Total | |
$ | 448,155 | | |
$ | 6,308 | | - |
$ | 454,463 | |
The
following table provides a summary of the Company’s outstanding debt as of December 31, 2023:
| |
December 31, 2023 | |
| |
Principal
balance | | |
Accrued
interest | | |
Unamortized
Debt
Discount and
Issuance Costs | | |
Net debt
balance | |
2023 Notes | |
$ | 1,836,000 | | |
$ | 13,078 | | |
$ | (1,197,200 | ) | |
$ | 651,878 | |
Financed insurance | |
| 197,249 | | |
| 5,570 | | |
| - | | |
| 202,819 | |
Total | |
$ | 2,033,249 | | |
$ | 18,648 | | |
$ | (1,197,200 | ) | |
$ | 854,697 | |
Interest
Expense
The
interest expense recognized for financed insurance was $148 and $2,092 for the three and six months ended June 30, 2024 and $0 and $1,497
for the three and six months ended June 30, 2023. Interest expense recognized for the 2023 Notes was $27,563 and $1.3 million for the
three and six months ended June 30, 2024, which consists of amortization of the debt discount and debt issuance costs and incurred and
accrued interest.
2023
Notes
On
October 23, 2023, the Company entered into a Securities Purchase Agreement (“SPA”) for an aggregate financing of $1.8 million
with investors, including $0.2 million with a board member. At the first closing under the SPA, which occurred on October 25, 2023, the
Company issued to the investors (i) senior secured convertible promissory notes in the aggregate principal amount of $612,000 for an
aggregate purchase price of $566,667 and (ii) warrants to purchase 1,255,697 shares of the Company’s common stock, par value $0.0001
per share in the aggregate. At the second closing under the SPA, which occurred on November 29, 2023, the Company issued to the investors
referenced above, (i) additional notes in the aggregate principal amount of $1,224,000 for an aggregate purchase price of $1,133,333
and (ii) additional warrants to purchase 2,511,394 shares of the common stock in the aggregate. The notes were scheduled to mature on
April 25, 2024 and May 28, 2024, respectively.
The
combined notes are subject to an original issue discount of 8%, have an original term of six months from their respective date of issuance
and accrue interest at the rate of 6.0% per annum. The notes are convertible into common stock, at a per share conversion price equal
to $1.5675. Beginning ninety days following issuance of the respective notes, the Company was obligated to redeem monthly one third of
the original principal amount under the applicable note, plus accrued but unpaid interest, liquidated damages and any other amounts then
owing to the holder of such note. The Company is required to pay the redemption amount in cash with a premium of 10% or, at the election
of the purchaser at any time, some or all of the principal amount and interest may be paid by conversion of shares under the note into
common stock based on a conversion price equal to $1.5675. The Company determined the 2023 Notes are to be accounted for as conventional
convertible debt as they provide for the holder an option to convert the outstanding balances into a fixed number of shares (or an equivalent
amount of cash at the discretion of the Company) and the option to convert meets the definition of an exception from derivative accounting.
As a result, the Company reflected the outstanding principal amount, the remaining unamortized discount (both original issue discount
and the relative fair value discount associated with the warrants discussed below) and the remaining debt issuance costs as a net amount
on the face of the balance sheet. The amortization of the original debt discount (approximately $0.1 million) and issuance costs (approximately
$0.3 million) was recorded as interest expense within the consolidated statements of operations. As of June 30, 2024, the original debt
discount and issuance costs were fully amortized to interest expense.
The
warrants have an exercise price of $1.5675, the same as the conversion price, and are exercisable for five years following the issuance
date. The warrants were equity classified as they are indexed to the Company’s stock and only settleable in shares. The warrants
were initially measured at fair value using a Black-Scholes valuation model and were allocated along with the 2023 Notes using the relative
fair value method. The initial fair value of $1.1 million allocated to the warrants was considered a debt discount and will be amortized
to interest expense over the remaining term of the notes. As of June 30, 2024, the discount associated with the warrants was fully amortized
to interest expense.
During
2024, the Company converted 745,521 shares of common stock with a conversion value of $1.2 million related to the 2023 Notes. In addition,
in connection with the SPA, the Company incurred a $1.0 million waiver fee in connection to the 2024 Warrant Inducement (see Note 8)
to pay down $0.5 million of 2023 Notes and $0.5 million in transaction costs recorded as such in the consolidated statement of stockholders’
equity. As of June 30, 2024, the remaining amount of the 2023 Notes relates to senior secured convertible promissory notes held with
a Company board member (see Note 10).
Financed
insurance premiums
In
June 2024, the Company renewed and financed its directors’ and officers’ liability insurance in the amount of $0.2 million.
Monthly payments are scheduled from July 2024 through March 2025.
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v3.24.2.u1
STOCKHOLDERS’ EQUITY
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
STOCKHOLDERS’ EQUITY |
NOTE
8 - STOCKHOLDERS’ EQUITY
The
Company’s current Certificate of Incorporation authorizes 250,000,000 shares of common stock and 1,500,000 shares of preferred
stock, both with par value equal to $0.0001. As of June 30, 2024, and December 31, 2023, there were no shares of preferred stock issued
and outstanding.
2024
Warrant Inducement
On
February 12, 2024, the Company executed an Inducement Letter with certain holders of existing warrants to purchase up to an aggregate
of 3,601,752 shares of the Company’s common stock issued to the holders in connection with the 2023 May Offering. Pursuant to the
Inducement Letter, the holders agreed to exercise for cash their existing warrants to purchase an aggregate of 3,601,752 shares of Common
Stock at a reduced exercise price of $1.31 per share in consideration of the Company’s agreement to issue new unregistered Series
A Warrants (the “Series A Warrants”) to purchase up to 3,601,752 shares of Common Stock and new unregistered Series B Warrants
(the “Series B Warrants”) to purchase up to 3,601,752 shares of Common Stock (collectively, the “New Warrant Shares”).
The Series A Warrants have an exercise price of $1.06 per share and have a term equal to eighteen months from the date of issuance. The
Series B Warrants have an exercise price of $1.06 per share and will expire on May 12, 2028. The gross proceeds to the Company from the
exercise of the warrants were approximately $4.7 million, prior to deducting placement agent fees and estimated offering expenses. As
the existing warrants and the new warrants were equity classified before and after the exchange, and as the exchange is directly attributable
to an equity offering, the Company recognized the effect of the modification of approximately $5.2 million as an equity issuance cost.
In
connection with the execution of the Inducement Letter, the Company executed a waiver related to the 2023 Notes’ SPA it had entered
as of October 23, 2023. The SPA contained restrictions on the Company’s ability to undertake certain transactions, which included
the execution of the Inducement Letter. The Waiver permitted the Company to execute the Inducement Letter but required repayment of the
certain investor held notes issued under the SPA with a premium following closing of the transaction contemplated thereby. Refer to Note
7 for the details of the waiver fee and the application of the amounts to the outstanding notes and as a transaction cost of the warrant
inducement.
The
Company utilized an exclusive placement agent for the 2024 Warrant Inducement and incurred approximately $0.3 million in legal fees and
other closing costs. Additionally, the Company issued to the placement agent as compensation unregistered warrants to purchase up to
252,123 shares of Common Stock, equal to 7.0% of the aggregate number of shares of Common Stock (or warrants) placed in the transaction.
The placement agent warrants expire on May 12, 2028, and have an exercise price of $1.6375 per share of Common Stock (equal to 125% of
the reduced exercise price per Existing Warrant).
The
closing of the offering occurred on February 14, 2024.
Abeyance
Shares
Related
to the 2024 Warrant Inducement, a holder left 1,488,144 shares in abeyance at the Company’s transfer agent to be delivered to the
holder at their request. During the quarter ended June 30, 2024, 822,000 shares held in abeyance were delivered to the holder and the
remaining shares are held in abeyance. Accordingly, as of June 30, 2024, 666,144 shares were held in abeyance, have not been issued and
are not outstanding.
Warrants
The
following table provides a summary of outstanding warrants to purchase shares of common stock as of June 30, 2024:
SCHEDULE
OF OUTSTANDING WARRANT
Reference | |
Shares
Underlying
Outstanding
Warrants | | |
Exercise
Price | | |
Description | |
Classification |
(a) | |
| 63,659 | | |
$ | 2,400.00 - 2,760.00 | | |
LACQ warrants | |
Equity |
(b) | |
| 4,608 | | |
$ | 1.31 | | |
Share subscription facility | |
Equity |
(c) | |
| 4,518 | | |
$ | 3.64 | | |
2021 Notes | |
Liability |
(d) | |
| 38,900 | | |
$ | 3.64 | | |
2022 Notes | |
Liability |
(e) | |
| 549,993 | | |
$ | 3.64 - 16.80 | | |
Public offering | |
Equity |
(f) | |
| 318,451 | | |
$ | 8.58 - 12.60 | | |
Public offering | |
Equity |
(g) | |
| 126,061 | | |
$ | 4.86 | | |
Public offering | |
Equity |
(h) | |
| 2,443,187 | | |
$ | 1.57 | | |
2023 Notes | |
Equity |
(i) | |
| 7,455,627 | | |
$ | 1.06 - 1.64 | | |
2024 Warrants | |
Equity |
| |
| 11,005,004 | | |
| | | |
| |
|
(a) |
On
June 30, 2021, as a result of the Closing of the Business Combination, the Company assumed a total of 78,751 warrants previously
issued by LACQ (subsequently in December 2022 and August 2023, 7,782 and 7,310 warrants, respectively, 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 21,993 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 per share. |
|
|
(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 and an initial exercise price of $2,402.40 per share. 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 prices 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, 2024 of $1.06 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 1,507 and 3,011 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
and November 4, 2026, respectively. 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 19,450 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 2022 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 549,993 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 conversion price) 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. In connection to the Inducement Letter entered into February 12, 2024, certain existing
warrant holders agreed to exercise 3,601,752 Series A-1 and A-2 warrants at a reduced exercise price of $1.31. The placement agent
warrants remain outstanding as of June 30, 2024. |
|
|
(h) |
On
October 25, 2023 and November 28, 2023, the Company issued warrants to purchase 1,255,697
shares and 2,511,394 shares, respectively. The warrants were immediately exercisable with
an exercise price of $1.5675 and expire on October 25, 2028 and November 28, 2028, respectively.
In January 2024, a holder of the warrants exercised 1,323,904 warrants at an exercise price
of $1.5675.
|
(i) |
On
February 12, 2024, the Company issued 7,455,627 equity classified warrants (Series A Warrants, Series B Warrants and placement agent
warrants) in connection with the Inducement Letter for the 2024 warrant inducement and related warrant restructuring. The Series
A and Series B Warrants were immediately exercisable with an exercise price of $1.06 and expire on August 14, 2025 and May 12, 2028,
respectively. The placement agent warrants were immediately exercisable with an exercise price of $1.6375 and expire on May 12, 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) | |
$ | 1.13 - $1,029.60 | | |
$ | 1.06- $680.23 | | |
| 0.38 - 2.58 | | |
| 91.3% - 140.5% | | |
| 1.04% - 5.43% | |
(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 | | |
$ | 1,831.20 | | |
| 5.00 | | |
| 94.1 | % | |
| 1.0 | % |
(c) Liability classified warrants (remeasured at 6/30/24) | |
$ | 0.50 | | |
$ | 3.64 | | |
| 2.25 - 2.35 | | |
| 133.7% - 135.4% | | |
| 4.6 | % |
(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 6/30/24) | |
$ | 0.50 | | |
$ | 3.64 | | |
| 3.00 - 3.11 | | |
| 126.7% - 128.6% | | |
| 4.4 | % |
|
X |
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- DefinitionThe entire disclosure for equity.
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v3.24.2.u1
STOCK-BASED COMPENSATION
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
STOCK-BASED COMPENSATION |
NOTE
9 - STOCK-BASED COMPENSATION
In
connection with the Business Combination, the Company assumed the 2021 Omnibus Incentive Plan. In February 2023, the Company’s
Board approved an annual increase of 26,725 shares and in August 2023, the Company’s stockholders approved a proposal for an increase
of 585,796 shares available for future grant under the 2021 Omnibus Plan.
The
Company recognized stock-based compensation expense within general and administrative expense of $18,658 and $42,146 for the three and
six months ended June 30, 2024 and $60,394 and $156,663 for the three and six months ended June 30, 2023. The Company recognized stock-based
compensation expense within research and development expense of $7,891 and $17,610 for the three and six months ended June 30, 2024 and
$17,023 and $37,887 for the three and six months ended June 30, 2023.
Option
Activity
There
were no stock options granted during the six months ended June 30, 2024 and June 30, 2023.
The
following table summarizes the Company’s stock option activity during the six months ended June 30, 2024:
SCHEDULE OF STOCK OPTION ACTIVITY
| |
| | |
Weighted average | | |
| |
| |
Options | | |
Exercise price | | |
Remaining contractual life | | |
Intrinsic value | |
Outstanding at December 31, 2023 | |
| 581,314 | | |
$ | 33.15 | | |
| 9.57 | | |
$ | - | |
Granted | |
| - | | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | | |
| - | |
Expired / Forfeited | |
| - | | |
| - | | |
| - | | |
| - | |
Outstanding at June 30, 2024 | |
| 581,314 | | |
| 33.15 | | |
| 9.08 | | |
| - | |
Exercisable at June 30, 2024 | |
| 580,188 | | |
| 32.28 | | |
| - | | |
| - | |
Vested and expected to vest | |
| 581,314 | | |
| 33.15 | | |
| 9.08 | | |
| - | |
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 during the six months ended June 30, 2024 and 2023):
|
● |
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. |
As
of June 30, 2024, the Company had an aggregate of $60,092 of unrecognized share-based compensation cost, which is expected to be recognized
over the weighted average period of 0.95 years.
Shares
Reserved for Future Issuance
The
following shares of common stock are reserved for future issuance:
SCHEDULE OF COMMON STOCK FUTURE ISSUANCE
| |
June 30, 2024 | |
Awards outstanding under the 2021 Omnibus Incentive Plan | |
| 581,314 | |
Awards available for future grant under 2021 Omnibus Incentive Plan | |
| 2,112 | |
Warrants outstanding | |
| 11,005,004 | |
Total shares of common stock reserved for future issuance | |
| 11,588,430 | |
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.24.2.u1
RELATED PARTIES
|
6 Months Ended |
Jun. 30, 2024 |
Related Party Transactions [Abstract] |
|
RELATED PARTIES |
NOTE
10 - RELATED PARTIES
As
of June 30, 2024, the Company held a $0.2 million senior secured convertible promissory note plus accrued interest and 0.4 million warrants
exercisable for common stock at $1.5675 per share issued from a board member in connection to the issuance of the 2023 Notes. On April
25, 2024, the Company and the board member entered into a forbearance agreement that will expire on April 25, 2025. Upon termination
of the forbearance period, the Company will owe the remaining outstanding principal balance together with unpaid interest. The Company
may pay the notes in full at any time prior to the conclusion of the forbearance period.
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Use of estimates and assumptions |
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.
|
Cash and cash equivalents |
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 |
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. Additionally, the Company had concentration in accounts
payable, as two research and development vendors made up greater than 10% individually, and 31% and 38% in aggregate, of the outstanding
accounts payable balance as of June 30, 2024 and December 31, 2023, respectively.
|
Property and equipment |
Property
and equipment
Property
and equipment are fully depreciated and as such there is no depreciation expense recognized in the periods presented.
|
Fair Value Measurement |
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, 2024, and December 31, 2023, 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.
Warrants
The
Company issued liability-classified warrants in connection with the issuance of the 2021 Notes and 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 June
30, 2024, and December 31, 2023.
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
June 30, 2024 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Liability classified warrants | |
$ | 9,615 | | |
$ | - | | |
$ | - | | |
$ | 9,615 | |
Total | |
$ | 9,615 | | |
$ | - | | |
$ | - | | |
$ | 9,615 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
December 31, 2023 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Liability classified warrants | |
| 26,388 | | |
| - | | |
| - | | |
| 26,388 | |
Total | |
$ | 26,388 | | |
$ | - | | |
$ | - | | |
$ | 26,388 | |
The
following table summarizes the change in fair value of the Company’s Level 3 liabilities for the six months ended June 30, 2024
(no level 3 assets as of the six months ended June 30, 2024):
SCHEDULE
OF CHANGE IN FAIR VALUE OF COMPANY’S LEVEL 3
| |
Liability
classified
warrants | |
Fair value, December 31, 2023 | |
$ | 26,388 | |
Change in fair value | |
| (16,773 | ) |
Fair value, June 30, 2024 | |
$ | 9,615 | |
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 initial grant was extended several times and cumulative funding under this grant of approximately
$10.7 million was completed in December 2023.
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 August 31, 2024. As of June 30, 2024, the remaining cash funding under the grant is $1.9 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 RECOGNITION UNDER GRANTS
| |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
MPAR | |
$ | - | | |
$ | 437,263 | | |
$ | - | | |
$ | 918,542 | |
TAAP/OUD | |
| 181,797 | | |
| 53,209 | | |
| 487,519 | | |
| 361,565 | |
Total | |
$ | 181,797 | | |
$ | 490,472 | | |
$ | 487,519 | | |
$ | 1,280,107 | |
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 in a timely manner,
no valuation allowances are recorded.
|
Research and development costs |
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
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 |
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.
|
Income taxes |
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 |
Net
loss 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. Basic shares outstanding include the weighted average effect
of the Company’s outstanding pre-funded warrants and abeyance shares, which require no consideration for the delivery of shares
of common stock. Diluted net loss per share is calculated by adjusting basic shares outstanding for the dilutive effect of common share
equivalents outstanding for 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 (the Company has utilized the principal balance outstanding and the end of period conversion price
for the Convertible Notes for the purposes of the weighted average share calculation below):
SCHEDULE
OF WEIGHTED AVERAGE SHARES OF ANTI-DILUTIVE SECURITIES
| |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Stock options | |
| 580,188 | | |
| 26,354 | | |
| 580,188 | | |
| 26,354 | |
RSUs | |
| - | | |
| 377 | | |
| - | | |
| 377 | |
Warrants | |
| 11,005,004 | | |
| 3,017,026 | | |
| 10,373,633 | | |
| 1,938,542 | |
Convertible notes | |
| 137,799 | | |
| - | | |
| 137,799 | | |
| - | |
Total | |
| 11,722,991 | | |
| 3,043,757 | | |
| 11,091,620 | | |
| 1,965,273 | |
|
Recently Issued Accounting Pronouncements |
Recently
Issued Accounting Pronouncements
In
November 2023, the FASB issued ASU 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures”,
which sets forth improvements to the current segment disclosure requirements in accordance with Topic 280 “Segment Reporting,”
including clarifying that entities with a single reportable segment are subject to both new and existing segment reporting requirements.
ASU 2023-07 will be effective retrospectively for fiscal years beginning after December 15, 2023, and interim periods beginning after
December 15, 2024. Adoption of this ASU is currently being evaluated by the Company.
In
December 2023, the FASB issued ASU No. 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” ASU 2023-09
requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income
taxes paid. ASU 2023-09 is effective for public entities with annual periods beginning after December 15, 2024, with early adoption permitted.
The Company is currently evaluating the impact of this guidance on its consolidated financial statements.
|
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE |
The
following tables present liabilities measured and recorded at fair value on the Company’s consolidated balance sheets as of June
30, 2024, and December 31, 2023.
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
June 30, 2024 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Liability classified warrants | |
$ | 9,615 | | |
$ | - | | |
$ | - | | |
$ | 9,615 | |
Total | |
$ | 9,615 | | |
$ | - | | |
$ | - | | |
$ | 9,615 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
December 31, 2023 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Liability classified warrants | |
| 26,388 | | |
| - | | |
| - | | |
| 26,388 | |
Total | |
$ | 26,388 | | |
$ | - | | |
$ | - | | |
$ | 26,388 | |
|
SCHEDULE OF CHANGE IN FAIR VALUE OF COMPANY’S LEVEL 3 |
The
following table summarizes the change in fair value of the Company’s Level 3 liabilities for the six months ended June 30, 2024
(no level 3 assets as of the six months ended June 30, 2024):
SCHEDULE
OF CHANGE IN FAIR VALUE OF COMPANY’S LEVEL 3
| |
Liability
classified
warrants | |
Fair value, December 31, 2023 | |
$ | 26,388 | |
Change in fair value | |
| (16,773 | ) |
Fair value, June 30, 2024 | |
$ | 9,615 | |
|
SCHEDULE OF REVENUE RECOGNITION UNDER GRANTS |
The
revenue recognized under the MPAR Grant and OUD Grant was as follows:
SCHEDULE
OF REVENUE RECOGNITION UNDER GRANTS
| |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
MPAR | |
$ | - | | |
$ | 437,263 | | |
$ | - | | |
$ | 918,542 | |
TAAP/OUD | |
| 181,797 | | |
| 53,209 | | |
| 487,519 | | |
| 361,565 | |
Total | |
$ | 181,797 | | |
$ | 490,472 | | |
$ | 487,519 | | |
$ | 1,280,107 | |
|
SCHEDULE OF WEIGHTED AVERAGE SHARES OF ANTI-DILUTIVE SECURITIES |
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 (the Company has utilized the principal balance outstanding and the end of period conversion price
for the Convertible Notes for the purposes of the weighted average share calculation below):
SCHEDULE
OF WEIGHTED AVERAGE SHARES OF ANTI-DILUTIVE SECURITIES
| |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Stock options | |
| 580,188 | | |
| 26,354 | | |
| 580,188 | | |
| 26,354 | |
RSUs | |
| - | | |
| 377 | | |
| - | | |
| 377 | |
Warrants | |
| 11,005,004 | | |
| 3,017,026 | | |
| 10,373,633 | | |
| 1,938,542 | |
Convertible notes | |
| 137,799 | | |
| - | | |
| 137,799 | | |
| - | |
Total | |
| 11,722,991 | | |
| 3,043,757 | | |
| 11,091,620 | | |
| 1,965,273 | |
|
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- DefinitionTabular disclosure of the fair value measurement of liabilities using significant unobservable inputs (Level 3), a reconciliation of the beginning and ending balances, separately presenting changes attributable to the following: (1) total gains or losses for the period (realized and unrealized), segregating those gains or losses included in earnings (or changes in net assets), and gains or losses recognized in other comprehensive income (loss) and a description of where those gains or losses included in earnings (or changes in net assets) are reported in the statement of income (or activities); (2) purchases, sales, issues, and settlements (each type disclosed separately); and (3) transfers in and transfers out of Level 3 (for example, transfers due to changes in the observability of significant inputs) by class of liability.
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v3.24.2.u1
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS |
Prepaid
expenses and other current assets consisted of the following:
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
June 30, 2024 | | |
December 31, 2023 | |
Prepaid research and development | |
$ | 539,208 | | |
$ | 535,474 | |
Prepaid insurance | |
| 418,215 | | |
| 441,871 | |
Other prepaid expenses | |
| 170,439 | | |
| 72,358 | |
Other current assets | |
| 64,421 | | |
| 18,000 | |
Total prepaid expenses and other current assets | |
$ | 1,192,283 | | |
$ | 1,067,703 | |
|
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v3.24.2.u1
ACCRUED EXPENSES AND OTHER LIABILITIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
SCHEDULE OF ACCRUED EXPENSES AND OTHER LIABILITIES |
Accrued
expenses and other liabilities consisted of the following:
SCHEDULE
OF ACCRUED EXPENSES AND OTHER LIABILITIES
| |
June 30, 2024 | | |
December 31, 2023 | |
Accrued research and development | |
$ | 208,992 | | |
$ | 329,228 | |
Professional fees | |
| 26,950 | | |
| 110,202 | |
Other accrued liabilities | |
| 134,244 | | |
| 102,830 | |
Total accrued expenses and other liabilities | |
$ | 370,186 | | |
$ | 542,260 | |
|
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v3.24.2.u1
NOTES PAYABLE (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
SCHEDULE OF DEBT |
The
following table provides a summary of the Company’s outstanding debt as of June 30, 2024:
SCHEDULE
OF DEBT
| |
Principal
balance | | |
Accrued
interest | | |
Net debt
balance | |
2023 Notes | |
$ | 216,000 | | |
| 6,308 | | - |
| 222,308 | |
Financed insurance | |
| 232,155 | | |
| - | | - |
| 232,155 | |
Total | |
$ | 448,155 | | |
$ | 6,308 | | - |
$ | 454,463 | |
The
following table provides a summary of the Company’s outstanding debt as of December 31, 2023:
| |
December 31, 2023 | |
| |
Principal
balance | | |
Accrued
interest | | |
Unamortized
Debt
Discount and
Issuance Costs | | |
Net debt
balance | |
2023 Notes | |
$ | 1,836,000 | | |
$ | 13,078 | | |
$ | (1,197,200 | ) | |
$ | 651,878 | |
Financed insurance | |
| 197,249 | | |
| 5,570 | | |
| - | | |
| 202,819 | |
Total | |
$ | 2,033,249 | | |
$ | 18,648 | | |
$ | (1,197,200 | ) | |
$ | 854,697 | |
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v3.24.2.u1
STOCKHOLDERS’ EQUITY (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
SCHEDULE OF OUTSTANDING WARRANT |
The
following table provides a summary of outstanding warrants to purchase shares of common stock as of June 30, 2024:
SCHEDULE
OF OUTSTANDING WARRANT
Reference | |
Shares
Underlying
Outstanding
Warrants | | |
Exercise
Price | | |
Description | |
Classification |
(a) | |
| 63,659 | | |
$ | 2,400.00 - 2,760.00 | | |
LACQ warrants | |
Equity |
(b) | |
| 4,608 | | |
$ | 1.31 | | |
Share subscription facility | |
Equity |
(c) | |
| 4,518 | | |
$ | 3.64 | | |
2021 Notes | |
Liability |
(d) | |
| 38,900 | | |
$ | 3.64 | | |
2022 Notes | |
Liability |
(e) | |
| 549,993 | | |
$ | 3.64 - 16.80 | | |
Public offering | |
Equity |
(f) | |
| 318,451 | | |
$ | 8.58 - 12.60 | | |
Public offering | |
Equity |
(g) | |
| 126,061 | | |
$ | 4.86 | | |
Public offering | |
Equity |
(h) | |
| 2,443,187 | | |
$ | 1.57 | | |
2023 Notes | |
Equity |
(i) | |
| 7,455,627 | | |
$ | 1.06 - 1.64 | | |
2024 Warrants | |
Equity |
| |
| 11,005,004 | | |
| | | |
| |
|
(a) |
On
June 30, 2021, as a result of the Closing of the Business Combination, the Company assumed a total of 78,751 warrants previously
issued by LACQ (subsequently in December 2022 and August 2023, 7,782 and 7,310 warrants, respectively, 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 21,993 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 per share. |
|
|
(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 and an initial exercise price of $2,402.40 per share. 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 prices 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, 2024 of $1.06 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 1,507 and 3,011 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
and November 4, 2026, respectively. 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 19,450 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 2022 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 549,993 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 conversion price) 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. In connection to the Inducement Letter entered into February 12, 2024, certain existing
warrant holders agreed to exercise 3,601,752 Series A-1 and A-2 warrants at a reduced exercise price of $1.31. The placement agent
warrants remain outstanding as of June 30, 2024. |
|
|
(h) |
On
October 25, 2023 and November 28, 2023, the Company issued warrants to purchase 1,255,697
shares and 2,511,394 shares, respectively. The warrants were immediately exercisable with
an exercise price of $1.5675 and expire on October 25, 2028 and November 28, 2028, respectively.
In January 2024, a holder of the warrants exercised 1,323,904 warrants at an exercise price
of $1.5675.
|
(i) |
On
February 12, 2024, the Company issued 7,455,627 equity classified warrants (Series A Warrants, Series B Warrants and placement agent
warrants) in connection with the Inducement Letter for the 2024 warrant inducement and related warrant restructuring. The Series
A and Series B Warrants were immediately exercisable with an exercise price of $1.06 and expire on August 14, 2025 and May 12, 2028,
respectively. The placement agent warrants were immediately exercisable with an exercise price of $1.6375 and expire on May 12, 2028. |
|
SCHEDULE OF WARRANTS FAIR VALUE ESTIMATION ASSUMPTIONS |
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) | |
$ | 1.13 - $1,029.60 | | |
$ | 1.06- $680.23 | | |
| 0.38 - 2.58 | | |
| 91.3% - 140.5% | | |
| 1.04% - 5.43% | |
(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 | | |
$ | 1,831.20 | | |
| 5.00 | | |
| 94.1 | % | |
| 1.0 | % |
(c) Liability classified warrants (remeasured at 6/30/24) | |
$ | 0.50 | | |
$ | 3.64 | | |
| 2.25 - 2.35 | | |
| 133.7% - 135.4% | | |
| 4.6 | % |
(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 6/30/24) | |
$ | 0.50 | | |
$ | 3.64 | | |
| 3.00 - 3.11 | | |
| 126.7% - 128.6% | | |
| 4.4 | % |
|
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v3.24.2.u1
STOCK-BASED COMPENSATION (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
SCHEDULE OF STOCK OPTION ACTIVITY |
The
following table summarizes the Company’s stock option activity during the six months ended June 30, 2024:
SCHEDULE OF STOCK OPTION ACTIVITY
| |
| | |
Weighted average | | |
| |
| |
Options | | |
Exercise price | | |
Remaining contractual life | | |
Intrinsic value | |
Outstanding at December 31, 2023 | |
| 581,314 | | |
$ | 33.15 | | |
| 9.57 | | |
$ | - | |
Granted | |
| - | | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | | |
| - | |
Expired / Forfeited | |
| - | | |
| - | | |
| - | | |
| - | |
Outstanding at June 30, 2024 | |
| 581,314 | | |
| 33.15 | | |
| 9.08 | | |
| - | |
Exercisable at June 30, 2024 | |
| 580,188 | | |
| 32.28 | | |
| - | | |
| - | |
Vested and expected to vest | |
| 581,314 | | |
| 33.15 | | |
| 9.08 | | |
| - | |
|
SCHEDULE OF COMMON STOCK FUTURE ISSUANCE |
The
following shares of common stock are reserved for future issuance:
SCHEDULE OF COMMON STOCK FUTURE ISSUANCE
| |
June 30, 2024 | |
Awards outstanding under the 2021 Omnibus Incentive Plan | |
| 581,314 | |
Awards available for future grant under 2021 Omnibus Incentive Plan | |
| 2,112 | |
Warrants outstanding | |
| 11,005,004 | |
Total shares of common stock reserved for future issuance | |
| 11,588,430 | |
|
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v3.24.2.u1
ORGANIZATION AND PRINCIPAL ACTIVITIES (Details Narrative) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Dec. 31, 2020 |
Common stock, shares authorized |
250,000,000
|
250,000,000
|
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
|
Preferred stock, shares authorized |
1,500,000
|
1,500,000
|
|
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
|
EBIR, Inc [Member] |
|
|
|
Ownership percentage |
79.20%
|
|
|
Common stock, shares authorized |
|
|
1,000,000
|
Common stock, par value |
|
|
$ 0.001
|
Preferred stock, shares authorized |
|
|
100,000
|
Preferred stock, par value |
|
|
$ 0.001
|
EBIR, Inc [Member] | Key Personnel [Member] |
|
|
|
Ownership percentage |
9.90%
|
|
|
EBIR, Inc [Member] | Unrelated Party [Member] |
|
|
|
Ownership percentage |
10.90%
|
|
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.2.u1
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Platform Operator, Crypto Asset [Line Items] |
|
|
Liability classified warrants |
$ 9,615
|
$ 26,388
|
Total |
9,615
|
26,388
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Platform Operator, Crypto Asset [Line Items] |
|
|
Liability classified warrants |
|
|
Total |
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Platform Operator, Crypto Asset [Line Items] |
|
|
Liability classified warrants |
|
|
Total |
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Platform Operator, Crypto Asset [Line Items] |
|
|
Liability classified warrants |
9,615
|
26,388
|
Total |
$ 9,615
|
$ 26,388
|
X |
- DefinitionFair value of asset after deduction of liability.
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v3.24.2.u1
SCHEDULE OF REVENUE RECOGNITION UNDER GRANTS (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Product Information [Line Items] |
|
|
|
|
Total |
$ 181,797
|
$ 490,472
|
$ 487,519
|
$ 1,280,107
|
MPAR [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Total |
|
437,263
|
|
918,542
|
TAAP/OUD [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Total |
$ 181,797
|
$ 53,209
|
$ 487,519
|
$ 361,565
|
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v3.24.2.u1
SCHEDULE OF WEIGHTED AVERAGE SHARES OF ANTI-DILUTIVE SECURITIES (Details) - shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total |
11,722,991
|
3,043,757
|
11,091,620
|
1,965,273
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total |
580,188
|
26,354
|
580,188
|
26,354
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total |
|
377
|
|
377
|
Warrant [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total |
11,005,004
|
3,017,026
|
10,373,633
|
1,938,542
|
Convertible Debt Securities [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total |
137,799
|
|
137,799
|
|
X |
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)
|
6 Months Ended |
12 Months Ended |
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Sep. 30, 2019 |
Product Information [Line Items] |
|
|
|
Concentration of risk |
two research and development vendors made up greater than 10% individually, and 31% and 38% in aggregate
|
|
|
Depreciation |
$ 0
|
$ 0
|
|
Grants receivable |
$ 1,900,000
|
$ 10,700,000
|
$ 5,400,000
|
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Customer [Member] |
|
|
|
Product Information [Line Items] |
|
|
|
Concentration of risk |
31.00%
|
38.00%
|
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v3.24.2.u1
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
|
Prepaid research and development |
$ 539,208
|
$ 535,474
|
Prepaid insurance |
418,215
|
441,871
|
Other prepaid expenses |
170,439
|
72,358
|
Other current assets |
64,421
|
18,000
|
Total prepaid expenses and other current assets |
$ 1,192,283
|
$ 1,067,703
|
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v3.24.2.u1
SCHEDULE OF ACCRUED EXPENSES AND OTHER LIABILITIES (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Payables and Accruals [Abstract] |
|
|
Accrued research and development |
$ 208,992
|
$ 329,228
|
Professional fees |
26,950
|
110,202
|
Other accrued liabilities |
134,244
|
102,830
|
Total accrued expenses and other liabilities |
$ 370,186
|
$ 542,260
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
|
|
|
|
|
|
|
|
|
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Feb. 12, 2024 |
Jan. 31, 2024 |
May 12, 2023 |
Aug. 09, 2022 |
Jul. 01, 2022 |
Nov. 05, 2021 |
Sep. 24, 2021 |
Aug. 03, 2021 |
Jul. 02, 2021 |
Jun. 30, 2021 |
Dec. 31, 2020 |
Contractual obligation |
$ 16,000,000
|
|
$ 16,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Future lease payments |
|
|
11,363
|
|
|
|
|
|
|
|
|
|
|
|
|
Rent expense |
$ 8,747
|
$ 8,375
|
$ 17,495
|
$ 16,749
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, subscriptions value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 60,000,000.0
|
Warrants issued shares |
|
|
|
|
|
|
|
19,450
|
19,450
|
3,011
|
1,507
|
|
4,608
|
78,751
|
|
Warrant term |
|
|
|
|
|
|
|
|
|
|
|
|
3 years
|
5 years
|
|
Warrant, exercise price |
$ 1.06
|
|
$ 1.06
|
|
$ 1.31
|
$ 1.5675
|
$ 3.64
|
$ 170.04
|
$ 170.04
|
$ 1,831.20
|
$ 1,831.20
|
$ 2,400.00
|
|
$ 2,760.00
|
|
Investor [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued shares |
|
|
|
|
|
|
|
|
|
|
|
|
4,608
|
|
|
Warrant term |
|
|
|
|
|
|
|
|
|
|
|
|
3 years
|
|
|
Warrant, exercise price |
|
|
|
|
$ 1.06
|
|
|
|
|
|
|
|
$ 2,402.40
|
|
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v3.24.2.u1
SCHEDULE OF DEBT (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Short-Term Debt [Line Items] |
|
|
Principal balance |
$ 448,155
|
$ 2,033,249
|
Accrued interest |
6,308
|
18,648
|
Unamortized Debt Discount & Issuance Costs |
|
(1,197,200)
|
Net debt balance |
454,463
|
854,697
|
2023 Notes [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Principal balance |
216,000
|
1,836,000
|
Accrued interest |
6,308
|
13,078
|
Unamortized Debt Discount & Issuance Costs |
|
(1,197,200)
|
Net debt balance |
222,308
|
651,878
|
Financed Insurance [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Principal balance |
232,155
|
197,249
|
Accrued interest |
|
5,570
|
Unamortized Debt Discount & Issuance Costs |
|
|
Net debt balance |
$ 232,155
|
$ 202,819
|
X |
- DefinitionFace (par) amount of debt instrument at time of issuance.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/exampleRef -Topic 835 -SubTopic 30 -Name Accounting Standards Codification -Section 55 -Paragraph 8 -Publisher FASB -URI https://asc.fasb.org/1943274/2147482949/835-30-55-8
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v3.24.2.u1
SCHEDULE OF OUTSTANDING WARRANT (Details) (Parenthetical) - $ / shares
|
Nov. 29, 2023 |
Jun. 30, 2021 |
Jun. 30, 2024 |
Feb. 12, 2024 |
Jan. 31, 2024 |
Dec. 31, 2023 |
Nov. 28, 2023 |
Oct. 25, 2023 |
Aug. 31, 2023 |
May 12, 2023 |
Feb. 06, 2023 |
Dec. 31, 2022 |
Dec. 09, 2022 |
Aug. 09, 2022 |
Jul. 31, 2022 |
Jul. 01, 2022 |
Nov. 05, 2021 |
Sep. 24, 2021 |
Aug. 03, 2021 |
Jul. 02, 2021 |
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued |
|
78,751
|
|
|
|
|
|
|
|
|
|
|
|
19,450
|
|
19,450
|
3,011
|
1,507
|
|
4,608
|
Warrants cancelled |
|
|
|
|
|
|
|
|
7,310
|
|
|
7,782
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
$ 2,760.00
|
$ 1.06
|
$ 1.31
|
$ 1.5675
|
|
|
|
|
$ 3.64
|
|
|
|
$ 170.04
|
|
$ 170.04
|
$ 1,831.20
|
$ 1,831.20
|
$ 2,400.00
|
|
Warrant expiration date |
|
Jun. 30, 2026
|
|
|
|
|
|
|
|
|
|
|
|
Aug. 08, 2027
|
|
Jun. 29, 2027
|
Nov. 04, 2026
|
Sep. 23, 2026
|
|
|
Warrant term |
|
5 years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 years
|
Shares amended |
|
|
250,000,000
|
|
|
250,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series B Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued |
|
|
|
3,601,752
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
|
$ 1.06
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant expiration date |
|
|
|
May 12, 2028
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued |
|
|
|
3,601,752
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
|
$ 1.06
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant expiration date |
|
|
|
Aug. 14, 2025
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and Administrative Expense [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 2,402.40
|
Public Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of warrant or right, outstanding |
|
41,666
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Private Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining of cashless warrant shares |
|
21,993
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued |
|
|
|
3,601,752
|
1,323,904
|
|
2,511,394
|
1,255,697
|
|
3,727,813
|
318,451
|
|
549,993
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
$ 1.5675
|
$ 1.6375
|
|
|
$ 1.5675
|
$ 1.5675
|
|
$ 0.125
|
|
|
$ 16.80
|
|
|
|
|
|
|
|
Warrant expiration date |
|
|
|
May 12, 2028
|
|
|
Nov. 28, 2028
|
Oct. 25, 2028
|
|
|
|
|
Dec. 09, 2027
|
|
|
|
|
|
|
|
Shares amended |
|
|
|
|
|
|
|
|
|
166,667
|
|
|
|
|
|
|
|
|
|
|
Warrant [Member] | Placement Agent Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued |
|
|
|
7,455,627
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant One [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant expiration date |
|
|
|
|
|
|
|
|
|
|
Feb. 02, 2028
|
|
|
|
|
|
|
|
|
|
Warrant Two [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant expiration date |
|
|
|
|
|
|
|
|
|
|
Aug. 07, 2028
|
|
|
|
|
|
|
|
|
|
Series A-1 Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant expiration date |
|
|
|
|
|
|
|
|
|
Nov. 12, 2024
|
|
|
|
|
|
|
|
|
|
|
Series A-2 Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant expiration date |
|
|
|
|
|
|
|
|
|
May 10, 2028
|
|
|
|
|
|
|
|
|
|
|
Placement Agent Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant expiration date |
|
|
|
|
|
|
|
|
|
May 12, 2028
|
|
|
|
|
|
|
|
|
|
|
Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
$ 2,400.00
|
$ 2,402.40
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Minimum [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
|
|
|
|
|
|
|
$ 3.64
|
$ 8.58
|
|
|
|
|
|
|
|
|
|
Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
$ 2,760.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maximum [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
|
|
|
|
|
|
|
4.86
|
$ 12.60
|
|
|
|
|
|
|
|
|
|
Subscription Arrangement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued |
|
2,083
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 Notes [Member] | First Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument maturity date |
Apr. 25, 2024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
2023 Notes [Member] | Second Securities Purchase Agreement [Member] |
|
|
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|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
Debt instrument maturity date |
May 28, 2024
|
|
|
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|
|
|
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|
2022 Notes [Member] |
|
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|
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|
|
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Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 187.20
|
|
|
|
|
|
2022 Notes and 2021 [Member] |
|
|
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|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
|
|
|
|
|
|
|
$ 0.125
|
|
|
|
|
|
|
|
|
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|
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v3.24.2.u1
NOTES PAYABLE (Details Narrative) - USD ($)
|
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nov. 29, 2023 |
Oct. 25, 2023 |
Oct. 23, 2023 |
Jun. 30, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Feb. 12, 2024 |
Jan. 31, 2024 |
Dec. 31, 2023 |
Nov. 28, 2023 |
May 12, 2023 |
Feb. 06, 2023 |
Dec. 09, 2022 |
Aug. 09, 2022 |
Jul. 01, 2022 |
Nov. 05, 2021 |
Sep. 24, 2021 |
Aug. 03, 2021 |
Jul. 02, 2021 |
Jun. 30, 2021 |
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
|
|
$ 148
|
$ 0
|
$ 2,092
|
$ 1,497
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate principal amount |
|
|
|
$ 448,155
|
$ 448,155
|
|
$ 448,155
|
|
|
|
$ 2,033,249
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19,450
|
19,450
|
3,011
|
1,507
|
|
4,608
|
78,751
|
Common stock, par value |
|
|
|
$ 0.0001
|
$ 0.0001
|
|
$ 0.0001
|
|
|
|
$ 0.0001
|
|
|
|
|
|
|
|
|
|
|
|
Warrant, exercise price |
|
|
|
$ 1.06
|
$ 1.06
|
|
$ 1.06
|
|
$ 1.31
|
$ 1.5675
|
|
|
$ 3.64
|
|
|
$ 170.04
|
$ 170.04
|
$ 1,831.20
|
$ 1,831.20
|
$ 2,400.00
|
|
$ 2,760.00
|
Conversion of shares |
|
|
|
|
|
|
745,521
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of shares value |
|
|
|
|
|
|
$ 1,168,600
|
3,056,892
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transaction cost |
|
|
|
|
|
|
4,718,295
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant inducement cost |
|
|
|
|
|
|
4,718,295
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transaction cost |
|
|
|
|
|
|
(806,862)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financed insurance premiums |
|
|
|
$ 200,000
|
|
|
$ 235,155
|
$ 445,737
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common shares |
|
1,255,697
|
|
|
|
|
|
|
3,601,752
|
1,323,904
|
|
2,511,394
|
3,727,813
|
318,451
|
549,993
|
|
|
|
|
|
|
|
Warrant, exercise price |
|
$ 1.5675
|
|
$ 1.5675
|
$ 1.5675
|
|
$ 1.5675
|
|
$ 1.6375
|
|
|
$ 1.5675
|
$ 0.125
|
|
$ 16.80
|
|
|
|
|
|
|
|
Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate purchase price |
|
|
$ 1,800,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant, exercise price |
|
|
$ 1.5675
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transaction cost |
|
|
|
|
|
|
$ 1,000,000.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant inducement cost |
|
|
|
|
|
|
500,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transaction cost |
|
|
|
|
|
|
500,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 Notes [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
|
|
$ 27,563
|
|
1,300,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate principal amount |
|
|
|
$ 216,000
|
$ 216,000
|
|
216,000
|
|
|
|
$ 1,836,000
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of debt discount premium |
|
|
|
|
|
|
100,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of financing costs |
|
|
|
|
|
|
300,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 Notes [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments of debt issuance costs |
|
|
|
|
|
|
$ 1,100,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 Notes [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate purchase price |
|
|
$ 200,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Original issue discount rate |
|
|
8.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument accrue interest rate |
|
|
6.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument conversion price |
|
|
$ 1.5675
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument redemption premium percentage |
|
|
10.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 Notes [Member] | First Closing Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate purchase price |
|
$ 566,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate principal amount |
|
$ 612,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common shares |
|
1,255,697
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, par value |
|
$ 0.0001
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 Notes [Member] | Second Closing Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate purchase price |
$ 1,133,333
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate principal amount |
$ 1,224,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common shares |
2,511,394
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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v3.24.2.u1
SCHEDULE OF OUTSTANDING WARRANT (Details) - $ / shares
|
6 Months Ended |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jun. 30, 2024 |
Feb. 12, 2024 |
Jan. 31, 2024 |
Nov. 28, 2023 |
Oct. 25, 2023 |
May 12, 2023 |
Feb. 06, 2023 |
Dec. 09, 2022 |
Aug. 09, 2022 |
Jul. 01, 2022 |
Nov. 05, 2021 |
Sep. 24, 2021 |
Aug. 03, 2021 |
Jul. 02, 2021 |
Jun. 30, 2021 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued |
|
|
|
|
|
|
|
|
|
19,450
|
19,450
|
3,011
|
1,507
|
|
4,608
|
78,751
|
Warrants, exercise price |
|
$ 1.06
|
$ 1.31
|
$ 1.5675
|
|
|
$ 3.64
|
|
|
$ 170.04
|
$ 170.04
|
$ 1,831.20
|
$ 1,831.20
|
$ 2,400.00
|
|
$ 2,760.00
|
Warrant expiration date |
|
|
|
|
|
|
|
|
|
Aug. 08, 2027
|
Jun. 29, 2027
|
Nov. 04, 2026
|
Sep. 23, 2026
|
|
|
Jun. 30, 2026
|
December Public Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants, exercise price |
|
|
|
|
|
|
|
|
|
$ 24.07
|
$ 24.07
|
|
|
|
|
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding warrant |
|
11,005,004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued |
|
|
3,601,752
|
1,323,904
|
2,511,394
|
1,255,697
|
3,727,813
|
318,451
|
549,993
|
|
|
|
|
|
|
|
Warrants, exercise price |
|
$ 1.5675
|
$ 1.6375
|
|
$ 1.5675
|
$ 1.5675
|
$ 0.125
|
|
$ 16.80
|
|
|
|
|
|
|
|
Warrant expiration date |
|
|
May 12, 2028
|
|
Nov. 28, 2028
|
Oct. 25, 2028
|
|
|
Dec. 09, 2027
|
|
|
|
|
|
|
|
Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants, exercise price |
|
$ 2,402.40
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 2,400.00
|
Minimum [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants, exercise price |
|
|
|
|
|
|
3.64
|
$ 8.58
|
|
|
|
|
|
|
|
|
Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants, exercise price |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 2,760.00
|
Maximum [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants, exercise price |
|
|
|
|
|
|
$ 4.86
|
$ 12.60
|
|
|
|
|
|
|
|
|
Warrant One [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding warrant |
[1] |
63,659
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant description |
[1] |
LACQ warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant One [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
[1] |
$ 2,400.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant One [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
[1] |
$ 2,760.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Two [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding warrant |
[2] |
4,608
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
[2] |
$ 1.31
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant description |
[2] |
Share subscription facility
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Three [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding warrant |
[3] |
4,518
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
[3] |
$ 3.64
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant description |
[3] |
2021 Notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Four [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding warrant |
[4] |
38,900
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
[4] |
$ 3.64
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant description |
[4] |
2022 Notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Five [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding warrant |
[5] |
549,993
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant description |
[5] |
Public offering
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Five [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
[5] |
$ 3.64
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Five [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
[5] |
$ 16.80
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Six [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding warrant |
[6] |
318,451
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant description |
[6] |
Public offering
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Six [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
[6] |
$ 8.58
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Six [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
[6] |
$ 12.60
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Seven [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding warrant |
[7] |
126,061
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
[7] |
$ 4.86
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant description |
[7] |
Public offering
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Eight [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding warrant |
[8] |
2,443,187
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
[8] |
$ 1.57
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant description |
[8] |
2023 Notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Nine [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding warrant |
[9] |
7,455,627
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant description |
[9] |
2024 Warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Nine [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
[9] |
$ 1.06
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Nine [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
[9] |
$ 1.64
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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v3.24.2.u1
SCHEDULE OF WARRANTS FAIR VALUE ESTIMATION ASSUMPTIONS (Details)
|
Jun. 30, 2024
$ / shares
|
Aug. 09, 2022
$ / shares
|
Jul. 01, 2022
$ / shares
|
Nov. 05, 2021
$ / shares
|
Sep. 24, 2021
$ / shares
|
Jul. 02, 2021
$ / shares
|
Jun. 30, 2021 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Expected term years |
|
|
|
|
|
3 years
|
5 years
|
Leisure Acquisition Corp A Delaware Corporation [Member] | Measurement Input, Share Price [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
3,477.60
|
|
|
|
|
|
|
Leisure Acquisition Corp A Delaware Corporation [Member] | Measurement Input, Exercise Price [Member] | Minimum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
2,400.00
|
|
|
|
|
|
|
Leisure Acquisition Corp A Delaware Corporation [Member] | Measurement Input, Exercise Price [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
2,760.00
|
|
|
|
|
|
|
Leisure Acquisition Corp A Delaware Corporation [Member] | Measurement Input, Expected Term [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Expected term years |
3 years
|
|
|
|
|
3 years
|
|
Leisure Acquisition Corp A Delaware Corporation [Member] | Measurement Input, Price Volatility [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
110.0
|
|
|
|
|
|
|
Leisure Acquisition Corp A Delaware Corporation [Member] | Measurement Input, Risk Free Interest Rate [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
0.5
|
|
|
|
|
|
|
Share Subscription Facility [Member] | Measurement Input, Share Price [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
|
|
|
|
|
3,477.60
|
|
Share Subscription Facility [Member] | Measurement Input, Share Price [Member] | Minimum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
1.13
|
|
|
|
|
|
|
Share Subscription Facility [Member] | Measurement Input, Share Price [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
1,029.60
|
|
|
|
|
|
|
Share Subscription Facility [Member] | Measurement Input, Exercise Price [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
|
|
|
|
|
2,402.40
|
|
Share Subscription Facility [Member] | Measurement Input, Exercise Price [Member] | Minimum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
1.06
|
|
|
|
|
|
|
Share Subscription Facility [Member] | Measurement Input, Exercise Price [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
680.23
|
|
|
|
|
|
|
Share Subscription Facility [Member] | Measurement Input, Expected Term [Member] | Minimum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Expected term years |
4 months 17 days
|
|
|
|
|
|
|
Share Subscription Facility [Member] | Measurement Input, Expected Term [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Expected term years |
2 years 6 months 29 days
|
|
|
|
|
|
|
Share Subscription Facility [Member] | Measurement Input, Price Volatility [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
|
|
|
|
|
110.0
|
|
Share Subscription Facility [Member] | Measurement Input, Price Volatility [Member] | Minimum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
91.3
|
|
|
|
|
|
|
Share Subscription Facility [Member] | Measurement Input, Price Volatility [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
140.5
|
|
|
|
|
|
|
Share Subscription Facility [Member] | Measurement Input, Risk Free Interest Rate [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
|
|
|
|
|
0.5
|
|
Share Subscription Facility [Member] | Measurement Input, Risk Free Interest Rate [Member] | Minimum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
1.04
|
|
|
|
|
|
|
Share Subscription Facility [Member] | Measurement Input, Risk Free Interest Rate [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
5.43
|
|
|
|
|
|
|
Liability Classified Warrants Grant Date [Member] | Measurement Input, Share Price [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
|
127.20
|
136.80
|
540
|
1,077.60
|
|
|
Liability Classified Warrants Grant Date [Member] | Measurement Input, Exercise Price [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
|
170.04
|
170.04
|
1,831.20
|
1,831.20
|
|
|
Liability Classified Warrants Grant Date [Member] | Measurement Input, Expected Term [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Expected term years |
|
5 years
|
5 years
|
5 years
|
5 years
|
|
|
Liability Classified Warrants Grant Date [Member] | Measurement Input, Price Volatility [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
|
102.8
|
98.9
|
94.1
|
94.1
|
|
|
Liability Classified Warrants Grant Date [Member] | Measurement Input, Risk Free Interest Rate [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
|
3.0
|
2.9
|
1.0
|
1.0
|
|
|
Liability Classified Warrants Remeasured [Member] | Measurement Input, Share Price [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
0.50
|
|
|
|
|
|
|
Liability Classified Warrants Remeasured [Member] | Measurement Input, Exercise Price [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
3.64
|
|
|
|
|
|
|
Liability Classified Warrants Remeasured [Member] | Measurement Input, Expected Term [Member] | Minimum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Expected term years |
2 years 3 months
|
|
|
|
|
|
|
Liability Classified Warrants Remeasured [Member] | Measurement Input, Expected Term [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Expected term years |
2 years 4 months 6 days
|
|
|
|
|
|
|
Liability Classified Warrants Remeasured [Member] | Measurement Input, Price Volatility [Member] | Minimum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
133.7
|
|
|
|
|
|
|
Liability Classified Warrants Remeasured [Member] | Measurement Input, Price Volatility [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
135.4
|
|
|
|
|
|
|
Liability Classified Warrants Remeasured [Member] | Measurement Input, Risk Free Interest Rate [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
4.6
|
|
|
|
|
|
|
Liability Classified Warrants Remeasured 2 [Member] | Measurement Input, Exercise Price [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
3.64
|
|
|
|
|
|
|
Liability Classified Warrants Remeasured 2 [Member] | Measurement Input, Expected Term [Member] | Minimum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Expected term years |
3 years
|
|
|
|
|
|
|
Liability Classified Warrants Remeasured 2 [Member] | Measurement Input, Expected Term [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Expected term years |
3 years 1 month 9 days
|
|
|
|
|
|
|
Liability Classified Warrants Remeasured 2 [Member] | Measurement Input, Price Volatility [Member] | Minimum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
126.7
|
|
|
|
|
|
|
Liability Classified Warrants Remeasured 2 [Member] | Measurement Input, Price Volatility [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
128.6
|
|
|
|
|
|
|
Liability Classified Warrants Remeasured 2 [Member] | Measurement Input, Risk Free Interest Rate [Member] |
|
|
|
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
|
|
|
Estimating fair value of warrants |
4.4
|
|
|
|
|
|
|
X |
- DefinitionLine items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.
+ ReferencesReference 1: http://www.xbrl.org/2009/role/commonPracticeRef -Topic 326 -SubTopic 20 -Name Accounting Standards Codification -Section 50 -Paragraph 13 -Publisher FASB -URI https://asc.fasb.org/1943274/2147479319/326-20-50-13
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- DefinitionPeriod between issuance and expiration of outstanding warrant and right embodying unconditional obligation requiring redemption by transferring asset at specified or determinable date or upon event certain to occur, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days.
+ ReferencesReference 1: http://www.xbrl.org/2009/role/commonPracticeRef -Topic 820 -SubTopic 10 -Name Accounting Standards Codification -Section 50 -Paragraph 2 -Subparagraph (bbb)(2)(i) -Publisher FASB -URI https://asc.fasb.org/1943274/2147482106/820-10-50-2
Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef -Topic 820 -SubTopic 10 -Name Accounting Standards Codification -Section 50 -Paragraph 2 -Subparagraph (bbb)(2) -Publisher FASB -URI https://asc.fasb.org/1943274/2147482106/820-10-50-2
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v3.24.2.u1
STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($) $ / shares in Units, $ in Millions |
|
3 Months Ended |
6 Months Ended |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Feb. 12, 2024 |
Jun. 30, 2024 |
Jun. 30, 2024 |
Jan. 31, 2024 |
Dec. 31, 2023 |
Nov. 28, 2023 |
Oct. 25, 2023 |
May 12, 2023 |
Feb. 06, 2023 |
Dec. 09, 2022 |
Aug. 09, 2022 |
Jul. 01, 2022 |
Nov. 05, 2021 |
Sep. 24, 2021 |
Aug. 03, 2021 |
Jul. 02, 2021 |
Jun. 30, 2021 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares authorized |
|
250,000,000
|
250,000,000
|
|
250,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
1,500,000
|
1,500,000
|
|
1,500,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock par value |
|
$ 0.0001
|
$ 0.0001
|
|
$ 0.0001
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares issued |
|
0
|
0
|
|
0
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares outstanding |
|
0
|
0
|
|
0
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common shares |
|
|
|
|
|
|
|
|
|
|
19,450
|
19,450
|
3,011
|
1,507
|
|
4,608
|
78,751
|
Warrant exercise price |
$ 1.31
|
$ 1.06
|
$ 1.06
|
$ 1.5675
|
|
|
|
$ 3.64
|
|
|
$ 170.04
|
$ 170.04
|
$ 1,831.20
|
$ 1,831.20
|
$ 2,400.00
|
|
$ 2,760.00
|
Warrant maturity date |
|
|
|
|
|
|
|
|
|
|
Aug. 08, 2027
|
Jun. 29, 2027
|
Nov. 04, 2026
|
Sep. 23, 2026
|
|
|
Jun. 30, 2026
|
Legal fees |
$ 0.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issue, description |
the Company issued to the placement agent as compensation unregistered warrants to purchase up to
252,123 shares of Common Stock, equal to 7.0% of the aggregate number of shares of Common Stock (or warrants) placed in the transaction.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common stock |
252,123
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares held in abeyance |
|
|
666,144
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common shares |
3,601,752
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
$ 1.06
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant maturity date |
Aug. 14, 2025
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series B Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common shares |
3,601,752
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
$ 1.06
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant maturity date |
May 12, 2028
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares authorized |
|
|
|
|
|
|
|
166,667
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common shares |
3,601,752
|
|
|
1,323,904
|
|
2,511,394
|
1,255,697
|
3,727,813
|
318,451
|
549,993
|
|
|
|
|
|
|
|
Share price |
$ 1.31
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
$ 1.6375
|
$ 1.5675
|
$ 1.5675
|
|
|
$ 1.5675
|
$ 1.5675
|
$ 0.125
|
|
$ 16.80
|
|
|
|
|
|
|
|
Warrant maturity date |
May 12, 2028
|
|
|
|
|
Nov. 28, 2028
|
Oct. 25, 2028
|
|
|
Dec. 09, 2027
|
|
|
|
|
|
|
|
Proceeds from warrants |
$ 4.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity issuance costs |
$ 5.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Inducement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares held in abeyance |
|
822,000
|
1,488,144
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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v3.24.2.u1
SCHEDULE OF STOCK OPTION ACTIVITY (Details) - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
|
Option outstanding, beginning balance |
581,314
|
|
Weighted average exercise price. beginning balance |
$ 33.15
|
|
Weighted average remaining contractual term |
9 years 29 days
|
9 years 6 months 25 days
|
Aggregate intrinsic value, beginning balance |
|
|
Option outstanding, granted |
|
|
Weighted average exercise price, granted |
|
|
Aggregate intrinsic value, granted |
|
|
Option outstanding, exercised |
|
|
Weighted average exercise price, exercised |
|
|
Aggregate intrinsic value, exercised |
|
|
Option outstanding, expired or forfeited |
|
|
Weighted average exercise price, expired or forfeited |
|
|
Aggregate intrinsic value, expired or forfeited |
|
|
Option outstanding, ending balance |
581,314
|
581,314
|
Weighted average exercise price, ending balance |
$ 33.15
|
$ 33.15
|
Aggregate intrinsic value, ending balance |
|
|
Option, exercisable |
580,188
|
|
Weighted average exercise price, exercisable |
$ 32.28
|
|
Aggregate intrinsic value, beginning balance |
|
|
Option vested or expected to vest |
581,314
|
|
Weighted average exercise price, vested or expected to vest |
$ 33.15
|
|
Weighted average remaining contractual term, exercisable |
9 years 29 days
|
|
Aggregate intrinsic value, vested or expected to vest |
|
|
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STOCK-BASED COMPENSATION (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Aug. 31, 2023 |
Feb. 28, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Common stock, capital shares reserved for future issuance |
11,588,430
|
|
11,588,430
|
|
|
|
Unrecognized stock based compensation |
$ 60,092
|
|
$ 60,092
|
|
|
|
Weighted average period |
|
|
11 months 12 days
|
|
|
|
General and Administrative Expense [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Share based compensation expense |
18,658
|
$ 60,394
|
$ 42,146
|
$ 156,663
|
|
|
Research and Development Expense [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Share based compensation expense |
$ 7,891
|
$ 17,023
|
$ 17,610
|
$ 37,887
|
|
|
2021 Omnibus Incentive Plan [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Common stock, capital shares reserved for future issuance |
|
|
|
|
585,796
|
26,725
|
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- DefinitionShare based payment award weighted average period expected to be recognized.
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v3.24.2.u1
RELATED PARTIES (Details Narrative) - USD ($) $ / shares in Units, shares in Millions, $ in Millions |
Apr. 25, 2024 |
Jun. 30, 2024 |
Feb. 12, 2024 |
Jan. 31, 2024 |
Nov. 28, 2023 |
Oct. 25, 2023 |
Oct. 23, 2023 |
May 12, 2023 |
Dec. 09, 2022 |
Aug. 09, 2022 |
Jul. 01, 2022 |
Nov. 05, 2021 |
Sep. 24, 2021 |
Aug. 03, 2021 |
Jun. 30, 2021 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercisable |
|
0.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant, exercise price |
|
$ 1.06
|
$ 1.31
|
$ 1.5675
|
|
|
|
$ 3.64
|
|
$ 170.04
|
$ 170.04
|
$ 1,831.20
|
$ 1,831.20
|
$ 2,400.00
|
$ 2,760.00
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant, exercise price |
|
$ 1.5675
|
$ 1.6375
|
|
$ 1.5675
|
$ 1.5675
|
|
$ 0.125
|
$ 16.80
|
|
|
|
|
|
|
Warrant, expiration date |
Apr. 25, 2025
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt financing amount |
|
$ 0.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant, exercise price |
|
|
|
|
|
|
$ 1.5675
|
|
|
|
|
|
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Ensysce Biosciences (NASDAQ:ENSC)
過去 株価チャート
から 7 2024 まで 8 2024
Ensysce Biosciences (NASDAQ:ENSC)
過去 株価チャート
から 8 2023 まで 8 2024