UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON
D.C. 20549
FORM
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the Quarterly Period Ended June 30, 2023
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: 001-40804
PASITHEA
THERAPEUTICS CORP.
(Exact
name of Registrant as specified in its charter)
Delaware | | 85-1591963 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
1111 Lincoln Road, Suite 500 Miami Beach, Florida | | 33139 |
(Address of principal executive offices) | | (Zip Code) |
Registrant’s
telephone number, including area code: (702) 514-4174
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, par value $0.0001 per share | | KTTA | | The Nasdaq Capital Market |
Warrants, to purchase shares of Common Stock, par value $0.0001 per share | | KTTAW | | The Nasdaq Capital Market |
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 and posted 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
As
of August 11, 2023, there were 26,143,407 shares of the registrant’s common stock outstanding.
PASITHEA
THERAPEUTICS CORP.
FORM
10-Q
For
the Quarter ended June 30, 2023
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
PASITHEA
THERAPEUTICS CORP.
CONDENSED
CONSOLIDATED BALANCE SHEETS
| |
June 30,
2023 | | |
December 31,
2022 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | |
| |
Current assets: | |
| | |
| |
Cash and cash equivalents | |
$ | 26,647,633 | | |
$ | 33,087,864 | |
Amount due from sale of assets | |
| 122,500 | | |
| - | |
Prepaid expenses | |
| 814,573 | | |
| 562,375 | |
Other current assets | |
| 452,195 | | |
| 262,992 | |
Current assets of discontinued operations | |
| - | | |
| 163,462 | |
Total current assets | |
| 28,036,901 | | |
| 34,076,693 | |
Property and equipment, net | |
| 173,298 | | |
| 125,197 | |
Right of use asset- operating lease | |
| 419,885 | | |
| 500,428 | |
Intangibles, net | |
| 8,256,396 | | |
| 8,571,478 | |
Goodwill | |
| 1,262,911 | | |
| 1,262,911 | |
Non-current assets of discontinued operations | |
| - | | |
| 643,382 | |
Total assets | |
$ | 38,149,391 | | |
$ | 45,180,089 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable and accrued liabilities | |
$ | 1,926,047 | | |
$ | 1,481,393 | |
Note payable | |
| 133,335 | | |
| - | |
Lease liability- short term portion | |
| 169,676 | | |
| 160,362 | |
Current liabilities of discontinued operations | |
| - | | |
| 235,879 | |
Total current liabilities | |
| 2,229,058 | | |
| 1,877,634 | |
| |
| | | |
| | |
Non-current liabilities | |
| | | |
| | |
Lease liability | |
| 256,084 | | |
| 344,021 | |
Warrant liabilities | |
| 74,055 | | |
| 140,611 | |
Non-current liabilities of discontinued operations | |
| - | | |
| 319,575 | |
Total non-current liabilities | |
| 330,139 | | |
| 804,207 | |
Total liabilities | |
| 2,559,197 | | |
| 2,681,841 | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Preferred stock, par value $0.0001, 5,000,000 shares authorized; 0 issued and outstanding | |
| - | | |
| - | |
Common stock, par value $0.0001, 495,000,000 shares authorized; 26,143,407 and 26,043,406 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | |
| 17,997 | | |
| 17,987 | |
Additional paid-in capital | |
| 62,233,447 | | |
| 61,837,802 | |
Accumulated other comprehensive loss | |
| (3,461 | ) | |
| (661 | ) |
Accumulated deficit | |
| (26,657,789 | ) | |
| (19,356,880 | ) |
Total stockholders’ equity | |
| 35,590,194 | | |
| 42,498,248 | |
Total liabilities and stockholders’ equity | |
$ | 38,149,391 | | |
$ | 45,180,089 | |
See accompanying notes to the unaudited condensed
consolidated financial statements.
PASITHEA
THERAPEUTICS CORP.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
| |
For the Three Months Ended June 30, | | |
For the Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Operating expenses: | |
| | |
| | |
| | |
| |
Selling, general and administrative | |
$ | 1,800,536 | | |
$ | 2,611,559 | | |
$ | 3,916,802 | | |
$ | 4,690,437 | |
Research and development | |
| 2,028,165 | | |
| - | | |
| 3,124,451 | | |
| - | |
Loss from operations | |
| (3,828,701 | ) | |
| (2,611,559 | ) | |
| (7,041,253 | ) | |
| (4,690,437 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income: | |
| | | |
| | | |
| | | |
| | |
Change in fair value of warrant liabilities | |
| 113,426 | | |
| 421,700 | | |
| 66,556 | | |
| 1,206,997 | |
Interest and dividends, net | |
| 117,191 | | |
| - | | |
| 110,803 | | |
| - | |
Other income, net | |
| 230,617 | | |
| 421,700 | | |
| 177,359 | | |
| 1,206,997 | |
| |
| | | |
| | | |
| | | |
| | |
Loss before income taxes | |
| (3,598,084 | ) | |
| (2,189,859 | ) | |
| (6,863,894 | ) | |
| (3,483,440 | ) |
Provision for income taxes | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss from continuing operations | |
$ | (3,598,084 | ) | |
$ | (2,189,859 | ) | |
$ | (6,863,894 | ) | |
$ | (3,483,440 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss from discontinued operations, net of tax | |
| (165,146 | ) | |
| (468,535 | ) | |
| (437,015 | ) | |
| (749,194 | ) |
Net loss | |
$ | (3,763,230 | ) | |
$ | (2,658,394 | ) | |
$ | (7,300,909 | ) | |
$ | (4,232,634 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted-average common shares outstanding, basic and diluted | |
| 26,128,022 | | |
| 23,444,135 | | |
| 26,100,681 | | |
| 23,226,253 | |
Basic and diluated loss per share from continuing operations | |
$ | (0.14 | ) | |
$ | (0.09 | ) | |
$ | (0.26 | ) | |
$ | (0.15 | ) |
Basic and diluted loss per share from discontinuing operations | |
$ | (0.01 | ) | |
$ | (0.02 | ) | |
$ | (0.02 | ) | |
$ | (0.03 | ) |
| |
| | | |
| | | |
| | | |
| | |
Comprehensive loss: | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (3,763,230 | ) | |
$ | (2,658,394 | ) | |
$ | (7,300,909 | ) | |
$ | (4,232,634 | ) |
Foreign currency translation | |
| (317 | ) | |
| (48,985 | ) | |
| (2,800 | ) | |
| (53,498 | ) |
Comprehensive loss | |
$ | (3,763,547 | ) | |
$ | (2,707,379 | ) | |
$ | (7,303,709 | ) | |
$ | (4,286,132 | ) |
See accompanying notes to the unaudited condensed
consolidated financial statements.
PASITHEA
THERAPEUTICS CORP.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)
| |
| | |
| | |
| | |
Accumulated | | |
| | |
| |
| |
| | |
| | |
Additional | | |
Other | | |
| | |
Total | |
| |
Common Stock | | |
Paid-in | | |
Comprehensive | | |
Accumulated | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Loss | | |
Deficit | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Balance at January 1, 2023 | |
| 26,043,406 | | |
$ | 17,987 | | |
$ | 61,837,802 | | |
$ | (661 | ) | |
$ | (19,356,880 | ) | |
$ | 42,498,248 | |
Stock-based compensation: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
-restricted share units | |
| 83,334 | | |
| 8 | | |
| 23,641 | | |
| - | | |
| - | | |
| 23,649 | |
-options | |
| - | | |
| - | | |
| 153,372 | | |
| - | | |
| - | | |
| 153,372 | |
Foreign currency translation | |
| - | | |
| - | | |
| - | | |
| (2,483 | ) | |
| - | | |
| (2,483 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,537,679 | ) | |
| (3,537,679 | ) |
Balance at March 31, 2023 | |
| 26,126,740 | | |
$ | 17,995 | | |
$ | 62,014,815 | | |
$ | (3,144 | ) | |
$ | (22,894,559 | ) | |
$ | 39,135,107 | |
Stock-based compensation: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
-restricted share units | |
| 16,667 | | |
| 2 | | |
| 23,910 | | |
| - | | |
| - | | |
| 23,912 | |
-options | |
| - | | |
| - | | |
| 194,722 | | |
| - | | |
| - | | |
| 194,722 | |
Foreign currency translation | |
| - | | |
| - | | |
| - | | |
| (317 | ) | |
| - | | |
| (317 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,763,230 | ) | |
| (3,763,230 | ) |
Balance at June 30, 2023 | |
| 26,143,407 | | |
$ | 17,997 | | |
$ | 62,233,447 | | |
$ | (3,461 | ) | |
$ | (26,657,789 | ) | |
$ | 35,590,194 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at January 1, 2022 | |
| 23,008,371 | | |
$ | 17,684 | | |
$ | 53,627,883 | | |
$ | (10,561 | ) | |
$ | (2,214,505 | ) | |
$ | 51,420,501 | |
Stock-based compensation expense: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
-restricted share units | |
| - | | |
| - | | |
| 26,540 | | |
| - | | |
| - | | |
| 26,540 | |
-options | |
| - | | |
| - | | |
| 94,295 | | |
| - | | |
| - | | |
| 94,295 | |
-restricted stock | |
| - | | |
| - | | |
| 14,795 | | |
| - | | |
| - | | |
| 14,795 | |
Foreign currency translation | |
| - | | |
| - | | |
| - | | |
| (4,513 | ) | |
| - | | |
| (4,513 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,574,240 | ) | |
| (1,574,240 | ) |
Balance at March 31, 2022 | |
| 23,008,371 | | |
$ | 17,684 | | |
$ | 53,763,513 | | |
$ | (15,074 | ) | |
$ | (3,788,745 | ) | |
$ | 49,977,378 | |
Stock-based compensation expense: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
-restricted share units | |
| - | | |
| - | | |
| 23,912 | | |
| - | | |
| - | | |
| 23,912 | |
-options | |
| - | | |
| - | | |
| 99,536 | | |
| - | | |
| - | | |
| 99,536 | |
-restricted stock | |
| 429,447 | | |
| 43 | | |
| 435,878 | | |
| - | | |
| - | | |
| 435,921 | |
Warrants issued for acquisition | |
| - | | |
| - | | |
| 350,722 | | |
| - | | |
| - | | |
| 350,722 | |
Common shares issued for acquisition | |
| 3,260,870 | | |
| 326 | | |
| 3,293,153 | | |
| - | | |
| - | | |
| 3,293,479 | |
Foreign currency translation | |
| - | | |
| - | | |
| - | | |
| (48,985 | ) | |
| - | | |
| (48,985 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,658,394 | ) | |
| (2,658,394 | ) |
Balance at June 30, 2022 | |
| 26,698,688 | | |
$ | 18,053 | | |
$ | 57,966,715 | | |
$ | (64,059 | ) | |
$ | (6,447,139 | ) | |
$ | 51,473,570 | |
See accompanying notes to the unaudited condensed
consolidated financial statements.
PASITHEA
THERAPEUTICS CORP.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| |
For the Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | |
| |
Net loss from continuing operations | |
$ | (6,863,894 | ) | |
$ | (3,483,440 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation | |
| 8,895 | | |
| 957 | |
Amortization expense | |
| 315,082 | | |
| - | |
Stock-based compensation | |
| 395,655 | | |
| 694,957 | |
Change in fair value of warrant liabilities | |
| (66,556 | ) | |
| (1,206,997 | ) |
Non-cash lease expense | |
| 1,920 | | |
| - | |
Gain on sale of assets | |
| (65,048 | ) | |
| - | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses | |
| (252,198 | ) | |
| (137,754 | ) |
Other assets | |
| (189,203 | ) | |
| (46,595 | ) |
Accounts payable and accrued liabilities | |
| 433,403 | | |
| 59,937 | |
Lease liabilities | |
| - | | |
| 31,350 | |
Net cash used in operating activities | |
| (6,281,944 | ) | |
| (4,087,585 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |
| | | |
| | |
Purchase of property and equipment | |
| (56,996 | ) | |
| (8,890 | ) |
Net cash proceeds from sale of assets | |
| 27,500 | | |
| - | |
Acquisition of business, net of cash acquired | |
| - | | |
| 77,060 | |
Net cash (used in) provided by investing activities | |
| (29,496 | ) | |
| 68,170 | |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Note payable proceeds | |
| 392,354 | | |
| - | |
Principal payments on note payable | |
| (259,019 | ) | |
| - | |
Net cash provided by financing activities | |
| 133,335 | | |
| - | |
| |
| | | |
| | |
Effect of foreign currency translation on cash | |
| (2,800 | ) | |
| (47,006 | ) |
Net cash used in operating activities of discontinued operations | |
| (583,133 | ) | |
| (400,554 | ) |
Net cash provided by (used in) investing activities of discontinued operations | |
| 323,807 | | |
| (538,835 | ) |
Net cash used in financing activities of discontinued operations | |
| - | | |
| - | |
| |
| | | |
| | |
NET CHANGE IN CASH | |
$ | (6,440,231 | ) | |
$ | (5,005,810 | ) |
Cash – Beginning of period | |
| 33,087,864 | | |
| 52,901,962 | |
Cash – End of period | |
$ | 26,647,633 | | |
$ | 47,896,152 | |
| |
| | | |
| | |
Supplemental disclosure of cash flow information: | |
| | | |
| | |
Amount due from sale of assets | |
$ | 122,500 | | |
$ | - | |
See accompanying notes to the unaudited condensed
consolidated financial statements.
PASITHEA
THERAPEUTICS CORP.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2023 AND 2022
NOTE
1 – NATURE OF THE ORGANIZATION AND BUSINESS
Pasithea
Therapeutics Corp. (“Pasithea” or the “Company”) was incorporated in the State of Delaware on May 12, 2020 and
completed an initial public offering (the “Initial Public Offering”) on September 17, 2021. The Company is a biotechnology
company focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders and other
diseases. The Company is leveraging its expertise in the fields of neuroscience, translational medicine, and drug development to advance
new molecular entities that target the pathophysiology underlying such diseases with the goal of bringing life-changing therapies to
patients.
The
Company’s therapeutic pipeline currently consists of four programs. The Company’s lead product candidate, PAS-004, is a next-generation
macrocyclic mitogen-activated protein kinase, or MEK inhibitor that the Company believes may address the limitations and liabilities
associated with existing drugs targeting a similar mechanism of action. The remaining three programs are in the discovery stage, which
the Company believes address limitations in the treatment paradigm of the indications the Company plans to address with these programs,
which are currently amyotrophic lateral sclerosis (“ALS”), multiple sclerosis (“MS”) and schizophrenia.
Through
December 31, 2022, the Company operated a Clinics business that was focused on providing business support services to anti-depression
clinics in the U.K. and in the United States. Its operations in the U.K. involved providing business support services to registered healthcare
providers who assess patients and, if appropriate, administer intravenous infusions of ketamine. Its operations in the United States
involved providing business support services to entities that furnish similar services to patients who personally pay for those services.
Operations in the U.K. and the United States were conducted through partnerships with healthcare providers and the Company did not provide
professional medical services or psychiatric assessments.
During the three months ended as of March 31,
2023, we discontinued our at-home services in New York, NY as well as our services in the U.K. During the three months ended as of June
30, 2023, we sold our assets associated with the Clinics operations in Los Angeles, CA and the lease associated with the related property
was assumed by the buyer in the transaction. Accordingly, as of the date of this Quarterly Report on Form 10-Q, the previously discontinued
operations of our Clinics segment have been disposed of.
Throughout
this report, the terms “our,” “we,” “us,” and the “Company” refer to Pasithea Therapeutics
Corp. and its subsidiaries, Pasithea Therapeutics Limited (U.K.), Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, Pasithea
Clinics Corp, Alpha-5 Integrin, LLC, and AlloMek Therapeutics, LLC. Pasithea Therapeutics Limited (U.K.) is a private limited Company,
registered in the United Kingdom (U.K.). Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda is a private limited Company, registered
in Portugal. Pasithea Clinics Corp. is incorporated in Delaware. Alpha-5 Integrin, LLC is a Delaware limited liability company. AlloMek
Therapeutics, LLC is a Delaware limited liability company.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles
generally accepted in the United States of America (“U.S. GAAP”).
Emerging
Growth Company
The
Company is an “emerging growth company,” as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart Our
Business Startups Act of 2012 (the “JOBS Act”), and it may take advantage of certain exemptions from various reporting requirements
that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required
to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations
regarding executive compensation in its periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding
advisory vote on executive compensation and approval of any golden parachute payments not previously approved. Further, Section 102(b)(1)
of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until
private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class
of securities registered under the Exchange Act) are required to comply with the new or revised financial accounting standards. The JOBS
Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging
growth companies but any such election to opt out is irrevocable. The Company has elected not to opt out of such extended transition
period which means that when a standard is issued or revised and it has different application dates for public or private companies,
the Company, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised
standard. This may make comparison of the Company’s condensed consolidated financial statements with another public company which
is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult
or impossible because of the potential differences in accounting standards used.
Liquidity
and Capital Resources
As of June 30, 2023, the Company had approximately
$26.6 million of cash and cash equivalents and working capital of approximately $25.8 million. The Company’s major sources
of cash have been comprised of proceeds from various private offerings, the Initial Public Offering, and the prior exercise of warrants. The
Company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities to continue to execute
its development plans and continue operations. Based on the foregoing, management believes that the Company will have sufficient
working capital to meet its needs through twelve months from the date of these condensed consolidated financial statements.
NOTE
2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Principles
of Consolidation
The
Company evaluates the need to consolidate affiliates based on standards set forth in Accounting Standards Codification (“ASC”)
810, “Consolidation,” (“ASC 810”). The condensed consolidated financial statements include the accounts of the
Company and its wholly owned subsidiaries, Pasithea Therapeutics Limited (U.K.) and Pasithea Clinics Corp. (“Pasithea Clinics”).
All significant intercompany transactions and balances have been eliminated in consolidation.
These
condensed consolidated financial statements are presented in U.S. Dollars.
Use
of Estimates
The
preparation of financial statements in conformity with U.S. GAAP requires the Company’s management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial
statement and the reported amounts of revenues and expenses during the reporting period.
Making
estimates requires management to exercise significant judgment. It is at least reasonably possible that the estimate of the effect of
a condition, situation or set of circumstances that existed at the date of the financial statements, which management considered in formulating
its estimate, could change in the near term due to one or more future confirming events. Management regularly makes estimates related
to the fair value of warrant liabilities; the recoverability of long-lived assets; the fair values and useful lives of intangible assets
acquired in business combinations; the potential impairment of goodwill; and income taxes. The Company bases its estimates on historical
experience and on various assumptions that are believed to be reasonable, the results of which form the basis for the amounts recorded
in the consolidated financial statements. As appropriate, the Company obtains reports from third-party valuation experts to inform and
support estimates related to fair value measurements.
Research
and Development
Research
and development costs are charged to operations when incurred and are included in operating expense, except for goodwill related
to intellectual property & patents. Our research and development costs consist principally of compensation of employees and consultants
that perform the Company’s research activities, payments to third parties for preclinical, non-clinical and regulatory activities,
costs to acquire drug product from contract development and manufacturing organizations and third-party contractors relating to chemistry,
manufacturing and controls (“CMC”) efforts, the fees paid for and to maintain the Company’s intellectual property,
and research and development costs related to our discovery programs. Depending upon the timing of payments to the service providers,
the Company recognizes prepaid expenses or accrued expenses related to these costs. These accrued or prepaid expenses are based on management’s
estimates of the work performed under service agreements, milestones achieved and experience with similar contracts. The Company monitors
each of these factors and adjusts estimates accordingly.
Selling,
General and Administrative
Our
selling, general and administrative expenses primarily consist of personnel and related costs, including stock-based compensation, legal
fees relating to both intellectual property and corporate matters, accounting and audit related costs, insurance, corporate communications
and public company expenses, information technology, office and facility rents and related expenses, including depreciation, amortization
and maintenance, and fees for consulting, business development and other professional services.
Cash
and Cash Equivalents
The
Company considers all short-term investments with an original maturity of three months or less when purchased to be cash equivalents.
The Company had cash equivalents of $10.1 million as of June 30, 2023, and did not have any cash equivalents as of December 31, 2022.
Property
and Equipment
Property
and equipment is recorded at cost, net of depreciation. Depreciation is computed using straight-line and accelerated methods over the
estimated useful lives of the related assets. Expenditures that enhance the useful lives of the assets are capitalized and depreciated.
Maintenance and repairs are expensed as incurred. When properties are retired or otherwise disposed of, related costs and related accumulated
depreciation are removed from the accounts.
Warrant
Liability
The Company accounts for the publicly traded warrants
issued in its Initial Public Offering (the “Public Warrants”) and the warrants issued as compensation to the underwriters
in its Initial Public Offering (the “Representative Warrants” and together with the Public Warrants, the “IPO Warrants”)
in accordance with the guidance contained in ASC 815, “Derivatives and Hedging,” under which the IPO Warrants do not meet
the criteria for equity treatment and must be recorded as derivative liabilities. Accordingly, the Company classifies the IPO Warrants
as liabilities at their fair value and adjusts the IPO Warrants to fair value at each reporting period. This liability is subject to re-measurement
at each balance sheet date until the IPO Warrants are exercised or expire, and any change in fair value is recognized in the Company’s
condensed consolidated statement of operations and comprehensive loss. The fair value of the IPO Warrants was initially measured using
a Black Scholes pricing model. Currently, the fair value of the Public Warrants is measured using quoted market prices, and the fair value
of the Representative Warrants is based on an estimate of the relative fair value to the Public Warrants, accounting for a small difference
in the exercise price.
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentrations of credit risk consist of a cash account in a financial institution,
which, at times, may exceed the Federal Depository Insurance Coverage of $250,000. As of June 30, 2023, the Company has not experienced
losses on this account and management believes the Company is not exposed to significant risks on such account.
Fair
Value of Financial Instruments
Except
for liabilities related to the IPO Warrants, described in the table below, the fair value of the Company’s assets and liabilities,
which qualify as financial instruments under ASC 820, “Fair Value Measurements and Disclosures,” approximates the carrying
amounts represented in the accompanying balance sheet, primarily due to their short-term nature.
Fair
Value Measurements
Fair
value is defined as the price that would be received for sale of an asset or paid for transfer of a liability, in an orderly transaction
between market participants at the measurement date. GAAP establishes a three-tier fair value hierarchy, which prioritizes the inputs
used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets
or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:
|
● |
Level
1, defined as observable inputs such as quoted prices (unadjusted) for identical instruments in active markets; |
|
● |
Level
2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted
prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active;
and |
|
● |
Level
3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions,
such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. |
The
following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring
basis and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value:
| |
| | |
Fair value measurements at reporting date using: | |
| |
Fair value | | |
Quoted prices in active markets for identical liabilities (Level 1) | | |
Significant other observable inputs (Level 2) | | |
Significant unobservable inputs (Level 3) | |
Assets: | |
| | |
| | |
| | |
| |
Cash equivalents, June 30, 2023 | |
$ | 10,122,758 | | |
$ | 10,122,758 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Public Warrants, June 30, 2023 | |
$ | 69,520 | | |
$ | 69,520 | | |
$ | - | | |
$ | - | |
Representative Warrants, June 30, 2023 | |
$ | 4,535 | | |
$ | - | | |
$ | - | | |
$ | 4,535 | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Public Warrants, December 31, 2022 | |
$ | 132,000 | | |
$ | 132,000 | | |
$ | - | | |
$ | - | |
Representative Warrants liabilities, December 31, 2022 | |
$ | 8,611 | | |
$ | - | | |
$ | - | | |
$ | 8,611 | |
The
following table presents a reconciliation of the Level 3 Representative Warrants liabilities:
|
|
For the three months ended
June 30, |
|
|
|
2023 |
|
|
2022 |
|
Beginning balance, March 31 |
|
$ |
11,482 |
|
|
$ |
48,797 |
|
Issuances |
|
|
- |
|
|
|
- |
|
Exercises |
|
|
- |
|
|
|
- |
|
Change in fair value |
|
|
(6,946 |
) |
|
|
(30,197 |
) |
Ending balance, June 30 |
|
$ |
4,535 |
|
|
$ |
18,600 |
|
| |
For the six months ended
June 30, | |
| |
2023 | | |
2022 | |
Beginning balance, December 31 | |
$ | 8,611 | | |
$ | 106,205 | |
Issuances | |
| - | | |
| - | |
Exercises | |
| - | | |
| - | |
Change in fair value | |
| (4,076 | ) | |
| (87,605 | ) |
Ending balance, June 30 | |
$ | 4,535 | | |
$ | 18,600 | |
The change in fair value of the Representative
Warrants liabilities is recorded in change in fair value of warrant liabilities on the condensed consolidated statement of operations
and comprehensive loss.
The
fair value of the cash equivalents is based on the fair value of marketable securities invested in U.S. government money market funds.
The
fair value of the liability associated with the Public Warrants as of June 30, 2023 was based on the quoted closing price on The Nasdaq
Capital Market and is classified as Level 1. The fair value of the liability associated with the Representative Warrants as of June 30,
2023 was based on an estimate of the relative fair value to the Public Warrants, accounting for a small difference in the exercise price,
and is classified as Level 3.
In
some circumstances, the inputs used to measure fair value might be categorized within different levels of the fair value hierarchy. In
those instances, the fair value measurement is categorized in its entirety in the fair value hierarchy based on the lowest level input
that is significant to the fair value measurement.
Net
Loss Per Share
Net
loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the reporting period.
Diluted earnings per share is computed similarly to the basic earnings per share, except the weighted average number of common shares
outstanding are increased to include additional shares from the assumed exercise of share options, if dilutive. The following outstanding
shares issuable upon exercise of stock options and warrants and vesting of restricted stock units were excluded from the computation
of diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect:
| |
Six months ended June 30, 2023 | |
| |
2023 | | |
2022 | |
Stock options | |
| 1,980,000 | | |
| 1,000,000 | |
Warrants | |
| 15,356,000 | | |
| 12,600,000 | |
Restricted stock units | |
| 99,999 | | |
| 200,000 | |
Foreign
Currency Translations
The
Company’s functional and reporting currency is the U.S. dollar. All transactions initiated in other currencies are translated into
U.S. dollars using the exchange rate prevailing on the date of transaction. Monetary assets and liabilities denominated in foreign currencies
are translated into the U.S. dollar at the rate of exchange in effect at the balance sheet date. Unrealized exchange gains and losses
arising from such transactions are deferred until realization and are included as a separate component of stockholders’ equity
(deficit) as a component of comprehensive income or loss. Upon realization, the amount deferred is recognized in income in the period
when it is realized.
Translation
of Foreign Operations
The
financial results and position of foreign operations whose functional currency is different from the Company’s presentation currency
are translated as follows:
|
● |
assets
and liabilities are translated at period-end exchange rates prevailing at that reporting date; |
|
● |
equity
is translated at historical exchange rates; and |
|
● |
income
and expenses are translated at average exchange rates for the period. |
Exchange
differences arising on translation of foreign operations are transferred directly to the Company’s accumulated other comprehensive
loss in the condensed consolidated financial statements. Transaction gains and losses arising from exchange rate fluctuation on transactions
denominated in a currency other than the functional currency are included in the condensed consolidated statements of operations and
comprehensive loss.
The
relevant translation rates are as follows:
| |
6/30/2023 | | |
12/31/2022 | |
Closing rate, British Pound (GBP) to $USD at period end | |
| 1.2714 | | |
| 1.2039 | |
Average rate, GBP to $USD for the period ended | |
| 1.2332 | | |
| 1.2362 | |
Closing rate, Euro (EUR) to $USD at period end | |
| 0.9166 | | |
| 0.9367 | |
Average rate, EUR to $USD for the period ended | |
| 0.9256 | | |
| 0.9517 | |
Comprehensive
Income (Loss)
ASC
220, “Comprehensive Income,” establishes standards for reporting and display of comprehensive income (loss) and its components
in a full set of general-purpose financial statements. As of June 30, 2023 and December 31, 2022, the Company had no material items of
other comprehensive income (loss) except for the foreign currency translation adjustment.
Recent
Accounting Pronouncements
Management
does not believe that any recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material
effect on the Company’s financial statements.
Recently
Adopted Accounting Pronouncements
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses, which requires entities to estimate
all expected credit losses for financial assets measured at amortized cost basis, including trade receivables, held at the reporting
date based on historical experience, current conditions, and reasonable and supportable forecasts. The Company adopted this guidance
on March 31, 2023. The adoption of this accounting standard did not have a material impact to the Company’s condensed consolidated
financial statements.
NOTE
3 – PROPERTY AND EQUIPMENT, NET
Property
and equipment, net consists of the following:
| |
As of
June 30,
2023 | | |
As of
December 31,
2022 | |
Leasehold improvements | |
$ | 3,193 | | |
$ | 3,193 | |
Medical equipment | |
| 155,363 | | |
| 99,220 | |
Office equipment | |
| 25,691 | | |
| 26,343 | |
Property and equipment, gross | |
| 184,247 | | |
| 128,756 | |
Less: accumulated depreciation | |
| (10,949 | ) | |
| (3,559 | ) |
Property and equipment, net | |
$ | 173,298 | | |
$ | 125,197 | |
NOTE
4 – LEASES
Laboratory
Lease – South San Francisco, California
In
August 2022, the Company, as a lessee, entered into an amended sublease agreement to sublease laboratory and office space in South San
Francisco, California. The lease commenced on August 15, 2022. The term of this sublease is for a period of thirty-nine and one-fourth
(39.25) months commencing on the effective date, until May 15, 2024. The lease has a gross monthly rent of $16,171 per month, which
will increase to $16,656 beginning January 1, 2024.
This
lease was accounted for as an operating lease under ASC 842, Leases, which resulted in the recognition of a right of use asset (“ROU
asset”) and liability of approximately $569,000 at inception. The ROU asset is recorded as a component of non-current assets
and the liability a component of current and non-current liabilities on the Company’s consolidated balance sheets. The Company
discounted the future lease payments of this lease using the prevailing collateralized lending rate which would be extended to the Company
based on its credit profile relative to the period of inception, and the duration of the lease from inception. The interest rate used
in calculating the fair value listed above was 7.8%.
As
of June 30, 2023, the Company recognized total ROU assets and lease liabilities as follows:
| |
As of June 30, 2023 | | |
As of December 31, 2022 | |
Non-current leases – right of use assets | |
$ | 419,885 | | |
$ | 500,428 | |
Current liabilities – operating lease liabilities | |
$ | 169,676 | | |
$ | 160,362 | |
Non-current liabilities – operating lease liabilities | |
$ | 256,084 | | |
$ | 344,021 | |
| |
| | | |
| | |
Operating lease expense | |
$ | 128,281 | | |
$ | 168,812 | |
Cash paid for amounts included in the measurement of operating lease liabilities | |
$ | - | | |
$ | 169,695 | |
The
following table summarizes the maturity of the Company’s operating lease payments as of June 30, 2023:
2023 (remaining) | |
$ | 97,511 | |
2024 | |
| 199,872 | |
2025 | |
| 183,216 | |
Total future minimum lease payments | |
$ | 480,599 | |
Amount representing interest | |
| (54,839 | ) |
Present value of net future minimum lease payments | |
$ | 425,760 | |
NOTE
5 – INTANGIBLE ASSETS AND GOODWILL
Intangible
assets, net consists of the following:
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
Gross Carrying Amount | | |
Accumulated Amortization | | |
Net | | |
Gross Carrying Amount | | |
Accumulated Amortization | | |
Net | |
In-process research and development | |
$ | 2,900,000 | | |
$ | - | | |
$ | 2,900,000 | | |
$ | 2,900,000 | | |
$ | - | | |
$ | 2,900,000 | |
Patents and intellectual property | |
| 5,513,937 | | |
| (157,541 | ) | |
| 5,356,396 | | |
| 5,671,478 | | |
| - | | |
| 5,671,478 | |
Intangible assets, net | |
$ | 8,413,937 | | |
$ | (157,541 | ) | |
$ | 8,256,396 | | |
$ | 8,571,478 | | |
$ | - | | |
$ | 8,571,478 | |
As
of June 30, 2023, future expected amortization expense of Intangible assets was as follows:
2023 | |
$ | 315,082 | |
2024 | |
| 630,164 | |
2025 | |
| 630,164 | |
2026 | |
| 630,164 | |
2027 | |
| 630,164 | |
Thereafter | |
| 5,420,658 | |
Remaining future amortization expense | |
$ | 8,256,396 | |
There
were no changes to goodwill for the six months ended June 30, 2023.
NOTE 6 – STOCKHOLDERS’ EQUITY
Common Stock
The Company had 26,143,407 and 26,698,688 shares
of its Common Stock issued and outstanding at June 30, 2023 and 2022, respectively.
Common Stock Issuances for the Three and Six
Months Ended June 30, 2023
During the three and six months ended June
30, 2023, the Company issued 16,667 and 100,001 shares of common stock, respectively, due to the vesting of restricted stock units
(“RSUs”), and recognized approximately $24,000 and $48,000, respectively, of stock-based compensation expense related to its
outstanding restricted stock units. Stock-based compensation expense related to the Company’s restricted stock units is recognized
within selling, general and administrative expense.
As of June
30, 2023, remaining unamortized RSU stock-based compensation expense was approximately $142,000.
The Company did not grant any RSUs or restricted
stock during the three and six months ended June 30, 2023.
NOTE 7 – STOCK OPTIONS
Stock Options Issued, Vested and Cancelled
During the three months ended June
30, 2023, no stock options were issued. During the three months ended June 30, 2023,
stock options to purchase an aggregate of 333,334 shares of Common Stock, subject to time-based milestone vesting conditions, vested.
During the three months ended June
30, 2023, stock options to purchase an aggregate of 200,000 shares of Common Stock were cancelled.
During the six months ended June 30, 2023, the
Company issued stock options under the 2021 Plan to employees, to purchase an aggregate of 880,000 shares of Common Stock with a strike
price equal to $0.491 per share and a term of ten years. One-third of these options vest on the one-year anniversary of the employee hire
date and then the remaining stock options vest in equal quarterly installments over the remaining two years. These options had a total
fair value of approximately $288,000, as calculated using the Black-Scholes pricing model with a volatility assumption of 68.64%.
During the six months ended June
30, 2023, stock options to purchase an aggregate of 350,001 shares of Common Stock, subject to time-based milestone vesting conditions,
vested. During the six months ended June 30, 2023, stock options to purchase an aggregate
of 200,000 shares of Common Stock were cancelled.
Stock-Based Compensation
For the
three months ended June 30, 2023 and 2022, total stock-based compensation expense related to the Company’s stock options was approximately
$195,000 and approximately $100,000, respectively. For the three months ended June 30, 2023, the Company recognized approximately
$136,000 of stock-based compensation related to its options within selling, general and administrative expense, and approximately $59,000
within research and development expense. For the three months ended June 30, 2022, all stock-based compensation expense was recorded within
selling, general and administrative expense.
For the
six months ended June 30, 2023 and 2022, total stock-based compensation expense related to the Company’s stock options was approximately
$348,000 and approximately $194,000, respectively. For the six months ended June 30, 2023, the Company recognized approximately $267,000
of stock-based compensation related to its options within selling, general and administrative expense, and approximately $81,000 within
research and development expense. For the six months ended June 30, 2022, all stock-based compensation expense was recorded within selling,
general and administrative expense.
The following
table summarizes the activity related to the Company’s stock options for the six months ended June 30, 2023:
| |
Number of Options | | |
Weighted average exercise price per share | | |
Weighted average remaining contractual term (years) | | |
Aggregate intrinsic value (in thousands) | |
Outstanding, January 1, 2023 | |
| 1,300,000 | | |
$ | 2.28 | | |
| 9.12 | | |
$ | - | |
Granted | |
| 880,000 | | |
| 0.49 | | |
| 9.66 | | |
| - | |
Expired/Cancelled | |
| (200,000 | ) | |
| 0.96 | | |
| 9.13 | | |
| - | |
Outstanding, June 30, 2023 | |
| 1,980,000 | | |
$ | 1.62 | | |
| 9.06 | | |
| - | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable, June 30, 2023 | |
| 566,668 | | |
$ | 2.18 | | |
| 8.84 | | |
$ | - | |
As of June
30, 2023, remaining unamortized stock-based compensation expense related to the stock options was approximately $581,000.
NOTE 8 – WARRANTS
As of June
30, 2023, the fair value of the Public Warrants was approximately $0.02 per Public Warrant based on the closing price of the warrants
on The Nasdaq Capital Market. The fair value of the Representative Warrants was approximately $0.02 per Representative Warrant which was
based on the relative fair value to the Public Warrants.
The following table summarizes the Company’s
outstanding warrants:
Exercise Price | | |
Number of warrants | | |
Weighted-
average remaining contractual term (years) | | |
Weighted average exercise price | |
$ | 1.88 | | |
| 2,000,000 | | |
| 4.13 | | |
| | |
$ | 3.50 | | |
| 8,680,000 | | |
| 3.40 | | |
| | |
$ | 6.00 | | |
| 276,000 | | |
| 3.22 | | |
| | |
$ | 6.25 | | |
| 4,400,000 | | |
| 3.22 | | |
| | |
| | | |
| 15,356,000 | | |
| 3.44 | | |
$ | 4.12 | |
No warrants were granted during the three and
six months ended June 30, 2023.
NOTE 9 – COMMITMENTS AND CONTINGENCIES
Legal
and Regulatory Environment
The healthcare
industry is subject to numerous laws and regulations of federal, state and local governments. These laws and regulations include, but
are not limited to, matters such as licensure, accreditation, government healthcare program participation requirement, reimbursement for
patient services and Medicare and Medicaid fraud and abuse. Government activity has increased with respect to investigations and allegations
concerning possible violations of fraud and abuse statutes and regulations by healthcare providers.
Violations
of these laws and regulations could result in expulsion from government healthcare programs, together with the imposition of significant
fines and penalties, as well as significant repayments for patient services previously billed. Management believes that the Company is
in compliance with fraud and abuse regulations, as well as other applicable government laws and regulations. While no material regulatory
inquiries have been made, compliance with such laws and regulations can be subject to future government review and interpretation, as
well as regulatory actions unknown or unasserted at this time.
NOTE 10 – DISCONTINUED OPERATIONS
During the
three months ended March 31, 2023, we discontinued our at-home services in New York, NY, our Clinics operations in Los Angeles, CA, as
well as our services in the U.K. During the three months ended June 30, 2023, we sold our assets associated with the Clinics operations
in Los Angeles, CA, and the lease associated with the related property was assumed by the buyer in the transaction. Accordingly, as of
June 30, 2023, the previously discontinued operations of our Clinics segment have been disposed of.
As of June 30, 2023, the carrying amounts of the
classes of assets and liabilities related to the discontinued operations of the Clinics operations were $0.
The results of operations from discontinued operations for
the three and six months ended June 30, 2023 and 2022, have been reflected as discontinued operations in
the condensed consolidated statements of operations and consist of the following:
| |
Three Months Ended
June 30, | | |
Six Months Ended
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenues | |
$ | - | | |
$ | 13,581 | | |
$ | - | | |
$ | 27,239 | |
Cost of services | |
| - | | |
| 15,101 | | |
| - | | |
| 28,038 | |
Gross margin | |
| - | | |
| (1,520 | ) | |
| - | | |
| (799 | ) |
| |
| | | |
| | | |
| | | |
| | |
Selling, general and administrative | |
| 165,146 | | |
| 467,016 | | |
| 502,063 | | |
| 793,395 | |
Loss from discontinued operations | |
| (165,146 | ) | |
| (468,535 | ) | |
| (502,063 | ) | |
| (794,194 | ) |
Gain on forgiveness of accounts payable | |
| - | | |
| - | | |
| - | | |
| 45,000 | |
Gain on sale of assets | |
| - | | |
| - | | |
| 65,048 | | |
| - | |
Loss from discontinued operations, before income tax | |
| (165,146 | ) | |
| (468,535 | ) | |
| (437,015 | ) | |
| (749,194 | ) |
Income tax expense | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss from discontinued operations, net of tax | |
| (165,146 | ) | |
| (468,535 | ) | |
| (437,015 | ) | |
| (749,194 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted-average common shares outstanding, basic and diluted | |
| 26,128,022 | | |
| 23,444,135 | | |
| 26,100,681 | | |
| 23,226,253 | |
Basic and diluated loss per share from discontinued operations | |
$ | (0.01 | ) | |
$ | (0.02 | ) | |
$ | (0.02 | ) | |
$ | (0.03 | ) |
The following table presents the gain on the sale
of assets in Los Angeles, CA:
| |
As of
June 30,
2023 | |
Cash proceeds | |
$ | 27,500 | |
Proceeds to receive in installments | |
| 122,500 | |
Total | |
$ | 150,000 | |
Less transaction costs | |
| (11,250 | ) |
Less book value of assets | |
| (73,702 | ) |
Gain on sale, before income tax | |
$ | 65,048 | |
Income tax expense | |
| - | |
Gain on sale, net of tax | |
$ | 65,048 | |
The following table presents non-cash items related
to discontinued operations, which are included in the Company’s unaudited condensed consolidated statement of cash flows:
| |
Six months ended
June 30,
2023 | |
Cash Flows From Operating Activities: | |
| |
Gain on sale of assets | |
$ | (65,048 | ) |
| |
| | |
Supplemental disclosure of cash flow information: | |
| | |
Amount due from sale of assets | |
$ | 122,500 | |
NOTE 11 – NOTE PAYABLE
Directors and Officer’s Liability Insurance
On January 9, 2023, the Company entered into a 9-month financing
agreement for its directors and officer’s liability insurance in the amount of approximately $392,000 that bears interest at an
annual rate of 7.8%. Monthly payments, including principal and interest, are approximately $45,000 per month. The balance due
under this financing agreement was approximately $133,000 and $0 at June 30, 2023 and December 31,
2022, respectively.
NOTE 12 – SUBSEQUENT EVENTS
On July 20, 2023, the Company announced that its
Board of Directors authorized the repurchase, through a $4.0 million tender offer of up to approximately 5.7 million shares of the
Company’s outstanding common stock at a cash purchase price of $0.70 per share (the “Tender Offer”). The Company
launched the Tender Offer on August 9, 2023, which is expected to expire on September 8, 2023, subject to the terms and conditions of
the Tender Offer.
Item 2. Management’s Discussion and Analysis of Financial
Condition and Results of Operations
You should read the following discussion and
analysis of financial condition and operating results together with our financial statements and the related notes and other financial
information included elsewhere in this quarterly report on Form 10-Q, as well as our audited consolidated financial statements and related
notes as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2022, as amended on April 4, 2023. This discussion
contains forward-looking statements that involve risks and uncertainties. As a result of many factors, such as those set forth in the
section of this report captioned “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q as well as the risk factors
set forth in the section titled “Risk Factors” included in our Annual Report on Form 10-K, our actual results may differ materially
from those anticipated in these forward-looking statements. For convenience of presentation some of the numbers have been rounded in the
text below.
Throughout this report, the terms “our,”
“we,” “us,” and the “Company” refer to Pasithea Therapeutics Corp. and its subsidiaries, Pasithea
Therapeutics Limited (UK), Pasithea Clinics Corp., Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, Alpha-5 integrin, LLC and
AlloMek Therapeutics, LLC. Pasithea Clinics Corp. is incorporated in Delaware Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda
is a private limited company, registered in Portugal. Alpha-5 integrin, LLC and AlloMek Therapeutics, LLC are both Delaware limited liability
companies.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report
on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended. These statements are generally identified by the use of such words as “may,”
“could,” “should,” “would,” “believe,” “anticipate,” “forecast,”
“estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,”
“will,” “potential” and similar statements of a future or forward-looking nature. These forward-looking statements
speak only as of the date of filing this Quarterly Report with the SEC and include, without limitation, statements about the following:
|
● |
our lack of operating history; |
|
● |
the expectation that we will incur significant operating losses for the foreseeable future and will need significant additional capital; |
|
● |
the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; |
|
● |
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
|
● |
our plans to develop and commercialize our product candidates; |
|
● |
the timing of our Investigational New Drug (“IND”) submission with the U.S. Food and Drug Administration or other regulatory submissions
with foreign regulatory agencies for PAS-004; |
|
● |
the timing of our planned clinical trials for PAS-004; |
|
● |
the ability of our clinical trials to demonstrate safety and efficacy of our future product candidates, and other positive results; |
|
● |
disruptions to the development of our product candidates due to the continued spread of COVID-19 and the resulting global pandemic; |
|
● |
the timing and focus of our future preclinical studies and clinical trials, and the reporting of data from those studies and trials; |
|
● |
the size of the market opportunity for our future product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; |
|
● |
the success of competing therapies that are or may become available; |
|
● |
the beneficial characteristics, safety, efficacy and therapeutic effects of our future product candidates; |
|
● |
our ability to obtain and maintain regulatory approval of our future product candidates; |
|
● |
our plans relating to the further development of our future product candidates, including additional disease states or indications we may pursue; |
|
● |
existing regulations and regulatory developments in the United States and other jurisdictions; |
|
● |
our dependence on third parties; |
|
● |
the need to hire additional personnel and our ability to attract and retain such personnel; |
|
● |
our plans and ability to obtain or protect intellectual property rights, including extensions of patent terms where available and our ability to avoid infringing the intellectual property rights of others; |
|
● |
our financial performance and sustaining an active trading market for our Common Stock and Warrants; and |
|
● |
our ability to restructure our operations to comply with any potential future changes in government regulation. |
Because forward-looking
statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond
our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected
in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the
forward-looking statements. You should refer to the “Risk Factors” section of this Quarterly Report for a discussion
of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements.
We operate in an evolving environment and new risk factors and uncertainties may emerge from time to time. It is not possible for management
to predict all risk factors and uncertainties. As a result of these factors, we cannot assure you that the forward-looking statements
in this Quarterly Report will prove to be accurate. Except as required by applicable law, we do not plan to publicly update or revise
any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
You should review the factors and risks and other information we describe in the reports we will file from time to time with the SEC.
Company Summary
We are a
biotechnology company primarily focused on the discovery, research and development of innovative treatments for central nervous
system (CNS) disorders and RASopathies. Our primary operations (the “Therapeutics” segment) are focused on developing
our lead therapeutic candidate, PAS-004, a macrocyclic MEK inhibitor for potential use in a range of CNS-related indications,
including neurofibromatosis type 1 (NF1) as well as Noonan syndrome, lamin A/C cardiomyopathy and certain oncology indications that
we acquired from AlloMek Therapeutics, LLC in October 2022. PAS-004 has completed pre-clinical testing and animal toxicology studies
to support a regulatory application to study PAS-004 for the treatment of NF1. We anticipate initiating our first-in-human Phase 1
clinical trial as soon as possible after the acceptance of our regulatory submission by the regulatory agencies. We are also focused
on the development of our discovery programs through lead identification of drug candidates, including PAS-003, a monoclonal
antibody targeting a5b1 integrin for the treatment of amyotrophic lateral sclerosis (ALS), PAS-002, a DNA vaccine targeting GlialCAM
for the treatment of multiple sclerosis (MS), and PAS-001, a small molecule targeting the compliment component 4 (C4) gene for the
treatment of schizophrenia.
Our ability to generate
product revenue will depend on the successful development, regulatory approval and eventual commercialization of one or more of our product
candidates. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through
the sale of equity, debt financings, or other capital sources, including potential collaborations with other companies or other strategic
transactions. Adequate funding may not be available to us on acceptable 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
our product candidates.
We expect to continue to incur significant expenses
and operating losses for the foreseeable future as we advance our product candidates through all stages of development and clinical trials
and, ultimately, seek regulatory approval. In addition, if we obtain marketing approval for any of our product candidates, we expect to
incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. We expect our expenses
and capital requirements will increase significantly in connection with our ongoing activities as we:
|
● |
continue our ongoing and planned research and development of our product candidates; |
|
● |
initiate nonclinical studies and clinical trials for any additional product candidates that we may pursue; |
|
● |
scale up external manufacturing capacity with the aim of securing sufficient quantities to meet our capacity requirements for clinical trials and potential commercialization; |
|
● |
establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing costs; |
|
● |
develop, maintain, expand, protect and enforce our intellectual property portfolio; |
|
● |
acquire or in-license product candidates and technologies; and |
|
● |
add clinical, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts. |
Recent Developments
Clinics Segment
During the first quarter of 2023, we discontinued
our at-home services in New York, NY as well as our services in the U.K. During the second quarter of 2023, we sold our assets associated
with the Clinics operations in Los Angeles, CA, and the lease associated with the related property was assumed by the buyer in the transaction.
Accordingly, as of the date of this Quarterly Report on Form 10-Q, the previously discontinued operations of our Clinics segment have
been disposed of.
Completion of GMP-Compliant Manufacturing
On June 29, 2023, we announced the successful
completion of manufacturing the GMP-compliant Phase 1 clinical supplies of the active pharmaceutical ingredient (“API”) of
our lead product candidate PAS-004. We intend to utilize this supply of PAS-004 for our upcoming Phase I clinical trial following acceptance
of our regulatory application.
Tender Offer to Repurchase Shares of Common
Stock
On July 20, 2023, we announced that our Board
of Directors authorized the repurchase, through a $4.0 million tender offer, of up to approximately 5.7 million shares of our outstanding
common stock at a cash purchase price of $0.70 per share (the “Tender Offer”). We launched the Tender Offer on August
9, 2023, which is expected to expire on September 8, 2023, subject to the terms and conditions of the Tender Offer.
Impact of Inflation
We have recently experienced
higher costs across our business as a result of inflation, including higher costs related to employee compensation and outside services.
We expect inflation to continue to have a negative impact throughout 2023, and it is uncertain whether we will be able to offset the impact
of inflationary pressures in the near term.
Results of Operations
Comparison of the Three and Six Months Ended
June 30, 2023 and 2022
Our financial results for the three and six months
ended June 30, 2023 and 2022 are summarized as follows:
| |
For the Three
Months Ended
June 30, | | |
| | |
| |
| |
2023 | | |
2022 | | |
Change | | |
%
Change | |
Selling, general and administrative | |
$ | 1,800,536 | | |
$ | 2,611,559 | | |
$ | (811,023 | ) | |
| (31.1 | )% |
Research and development | |
| 2,028,165 | | |
| - | | |
| 2,028,165 | | |
| 100.0 | % |
Loss from operations | |
| (3,828,701 | ) | |
| (2,611,559 | ) | |
| (1,217,142 | ) | |
| (31.8 | )% |
Other income, net | |
| 230,617 | | |
| 421,700 | | |
| (191,083 | ) | |
| 82.9 | % |
Net loss from continuing operations | |
| (3,598,084 | ) | |
| (2,189,859 | ) | |
| (1,408,225 | ) | |
| (39.1 | )% |
Net loss from discontinued operations, net of tax | |
| (165,146 | ) | |
| (468,535 | ) | |
| 303,389 | | |
| 183.7 | % |
Net loss | |
$ | (3,763,230 | ) | |
$ | (2,658,394 | ) | |
$ | (1,104,836 | ) | |
| (29.4 | )% |
| |
For the Six
Months Ended
June 30, | | |
| | |
| |
| |
2023 | | |
2022 | | |
Change | | |
%
Change | |
Selling, general and administrative | |
$ | 3,916,802 | | |
$ | 4,690,437 | | |
$ | (773,635 | ) | |
| (16.5 | )% |
Research and development | |
| 3,124,451 | | |
| - | | |
| 3,124,451 | | |
| 100.0 | % |
Loss from operations | |
| (7,041,253 | ) | |
| (4,690,437 | ) | |
| (2,350,816 | ) | |
| (33.4 | )% |
Other income, net | |
| 177,359 | | |
| 1,206,997 | | |
| (1,029,638 | ) | |
| 580.5 | % |
Net loss from continuing operations | |
| (6,863,894 | ) | |
| (3,483,440 | ) | |
| (3,380,454 | ) | |
| (49.2 | )% |
Net loss from discontinued operations, net of tax | |
| (437,015 | ) | |
| (749,194 | ) | |
| 312,179 | | |
| 71.4 | % |
Net loss | |
$ | (7,300,909 | ) | |
$ | (4,232,634 | ) | |
$ | (3,068,275 | ) | |
| (42.0 | )% |
Selling, general and administrative
Selling, general and administrative expenses consist
primarily of personnel expenses, including salaries, benefits, and stock-based compensation expense, for employees and consultants in
executive, finance and accounting, legal, operations support, information technology and human resource functions. Selling, general and
administrative expense also includes corporate facility costs not otherwise included in research and development expense, including rent,
utilities, depreciation, amortization and maintenance, as well as legal fees related to intellectual property and corporate matters and
fees for accounting and consulting services.
For the three and six months ended June 30, 2023,
selling, general and administrative expenses were approximately $1.8 million and $3.9 million, respectively. Selling, general and administrative
expenses decreased for the three and six months ended June 30, 2023 compared to the three and six months ended June 30, 2022 primarily
due to the discontinued Clinics operations in 2023.
We expect selling, general and administrative
expenses to remain relatively flat throughout 2023.
Research and Development
Research and development
expenses relate to our activities performed by our Therapeutics segment, which are primarily focused on the development of PAS-004, our
lead product candidate, and PAS-003, our most advanced discovery candidate.
For the three and six
months ended June 30, 2023, research and development expenses were approximately $2.0 million and $3.1 million, respectively. There were
no research and development expenses for the three and six months ended June 30, 2022. The increase is due to the commencement and expansion
of our drug development activities primarily related to PAS-004 and PAS-003.
We expect research and
development expenses to increase throughout 2023 primarily related to manufacturing, regulatory and clinical development of PAS-004.
Other income, net
For the three months
ended June 30, 2023, other income, net decreased by approximately $191,000 compared to the three months ended June 30, 2022. The decrease
is primarily due to the larger decrease in the fair value of the publicly traded warrants issued in our Initial Public Offering (the “Public
Warrants”) and the warrants issued as compensation to the underwriters in our Initial Public Offering (the “Representative
Warrants”) that occurred during the three months ended June 30, 2022, compared to the decrease that occurred during the three months
ended June 30, 2023.
For the six months ended
June 30, 2023, other income, net decreased by approximately $1.0 million compared to the six months ended June 30, 2022. The decrease
is primarily due to the $1.4 million decrease in the fair value of our Public Warrants and Representative Warrants that occurred during
the six months ended June 30, 2022, compared to a decrease of approximately $67,000 that occurred during the six months ended June 30,
2023.
Working Capital
|
|
As of
June 30,
2023 |
|
|
As of
December 31,
2022 |
|
Current assets |
|
$ |
28,036,901 |
|
|
$ |
33,913,231 |
|
Current liabilities |
|
|
2,229,058 |
|
|
|
1,641,755 |
|
Working capital |
|
$ |
25,807,843 |
|
|
$ |
32,271,476 |
|
Working capital decreased by approximately $6.5
million between December 31, 2022 and June 30, 2023 due primarily to cash used to fund operations for the six months ended June 30, 2023.
Liquidity and Financial Condition
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Net loss from continuing operations | |
$ | (6,863,894 | ) | |
$ | (3,483,440 | ) |
| |
| | | |
| | |
Net cash used in operating activities | |
$ | (6,281,944 | ) | |
$ | (4,087,585 | ) |
Net cash used in (provided by) investing activities | |
| (29,496 | ) | |
| 68,170 | |
Net cash provided by financing activities | |
| 133,335 | | |
| - | |
Effect of foreign currency translation | |
| (2,800 | ) | |
| (47,006 | ) |
Net cash used in discontinued operations | |
| (259,326 | ) | |
| (939,389 | ) |
| |
| | | |
| | |
Decrease in cash and cash equivalents | |
$ | (6,440,231 | ) | |
$ | (5,005,810 | ) |
Cash and cash equivalents decreased by approximately
$6.4 million for the six months ended June 30, 2023, which was primarily attributable to cash used to fund operations and make equipment
purchases during the period.
Liquidity & Capital Resources Outlook
As of June 30, 2023, we had approximately $26.6
million in operating bank accounts and money market funds, with working capital of approximately $25.8 million. We are dependent on obtaining
additional working capital funding from the sale of equity and/or debt securities in order to continue to execute our development plans
and continue operations. Subsequent to the consummation of the Initial Public Offering, our liquidity was and will continue to be satisfied
through the net proceeds from the Initial Public Offering, a private placement in November 2021 and the receipt of cash upon the prior
exercise of our outstanding warrants. Based on the foregoing, management believes that we will have sufficient working capital to meet
our needs through twelve months from the issuance date of the financial statements included in this quarterly report.
Liquidity & Capital Resources Outlook
Our primary use of cash is to fund operating expenses,
primarily selling, general and administrative and research and development expenditures. 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.
Because of the numerous risks and uncertainties
associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of
our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:
|
● |
the scope, timing, progress and results of discovery, preclinical development, laboratory testing and clinical trials for our product candidates; |
|
● |
the costs of manufacturing our product candidates for clinical trials and in preparation for marketing approval and commercialization; |
|
● |
the extent to which we enter into collaborations or other arrangements with third parties in order to further develop our product candidates; |
|
● |
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; |
|
● |
the costs and fees associated with the discovery, acquisition or in-license of additional product candidates or technologies; |
|
● |
expenses needed to attract and retain skilled personnel; |
|
● |
the costs required to scale up our clinical, regulatory and manufacturing capabilities; |
|
● |
the costs of future commercialization activities, if any, including establishing sales, marketing, manufacturing and distribution capabilities, for any of our product candidates for which we receive marketing approval; and |
|
● |
revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval. |
We will need significant additional funds to meet
operational needs and capital requirements for clinical trials, other research and development expenditures, and business development
activities. We currently have no credit facility or committed sources of capital. Because of the numerous risks and uncertainties associated
with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays
and operating expenditures associated with our current and anticipated clinical studies.
Tender Offer to Repurchase Shares of Common Stock
On July 20, 2023, we announced that our Board of Directors authorized
the Tender Offer to repurchase approximately 5.7 million shares of our outstanding common stock at a cash purchase price of $0.70 per
share, totaling $4.0 million. We launched the Tender Offer on August 9, 2023, which is expected to expire on September 8, 2023, subject
to the terms and conditions of the Tender Offer. On a proforma basis giving effect to the Tender Offer, management believes that we will
have sufficient working capital to meet our needs through twelve months from the issuance date of the financial statements included in
this quarterly report.
Contractual Obligations
See Note 9 – Commitments and Contingencies
in the Notes to Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this Form 10-Q for a summary of our contractual
obligations.
Off-Balance Sheet Arrangements
During the periods presented, we did not have
any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K promulgated under the Exchange Act.
Critical Accounting Policies and Estimates
Our critical accounting policies and estimates,
which include (1) revenue recognition, (2) stock-based compensation and (3) fair value measurements, are more fully described in the Notes
to our Consolidated Financial Statements included in our Form 10-K for the fiscal year ended December 31, 2022, as amended on April 4,
2023. During the three and six months ended June 30, 2023, there were no material changes to our critical accounting policies and estimates
from those described in our Form 10-K.
We believe that the following critical accounting
estimates are particularly subject to management’s judgment and could materially affect our financial condition and results of operations.
|
● |
Assumptions used in the Black-Scholes pricing model for valuation of stock option awards, such as expected volatility, risk-free interest rate, expected term and expected dividends. |
|
● |
Valuation of the liability for Representative Warrants, for which there is no active market, based on the relative fair value to the quoted market price of the Public Warrants, accounting for a small difference in the exercise price. |
Recent Accounting Pronouncements
See Note 2 – Summary of Significant Accounting
Policies in the Notes to our Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this Form 10-Q for a description
of recent accounting pronouncements applicable to our financial statements.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Not Applicable. As a smaller reporting company, we are not required
to provide the information required by this Item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our Chief Executive Officer and Chief Financial
Officer have evaluated the Company’s disclosure controls and procedures, and have concluded, based on their evaluation as of the
end of the period covered by this report, that our disclosure controls and procedures, as defined in the Securities Exchange Act of 1934,
as amended (the Exchange Act), Rule 13a-15(e), are effective to ensure that the information required to be disclosed in the reports that
the Company files or submits under the Exchange Act (i) is recorded, processed, summarized and reported within the time periods specified
in the Securities and Exchange Commission’s rules and forms, and (ii) is accumulated and communicated to the Company’s management,
including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
Evaluation of Changes in Internal Control over
Financial Reporting
There have been no changes in the Company’s
internal control over financial reporting during the three months ended June 30, 2023 that have materially affected, or are reasonably
likely to materially affect, the Company’s internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
We are not currently subject to any material legal proceedings.
Item 1A. Risk Factors
There have been no material changes to the risk
factors set forth in the section titled “Risk Factors” included in our Annual Report on Form 10-K for the year ended December
31, 2022, as amended on April 4, 2023. Our business involves significant risks. You should carefully consider the risks and uncertainties
described in our Form 10-K, together with all of the other information in this Quarterly Report on Form 10-Q, as well as our audited consolidated
financial statements and related notes as disclosed in our Form 10-K. The risks and uncertainties described in our Form 10-K are not the
only ones we face. Additional risk and uncertainties that we are unaware of or that we deem immaterial may also become important factors
that adversely affect our business. The realization of any of these risks and uncertainties could have a material adverse effect on our
reputation, business, financial condition, results of operations, growth and future prospects as well as our ability to accomplish our
strategic objectives. In that event, the market price of our common stock and Public Warrants could decline, and you could lose part or
all of your investment.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
None.
Item 6. Exhibits
+ |
Indicates a management contract or any compensatory plan, contract or arrangement. |
# |
Certain
identified information has been excluded from this exhibit (indicated by asterisks) because it is both not material and the type of information
that the Company treats as private or confidential, in accordance with the rules of the SEC.
|
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.
PASITHEA THERAPEUTICS CORP. |
|
|
|
By: |
/s/ Tiago Reis Marques |
|
|
Tiago Reis Marques |
|
|
Chief Executive Officer |
|
|
(Principal Executive Officer) |
|
|
|
|
Date: August 11, 2023 |
|
By: |
/s/ Daniel Schneiderman |
|
|
Daniel Schneiderman |
|
|
Chief Financial Officer |
|
|
(Principal Financial Officer and
Principal Accounting Officer) |
|
|
|
|
Date: August 11, 2023 |
|
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Exhibit 10.1
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED
FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. INFORMATION THAT
WAS OMITTED HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.
June 21, 2022
Graeme Currie
[***]
Delivered via Email
Re: Offer of Employment
Dear Dr. Graeme Currie:
We are excited that you will be joining Pasithea Therapeutics Corp.
(the “we,” “us” or the “Company”) and helping us to build our business. We are
pleased to offer you employment on the following terms.
POSITION AND RESPONSIBILITIES.
You will serve as a full-time employee with Pasithea,
your title will be Chief Development Officer and you will report to the CEO and the board. Your start date will be June 22, 2022. Notwithstanding
the foregoing, during the Part-Time Employment Period (as defined below), you shall be required to devote seventy-five (75%) percent of
your working time, up to thirty hours per week, in your role for Pasithea. “Part-Time Employment Period” means the
period of time commencing on the start date and ending on the earlier to occur of (a) the first anniversary of the start date, and (b)
the date on which this agreement is terminated in accordance with the terms hereof. During the Part-Time Employment Period, all Company
policies shall still apply, other than a requirement of full time work, and you shall comply with the terms of the Non-Disclosure, Non-Competition,
Confidential Information, and Non- Solicitation Agreement (the “RCA”) (including, for the sake of clarity, its restrictions
on engaging in any work for a Competitive Business). You further agree to take all commercially reasonable steps during the Part-Time
Employment Period to ensure that (a) any Assigned Inventions (as defined in the RCA) shall be assigned to the Company, and (b) no confidential
information belonging to any third party is brought to the Company’s premises or used in the performance of your duties.
COMPENSATION.
a. Salary.
You will be paid an annual base salary of $375,000, payable in biweekly installments as well a discretionary annual bonus and subject
to withholding in accordance with the Company's standard payroll practices for salaried employees. Salary may be increased or decreased
upon prior, written notice to you at any time at the Company’s discretion.
b. Discretionary
Annual Bonus. For each year of your employment, you will be considered for an annual incentive bonus with respect to each fiscal
year of your employment with Pasithea, the amount, terms and conditions of such bonus (if any) are to be determined at the sole
discretion of the Company. Your discretionary annual bonus shall be up to 35% of your base annual salary and contingent upon you
being employed by Pasithea as of the payment date of such incentive bonus. The bonus will also be subject to your employment for the
full period covered by the bonus, approval by, and adjustment at the discretion of the Company and the terms of any applicable bonus
plan. The annual performance bonus, if any, shall be paid between March 15th and May 15th of the calendar year following the
calendar year for which such bonus was earned. You must be employed on the date of the bonus payment date in order to be eligible
for any bonus.
c. Sign on bonus. You will be paid a
sign on bonus of $30,000, payable within fifteen (15) days of your start date. In the event of you are not employed by the Company
on or prior the first anniversary of your start date, you shall repay the sign-on bonus within ten (10) days of your termination
date.
d. Equity
grant. After joining the Company, and subject to (i) the Company’s obtaining stockholder approval to increase the number of
shares of the Company’s Common Stock issuable under its 2021 Stock Incentive Plan (the “Amended Plan”) in an
amount determined by the Company in its sole discretion in connection with its next annual meeting of stockholders, (ii) the Company’
Registration Statement on Form S-8 covering the Amended Plan being declared effective by the Securities and Exchange Commission, (iii)
the approval of the equity grant to you contemplated herein by Pasithea’s Board of Directors, and (iv) your execution of a stock
option grant agreement provided by the Company, you will be granted an option to purchase 300,000 shares of Pasithea’s Common Stock
at an exercise price per share equal to the then fair market value of a share of Common Stock of Pasithea (the “Option”),
as determined in accordance with Pasithea’s then-current equity award granting policy. Subject to the approval of Pasithea’s
Board of Directors, the Option shall vest in accordance with the terms set forth in your stock option grant agreement, subject to your
continuing employment with the Company. This option grant shall be subject to the then-current terms and conditions of Pasithea’s
employee stock option plan and agreement and shall be the governing document as regards the Option. No right to any stock is earned or
accrued until such time that vesting occurs, not does the grant confer any right to continue vesting or employment
e. Benefits.
As a regular employee of the Company, you will be eligible to participate in a number of Company-sponsored benefits, such as health
insurance, paid time off of up to 21 days per year, and long term disability insurance, in each case, upon completion of 30 days of employment.
DISCLOSURE. You represent and warrant to
the Company that you are not party to any agreements, whether relating to your prior employment or otherwise, that may prevent you from
performing the duties of your position as contemplated herein or affect your eligibility to be employed by the Company or limit the manner
in which you may be employed. You further represent that you have not used for the Company’s behalf, and will not disclose, any
trade secrets or other proprietary right of any previous employer or any other party.
PERIOD OF EMPLOYMENT. You shall be an at-will
employee, and either you or the Company may terminate your employment at any time, for any reason, with or without advance notice. Subject
to the foregoing sentence, your employment with the Company will last at a minimum for three years after the date hereof. In the event
of unexpected circumstances outside of your and the Company’s control, at no fault of either party, that leads to your termination
of employment prior to three years, the Company will offer you a 6-month severance equal to 6 months of your base salary paid in accordance
with the Company’s customary payroll procedures, which severance shall be conditioned on you agreeing to and signing a general release
of claims in favor of the Company, which form would be provided to you by the Company. Whether a cause of termination constitutes unexpected
circumstances shall be in the sole discretion of the Company.
Although your job duties, title, compensation
and benefits, as well as the Company's personnel policies and procedures, may change from time to time, the period of employment may only
be changed in an express written agreement signed by you and a duly authorized officer of the Company.
PROOF OF RIGHT TO WORK. For purposes of
federal immigration law, you will be required to provide to the Company within 3 business days of your start date documentary evidence
of your identity and eligibility for employment in the United States.
WITHHOLDING TAXES. All forms of cash compensation
referred to in this letter are subject to reduction to reflect applicable withholdings and deductions as required by law and as authorized
by you.
Restrictive Covenants. You also will be
required to sign, as a condition of your employment, a Non- Disclosure, Non-Competition, Confidential Information, and Non-Solicitation
Agreement, a copy of which is enclosed.
ENTIRE ARRANGEMENT. This letter, together
with the addendum hereto as Exhibit A, contains all of the terms of your employment with the Company and supersedes any prior understandings
or agreements, whether oral or written, between you and the Company. This letter may not be amended other than in a signed writing of
both parties. Our offer of employment is also conditioned upon verification of your employment application, and the receipt by Pasithea
of satisfactory results from a background verification.
DISPUTE RESOLUTION AND GOVERNING LAW. The
terms of the Offer Letter and the resolution of any disputes as to the meaning, effect, performance, or validity of the Offer Letter of
arising out of, related to, or in any way connected with, this Offer Letter or your employment or any relationship to Pasithea (the “Disputes”)
will be governed by Delaware law, excluding laws relating to conflicts or choice of law. You and Pasithea submit to the exclusive personal
jurisdiction of the federal and state courts located in the State of Florida in connection with any Dispute or any claim related to any
Dispute.
We hope that you find the foregoing terms acceptable.
You may indicate your agreement with these terms and accept our offer of employment by signing and dating both the enclosed duplicate
original of this letter and returning them to me to the physical or email addresses set forth below. This offer of employment will expire
on three days as of the date set forth above.
[Remainder of page intentionally left blank]
Very truly yours,
/s/ Tiago Reis Marques |
|
Pasithea Therapeutics Corp. |
|
Name: |
Tiago Reis Marques |
|
Title: |
Chief Executive Officer |
|
Address: |
1111 Lincoln Road |
|
|
Suite 500 |
|
|
Miami Beach, FL 33139 |
|
Email: |
[***] |
|
I have read and accept this employment offer as of June 21, 2022:
/s/ Graeme Currie |
|
Print Name: Graeme Currie |
|
EXHIBIT A
NON-DISCLOSURE, NON-COMPETITION, CONFIDENTIAL
INFORMATION,
AND NON-SOLICITATION AGREEMENT
This Non-Disclosure, Non-Competition,
Confidential Information, and Non-Solicitation Agreement (the “Agreement”) is a legal agreement between you (the “Employee”)
and the Pasithea Therapeutics, Corp. (the “Company”). Please read it carefully. By accepting the Company’s offer
of employment and/or by continuing your employment with the Company, you will be expressly affirming that you acknowledge, understand,
accept, and agree to be bound by this Agreement.
RECITALS
A. The
Employee has received an offer of employment from the Company and/or is currently working for the Company.
B. As
an Employee of the Company, the Employee will become exposed to Confidential Information (as defined below) of the Company, and the Company
has a legitimate, business interest in preventing unauthorized use or transfer of such Confidential Information. Employee acknowledges
that maintaining complete privacy and avoiding disclosure of Confidential Information is critically important to the Company and its clients.
C. The
Employee is required, as a condition of his or her employment and continued employment, to sign this Agreement.
D. The
Employee desires to enter into this Agreement in order to satisfy such condition.
E. The
consideration for the Employee’s entering into this Agreement consists of the offer of employment with the Company; continued employment
with the Company; and the compensation, benefits, and opportunities that the Employee will receive by virtue of such employment and/or
continued employment.
NOW, THEREFORE, the parties hereby agree as follows:
| 1. | Consideration For Agreement |
The Employee acknowledges
and agrees that the execution of this Agreement is a condition precedent to his or her employment and/or continued employment with the
Company.
| 2. | Restrictive Covenants: Competition and Clients |
The Employee acknowledges
and agrees that solely by reason of employment by the Company, the Employee has and will come into contact with a significant number of
the Company’s customers and prospective customers and have access to Confidential Information (as defined below) and trade secrets
relating thereto, including those regarding the Company’s clients, prospective clients, proprietary business models and strategies,
and related information.
Consequently, the
Employee covenants and agrees that he or she will not, for a period of twelve (12) months following the end of his or her employment
with the Company for any reason, whether voluntary or involuntary (the “Restricted Period”), directly or
indirectly: (i) enter into the employ of or render any services to any person, firm, or corporation, which is engaged, in any part,
in a Competitive Business (as defined below); (ii) engage in any directly Competitive Business for his own account; (iii) become
associated with or interested in through retention or by employment any Competitive Business as an individual, partner, shareholder,
creditor, director, officer, principal, agent, employee, trustee, consultant, advisor, or in any other relationship or capacity;
(iv) initiate contact with, or respond to inquiries from, customers the Company for the purpose of providing products or services of
the type provided by the Employee while employed by the Company; (vii) encourage investors, clients or prospective investors or
clients of the Company to terminate, cancel, not renew, or not place business with the Company, or to place business with another
company which is similar to the business of the Company; or (viii) perform or supervise the performance of services or provision of
products of the type sold or provided by the Employee while he or she was employed by the Company on behalf of any customers or
prospective customers of the Company. These restrictions shall apply only to those customers of the Company with which the Employee
had contact or about which the Employee obtained or had access to Confidential Information or trade secrets during the last two (2)
years of his or her employment with the Company. For the purposes of this Section 2, the term “contact” means
interaction between the Employee and the customer which takes place to further the business relationship, or making (or assisting or
supervising the making of) sales to or performing or providing (or assisting or supervising the performance or provision of)
services or products for the customer on behalf of the Company. For purposes of this Section 2, the term “contact” with
respect to a “prospective” customer means interaction between the Employee and a potential customer of the Company which
takes place to obtain the business of the customer on behalf of the Company. For purposes of this Section 2, “Competitive
Business” for purposes of this Agreement shall mean any business or enterprise: (a) which engages in the research and
discovery of new and effective treatments for psychiatric and neurological disorders, or (b) in which the Company engages in or has
made material steps to engage in during the Term pursuant to a determination of the Board and from which the Company derives a
material amount of revenue or in which the Company has made a material capital investment. Nothing in this Agreement shall preclude
Executive from taking employment in the banking or related financial services industries nor from investing his personal assets in
the securities or any Competitive Business if such securities are traded on a national stock exchange or in the over- the-counter
market and if such investment does not result in his beneficially owning, at any time, more than five percent (5.0%) of the
publicly-traded equity securities of such Competitive Business.
| 3. | Restrictive Covenants: Employees |
The Employee acknowledges
and agrees that solely as a result of employment with the Company, and in light of the broad responsibilities of such employment which
include working with other employees of the Company, the Employee has and will come into contact with and acquire Confidential Information
and trade secrets regarding the Company’s other employees and its principals. Accordingly, the Employee covenants and agrees that
both during his or her employment with the Company and during the a period of six (6) months following the end of his or her employment
with the Company for any reason, whether voluntary or involuntary, the Employee will not, either on the Employee’s own account or
on behalf of any person, company, corporation, or other entity, directly or indirectly, (a) solicit, hire, encourage, or assist others
to solicit or to hire any individual who worked for the Company during the last two (2) years of Employee’s employment with the
Company; or (b) encourage any such individuals to terminate their employment or other working relationship with the Company, or to breach
their obligations to the Company.
| 4. | Restrictive Covenants: Confidentiality And Non-Disparagement |
(a) The Employee
agrees that he or she will not, during his or her employment with the Company or at any time after such employment ends for any
reason (whether voluntary or involuntary), use for his or her own or another’s purposes, or disclose to any other person or
entity (other than in the proper course of employment with the Company) any Confidential Information. This Section 3(a) shall not
apply to any part of such Confidential Information that comes into the public domain otherwise than by reason of an unauthorized
disclosure, or that is disclosed to the Employee on a non-confidential basis by a third party who is not bound by a duty of
confidentiality. “Confidential Information” shall be given its broadest possible interpretation and shall mean
any and all information of the Company, its affiliates, subsidiaries, parents, any fund managed by them (collectively,
“Company Entities”), including without limitation: (i) financial and business information relating to any Company
Entity, such as information with respect to costs, fees, profits, revenues, markets, mailing/client lists, strategies and plans for
future business, new business, product or other development, potential acquisitions or divestitures and new marketing ideas; (ii)
product and technical information relating to any Company Entity, such as software, software codes, computer models and research and
development projects; (iii) donor or investor information; (iv) personnel information, such as the identity and number of any
Company Entity’s other employees and officers, their salaries, bonuses, benefits, skills, qualifications, and abilities; (v)
any and all information in whatever form relating to any donor or prospective donor of a Company Entity, including but not limited
to its business, employees, operations, systems, assets, liabilities, finances, products, and marketing, selling and operating
practices; (vi) any information related to any security system of any Company Entity or any of employees, or (vii) any information
not included in (i) through (vii), above, which the Employee knows or should know is subject to a restriction on disclosure or which
the Employee knows or should know is considered by any Company Entity to be confidential, sensitive, proprietary, or a trade secret
or is not readily available to the public. . Confidential Information can be in any form, including but not limited to verbal,
written, or machine readable, including electronic files, photos or videos. By way of example but not limitation of the foregoing,
Confidential Information may be acquired by observing documents, things, people or events, by direct communication with clients or
others or by overhearing conversations in person or over the telephone or otherwise.
(b) Immediately
upon the termination of employment with the Company for any reason, or at any time the Company so requests, the Employee will return to
the Company: (i) any originals and all copies of all files, notes, documents, slides (including transparencies), computer disks, printouts,
reports, lists of the Company’s donors or leads or referrals to prospective clients, and other media or property in the Employee’s
possession or control that contain or pertain to Confidential Information or trade secrets; and (ii) all property of the Company, including,
but not limited to, supplies, keys, access devices, books, identification cards, computers, telephones and other equipment. The Employee
agrees that on completion of the obligations set forth in this subparagraph, and if requested by the Company, the Employee will execute
a statement declaring that he or she has retained no property of the Company or materials containing Confidential Information, nor has
he or she supplied the same to any person, except as required to carry out his or her duties as an employee of the Company.
(c) The
Employee further agrees that, except as required by law, the Employee will not do or say (or omit to do or say) anything that is intended,
or might reasonably be expected, to harm or disparage the Company Entities, any of its or their donors or prospective donors or any of
the Company Entity’s employees or to impair the reputation of any of the foregoing, or the reputation of any of its services, products,
officers, or employees.
(d) Employee
further agrees that Employee shall not, on Employee’s own initiative or in response to an inquiry, discuss or disclose, in any medium,
any matters affecting or concerning any Company Entity with a member of the media, unless a duly authorized representative of the affected
Company Entity has provided prior written consent. Any media inquiries regarding either of the aforementioned should be referred immediately
to Employee’s immediate superior.
Employee agrees to promptly
disclose in confidence to the Company, or to any person designated by it, all Inventions that Employee may make, create, conceive or first
reduce to practice, either alone or jointly with others, during the period of employment, whether or not in the course of Employee’s
employment, and whether or not patentable, copyrightable or protectable as trade secrets. Employee acknowledges and agrees that any copyrightable
works prepared by me within the scope of Employee’s employment will be “works made for hire” under the Copyright Act
and that the Company will be considered the author and owner of such copyrightable works. Employee agrees that all Inventions that Employee
makes, creates, conceives or first reduces to practice during the period of employment, whether or not in the course of Employee’s
employment, and whether or not patentable, copyrightable or protectable as trade secrets, and that (i) are developed using equipment,
supplies, facilities or trade secrets of the Company; (ii) result from work performed by Employee for the Company; or (iii) relate to
the Company’s business or actual or demonstrably anticipated research or development (the “Assigned Inventions”),
will be the sole and exclusive property of the Company. Employee agrees to execute any documentation in order to effectuate the terms
herein. Inventions” means inventions, improvements, designs, original works of authorship, formulas, processes, compositions of
matter, computer software programs, databases, mask works, confidential information and trade secrets.
| 6. | Employee’s Acknowledgment |
The Employee hereby expressly
acknowledges and agrees that (a) the restrictions and obligations set forth in and imposed by Sections 2, 3, and 4 will not prevent Employee
from obtaining gainful employment in Employee’s field of expertise or cause Employee undue hardship; and (b) the restrictions and
obligations imposed on Employee under Sections 2, 3, and 4 are necessary to protect the legitimate business interests of the Company including
its Confidential Information, and are reasonable in view of the benefits and consideration Employee has received or will receive from
the Company. Employee agrees to provide a copy of this Agreement to any prospective employer or business partner prior to accepting employment
or entering into any other business relationship with such prospective employer or business partner. Employee further acknowledges that
nothing herein is intended to or shall be read to interfere with Employee’s rights under governing law, including without limitation
from engaging in any rights protected by Section 7 of the National Labor Relations Act,
In recognition of the
fact that irreparable injury will result to the Company in the event of a breach by the Employee of his or her obligations under
Section 2, 3, or 4 of this Agreement, that monetary damages for such breach would not be readily calculable, and that the Company
would not have an adequate remedy at law therefor, the Employee acknowledges, consents, and agrees that in the event of such breach,
or the threat thereof, the Company shall be entitled, in addition to any other legal remedies and damages available, to (a) specific
performance thereof and to temporary and permanent injunctive relief (without the necessity of posting a bond) to restrain the
violation or threatened violation of such obligations by the Employee and persons acting for or in connection with the Employee and
(b) recovery of all reasonable sums and costs, including attorneys’ fees, incurred by the Company in seeking to enforce the
provisions of this Agreement.
The parties agree they have
attempted to limit the scope of the post-employment restrictions contained herein to the extent necessary to protect Confidential Information
and trade secrets, client relationships, and goodwill. It is the desire and intent of the parties that the provisions of this Agreement
shall be enforced to the fullest extent permissible under applicable law and public policies. Accordingly, if any particular portion of
this Agreement shall be adjudicated to be invalid or unenforceable, this Agreement shall be deemed amended to delete therefrom such invalid
portion, and reformed to the extent valid and enforceable. Such deletion and reformation shall apply only with respect to the operation
of this Agreement in the particular jurisdiction in which such adjudication is made.
| 9. | Other Agreements and Obligations Survive |
Neither the Employee nor
the Company intends to waive or release the applicability of any other more extensive legal or contractual obligations the Employee may
owe the Company at any particular time, including under any employment agreement between the Employee and the Company whether executed
prior to this Agreement or at any time hereafter with regard to the subject matters of Sections 2, 3, or 4.
The obligations of the Employee
under this Agreement shall be independent of, and unaffected by, and shall not affect, other agreements, if any, binding the Employee
that apply to the Employee’s business activities during and/or subsequent to the Employee’s employment by the Company, including
any employment agreement between the Employee and the Company whether executed prior to this Agreement or at any time hereafter. The obligations
under this Agreement also shall survive any changes made in the future to the employment terms of the Employee, including, but not limited
to, changes in salary, benefits, bonus or incentive compensation, job title, and job responsibilities.
The Employee understands
that this Agreement does not constitute a contract of employment and does not promise or imply that his or her employment will continue
for any period of time. Unless otherwise agreed to under any employment or other agreement between the Employee and the Company whether
executed prior to this Agreement or at any time hereafter, employment with the Company is “at will” and may be terminated
either by the Employee or the Company at any time, for any or no reason, and with or without notice.
| 11. | Binding Effect; Assignment |
The Employee expressly consents
to be bound by the provisions of this Agreement for the benefit of the Company or any of its subsidiaries or affiliates to whose employ
he or she may be transferred without the necessity that this Agreement be re-signed at the time of such transfer. Further, the rights
of the Company hereunder may be assigned, without consent of the Employee, at any time, to any successor in interest of the Company, or
any portion thereof, by reason of merger, consolidation, sale, lease or other disposition of any or all of the assets or stock of the
Company.
The parties, being desirous
of having any disputes resolved in a forum having a substantial body of law and experience with the matters contained herein, agree that
any action or proceeding , other than with respect to Paragraph 6 of this Agreement, shall be brought as provided in the “Dispute
Resolutions and Governing Law” section of the Offer Letter to which this Agreement is appended.
The failure of either the
Company or the Employee, whether purposeful or otherwise, to exercise in any instance any right, power, or privilege under this Agreement
or under law shall not constitute a waiver of any other right, power, or privilege, nor of the same right, power, or privilege in any
other instance. Any waiver by the Company or by the Employee must be in a written or electronic instrument signed by either the Employee,
if the Employee is seeking to waive any of his or her rights under this Agreement, or by a senior executive officer of the Employer, if
the Company is seeking to waive any of its rights under this Agreement.
No modification of this
Agreement shall be valid unless made in a written or electronic instrument signed by both parties hereto, wherein specific reference is
made to this Agreement.
Both during the Employee’s
employment with the Company and after the termination thereof for any reason, the Employee agrees to provide the Company with such information
relating to his or her work for the Company or others, as the Company may from time to time reasonably request in order to determine his
or her compliance with this Agreement.
The Employee hereby specifically
authorizes the Company to contact his or her future employers to determine his or her compliance with the Agreement or to communicate
the contents of this Agreement to such employers. The Employee further specifically authorizes the Company to, in its sole discretion
and without further permission from the Employee, furnish copies of the Agreement to any client or prospective client of the Company and
indicate that the Employee has entered into this Agreement with the intention that the Company and each of its clients or prospective
clients may rely on his or her compliance with this Agreement.
Section headings are used
herein for convenience or reference only and shall not affect the meaning of any provision of this Agreement.
Employee has been individually
represented by legal counsel of Employee’s own choice in the negotiations of this Agreement in general and Section 2 and Section
12 (including its choice-of-law and exclusive venue provisions) in particular.
* * *
ACCEPTED AND AGREED TO:
EMPLOYEE:
/s/ Graeme Currie |
|
Graeme Currie |
|
12
Exhibit 31.1
PASITHEA THERAPEUTICS CORP.
CERTIFICATION PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
I, Tiago Reis Marques, certify that:
1. | I have reviewed this Quarterly Report on Form 10-Q for the period
ended June 30, 2023 of Pasithea Therapeutics Corp. (the “Registrant”); |
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))
and internal control over financial reporting (as defined in Exchange Act Rules 13a–15(f) and 15d–15(f)) 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) | designed such internal control over financial reporting,
or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally
accepted accounting principles; |
| (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. |
By: |
/s/ Tiago Reis Marques |
|
|
Tiago Reis Marques |
|
|
Chief Executive Officer |
|
|
(Principal Executive Officer) |
|
Date: August 11, 2023
Exhibit 31.2
PASITHEA THERAPEUTICS CORP.
CERTIFICATION PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
I, Daniel Schneiderman, certify that:
1. | I have reviewed this quarterly report on Form 10-Q for the period
ended June 30, 2023 of Pasithea Therapeutics Corp. (the “Registrant”); |
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))
and internal control over financial reporting (as defined in Exchange Act Rules 13a–15(f) and 15d–15(f)) 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) | designed such internal control over financial reporting,
or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally
accepted accounting principles; |
| (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. |
By: |
/s/ Daniel Schneiderman |
|
|
Daniel Schneiderman |
|
|
Chief Financial Officer |
|
|
(Principal Financial Officer and |
|
|
Principal Accounting Officer) |
|
Date: August 11, 2023
Exhibit 32.1
PASITHEA THERAPEUTICS CORP.
CERTIFICATION PURSUANT TO SECTION 906 OF THE
SARBANES-OXLEY ACT OF 2002
In connection with this Quarterly
Report on Form 10-Q for the period ended June 30, 2023 of Pasithea Therapeutics Corp. (the “Company”) as filed with the Securities
and Exchange Commission on the date hereof (the “Report”), the undersigned, in the capacity and on the date indicated below,
hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his
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 and results of operations of the Company. |
By: |
/s/ Tiago Reis Marques |
|
|
Tiago Reis Marques |
|
|
Chief Executive Officer |
|
|
(Principal Executive Officer) |
|
Date: August 11, 2023
The foregoing certification is being furnished
solely pursuant to 18 U.S.C. Section 1350 and is not being filed as part of the Report or as a separate disclosure document.
Exhibit 32.2
PASITHEA THERAPEUTICS CORP.
CERTIFICATION PURSUANT TO SECTION 906 OF THE
SARBANES-OXLEY ACT OF 2002
In connection with this Quarterly Report on Form 10-Q for the period
ended June 30, 2023 of Pasithea Therapeutics Corp. (the “Company”) as filed with the Securities and Exchange Commission on
the date hereof (the “Report”), the undersigned, in the capacity and on the date indicated below, hereby certifies pursuant
to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his 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 and results of operations of the Company. |
By: |
/s/ Daniel Schneiderman |
|
|
Daniel Schneiderman |
|
|
Chief Financial Officer |
|
|
(Principal Financial Officer and |
|
|
Principal Accounting Officer) |
|
Date: August 11, 2023
The foregoing certification is being furnished solely pursuant to 18
U.S.C. Section 1350 and is not being filed as part of the Report or as a separate disclosure document.
v3.23.2
Document And Entity Information - shares
|
6 Months Ended |
|
Jun. 30, 2023 |
Aug. 11, 2023 |
Document Information Line Items |
|
|
Entity Registrant Name |
PASITHEA
THERAPEUTICS CORP.
|
|
Document Type |
10-Q
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity Common Stock, Shares Outstanding |
|
26,143,407
|
Amendment Flag |
false
|
|
Entity Central Index Key |
0001841330
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Document Period End Date |
Jun. 30, 2023
|
|
Document Fiscal Year Focus |
2023
|
|
Document Fiscal Period Focus |
Q2
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
true
|
|
Entity Shell Company |
false
|
|
Entity Ex Transition Period |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Entity File Number |
001-40804
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Tax Identification Number |
85-1591963
|
|
Entity Address, Address Line One |
1111 Lincoln Road
|
|
Entity Address, Address Line Two |
Suite 500
|
|
Entity Address, City or Town |
Miami Beach
|
|
Entity Address, State or Province |
FL
|
|
Entity Address, Postal Zip Code |
33139
|
|
City Area Code |
(702)
|
|
Local Phone Number |
514-4174
|
|
Entity Interactive Data Current |
Yes
|
|
Common Stock, par value $0.0001 per share |
|
|
Document Information Line Items |
|
|
Trading Symbol |
KTTA
|
|
Title of 12(b) Security |
Common Stock, par value $0.0001 per share
|
|
Security Exchange Name |
NASDAQ
|
|
Warrants, to purchase shares of Common Stock, par value $0.0001 per share |
|
|
Document Information Line Items |
|
|
Trading Symbol |
KTTAW
|
|
Title of 12(b) Security |
Warrants, to purchase shares of Common Stock, par value $0.0001 per share
|
|
Security Exchange Name |
NASDAQ
|
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v3.23.2
Condensed Consolidated Balance Sheets - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 26,647,633
|
$ 33,087,864
|
Amount due from sale of assets |
122,500
|
|
Prepaid expenses |
814,573
|
562,375
|
Other current assets |
452,195
|
262,992
|
Current assets of discontinued operations |
|
163,462
|
Total current assets |
28,036,901
|
34,076,693
|
Property and equipment, net |
173,298
|
125,197
|
Right of use asset- operating lease |
419,885
|
500,428
|
Intangibles, net |
8,256,396
|
8,571,478
|
Goodwill |
1,262,911
|
1,262,911
|
Non-current assets of discontinued operations |
|
643,382
|
Total assets |
38,149,391
|
45,180,089
|
Current liabilities: |
|
|
Accounts payable and accrued liabilities |
1,926,047
|
1,481,393
|
Note payable |
133,335
|
|
Lease liability- short term portion |
169,676
|
160,362
|
Current liabilities of discontinued operations |
|
235,879
|
Total current liabilities |
2,229,058
|
1,877,634
|
Non-current liabilities |
|
|
Lease liability |
256,084
|
344,021
|
Warrant liabilities |
74,055
|
140,611
|
Non-current liabilities of discontinued operations |
|
319,575
|
Total non-current liabilities |
330,139
|
804,207
|
Total liabilities |
2,559,197
|
2,681,841
|
Stockholders’ equity: |
|
|
Preferred stock, par value $0.0001, 5,000,000 shares authorized; 0 issued and outstanding |
|
|
Common stock, par value $0.0001, 495,000,000 shares authorized; 26,143,407 and 26,043,406 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively |
17,997
|
17,987
|
Additional paid-in capital |
62,233,447
|
61,837,802
|
Accumulated other comprehensive loss |
(3,461)
|
(661)
|
Accumulated deficit |
(26,657,789)
|
(19,356,880)
|
Total stockholders’ equity |
35,590,194
|
42,498,248
|
Total liabilities and stockholders’ equity |
$ 38,149,391
|
$ 45,180,089
|
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v3.23.2
Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value (in Dollars per share) |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
5,000,000
|
5,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value (in Dollars per share) |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
495,000,000
|
495,000,000
|
Common stock, shares issued |
26,143,407
|
26,043,406
|
Common stock, shares outstanding |
26,143,407
|
26,043,406
|
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v3.23.2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Operating expenses: |
|
|
|
|
Selling, general and administrative |
$ 1,800,536
|
$ 2,611,559
|
$ 3,916,802
|
$ 4,690,437
|
Research and development |
2,028,165
|
|
3,124,451
|
|
Loss from operations |
(3,828,701)
|
(2,611,559)
|
(7,041,253)
|
(4,690,437)
|
Other income: |
|
|
|
|
Change in fair value of warrant liabilities |
113,426
|
421,700
|
66,556
|
1,206,997
|
Interest and dividends, net |
117,191
|
|
110,803
|
|
Other income, net |
230,617
|
421,700
|
177,359
|
1,206,997
|
Loss before income taxes |
(3,598,084)
|
(2,189,859)
|
(6,863,894)
|
(3,483,440)
|
Provision for income taxes |
|
|
|
|
Net loss from continuing operations |
(3,598,084)
|
(2,189,859)
|
(6,863,894)
|
(3,483,440)
|
Net loss from discontinued operations, net of tax |
(165,146)
|
(468,535)
|
(437,015)
|
(749,194)
|
Net loss |
$ (3,763,230)
|
$ (2,658,394)
|
$ (7,300,909)
|
$ (4,232,634)
|
Weighted-average common shares outstanding, diluted (in Shares) |
26,128,022
|
23,444,135
|
26,100,681
|
23,226,253
|
Basic loss per share from continuing operations (in Dollars per share) |
$ (0.14)
|
$ (0.09)
|
$ (0.26)
|
$ (0.15)
|
Basic loss per share from discontinuing operations (in Dollars per share) |
$ (0.01)
|
$ (0.02)
|
$ (0.02)
|
$ (0.03)
|
Net loss |
$ (3,763,230)
|
$ (2,658,394)
|
$ (7,300,909)
|
$ (4,232,634)
|
Foreign currency translation |
(317)
|
(48,985)
|
(2,800)
|
(53,498)
|
Comprehensive loss |
$ (3,763,547)
|
$ (2,707,379)
|
$ (7,303,709)
|
$ (4,286,132)
|
X |
- DefinitionAmount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.
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v3.23.2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (Parentheticals) - $ / shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Weighted-average common shares outstanding, basic (in Shares) |
26,128,022
|
23,444,135
|
26,100,681
|
23,226,253
|
Diluated loss per share from continuing operations |
$ (0.14)
|
$ (0.09)
|
$ (0.26)
|
$ (0.15)
|
Diluted loss per share from discontinuing operations |
$ (0.01)
|
$ (0.02)
|
$ (0.02)
|
$ (0.03)
|
X |
- DefinitionThe amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.
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v3.23.2
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Unaudited) - USD ($)
|
Common Stock |
Additional Paid-in Capital |
Accumulated Other Comprehensive Loss |
Accumulated Deficit |
Total |
Balance at Dec. 31, 2021 |
$ 17,684
|
$ 53,627,883
|
$ (10,561)
|
$ (2,214,505)
|
$ 51,420,501
|
Balance (in Shares) at Dec. 31, 2021 |
23,008,371
|
|
|
|
|
-restricted share units |
|
26,540
|
|
|
26,540
|
-options |
|
94,295
|
|
|
94,295
|
-restricted stock |
|
14,795
|
|
|
14,795
|
Foreign currency translation |
|
|
(4,513)
|
|
(4,513)
|
Net loss |
|
|
|
(1,574,240)
|
(1,574,240)
|
Balance at Mar. 31, 2022 |
$ 17,684
|
53,763,513
|
(15,074)
|
(3,788,745)
|
49,977,378
|
Balance (in Shares) at Mar. 31, 2022 |
23,008,371
|
|
|
|
|
Balance at Dec. 31, 2021 |
$ 17,684
|
53,627,883
|
(10,561)
|
(2,214,505)
|
51,420,501
|
Balance (in Shares) at Dec. 31, 2021 |
23,008,371
|
|
|
|
|
Net loss |
|
|
|
|
(4,232,634)
|
Balance at Jun. 30, 2022 |
$ 18,053
|
57,966,715
|
(64,059)
|
(6,447,139)
|
51,473,570
|
Balance (in Shares) at Jun. 30, 2022 |
26,698,688
|
|
|
|
|
Balance at Mar. 31, 2022 |
$ 17,684
|
53,763,513
|
(15,074)
|
(3,788,745)
|
49,977,378
|
Balance (in Shares) at Mar. 31, 2022 |
23,008,371
|
|
|
|
|
-restricted share units |
|
23,912
|
|
|
23,912
|
-options |
|
99,536
|
|
|
99,536
|
-restricted stock |
$ 43
|
435,878
|
|
|
435,921
|
-restricted stock (in Shares) |
429,447
|
|
|
|
|
Warrants issued for acquisition |
|
350,722
|
|
|
350,722
|
Common shares issued for acquisition |
$ 326
|
3,293,153
|
|
|
3,293,479
|
Common shares issued for acquisition (in Shares) |
3,260,870
|
|
|
|
|
Foreign currency translation |
|
|
(48,985)
|
|
(48,985)
|
Net loss |
|
|
|
(2,658,394)
|
(2,658,394)
|
Balance at Jun. 30, 2022 |
$ 18,053
|
57,966,715
|
(64,059)
|
(6,447,139)
|
51,473,570
|
Balance (in Shares) at Jun. 30, 2022 |
26,698,688
|
|
|
|
|
Balance at Dec. 31, 2022 |
$ 17,987
|
61,837,802
|
(661)
|
(19,356,880)
|
42,498,248
|
Balance (in Shares) at Dec. 31, 2022 |
26,043,406
|
|
|
|
|
-restricted share units |
$ 8
|
23,641
|
|
|
23,649
|
-restricted share units (in Shares) |
83,334
|
|
|
|
|
-options |
|
153,372
|
|
|
153,372
|
Foreign currency translation |
|
|
(2,483)
|
|
(2,483)
|
Net loss |
|
|
|
(3,537,679)
|
(3,537,679)
|
Balance at Mar. 31, 2023 |
$ 17,995
|
62,014,815
|
(3,144)
|
(22,894,559)
|
39,135,107
|
Balance (in Shares) at Mar. 31, 2023 |
26,126,740
|
|
|
|
|
Balance at Dec. 31, 2022 |
$ 17,987
|
61,837,802
|
(661)
|
(19,356,880)
|
42,498,248
|
Balance (in Shares) at Dec. 31, 2022 |
26,043,406
|
|
|
|
|
Net loss |
|
|
|
|
(7,300,909)
|
Balance at Jun. 30, 2023 |
$ 17,997
|
62,233,447
|
(3,461)
|
(26,657,789)
|
35,590,194
|
Balance (in Shares) at Jun. 30, 2023 |
26,143,407
|
|
|
|
|
Balance at Mar. 31, 2023 |
$ 17,995
|
62,014,815
|
(3,144)
|
(22,894,559)
|
39,135,107
|
Balance (in Shares) at Mar. 31, 2023 |
26,126,740
|
|
|
|
|
-restricted share units |
$ 2
|
23,910
|
|
|
23,912
|
-restricted share units (in Shares) |
16,667
|
|
|
|
|
-options |
|
194,722
|
|
|
194,722
|
Foreign currency translation |
|
|
(317)
|
|
(317)
|
Net loss |
|
|
|
(3,763,230)
|
(3,763,230)
|
Balance at Jun. 30, 2023 |
$ 17,997
|
$ 62,233,447
|
$ (3,461)
|
$ (26,657,789)
|
$ 35,590,194
|
Balance (in Shares) at Jun. 30, 2023 |
26,143,407
|
|
|
|
|
X |
- DefinitionAmount of warrants issued for acquisition.
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v3.23.2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
Net loss from continuing operations |
$ (6,863,894)
|
$ (3,483,440)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation |
8,895
|
957
|
Amortization expense |
315,082
|
|
Stock-based compensation |
395,655
|
694,957
|
Change in fair value of warrant liabilities |
(66,556)
|
(1,206,997)
|
Non-cash lease expense |
1,920
|
|
Gain on sale of assets |
(65,048)
|
|
Changes in operating assets and liabilities: |
|
|
Prepaid expenses |
(252,198)
|
(137,754)
|
Other assets |
(189,203)
|
(46,595)
|
Accounts payable and accrued liabilities |
433,403
|
59,937
|
Lease liabilities |
|
31,350
|
Net cash used in operating activities |
(6,281,944)
|
(4,087,585)
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
Purchase of property and equipment |
(56,996)
|
(8,890)
|
Net cash proceeds from sale of assets |
27,500
|
|
Acquisition of business, net of cash acquired |
|
77,060
|
Net cash (used in) provided by investing activities |
(29,496)
|
68,170
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
Note payable proceeds |
392,354
|
|
Principal payments on note payable |
(259,019)
|
|
Net cash provided by financing activities |
133,335
|
|
Effect of foreign currency translation on cash |
(2,800)
|
(47,006)
|
Net cash used in operating activities of discontinued operations |
(583,133)
|
(400,554)
|
Net cash provided by (used in) investing activities of discontinued operations |
323,807
|
(538,835)
|
Net cash used in financing activities of discontinued operations |
|
|
NET CHANGE IN CASH |
(6,440,231)
|
(5,005,810)
|
Cash – Beginning of period |
33,087,864
|
52,901,962
|
Cash – End of period |
26,647,633
|
47,896,152
|
Supplemental disclosure of cash flow information: |
|
|
Amount due from sale of assets |
$ 122,500
|
|
X |
- DefinitionAmount due from sale of assets.
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v3.23.2
Nature of the Organization and Business
|
6 Months Ended |
Jun. 30, 2023 |
Nature of the Organization and Business [Abstract] |
|
NATURE OF THE ORGANIZATION AND BUSINESS |
NOTE
1 – NATURE OF THE ORGANIZATION AND BUSINESS
Pasithea
Therapeutics Corp. (“Pasithea” or the “Company”) was incorporated in the State of Delaware on May 12, 2020 and
completed an initial public offering (the “Initial Public Offering”) on September 17, 2021. The Company is a biotechnology
company focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders and other
diseases. The Company is leveraging its expertise in the fields of neuroscience, translational medicine, and drug development to advance
new molecular entities that target the pathophysiology underlying such diseases with the goal of bringing life-changing therapies to
patients.
The
Company’s therapeutic pipeline currently consists of four programs. The Company’s lead product candidate, PAS-004, is a next-generation
macrocyclic mitogen-activated protein kinase, or MEK inhibitor that the Company believes may address the limitations and liabilities
associated with existing drugs targeting a similar mechanism of action. The remaining three programs are in the discovery stage, which
the Company believes address limitations in the treatment paradigm of the indications the Company plans to address with these programs,
which are currently amyotrophic lateral sclerosis (“ALS”), multiple sclerosis (“MS”) and schizophrenia.
Through
December 31, 2022, the Company operated a Clinics business that was focused on providing business support services to anti-depression
clinics in the U.K. and in the United States. Its operations in the U.K. involved providing business support services to registered healthcare
providers who assess patients and, if appropriate, administer intravenous infusions of ketamine. Its operations in the United States
involved providing business support services to entities that furnish similar services to patients who personally pay for those services.
Operations in the U.K. and the United States were conducted through partnerships with healthcare providers and the Company did not provide
professional medical services or psychiatric assessments.
During the three months ended as of March 31,
2023, we discontinued our at-home services in New York, NY as well as our services in the U.K. During the three months ended as of June
30, 2023, we sold our assets associated with the Clinics operations in Los Angeles, CA and the lease associated with the related property
was assumed by the buyer in the transaction. Accordingly, as of the date of this Quarterly Report on Form 10-Q, the previously discontinued
operations of our Clinics segment have been disposed of.
Throughout
this report, the terms “our,” “we,” “us,” and the “Company” refer to Pasithea Therapeutics
Corp. and its subsidiaries, Pasithea Therapeutics Limited (U.K.), Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, Pasithea
Clinics Corp, Alpha-5 Integrin, LLC, and AlloMek Therapeutics, LLC. Pasithea Therapeutics Limited (U.K.) is a private limited Company,
registered in the United Kingdom (U.K.). Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda is a private limited Company, registered
in Portugal. Pasithea Clinics Corp. is incorporated in Delaware. Alpha-5 Integrin, LLC is a Delaware limited liability company. AlloMek
Therapeutics, LLC is a Delaware limited liability company.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles
generally accepted in the United States of America (“U.S. GAAP”). Emerging
Growth Company
The
Company is an “emerging growth company,” as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart Our
Business Startups Act of 2012 (the “JOBS Act”), and it may take advantage of certain exemptions from various reporting requirements
that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required
to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations
regarding executive compensation in its periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding
advisory vote on executive compensation and approval of any golden parachute payments not previously approved. Further, Section 102(b)(1)
of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until
private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class
of securities registered under the Exchange Act) are required to comply with the new or revised financial accounting standards. The JOBS
Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging
growth companies but any such election to opt out is irrevocable. The Company has elected not to opt out of such extended transition
period which means that when a standard is issued or revised and it has different application dates for public or private companies,
the Company, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised
standard. This may make comparison of the Company’s condensed consolidated financial statements with another public company which
is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult
or impossible because of the potential differences in accounting standards used.
Liquidity
and Capital Resources
As of June 30, 2023, the Company had approximately
$26.6 million of cash and cash equivalents and working capital of approximately $25.8 million. The Company’s major sources
of cash have been comprised of proceeds from various private offerings, the Initial Public Offering, and the prior exercise of warrants. The
Company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities to continue to execute
its development plans and continue operations. Based on the foregoing, management believes that the Company will have sufficient
working capital to meet its needs through twelve months from the date of these condensed consolidated financial statements.
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v3.23.2
Summary of Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
NOTE
2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Principles
of Consolidation
The
Company evaluates the need to consolidate affiliates based on standards set forth in Accounting Standards Codification (“ASC”)
810, “Consolidation,” (“ASC 810”). The condensed consolidated financial statements include the accounts of the
Company and its wholly owned subsidiaries, Pasithea Therapeutics Limited (U.K.) and Pasithea Clinics Corp. (“Pasithea Clinics”).
All significant intercompany transactions and balances have been eliminated in consolidation.
These
condensed consolidated financial statements are presented in U.S. Dollars.
Use
of Estimates
The
preparation of financial statements in conformity with U.S. GAAP requires the Company’s management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial
statement and the reported amounts of revenues and expenses during the reporting period.
Making
estimates requires management to exercise significant judgment. It is at least reasonably possible that the estimate of the effect of
a condition, situation or set of circumstances that existed at the date of the financial statements, which management considered in formulating
its estimate, could change in the near term due to one or more future confirming events. Management regularly makes estimates related
to the fair value of warrant liabilities; the recoverability of long-lived assets; the fair values and useful lives of intangible assets
acquired in business combinations; the potential impairment of goodwill; and income taxes. The Company bases its estimates on historical
experience and on various assumptions that are believed to be reasonable, the results of which form the basis for the amounts recorded
in the consolidated financial statements. As appropriate, the Company obtains reports from third-party valuation experts to inform and
support estimates related to fair value measurements. Research
and Development
Research
and development costs are charged to operations when incurred and are included in operating expense, except for goodwill related
to intellectual property & patents. Our research and development costs consist principally of compensation of employees and consultants
that perform the Company’s research activities, payments to third parties for preclinical, non-clinical and regulatory activities,
costs to acquire drug product from contract development and manufacturing organizations and third-party contractors relating to chemistry,
manufacturing and controls (“CMC”) efforts, the fees paid for and to maintain the Company’s intellectual property,
and research and development costs related to our discovery programs. Depending upon the timing of payments to the service providers,
the Company recognizes prepaid expenses or accrued expenses related to these costs. These accrued or prepaid expenses are based on management’s
estimates of the work performed under service agreements, milestones achieved and experience with similar contracts. The Company monitors
each of these factors and adjusts estimates accordingly.
Selling,
General and Administrative
Our
selling, general and administrative expenses primarily consist of personnel and related costs, including stock-based compensation, legal
fees relating to both intellectual property and corporate matters, accounting and audit related costs, insurance, corporate communications
and public company expenses, information technology, office and facility rents and related expenses, including depreciation, amortization
and maintenance, and fees for consulting, business development and other professional services.
Cash
and Cash Equivalents
The
Company considers all short-term investments with an original maturity of three months or less when purchased to be cash equivalents.
The Company had cash equivalents of $10.1 million as of June 30, 2023, and did not have any cash equivalents as of December 31, 2022.
Property
and Equipment
Property
and equipment is recorded at cost, net of depreciation. Depreciation is computed using straight-line and accelerated methods over the
estimated useful lives of the related assets. Expenditures that enhance the useful lives of the assets are capitalized and depreciated.
Maintenance and repairs are expensed as incurred. When properties are retired or otherwise disposed of, related costs and related accumulated
depreciation are removed from the accounts.
Warrant
Liability
The Company accounts for the publicly traded warrants
issued in its Initial Public Offering (the “Public Warrants”) and the warrants issued as compensation to the underwriters
in its Initial Public Offering (the “Representative Warrants” and together with the Public Warrants, the “IPO Warrants”)
in accordance with the guidance contained in ASC 815, “Derivatives and Hedging,” under which the IPO Warrants do not meet
the criteria for equity treatment and must be recorded as derivative liabilities. Accordingly, the Company classifies the IPO Warrants
as liabilities at their fair value and adjusts the IPO Warrants to fair value at each reporting period. This liability is subject to re-measurement
at each balance sheet date until the IPO Warrants are exercised or expire, and any change in fair value is recognized in the Company’s
condensed consolidated statement of operations and comprehensive loss. The fair value of the IPO Warrants was initially measured using
a Black Scholes pricing model. Currently, the fair value of the Public Warrants is measured using quoted market prices, and the fair value
of the Representative Warrants is based on an estimate of the relative fair value to the Public Warrants, accounting for a small difference
in the exercise price.
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentrations of credit risk consist of a cash account in a financial institution,
which, at times, may exceed the Federal Depository Insurance Coverage of $250,000. As of June 30, 2023, the Company has not experienced
losses on this account and management believes the Company is not exposed to significant risks on such account. Fair
Value of Financial Instruments
Except
for liabilities related to the IPO Warrants, described in the table below, the fair value of the Company’s assets and liabilities,
which qualify as financial instruments under ASC 820, “Fair Value Measurements and Disclosures,” approximates the carrying
amounts represented in the accompanying balance sheet, primarily due to their short-term nature.
Fair
Value Measurements
Fair
value is defined as the price that would be received for sale of an asset or paid for transfer of a liability, in an orderly transaction
between market participants at the measurement date. GAAP establishes a three-tier fair value hierarchy, which prioritizes the inputs
used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets
or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:
|
● |
Level
1, defined as observable inputs such as quoted prices (unadjusted) for identical instruments in active markets; |
|
● |
Level
2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted
prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active;
and |
|
● |
Level
3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions,
such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. |
The
following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring
basis and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value:
| |
| | |
Fair value measurements at reporting date using: | |
| |
Fair value | | |
Quoted prices in active markets for identical liabilities (Level 1) | | |
Significant other observable inputs (Level 2) | | |
Significant unobservable inputs (Level 3) | |
Assets: | |
| | |
| | |
| | |
| |
Cash equivalents, June 30, 2023 | |
$ | 10,122,758 | | |
$ | 10,122,758 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Public Warrants, June 30, 2023 | |
$ | 69,520 | | |
$ | 69,520 | | |
$ | - | | |
$ | - | |
Representative Warrants, June 30, 2023 | |
$ | 4,535 | | |
$ | - | | |
$ | - | | |
$ | 4,535 | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Public Warrants, December 31, 2022 | |
$ | 132,000 | | |
$ | 132,000 | | |
$ | - | | |
$ | - | |
Representative Warrants liabilities, December 31, 2022 | |
$ | 8,611 | | |
$ | - | | |
$ | - | | |
$ | 8,611 | |
The
following table presents a reconciliation of the Level 3 Representative Warrants liabilities:
|
|
For the three months ended
June 30, |
|
|
|
2023 |
|
|
2022 |
|
Beginning balance, March 31 |
|
$ |
11,482 |
|
|
$ |
48,797 |
|
Issuances |
|
|
- |
|
|
|
- |
|
Exercises |
|
|
- |
|
|
|
- |
|
Change in fair value |
|
|
(6,946 |
) |
|
|
(30,197 |
) |
Ending balance, June 30 |
|
$ |
4,535 |
|
|
$ |
18,600 |
|
| |
For the six months ended
June 30, | |
| |
2023 | | |
2022 | |
Beginning balance, December 31 | |
$ | 8,611 | | |
$ | 106,205 | |
Issuances | |
| - | | |
| - | |
Exercises | |
| - | | |
| - | |
Change in fair value | |
| (4,076 | ) | |
| (87,605 | ) |
Ending balance, June 30 | |
$ | 4,535 | | |
$ | 18,600 | |
The change in fair value of the Representative
Warrants liabilities is recorded in change in fair value of warrant liabilities on the condensed consolidated statement of operations
and comprehensive loss.
The
fair value of the cash equivalents is based on the fair value of marketable securities invested in U.S. government money market funds.
The
fair value of the liability associated with the Public Warrants as of June 30, 2023 was based on the quoted closing price on The Nasdaq
Capital Market and is classified as Level 1. The fair value of the liability associated with the Representative Warrants as of June 30,
2023 was based on an estimate of the relative fair value to the Public Warrants, accounting for a small difference in the exercise price,
and is classified as Level 3.
In
some circumstances, the inputs used to measure fair value might be categorized within different levels of the fair value hierarchy. In
those instances, the fair value measurement is categorized in its entirety in the fair value hierarchy based on the lowest level input
that is significant to the fair value measurement.
Net
Loss Per Share
Net
loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the reporting period.
Diluted earnings per share is computed similarly to the basic earnings per share, except the weighted average number of common shares
outstanding are increased to include additional shares from the assumed exercise of share options, if dilutive. The following outstanding
shares issuable upon exercise of stock options and warrants and vesting of restricted stock units were excluded from the computation
of diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect:
| |
Six months ended June 30, 2023 | |
| |
2023 | | |
2022 | |
Stock options | |
| 1,980,000 | | |
| 1,000,000 | |
Warrants | |
| 15,356,000 | | |
| 12,600,000 | |
Restricted stock units | |
| 99,999 | | |
| 200,000 | |
Foreign
Currency Translations
The
Company’s functional and reporting currency is the U.S. dollar. All transactions initiated in other currencies are translated into
U.S. dollars using the exchange rate prevailing on the date of transaction. Monetary assets and liabilities denominated in foreign currencies
are translated into the U.S. dollar at the rate of exchange in effect at the balance sheet date. Unrealized exchange gains and losses
arising from such transactions are deferred until realization and are included as a separate component of stockholders’ equity
(deficit) as a component of comprehensive income or loss. Upon realization, the amount deferred is recognized in income in the period
when it is realized.
Translation
of Foreign Operations
The
financial results and position of foreign operations whose functional currency is different from the Company’s presentation currency
are translated as follows:
|
● |
assets
and liabilities are translated at period-end exchange rates prevailing at that reporting date; |
|
● |
equity
is translated at historical exchange rates; and |
|
● |
income
and expenses are translated at average exchange rates for the period. |
Exchange
differences arising on translation of foreign operations are transferred directly to the Company’s accumulated other comprehensive
loss in the condensed consolidated financial statements. Transaction gains and losses arising from exchange rate fluctuation on transactions
denominated in a currency other than the functional currency are included in the condensed consolidated statements of operations and
comprehensive loss. The
relevant translation rates are as follows:
| |
6/30/2023 | | |
12/31/2022 | |
Closing rate, British Pound (GBP) to $USD at period end | |
| 1.2714 | | |
| 1.2039 | |
Average rate, GBP to $USD for the period ended | |
| 1.2332 | | |
| 1.2362 | |
Closing rate, Euro (EUR) to $USD at period end | |
| 0.9166 | | |
| 0.9367 | |
Average rate, EUR to $USD for the period ended | |
| 0.9256 | | |
| 0.9517 | |
Comprehensive
Income (Loss)
ASC
220, “Comprehensive Income,” establishes standards for reporting and display of comprehensive income (loss) and its components
in a full set of general-purpose financial statements. As of June 30, 2023 and December 31, 2022, the Company had no material items of
other comprehensive income (loss) except for the foreign currency translation adjustment.
Recent
Accounting Pronouncements
Management
does not believe that any recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material
effect on the Company’s financial statements.
Recently
Adopted Accounting Pronouncements
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses, which requires entities to estimate
all expected credit losses for financial assets measured at amortized cost basis, including trade receivables, held at the reporting
date based on historical experience, current conditions, and reasonable and supportable forecasts. The Company adopted this guidance
on March 31, 2023. The adoption of this accounting standard did not have a material impact to the Company’s condensed consolidated
financial statements.
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v3.23.2
Property and Equipment, Net
|
6 Months Ended |
Jun. 30, 2023 |
Property and Equipment, Net [Abstract] |
|
PROPERTY AND EQUIPMENT, NET |
NOTE
3 – PROPERTY AND EQUIPMENT, NET
Property
and equipment, net consists of the following:
| |
As of
June 30,
2023 | | |
As of
December 31,
2022 | |
Leasehold improvements | |
$ | 3,193 | | |
$ | 3,193 | |
Medical equipment | |
| 155,363 | | |
| 99,220 | |
Office equipment | |
| 25,691 | | |
| 26,343 | |
Property and equipment, gross | |
| 184,247 | | |
| 128,756 | |
Less: accumulated depreciation | |
| (10,949 | ) | |
| (3,559 | ) |
Property and equipment, net | |
$ | 173,298 | | |
$ | 125,197 | |
|
X |
- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.23.2
Leases
|
6 Months Ended |
Jun. 30, 2023 |
Leases [Abstract] |
|
LEASES |
NOTE
4 – LEASES
Laboratory
Lease – South San Francisco, California
In
August 2022, the Company, as a lessee, entered into an amended sublease agreement to sublease laboratory and office space in South San
Francisco, California. The lease commenced on August 15, 2022. The term of this sublease is for a period of thirty-nine and one-fourth
(39.25) months commencing on the effective date, until May 15, 2024. The lease has a gross monthly rent of $16,171 per month, which
will increase to $16,656 beginning January 1, 2024.
This
lease was accounted for as an operating lease under ASC 842, Leases, which resulted in the recognition of a right of use asset (“ROU
asset”) and liability of approximately $569,000 at inception. The ROU asset is recorded as a component of non-current assets
and the liability a component of current and non-current liabilities on the Company’s consolidated balance sheets. The Company
discounted the future lease payments of this lease using the prevailing collateralized lending rate which would be extended to the Company
based on its credit profile relative to the period of inception, and the duration of the lease from inception. The interest rate used
in calculating the fair value listed above was 7.8%. As
of June 30, 2023, the Company recognized total ROU assets and lease liabilities as follows:
| |
As of June 30, 2023 | | |
As of December 31, 2022 | |
Non-current leases – right of use assets | |
$ | 419,885 | | |
$ | 500,428 | |
Current liabilities – operating lease liabilities | |
$ | 169,676 | | |
$ | 160,362 | |
Non-current liabilities – operating lease liabilities | |
$ | 256,084 | | |
$ | 344,021 | |
| |
| | | |
| | |
Operating lease expense | |
$ | 128,281 | | |
$ | 168,812 | |
Cash paid for amounts included in the measurement of operating lease liabilities | |
$ | - | | |
$ | 169,695 | |
The
following table summarizes the maturity of the Company’s operating lease payments as of June 30, 2023:
2023 (remaining) | |
$ | 97,511 | |
2024 | |
| 199,872 | |
2025 | |
| 183,216 | |
Total future minimum lease payments | |
$ | 480,599 | |
Amount representing interest | |
| (54,839 | ) |
Present value of net future minimum lease payments | |
$ | 425,760 | |
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v3.23.2
Intangible Assets and Goodwill
|
6 Months Ended |
Jun. 30, 2023 |
Intangible Assets and Goodwill [Abstract] |
|
INTANGIBLE ASSETS AND GOODWILL |
NOTE
5 – INTANGIBLE ASSETS AND GOODWILL
Intangible
assets, net consists of the following:
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
Gross Carrying Amount | | |
Accumulated Amortization | | |
Net | | |
Gross Carrying Amount | | |
Accumulated Amortization | | |
Net | |
In-process research and development | |
$ | 2,900,000 | | |
$ | - | | |
$ | 2,900,000 | | |
$ | 2,900,000 | | |
$ | - | | |
$ | 2,900,000 | |
Patents and intellectual property | |
| 5,513,937 | | |
| (157,541 | ) | |
| 5,356,396 | | |
| 5,671,478 | | |
| - | | |
| 5,671,478 | |
Intangible assets, net | |
$ | 8,413,937 | | |
$ | (157,541 | ) | |
$ | 8,256,396 | | |
$ | 8,571,478 | | |
$ | - | | |
$ | 8,571,478 | |
As
of June 30, 2023, future expected amortization expense of Intangible assets was as follows:
2023 | |
$ | 315,082 | |
2024 | |
| 630,164 | |
2025 | |
| 630,164 | |
2026 | |
| 630,164 | |
2027 | |
| 630,164 | |
Thereafter | |
| 5,420,658 | |
Remaining future amortization expense | |
$ | 8,256,396 | |
There
were no changes to goodwill for the six months ended June 30, 2023.
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v3.23.2
Stockholders’ Equity
|
6 Months Ended |
Jun. 30, 2023 |
Stockholders’ Equity [Abstract] |
|
STOCKHOLDERS’ EQUITY |
NOTE 6 – STOCKHOLDERS’ EQUITY
Common Stock
The Company had 26,143,407 and 26,698,688 shares
of its Common Stock issued and outstanding at June 30, 2023 and 2022, respectively.
Common Stock Issuances for the Three and Six
Months Ended June 30, 2023
During the three and six months ended June
30, 2023, the Company issued 16,667 and 100,001 shares of common stock, respectively, due to the vesting of restricted stock units
(“RSUs”), and recognized approximately $24,000 and $48,000, respectively, of stock-based compensation expense related to its
outstanding restricted stock units. Stock-based compensation expense related to the Company’s restricted stock units is recognized
within selling, general and administrative expense.
As of June
30, 2023, remaining unamortized RSU stock-based compensation expense was approximately $142,000.
The Company did not grant any RSUs or restricted
stock during the three and six months ended June 30, 2023.
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v3.23.2
Stock Options
|
6 Months Ended |
Jun. 30, 2023 |
Stock Option [Abstract] |
|
STOCK OPTIONS |
NOTE 7 – STOCK OPTIONS
Stock Options Issued, Vested and Cancelled
During the three months ended June
30, 2023, no stock options were issued. During the three months ended June 30, 2023,
stock options to purchase an aggregate of 333,334 shares of Common Stock, subject to time-based milestone vesting conditions, vested.
During the three months ended June
30, 2023, stock options to purchase an aggregate of 200,000 shares of Common Stock were cancelled.
During the six months ended June 30, 2023, the
Company issued stock options under the 2021 Plan to employees, to purchase an aggregate of 880,000 shares of Common Stock with a strike
price equal to $0.491 per share and a term of ten years. One-third of these options vest on the one-year anniversary of the employee hire
date and then the remaining stock options vest in equal quarterly installments over the remaining two years. These options had a total
fair value of approximately $288,000, as calculated using the Black-Scholes pricing model with a volatility assumption of 68.64%.
During the six months ended June
30, 2023, stock options to purchase an aggregate of 350,001 shares of Common Stock, subject to time-based milestone vesting conditions,
vested. During the six months ended June 30, 2023, stock options to purchase an aggregate
of 200,000 shares of Common Stock were cancelled.
Stock-Based Compensation
For the
three months ended June 30, 2023 and 2022, total stock-based compensation expense related to the Company’s stock options was approximately
$195,000 and approximately $100,000, respectively. For the three months ended June 30, 2023, the Company recognized approximately
$136,000 of stock-based compensation related to its options within selling, general and administrative expense, and approximately $59,000
within research and development expense. For the three months ended June 30, 2022, all stock-based compensation expense was recorded within
selling, general and administrative expense.
For the
six months ended June 30, 2023 and 2022, total stock-based compensation expense related to the Company’s stock options was approximately
$348,000 and approximately $194,000, respectively. For the six months ended June 30, 2023, the Company recognized approximately $267,000
of stock-based compensation related to its options within selling, general and administrative expense, and approximately $81,000 within
research and development expense. For the six months ended June 30, 2022, all stock-based compensation expense was recorded within selling,
general and administrative expense.
The following
table summarizes the activity related to the Company’s stock options for the six months ended June 30, 2023:
| |
Number of Options | | |
Weighted average exercise price per share | | |
Weighted average remaining contractual term (years) | | |
Aggregate intrinsic value (in thousands) | |
Outstanding, January 1, 2023 | |
| 1,300,000 | | |
$ | 2.28 | | |
| 9.12 | | |
$ | - | |
Granted | |
| 880,000 | | |
| 0.49 | | |
| 9.66 | | |
| - | |
Expired/Cancelled | |
| (200,000 | ) | |
| 0.96 | | |
| 9.13 | | |
| - | |
Outstanding, June 30, 2023 | |
| 1,980,000 | | |
$ | 1.62 | | |
| 9.06 | | |
| - | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable, June 30, 2023 | |
| 566,668 | | |
$ | 2.18 | | |
| 8.84 | | |
$ | - | |
As of June
30, 2023, remaining unamortized stock-based compensation expense related to the stock options was approximately $581,000.
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.2
Warrants
|
6 Months Ended |
Jun. 30, 2023 |
Warrant [Abstract] |
|
WARRANTS |
NOTE 8 – WARRANTS
As of June
30, 2023, the fair value of the Public Warrants was approximately $0.02 per Public Warrant based on the closing price of the warrants
on The Nasdaq Capital Market. The fair value of the Representative Warrants was approximately $0.02 per Representative Warrant which was
based on the relative fair value to the Public Warrants.
The following table summarizes the Company’s
outstanding warrants:
Exercise Price | | |
Number of warrants | | |
Weighted-
average remaining contractual term (years) | | |
Weighted average exercise price | |
$ | 1.88 | | |
| 2,000,000 | | |
| 4.13 | | |
| | |
$ | 3.50 | | |
| 8,680,000 | | |
| 3.40 | | |
| | |
$ | 6.00 | | |
| 276,000 | | |
| 3.22 | | |
| | |
$ | 6.25 | | |
| 4,400,000 | | |
| 3.22 | | |
| | |
| | | |
| 15,356,000 | | |
| 3.44 | | |
$ | 4.12 | |
No warrants were granted during the three and
six months ended June 30, 2023.
|
X |
- DefinitionThe entire disclosure for derivative instruments and hedging activities including, but not limited to, risk management strategies, non-hedging derivative instruments, assets, liabilities, revenue and expenses, and methodologies and assumptions used in determining the amounts.
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v3.23.2
Commitment and Contingencies
|
6 Months Ended |
Jun. 30, 2023 |
Commitment and Contingencies [Abstract] |
|
COMMITMENT AND CONTINGENCIES |
NOTE 9 – COMMITMENTS AND CONTINGENCIES
Legal
and Regulatory Environment
The healthcare
industry is subject to numerous laws and regulations of federal, state and local governments. These laws and regulations include, but
are not limited to, matters such as licensure, accreditation, government healthcare program participation requirement, reimbursement for
patient services and Medicare and Medicaid fraud and abuse. Government activity has increased with respect to investigations and allegations
concerning possible violations of fraud and abuse statutes and regulations by healthcare providers.
Violations
of these laws and regulations could result in expulsion from government healthcare programs, together with the imposition of significant
fines and penalties, as well as significant repayments for patient services previously billed. Management believes that the Company is
in compliance with fraud and abuse regulations, as well as other applicable government laws and regulations. While no material regulatory
inquiries have been made, compliance with such laws and regulations can be subject to future government review and interpretation, as
well as regulatory actions unknown or unasserted at this time.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.23.2
Discontinued Operations
|
6 Months Ended |
Jun. 30, 2023 |
Discontinued Operations and Disposal Groups [Abstract] |
|
DISCONTINUED OPERATIONS |
NOTE 10 – DISCONTINUED OPERATIONS
During the
three months ended March 31, 2023, we discontinued our at-home services in New York, NY, our Clinics operations in Los Angeles, CA, as
well as our services in the U.K. During the three months ended June 30, 2023, we sold our assets associated with the Clinics operations
in Los Angeles, CA, and the lease associated with the related property was assumed by the buyer in the transaction. Accordingly, as of
June 30, 2023, the previously discontinued operations of our Clinics segment have been disposed of. As of June 30, 2023, the carrying amounts of the
classes of assets and liabilities related to the discontinued operations of the Clinics operations were $0.
The results of operations from discontinued operations for
the three and six months ended June 30, 2023 and 2022, have been reflected as discontinued operations in
the condensed consolidated statements of operations and consist of the following:
| |
Three Months Ended
June 30, | | |
Six Months Ended
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenues | |
$ | - | | |
$ | 13,581 | | |
$ | - | | |
$ | 27,239 | |
Cost of services | |
| - | | |
| 15,101 | | |
| - | | |
| 28,038 | |
Gross margin | |
| - | | |
| (1,520 | ) | |
| - | | |
| (799 | ) |
| |
| | | |
| | | |
| | | |
| | |
Selling, general and administrative | |
| 165,146 | | |
| 467,016 | | |
| 502,063 | | |
| 793,395 | |
Loss from discontinued operations | |
| (165,146 | ) | |
| (468,535 | ) | |
| (502,063 | ) | |
| (794,194 | ) |
Gain on forgiveness of accounts payable | |
| - | | |
| - | | |
| - | | |
| 45,000 | |
Gain on sale of assets | |
| - | | |
| - | | |
| 65,048 | | |
| - | |
Loss from discontinued operations, before income tax | |
| (165,146 | ) | |
| (468,535 | ) | |
| (437,015 | ) | |
| (749,194 | ) |
Income tax expense | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss from discontinued operations, net of tax | |
| (165,146 | ) | |
| (468,535 | ) | |
| (437,015 | ) | |
| (749,194 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted-average common shares outstanding, basic and diluted | |
| 26,128,022 | | |
| 23,444,135 | | |
| 26,100,681 | | |
| 23,226,253 | |
Basic and diluated loss per share from discontinued operations | |
$ | (0.01 | ) | |
$ | (0.02 | ) | |
$ | (0.02 | ) | |
$ | (0.03 | ) |
The following table presents the gain on the sale
of assets in Los Angeles, CA:
| |
As of
June 30,
2023 | |
Cash proceeds | |
$ | 27,500 | |
Proceeds to receive in installments | |
| 122,500 | |
Total | |
$ | 150,000 | |
Less transaction costs | |
| (11,250 | ) |
Less book value of assets | |
| (73,702 | ) |
Gain on sale, before income tax | |
$ | 65,048 | |
Income tax expense | |
| - | |
Gain on sale, net of tax | |
$ | 65,048 | |
The following table presents non-cash items related
to discontinued operations, which are included in the Company’s unaudited condensed consolidated statement of cash flows:
| |
Six months ended
June 30,
2023 | |
Cash Flows From Operating Activities: | |
| |
Gain on sale of assets | |
$ | (65,048 | ) |
| |
| | |
Supplemental disclosure of cash flow information: | |
| | |
Amount due from sale of assets | |
$ | 122,500 | |
|
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v3.23.2
Note Payable
|
6 Months Ended |
Jun. 30, 2023 |
Note Payable [Abstract] |
|
Note Payable |
NOTE 11 – NOTE PAYABLE
Directors and Officer’s Liability Insurance
On January 9, 2023, the Company entered into a 9-month financing
agreement for its directors and officer’s liability insurance in the amount of approximately $392,000 that bears interest at an
annual rate of 7.8%. Monthly payments, including principal and interest, are approximately $45,000 per month. The balance due
under this financing agreement was approximately $133,000 and $0 at June 30, 2023 and December 31,
2022, respectively.
|
X |
- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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|
v3.23.2
Subsequent Events
|
6 Months Ended |
Jun. 30, 2023 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE 12 – SUBSEQUENT EVENTS
On July 20, 2023, the Company announced that its
Board of Directors authorized the repurchase, through a $4.0 million tender offer of up to approximately 5.7 million shares of the
Company’s outstanding common stock at a cash purchase price of $0.70 per share (the “Tender Offer”). The Company
launched the Tender Offer on August 9, 2023, which is expected to expire on September 8, 2023, subject to the terms and conditions of
the Tender Offer.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.23.2
Accounting Policies, by Policy (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Principles of Consolidation |
Principles
of Consolidation The
Company evaluates the need to consolidate affiliates based on standards set forth in Accounting Standards Codification (“ASC”)
810, “Consolidation,” (“ASC 810”). The condensed consolidated financial statements include the accounts of the
Company and its wholly owned subsidiaries, Pasithea Therapeutics Limited (U.K.) and Pasithea Clinics Corp. (“Pasithea Clinics”).
All significant intercompany transactions and balances have been eliminated in consolidation. These
condensed consolidated financial statements are presented in U.S. Dollars.
|
Use of Estimates |
Use
of Estimates The
preparation of financial statements in conformity with U.S. GAAP requires the Company’s management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial
statement and the reported amounts of revenues and expenses during the reporting period. Making
estimates requires management to exercise significant judgment. It is at least reasonably possible that the estimate of the effect of
a condition, situation or set of circumstances that existed at the date of the financial statements, which management considered in formulating
its estimate, could change in the near term due to one or more future confirming events. Management regularly makes estimates related
to the fair value of warrant liabilities; the recoverability of long-lived assets; the fair values and useful lives of intangible assets
acquired in business combinations; the potential impairment of goodwill; and income taxes. The Company bases its estimates on historical
experience and on various assumptions that are believed to be reasonable, the results of which form the basis for the amounts recorded
in the consolidated financial statements. As appropriate, the Company obtains reports from third-party valuation experts to inform and
support estimates related to fair value measurements.
|
Research and Development |
Research
and Development Research
and development costs are charged to operations when incurred and are included in operating expense, except for goodwill related
to intellectual property & patents. Our research and development costs consist principally of compensation of employees and consultants
that perform the Company’s research activities, payments to third parties for preclinical, non-clinical and regulatory activities,
costs to acquire drug product from contract development and manufacturing organizations and third-party contractors relating to chemistry,
manufacturing and controls (“CMC”) efforts, the fees paid for and to maintain the Company’s intellectual property,
and research and development costs related to our discovery programs. Depending upon the timing of payments to the service providers,
the Company recognizes prepaid expenses or accrued expenses related to these costs. These accrued or prepaid expenses are based on management’s
estimates of the work performed under service agreements, milestones achieved and experience with similar contracts. The Company monitors
each of these factors and adjusts estimates accordingly.
|
Selling, General and Administrative |
Selling,
General and Administrative Our
selling, general and administrative expenses primarily consist of personnel and related costs, including stock-based compensation, legal
fees relating to both intellectual property and corporate matters, accounting and audit related costs, insurance, corporate communications
and public company expenses, information technology, office and facility rents and related expenses, including depreciation, amortization
and maintenance, and fees for consulting, business development and other professional services.
|
Cash and cash equivalents |
Cash
and Cash Equivalents The
Company considers all short-term investments with an original maturity of three months or less when purchased to be cash equivalents.
The Company had cash equivalents of $10.1 million as of June 30, 2023, and did not have any cash equivalents as of December 31, 2022.
|
Property and Equipment |
Property
and Equipment Property
and equipment is recorded at cost, net of depreciation. Depreciation is computed using straight-line and accelerated methods over the
estimated useful lives of the related assets. Expenditures that enhance the useful lives of the assets are capitalized and depreciated.
Maintenance and repairs are expensed as incurred. When properties are retired or otherwise disposed of, related costs and related accumulated
depreciation are removed from the accounts.
|
Warrant Liability |
Warrant
Liability The Company accounts for the publicly traded warrants
issued in its Initial Public Offering (the “Public Warrants”) and the warrants issued as compensation to the underwriters
in its Initial Public Offering (the “Representative Warrants” and together with the Public Warrants, the “IPO Warrants”)
in accordance with the guidance contained in ASC 815, “Derivatives and Hedging,” under which the IPO Warrants do not meet
the criteria for equity treatment and must be recorded as derivative liabilities. Accordingly, the Company classifies the IPO Warrants
as liabilities at their fair value and adjusts the IPO Warrants to fair value at each reporting period. This liability is subject to re-measurement
at each balance sheet date until the IPO Warrants are exercised or expire, and any change in fair value is recognized in the Company’s
condensed consolidated statement of operations and comprehensive loss. The fair value of the IPO Warrants was initially measured using
a Black Scholes pricing model. Currently, the fair value of the Public Warrants is measured using quoted market prices, and the fair value
of the Representative Warrants is based on an estimate of the relative fair value to the Public Warrants, accounting for a small difference
in the exercise price.
|
Concentration of Credit Risk |
Concentration
of Credit Risk Financial
instruments that potentially subject the Company to concentrations of credit risk consist of a cash account in a financial institution,
which, at times, may exceed the Federal Depository Insurance Coverage of $250,000. As of June 30, 2023, the Company has not experienced
losses on this account and management believes the Company is not exposed to significant risks on such account.
|
Fair Value of Financial Instruments |
Fair
Value of Financial Instruments Except
for liabilities related to the IPO Warrants, described in the table below, the fair value of the Company’s assets and liabilities,
which qualify as financial instruments under ASC 820, “Fair Value Measurements and Disclosures,” approximates the carrying
amounts represented in the accompanying balance sheet, primarily due to their short-term nature.
|
Fair Value Measurements |
Fair
Value Measurements Fair
value is defined as the price that would be received for sale of an asset or paid for transfer of a liability, in an orderly transaction
between market participants at the measurement date. GAAP establishes a three-tier fair value hierarchy, which prioritizes the inputs
used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets
or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:
|
● |
Level
1, defined as observable inputs such as quoted prices (unadjusted) for identical instruments in active markets; |
|
● |
Level
2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted
prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active;
and |
|
● |
Level
3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions,
such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. |
The
following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring
basis and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value:
| |
| | |
Fair value measurements at reporting date using: | |
| |
Fair value | | |
Quoted prices in active markets for identical liabilities (Level 1) | | |
Significant other observable inputs (Level 2) | | |
Significant unobservable inputs (Level 3) | |
Assets: | |
| | |
| | |
| | |
| |
Cash equivalents, June 30, 2023 | |
$ | 10,122,758 | | |
$ | 10,122,758 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Public Warrants, June 30, 2023 | |
$ | 69,520 | | |
$ | 69,520 | | |
$ | - | | |
$ | - | |
Representative Warrants, June 30, 2023 | |
$ | 4,535 | | |
$ | - | | |
$ | - | | |
$ | 4,535 | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Public Warrants, December 31, 2022 | |
$ | 132,000 | | |
$ | 132,000 | | |
$ | - | | |
$ | - | |
Representative Warrants liabilities, December 31, 2022 | |
$ | 8,611 | | |
$ | - | | |
$ | - | | |
$ | 8,611 | |
The
following table presents a reconciliation of the Level 3 Representative Warrants liabilities:
|
|
For the three months ended
June 30, |
|
|
|
2023 |
|
|
2022 |
|
Beginning balance, March 31 |
|
$ |
11,482 |
|
|
$ |
48,797 |
|
Issuances |
|
|
- |
|
|
|
- |
|
Exercises |
|
|
- |
|
|
|
- |
|
Change in fair value |
|
|
(6,946 |
) |
|
|
(30,197 |
) |
Ending balance, June 30 |
|
$ |
4,535 |
|
|
$ |
18,600 |
|
| |
For the six months ended
June 30, | |
| |
2023 | | |
2022 | |
Beginning balance, December 31 | |
$ | 8,611 | | |
$ | 106,205 | |
Issuances | |
| - | | |
| - | |
Exercises | |
| - | | |
| - | |
Change in fair value | |
| (4,076 | ) | |
| (87,605 | ) |
Ending balance, June 30 | |
$ | 4,535 | | |
$ | 18,600 | |
The change in fair value of the Representative
Warrants liabilities is recorded in change in fair value of warrant liabilities on the condensed consolidated statement of operations
and comprehensive loss. The
fair value of the cash equivalents is based on the fair value of marketable securities invested in U.S. government money market funds. The
fair value of the liability associated with the Public Warrants as of June 30, 2023 was based on the quoted closing price on The Nasdaq
Capital Market and is classified as Level 1. The fair value of the liability associated with the Representative Warrants as of June 30,
2023 was based on an estimate of the relative fair value to the Public Warrants, accounting for a small difference in the exercise price,
and is classified as Level 3. In
some circumstances, the inputs used to measure fair value might be categorized within different levels of the fair value hierarchy. In
those instances, the fair value measurement is categorized in its entirety in the fair value hierarchy based on the lowest level input
that is significant to the fair value measurement.
|
Net Loss Per Share |
Net
Loss Per Share Net
loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the reporting period.
Diluted earnings per share is computed similarly to the basic earnings per share, except the weighted average number of common shares
outstanding are increased to include additional shares from the assumed exercise of share options, if dilutive. The following outstanding
shares issuable upon exercise of stock options and warrants and vesting of restricted stock units were excluded from the computation
of diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect:
| |
Six months ended June 30, 2023 | |
| |
2023 | | |
2022 | |
Stock options | |
| 1,980,000 | | |
| 1,000,000 | |
Warrants | |
| 15,356,000 | | |
| 12,600,000 | |
Restricted stock units | |
| 99,999 | | |
| 200,000 | |
|
Foreign Currency Translations |
Foreign
Currency Translations The
Company’s functional and reporting currency is the U.S. dollar. All transactions initiated in other currencies are translated into
U.S. dollars using the exchange rate prevailing on the date of transaction. Monetary assets and liabilities denominated in foreign currencies
are translated into the U.S. dollar at the rate of exchange in effect at the balance sheet date. Unrealized exchange gains and losses
arising from such transactions are deferred until realization and are included as a separate component of stockholders’ equity
(deficit) as a component of comprehensive income or loss. Upon realization, the amount deferred is recognized in income in the period
when it is realized.
|
Translation of Foreign Operations |
Translation
of Foreign Operations The
financial results and position of foreign operations whose functional currency is different from the Company’s presentation currency
are translated as follows:
|
● |
assets
and liabilities are translated at period-end exchange rates prevailing at that reporting date; |
|
● |
equity
is translated at historical exchange rates; and |
|
● |
income
and expenses are translated at average exchange rates for the period. |
Exchange
differences arising on translation of foreign operations are transferred directly to the Company’s accumulated other comprehensive
loss in the condensed consolidated financial statements. Transaction gains and losses arising from exchange rate fluctuation on transactions
denominated in a currency other than the functional currency are included in the condensed consolidated statements of operations and
comprehensive loss. The
relevant translation rates are as follows:
| |
6/30/2023 | | |
12/31/2022 | |
Closing rate, British Pound (GBP) to $USD at period end | |
| 1.2714 | | |
| 1.2039 | |
Average rate, GBP to $USD for the period ended | |
| 1.2332 | | |
| 1.2362 | |
Closing rate, Euro (EUR) to $USD at period end | |
| 0.9166 | | |
| 0.9367 | |
Average rate, EUR to $USD for the period ended | |
| 0.9256 | | |
| 0.9517 | |
|
Comprehensive Income (Loss) |
Comprehensive
Income (Loss) ASC
220, “Comprehensive Income,” establishes standards for reporting and display of comprehensive income (loss) and its components
in a full set of general-purpose financial statements. As of June 30, 2023 and December 31, 2022, the Company had no material items of
other comprehensive income (loss) except for the foreign currency translation adjustment.
|
Recent Accounting Pronouncements |
Recent
Accounting Pronouncements Management
does not believe that any recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material
effect on the Company’s financial statements. Recently
Adopted Accounting Pronouncements In
June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses, which requires entities to estimate
all expected credit losses for financial assets measured at amortized cost basis, including trade receivables, held at the reporting
date based on historical experience, current conditions, and reasonable and supportable forecasts. The Company adopted this guidance
on March 31, 2023. The adoption of this accounting standard did not have a material impact to the Company’s condensed consolidated
financial statements.
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v3.23.2
Summary of Significant Accounting Policies (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Schedule of Measured at Fair Value on a Recurring Basis |
The
following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring
basis and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value:
| |
| | |
Fair value measurements at reporting date using: | |
| |
Fair value | | |
Quoted prices in active markets for identical liabilities (Level 1) | | |
Significant other observable inputs (Level 2) | | |
Significant unobservable inputs (Level 3) | |
Assets: | |
| | |
| | |
| | |
| |
Cash equivalents, June 30, 2023 | |
$ | 10,122,758 | | |
$ | 10,122,758 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Public Warrants, June 30, 2023 | |
$ | 69,520 | | |
$ | 69,520 | | |
$ | - | | |
$ | - | |
Representative Warrants, June 30, 2023 | |
$ | 4,535 | | |
$ | - | | |
$ | - | | |
$ | 4,535 | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Public Warrants, December 31, 2022 | |
$ | 132,000 | | |
$ | 132,000 | | |
$ | - | | |
$ | - | |
Representative Warrants liabilities, December 31, 2022 | |
$ | 8,611 | | |
$ | - | | |
$ | - | | |
$ | 8,611 | |
|
Schedule of Reconciliation of the Level 3 Representative Warrant Liabilities |
|
|
For the three months ended
June 30, |
|
|
|
2023 |
|
|
2022 |
|
Beginning balance, March 31 |
|
$ |
11,482 |
|
|
$ |
48,797 |
|
Issuances |
|
|
- |
|
|
|
- |
|
Exercises |
|
|
- |
|
|
|
- |
|
Change in fair value |
|
|
(6,946 |
) |
|
|
(30,197 |
) |
Ending balance, June 30 |
|
$ |
4,535 |
|
|
$ |
18,600 |
|
| |
For the six months ended
June 30, | |
| |
2023 | | |
2022 | |
Beginning balance, December 31 | |
$ | 8,611 | | |
$ | 106,205 | |
Issuances | |
| - | | |
| - | |
Exercises | |
| - | | |
| - | |
Change in fair value | |
| (4,076 | ) | |
| (87,605 | ) |
Ending balance, June 30 | |
$ | 4,535 | | |
$ | 18,600 | |
|
Schedule of Net Loss Per Share |
The following outstanding
shares issuable upon exercise of stock options and warrants and vesting of restricted stock units were excluded from the computation
of diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect:
| |
Six months ended June 30, 2023 | |
| |
2023 | | |
2022 | |
Stock options | |
| 1,980,000 | | |
| 1,000,000 | |
Warrants | |
| 15,356,000 | | |
| 12,600,000 | |
Restricted stock units | |
| 99,999 | | |
| 200,000 | |
|
Schedule of Relevant Translation Rates |
The
relevant translation rates are as follows:
| |
6/30/2023 | | |
12/31/2022 | |
Closing rate, British Pound (GBP) to $USD at period end | |
| 1.2714 | | |
| 1.2039 | |
Average rate, GBP to $USD for the period ended | |
| 1.2332 | | |
| 1.2362 | |
Closing rate, Euro (EUR) to $USD at period end | |
| 0.9166 | | |
| 0.9367 | |
Average rate, EUR to $USD for the period ended | |
| 0.9256 | | |
| 0.9517 | |
|
X |
- DefinitionTabular disclosure of relevant translation rate of foreign operations.
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- DefinitionTabular disclosure of securities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) in the future that were not included in the computation of diluted EPS because to do so would increase EPS amounts or decrease loss per share amounts for the period presented, by antidilutive securities.
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v3.23.2
Property and Equipment, Net (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Property and Equipment, Net (Tables) [Line Items] |
|
Schedule of Property and Equipment |
Property
and equipment, net consists of the following:
| |
As of
June 30,
2023 | | |
As of
December 31,
2022 | |
Leasehold improvements | |
$ | 3,193 | | |
$ | 3,193 | |
Medical equipment | |
| 155,363 | | |
| 99,220 | |
Office equipment | |
| 25,691 | | |
| 26,343 | |
Property and equipment, gross | |
| 184,247 | | |
| 128,756 | |
Less: accumulated depreciation | |
| (10,949 | ) | |
| (3,559 | ) |
Property and equipment, net | |
$ | 173,298 | | |
$ | 125,197 | |
|
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- DefinitionTabular disclosure of physical assets used in the normal conduct of business and not intended for resale. Includes, but is not limited to, balances by class of assets, depreciation and depletion expense and method used, including composite depreciation, and accumulated deprecation.
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v3.23.2
Leases (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Leases [Abstract] |
|
Schedule of Company Recognized Total ROU Assets and Lease Liabilities |
As
of June 30, 2023, the Company recognized total ROU assets and lease liabilities as follows:
| |
As of June 30, 2023 | | |
As of December 31, 2022 | |
Non-current leases – right of use assets | |
$ | 419,885 | | |
$ | 500,428 | |
Current liabilities – operating lease liabilities | |
$ | 169,676 | | |
$ | 160,362 | |
Non-current liabilities – operating lease liabilities | |
$ | 256,084 | | |
$ | 344,021 | |
| |
| | | |
| | |
Operating lease expense | |
$ | 128,281 | | |
$ | 168,812 | |
Cash paid for amounts included in the measurement of operating lease liabilities | |
$ | - | | |
$ | 169,695 | |
|
Schedule of Company’s Operating Lease Payments |
The
following table summarizes the maturity of the Company’s operating lease payments as of June 30, 2023:
2023 (remaining) | |
$ | 97,511 | |
2024 | |
| 199,872 | |
2025 | |
| 183,216 | |
Total future minimum lease payments | |
$ | 480,599 | |
Amount representing interest | |
| (54,839 | ) |
Present value of net future minimum lease payments | |
$ | 425,760 | |
|
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v3.23.2
Intangible Assets and Goodwill (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Intangible Assets and Goodwill (Tables) [Line Items] |
|
Schedule of Intangible Assets, Net |
Intangible
assets, net consists of the following:
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
Gross Carrying Amount | | |
Accumulated Amortization | | |
Net | | |
Gross Carrying Amount | | |
Accumulated Amortization | | |
Net | |
In-process research and development | |
$ | 2,900,000 | | |
$ | - | | |
$ | 2,900,000 | | |
$ | 2,900,000 | | |
$ | - | | |
$ | 2,900,000 | |
Patents and intellectual property | |
| 5,513,937 | | |
| (157,541 | ) | |
| 5,356,396 | | |
| 5,671,478 | | |
| - | | |
| 5,671,478 | |
Intangible assets, net | |
$ | 8,413,937 | | |
$ | (157,541 | ) | |
$ | 8,256,396 | | |
$ | 8,571,478 | | |
$ | - | | |
$ | 8,571,478 | |
|
Schedule of Future Expected Amortization Expense of Intangible Assets |
As
of June 30, 2023, future expected amortization expense of Intangible assets was as follows:
2023 | |
$ | 315,082 | |
2024 | |
| 630,164 | |
2025 | |
| 630,164 | |
2026 | |
| 630,164 | |
2027 | |
| 630,164 | |
Thereafter | |
| 5,420,658 | |
Remaining future amortization expense | |
$ | 8,256,396 | |
|
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v3.23.2
Stock Options (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Stock Options [Abstract] |
|
Schedule of Stock Option Activity |
The following
table summarizes the activity related to the Company’s stock options
| |
Number of Options | | |
Weighted average exercise price per share | | |
Weighted average remaining contractual term (years) | | |
Aggregate intrinsic value (in thousands) | |
Outstanding, January 1, 2023 | |
| 1,300,000 | | |
$ | 2.28 | | |
| 9.12 | | |
$ | - | |
Granted | |
| 880,000 | | |
| 0.49 | | |
| 9.66 | | |
| - | |
Expired/Cancelled | |
| (200,000 | ) | |
| 0.96 | | |
| 9.13 | | |
| - | |
Outstanding, June 30, 2023 | |
| 1,980,000 | | |
$ | 1.62 | | |
| 9.06 | | |
| - | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable, June 30, 2023 | |
| 566,668 | | |
$ | 2.18 | | |
| 8.84 | | |
$ | - | |
|
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v3.23.2
Warrants (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Warrant [Abstract] |
|
Schedule of outstanding warrants |
The following table summarizes the Company’s
outstanding warrants:
Exercise Price | | |
Number of warrants | | |
Weighted-
average remaining contractual term (years) | | |
Weighted average exercise price | |
$ | 1.88 | | |
| 2,000,000 | | |
| 4.13 | | |
| | |
$ | 3.50 | | |
| 8,680,000 | | |
| 3.40 | | |
| | |
$ | 6.00 | | |
| 276,000 | | |
| 3.22 | | |
| | |
$ | 6.25 | | |
| 4,400,000 | | |
| 3.22 | | |
| | |
| | | |
| 15,356,000 | | |
| 3.44 | | |
$ | 4.12 | |
|
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v3.23.2
Discontinued Operations (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Discontinued Operations and Disposal Groups [Abstract] |
|
Schedule of Discontinued Operations in the Condensed Consolidated Statements of perations |
The results of operations from discontinued operations for
the three and six months ended June 30, 2023 and 2022, have been reflected as discontinued operations in
the condensed consolidated statements of operations and consist of the following:
| |
Three Months Ended
June 30, | | |
Six Months Ended
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenues | |
$ | - | | |
$ | 13,581 | | |
$ | - | | |
$ | 27,239 | |
Cost of services | |
| - | | |
| 15,101 | | |
| - | | |
| 28,038 | |
Gross margin | |
| - | | |
| (1,520 | ) | |
| - | | |
| (799 | ) |
| |
| | | |
| | | |
| | | |
| | |
Selling, general and administrative | |
| 165,146 | | |
| 467,016 | | |
| 502,063 | | |
| 793,395 | |
Loss from discontinued operations | |
| (165,146 | ) | |
| (468,535 | ) | |
| (502,063 | ) | |
| (794,194 | ) |
Gain on forgiveness of accounts payable | |
| - | | |
| - | | |
| - | | |
| 45,000 | |
Gain on sale of assets | |
| - | | |
| - | | |
| 65,048 | | |
| - | |
Loss from discontinued operations, before income tax | |
| (165,146 | ) | |
| (468,535 | ) | |
| (437,015 | ) | |
| (749,194 | ) |
Income tax expense | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss from discontinued operations, net of tax | |
| (165,146 | ) | |
| (468,535 | ) | |
| (437,015 | ) | |
| (749,194 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted-average common shares outstanding, basic and diluted | |
| 26,128,022 | | |
| 23,444,135 | | |
| 26,100,681 | | |
| 23,226,253 | |
Basic and diluated loss per share from discontinued operations | |
$ | (0.01 | ) | |
$ | (0.02 | ) | |
$ | (0.02 | ) | |
$ | (0.03 | ) |
|
Schedule of Gain on the Sale of Assets |
The following table presents the gain on the sale
of assets in Los Angeles, CA:
| |
As of
June 30,
2023 | |
Cash proceeds | |
$ | 27,500 | |
Proceeds to receive in installments | |
| 122,500 | |
Total | |
$ | 150,000 | |
Less transaction costs | |
| (11,250 | ) |
Less book value of assets | |
| (73,702 | ) |
Gain on sale, before income tax | |
$ | 65,048 | |
Income tax expense | |
| - | |
Gain on sale, net of tax | |
$ | 65,048 | |
|
Schedule of Condensed Consolidated Statement of Cash Flows |
The following table presents non-cash items related
to discontinued operations, which are included in the Company’s unaudited condensed consolidated statement of cash flows:
| |
Six months ended
June 30,
2023 | |
Cash Flows From Operating Activities: | |
| |
Gain on sale of assets | |
$ | (65,048 | ) |
| |
| | |
Supplemental disclosure of cash flow information: | |
| | |
Amount due from sale of assets | |
$ | 122,500 | |
|
X |
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v3.23.2
Summary of Significant Accounting Policies (Details) - Schedule of Measured at Fair Value on a Recurring Basis - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Assets: |
|
|
Cash equivalents |
$ 10,122,758
|
|
Liabilities: |
|
|
Public warrant liabilities |
69,520
|
$ 132,000
|
Representative warrant liabilities |
4,535
|
8,611
|
Quoted prices in active markets for identical liabilities (Level 1) [Member] |
|
|
Assets: |
|
|
Cash equivalents |
10,122,758
|
|
Liabilities: |
|
|
Public warrant liabilities |
69,520
|
132,000
|
Representative warrant liabilities |
|
|
Significant other observable inputs (Level 2) [Member] |
|
|
Assets: |
|
|
Cash equivalents |
|
|
Liabilities: |
|
|
Public warrant liabilities |
|
|
Representative warrant liabilities |
|
|
Significant unobservable inputs (Level 3) [Member] |
|
|
Assets: |
|
|
Cash equivalents |
|
|
Liabilities: |
|
|
Public warrant liabilities |
|
|
Representative warrant liabilities |
$ 4,535
|
$ 8,611
|
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v3.23.2
Summary of Significant Accounting Policies (Details) - Schedule of Reconciliation of the Level 3 Representative Warrant Liabilities
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023
USD ($)
|
Jun. 30, 2023
USD ($)
|
Accounting Policies [Line Items] |
|
|
Representative warrant liabilities, Balance Beginning |
$ 48,797
|
$ 106,205
|
Issuances |
|
|
Exercises |
|
|
Change in fair value |
(30,197)
|
(87,605)
|
Representative warrant liabilities, Balance ending |
18,600
|
18,600
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Accounting Policies [Line Items] |
|
|
Representative warrant liabilities, Balance Beginning |
11,482
|
8,611
|
Issuances |
|
|
Exercises |
|
|
Change in fair value |
(6,946)
|
(4,076)
|
Representative warrant liabilities, Balance ending |
$ 4,535
|
$ 4,535
|
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v3.23.2
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|
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Schedule of Net Loss Per Share [Abstract] |
|
|
Stock options |
1,980,000
|
1,000,000
|
Warrants |
15,356,000
|
12,600,000
|
Restricted stock units |
99,999
|
200,000
|
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v3.23.2
Property and Equipment, Net (Details) - Schedule of Property and Equipment - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 184,247
|
$ 128,756
|
Less: accumulated depreciation |
(10,949)
|
(3,559)
|
Property and equipment, net |
173,298
|
125,197
|
Leasehold improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
3,193
|
3,193
|
Medical equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
155,363
|
99,220
|
Office equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 25,691
|
$ 26,343
|
X |
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v3.23.2
Leases (Details) - Schedule of Company Recognized Total ROU Assets and Lease Liabilities - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
ROU assets and Lease Liabilities [Abstract] |
|
|
Non-current leases – right of use assets |
$ 419,885
|
$ 500,428
|
Current liabilities – operating lease liabilities |
169,676
|
160,362
|
Non-current liabilities – operating lease liabilities |
256,084
|
344,021
|
Operating lease expense |
128,281
|
168,812
|
Cash paid for amounts included in the measurement of operating lease liabilities |
|
$ 169,695
|
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v3.23.2
Leases (Details) - Schedule of Company’s Operating Lease Payments
|
Jun. 30, 2023
USD ($)
|
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] |
|
2023 (remaining) |
$ 97,511
|
2024 |
199,872
|
2025 |
183,216
|
Total future minimum lease payments |
480,599
|
Amount representing interest |
(54,839)
|
Present value of net future minimum lease payments |
$ 425,760
|
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v3.23.2
Intangible Assets and Goodwill (Details) - Schedule of Intangible Assets, Net - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
In-process research and development [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Gross Carrying Amount |
$ 2,900,000
|
$ 2,900,000
|
Accumulated Amortization |
|
|
Intangible assets, net |
2,900,000
|
2,900,000
|
Patents and intellectual property [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Gross Carrying Amount |
5,513,937
|
5,671,478
|
Accumulated Amortization |
(157,541)
|
|
Intangible assets, net |
5,356,396
|
5,671,478
|
Intangible assets, net [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Gross Carrying Amount |
8,413,937
|
8,571,478
|
Accumulated Amortization |
(157,541)
|
|
Intangible assets, net |
$ 8,256,396
|
$ 8,571,478
|
X |
- DefinitionAccumulated amount of amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life.
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v3.23.2
Intangible Assets and Goodwill (Details) - Schedule of Future Expected Amortization Expense of Intangible Assets
|
Jun. 30, 2023
USD ($)
|
Schedule of Future Expected Amortization Expense of Intangible Assets [Abstract] |
|
2023 |
$ 315,082
|
2024 |
630,164
|
2025 |
630,164
|
2026 |
630,164
|
2027 |
630,164
|
Thereafter |
5,420,658
|
Remaining future amortization expense |
$ 8,256,396
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v3.23.2
Stockholders’ Equity (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
|
Jun. 30, 2023 |
Jun. 30, 2023 |
Dec. 31, 2022 |
Jun. 30, 2022 |
Stockholders’ Equity [Line Items] |
|
|
|
|
Common stock, shares issued |
26,143,407
|
26,143,407
|
26,043,406
|
|
Common stock, shares outstanding |
26,143,407
|
26,143,407
|
26,043,406
|
|
Restricted common stock |
16,667
|
100,001
|
|
|
Stock based compensation expense (in Dollars) |
$ 24,000
|
$ 48,000
|
|
|
Common Stock [Member] |
|
|
|
|
Stockholders’ Equity [Line Items] |
|
|
|
|
Common stock, shares issued |
26,143,407
|
26,143,407
|
|
|
Common stock, shares outstanding |
26,143,407
|
26,143,407
|
|
26,698,688
|
Common Stock [Member] |
|
|
|
|
Stockholders’ Equity [Line Items] |
|
|
|
|
Common stock, shares issued |
|
|
|
26,698,688
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
Stockholders’ Equity [Line Items] |
|
|
|
|
Stock based compensation expense (in Dollars) |
|
$ 142,000
|
|
|
X |
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v3.23.2
Stock Options (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Stock Options [Line Items] |
|
|
|
|
Aggregate shares of common stock (in Shares) |
|
|
200,000
|
|
Common stock, per share (in Dollars per share) |
$ 0.491
|
|
$ 0.491
|
|
Term years |
|
|
10 years
|
|
Options vest over a period |
|
|
2 years
|
|
Total fair value |
|
|
$ 288,000
|
|
Volatility assumption, percentage |
|
|
68.64%
|
|
Stock-based compensation expense |
|
|
$ 581,000
|
|
Selling general and administrative expense |
|
|
$ 267,000
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Exercise Price (in Dollars per share) |
$ 81,000
|
|
$ 81,000
|
|
Stock Options [Member] |
|
|
|
|
Stock Options [Line Items] |
|
|
|
|
Aggregate shares of common stock (in Shares) |
333,334
|
|
350,001
|
|
Aggregate shares of common stock cancelled (in Shares) |
200,000
|
|
|
|
Stock-based compensation expense |
$ 195,000
|
$ 100,000
|
$ 348,000
|
$ 194,000
|
Selling general and administrative expense |
136,000
|
|
|
|
Research and development expense |
$ 59,000
|
|
|
|
Stock Options [Member] | Stock Options [Member] |
|
|
|
|
Stock Options [Line Items] |
|
|
|
|
Aggregate shares of common stock (in Shares) |
|
|
880,000
|
|
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v3.23.2
Stock Options (Details) - Schedule of Stock Option Activity - Stock Options [Member]
|
6 Months Ended |
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of Options, Outstanding Beginning | shares |
1,300,000
|
Weighted average exercise price per share, Outstanding Beginning | $ / shares |
$ 2.28
|
Weighted-average remaining contractual term (years), Outstanding Beginning |
9 years 1 month 13 days
|
Aggregate intrinsic value, Outstanding Beginning | $ |
|
Number of Options, Granted | shares |
880,000
|
Weighted average exercise price per share, Granted | $ / shares |
$ 0.49
|
Weighted-average remaining contractual term (years), Granted |
9 years 7 months 28 days
|
Aggregate intrinsic value, Granted | $ |
|
Number of Options, Expired/Cancelled | shares |
(200,000)
|
Weighted average exercise price per share, Expired/Cancelled | $ / shares |
$ 0.96
|
Weighted-average remaining contractual term (years), Expired/Cancelled |
9 years 1 month 17 days
|
Aggregate intrinsic value, Expired/Cancelled | $ |
|
Number of Options, Outstanding Ending | shares |
1,980,000
|
Weighted average exercise price per share, Outstanding Ending | $ / shares |
$ 1.62
|
Weighted-average remaining contractual term (years), Outstanding Ending |
9 years 21 days
|
Aggregate intrinsic value, Outstanding Ending | $ |
|
Number of Options, Exercisable | shares |
566,668
|
Weighted average exercise price per share, Exercisable | $ / shares |
$ 2.18
|
Weighted-average remaining contractual term (years), Exercisable |
8 years 10 months 2 days
|
Aggregate intrinsic value, Exercisable | $ |
|
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Warrants (Details) - Schedule of Outstanding Warrants
|
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Warrant [Line Items] |
|
Number of warrants | shares |
15,356,000
|
Weighted-average remaining contractual term (years) |
3 years 5 months 8 days
|
Weighted-average exercise price | $ / shares |
$ 4.12
|
1.88 [Member] |
|
Warrant [Line Items] |
|
Exercise Price | $ / shares |
$ 1.88
|
Number of warrants | shares |
2,000,000
|
Weighted-average remaining contractual term (years) |
4 years 1 month 17 days
|
3.50 [Member] |
|
Warrant [Line Items] |
|
Exercise Price | $ / shares |
$ 3.5
|
Number of warrants | shares |
8,680,000
|
Weighted-average remaining contractual term (years) |
3 years 4 months 24 days
|
6.00 [Member] |
|
Warrant [Line Items] |
|
Exercise Price | $ / shares |
$ 6
|
Number of warrants | shares |
276,000
|
Weighted-average remaining contractual term (years) |
3 years 2 months 19 days
|
6.25 [Member] |
|
Warrant [Line Items] |
|
Exercise Price | $ / shares |
$ 6.25
|
Number of warrants | shares |
4,400,000
|
Weighted-average remaining contractual term (years) |
3 years 2 months 19 days
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v3.23.2
Discontinued Operations (Details) - Schedule of Discontinued Operations in the Condensed Consolidated Statements of perations - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Discontinued Operation, Income (Loss) from Discontinued Operation Disclosures [Abstract] |
|
|
|
|
Revenues |
|
$ 13,581
|
|
$ 27,239
|
Cost of services |
|
15,101
|
|
28,038
|
Gross margin |
|
(1,520)
|
|
(799)
|
Selling, general and administrative |
165,146
|
467,016
|
502,063
|
793,395
|
Loss from discontinued operations |
(165,146)
|
(468,535)
|
(502,063)
|
(794,194)
|
Gain on forgiveness of accounts payable |
|
|
|
45,000
|
Gain on sale of assets |
|
|
65,048
|
|
Loss from discontinued operations, before income tax |
(165,146)
|
(468,535)
|
(437,015)
|
(749,194)
|
Income tax expense |
|
|
|
|
Net loss from discontinued operations, net of tax |
$ (165,146)
|
$ (468,535)
|
$ (437,015)
|
$ (749,194)
|
Weighted-average common shares outstanding, basic (in Shares) |
26,128,022
|
23,444,135
|
26,100,681
|
23,226,253
|
Basic loss per share from discontinued operations (in Dollars per share) |
$ (0.01)
|
$ (0.02)
|
$ (0.02)
|
$ (0.03)
|
X |
- DefinitionAmount after tax of an increase (decrease) to a gain (loss) previously reported in discontinued operations in a prior period.
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v3.23.2
Discontinued Operations (Details) - Schedule of Discontinued Operations in the Condensed Consolidated Statements of perations (Parentheticals) - $ / shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Discontinued Operation, Income (Loss) from Discontinued Operation Disclosures [Abstract] |
|
|
|
|
Weighted-average common shares outstanding, diluted |
26,128,022
|
23,444,135
|
26,100,681
|
23,226,253
|
Diluated loss per share from discontinued operations |
$ (0.01)
|
$ (0.02)
|
$ (0.02)
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$ (0.03)
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v3.23.2
Discontinued Operations (Details) - Schedule of Gain on the Sale of Assets
|
6 Months Ended |
Jun. 30, 2023
USD ($)
|
Proceeds from Sale of Productive Assets [Abstract] |
|
Cash proceeds |
$ 27,500
|
Proceeds to receive in installments |
122,500
|
Total |
150,000
|
Less transaction costs |
(11,250)
|
Less book value of assets |
(73,702)
|
Gain on sale, before income tax |
65,048
|
Income tax expense |
|
Gain on sale, net of tax |
$ 65,048
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