UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON D.C. 20549
FORM
For the Quarterly Period
Ended
OR
For the transition period from _______ to ________.
Commission file number:
(Exact name of Registrant as specified in its charter)
(State or other jurisdiction of | (I.R.S. Employer | |
incorporation or organization) | Identification No.) |
(Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code:
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
The | ||||
Warrants, exercisable for one share of Common Stock | 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
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Indicate
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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 | ☐ | |
☒ | 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
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Indicate
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As of May 9, 2022, there were
PASITHEA THERAPEUTICS CORP.
FORM 10-Q
For the Quarter ended March 31, 2022
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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
PASITHEA THERAPEUTICS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
March 31, 2022 | December 31, 2021 | ||||||||
(Unaudited) | |||||||||
ASSETS | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | $ | |||||||
Prepaid expenses | |||||||||
Total current assets | |||||||||
Property and equipment | |||||||||
Total assets | $ | $ | |||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||
Current liabilities: | |||||||||
Accounts payable and accrued liabilities | $ | $ | |||||||
Total current liabilities | |||||||||
Non-current liabilities | |||||||||
Warrant liabilities | |||||||||
Total non-current liabilities | |||||||||
Total liabilities | |||||||||
Commitments and Contingencies (Note 4) | |||||||||
Stockholders’ equity: | |||||||||
Preferred stock, par value $ | |||||||||
Common stock, par value $ |
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Additional paid-in capital | |||||||||
Accumulated other comprehensive loss | ( | ) | ( | ) | |||||
Accumulated deficit | ( | ) | ( | ) | |||||
Total stockholders’ equity | |||||||||
Total liabilities and stockholders’ equity | $ | $ |
The accompanying notes are in integral part of these unaudited condensed consolidated financial statements.
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PASITHEA THERAPEUTICS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
For the Three Months Ended | ||||||||
March 31, | March 31, | |||||||
2022 | 2021 | |||||||
Revenues | $ | $ | ||||||
Cost of services | ||||||||
Gross margin | ||||||||
Operating expenses: | ||||||||
Selling, general and administrative | ||||||||
Loss from operations | ( | ) | ( | ) | ||||
Other income: | ||||||||
Change in fair value of warrant liabilities | ||||||||
Gain on forgiveness of accounts payable | ||||||||
Other income | ||||||||
Loss before income taxes | ( | ) | ( | ) | ||||
Provision for income taxes | ||||||||
Net loss | $ | ( | ) | $ | ( | ) | ||
Weighted-average common shares outstanding, basic and diluted | ||||||||
Basic and diluted net loss per common share | $ | ( | ) | $ | ( | ) | ||
Comprehensive loss: | ||||||||
Net loss | $ | ( | ) | $ | ( | ) | ||
Foreign currency translation | ( | ) | ||||||
Comprehensive loss | $ | ( | ) | $ | ( | ) |
The accompanying notes are in integral part of these unaudited condensed consolidated financial statements.
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PASITHEA THERAPEUTICS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)
Additional | Other | Total | ||||||||||||||||||||||
Common Stock | Paid-in | Comprehensive | Accumulated | Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Loss | Deficit | Equity | |||||||||||||||||||
Balance at December 31, 2020 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||
Issuance of common stock for cash | ||||||||||||||||||||||||
Net loss | - | ( | ) | ( | ) | |||||||||||||||||||
Balance at March 31, 2021 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||
Balance at December 31, 2021 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||
Stock-based compensation expense | - | |||||||||||||||||||||||
Foreign currency translation | - | ( | ) | ( | ) | |||||||||||||||||||
Net loss | - | ( | ) | ( | ) | |||||||||||||||||||
Balance at March 31, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | $ |
The accompanying notes are in integral part of these unaudited condensed consolidated financial statements.
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PASITHEA THERAPEUTICS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
For the Three Months Ended | |||||||||
March 31, 2022 | March 31, 2021 | ||||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | |||||||||
Net loss | $ | ( | ) | $ | ( | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||
Depreciation | |||||||||
Stock-based compensation | |||||||||
Change in fair value of warrant liabilities | ( | ) | |||||||
Changes in operating assets and liabilities: | |||||||||
Changes in prepaid expenses | ( | ) | ( | ) | |||||
Changes in accounts payable and accrued liabilities | ( | ) | |||||||
Net cash used in operating activities | ( | ) | ( | ) | |||||
CASH FLOWS FROM INVESTING ACTIVITIES: | |||||||||
Purchase of property and equipment | ( | ) | |||||||
Net cash used in investing activities | ( | ) | |||||||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||||||
Cash proceeds from issuance of common stock | |||||||||
Net cash provided by financing activities | |||||||||
Effect of foreign currency translation on cash | ( | ) | |||||||
NET CHANGE IN CASH | ( | ) | |||||||
Cash - Beginning of period | |||||||||
Cash - End of period | $ | $ |
The accompanying notes are in integral part of these unaudited condensed consolidated financial statements.
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PASITHEA THERAPEUTICS CORP.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2022 AND 2021
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. The Company is a biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders. The Company’s primary biotech operations focus on developing drugs that target the pathophysiology underlying such disorders rather than symptomatic treatments, with the goal of developing new pharmacological agents that display significant advantages over conventional therapies with respect to efficacy and tolerability.
The Company’s secondary operations are 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. involve 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 involve providing business support services to entities that furnish similar services to patients who personally pay for those services. Operations are expected to initially take place across the United States and the U.K. through partnerships with healthcare companies.
The Company is located in Miami Beach, Florida, USA.
On September 17, 2021, the Company sold
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 and Pasithea Clinics Corp. 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.
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”) for interim financial information and are unaudited. In the opinion of management, such financial information includes all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the Company’s financial position at such dates and the operating results and cash flows for such periods. Certain information and disclosures normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. The condensed consolidated balance sheet as of December 31, 2021 was derived from our audited financial statements but does not include all disclosures required by U.S. GAAP. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and related notes included in its annual report on Form 10-K, as filed with the Securities and Exchange Commission on March 30, 2022. The results of operations for the three months ended March 31, 2022 are not necessarily indicative of the results for the year ending December 31, 2022 or for any future period.
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.
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COVID-19 Pandemic
In March 2020, the World Health Organization (the “WHO”) characterized the outbreak of the novel strain of coronavirus, specifically identified as COVID-19, as a global pandemic. This has resulted in governments enacting emergency measures to combat the spread of the virus. These measures, which include the implementation of travel bans, self-imposed quarantine periods and social distancing, have caused material disruption to business, resulting in a global economic slowdown. Equity markets have experienced significant volatility and weakness and the governments and central banks have reacted with significant monetary and fiscal interventions designed to stabilize economic conditions.
The current challenging economic climate may lead to adverse changes in cash flows, working capital levels and/or debt balances, which may also have a direct impact on the Company’s operating results and financial position in the future. The ultimate duration and magnitude of the impact and the efficacy of government interventions on the economy and the financial effect on the Company is not known at this time. The extent of such impact will depend on future developments, which are highly uncertain and not in the Company’s control, including new information which may emerge concerning the spread and severity of COVID-19, or any of its variants, and actions taken to address its impact, among others. The repercussions of this health crisis could have a material adverse effect on the Company’s business, financial condition, liquidity and operating results.
In response to COVID-19, the Company has implemented working practices to address potential impacts to its operations, employees and customers, and will take further measures in the future if and as required. At present, we do not believe there has been any appreciable impact on the Company specifically associated with COVID-19.
Liquidity and Capital Resources
As of March 31, 2022, the Company had $
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.
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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. One of the more significant accounting estimates included in these condensed consolidated financial statements is the determination of fair value of the warrant liabilities. Accordingly, the actual results could differ significantly from those estimates.
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 no cash equivalents as of March 31, 2022 and December 31, 2021.
Property and Equipment
Property and equipment is recorded at cost. 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. As of March 31, 2022
and December 31, 2021, the Company had capitalized total property and equipment costs of $
Offering Costs
Offering costs consist of professional fees, filing,
regulatory and other costs incurred through the balance sheet date that are directly related to the Initial Public Offering. In September
2021, the Company recognized offering costs of $
Warrant Liability
The Company accounts for its Public and Representative Warrants (each, the “Public Warrants” and “Representative Warrants” and, collectively, the “Warrants”) in accordance with the guidance contained in ASC 815, “Derivatives and Hedging,” under which the Warrants do not meet the criteria for equity treatment and must be recorded as derivative liabilities. Accordingly, the Company classifies the Warrants as liabilities at their fair value and adjusts the Warrants to fair value at each reporting period. This liability is subject to re-measurement at each balance sheet date until the 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 Public and Representative Warrants was initially measured at the end of each reporting period, using a Black-Scholes option pricing model. At March 31, 2022, the fair value of the Public Warrants was measured using quoted market prices, and the fair value of the Representative Warrants was based on an estimate of the relative fair value to the Public Warrants, accounting for a small difference in the exercise price.
Income Taxes
The Company follows the asset and liability method of accounting for income taxes under ASC 740, “Income Taxes.” Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases.
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Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that included the enactment date. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected to be realized.
ASC 740 prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. The Company recognizes accrued interest and penalties related to unrecognized tax benefits as income tax expense. There were no unrecognized tax benefits and no amounts accrued for interest and penalties as of March 31, 2022 and December 31, 2021. The Company is currently not aware of any issues under review that could result in significant payments, accruals or material deviation from its position. The Company is subject to income tax examinations by major taxing authorities since inception.
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 $
Fair Value of Financial Instruments
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. |
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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: | ||||||||||||||||
Description | 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 and cash equivalents, March 31, 2022 | $ | $ | $ | $ | ||||||||||||
Liabilities: | ||||||||||||||||
Public Warrant liabilities, March 31, 2022 | $ | $ | $ | $ | - | |||||||||||
Representative Warrant liabilities, March 31, 2022 | $ | $ | - | $ | - | $ | ||||||||||
Assets: | ||||||||||||||||
Cash and cash equivalents, December 31, 2021 | $ | $ | $ | $ | ||||||||||||
Liabilities: | ||||||||||||||||
Public Warrant liabilities, December 31, 2021 | $ | $ | $ | $ | ||||||||||||
Representative Warrant liabilities, December 31, 2021 | $ | $ | - | $ | - | $ |
The fair value of the liability associated with the Public Warrants at March 31, 2022 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 at March 31, 2022 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. The change of the Public Warrant liability from Level 3 to Level 1 was the only change between levels of the fair value hierarchy from December 31, 2021 to March 31, 2022.
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.
Revenue
The Company accounts for revenue in accordance with ASC Topic 606, “Revenue from Contracts with Customers.”
The Company currently derives all its revenue
from its operations in the U.K., providing business support services to registered healthcare providers who assess patients, and if appropriate,
administer intravenous infusions of ketamine. Under the business support services agreements, the Company, among other things, markets
the treatments to the extent permitted under law, arranges and pays for the fit-out of the consulting room, provides equipment necessary
for the treatments, develops, operates and maintains a booking website for the treatments, makes bookings and takes payments, and employs
or engages customer service advisers to liaise with clinical staff and pay certain staff costs. The price of the treatments are fixed
amounts jointly established by the Company and the healthcare providers. The Company collects
The Company also may arrange psychotherapy sessions with independent therapy professionals for patients. In such cases, the Company acts as a principal and recognizes the gross amount of revenue earned from such sessions, with the cost paid to the independent therapy professionals recognized in cost of services in the unaudited condensed consolidated statement of operations and comprehensive loss.
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The Company’s performance obligation is satisfied when the services are rendered to the customer. There were no contract assets or liabilities at March 31, 2022 or December 31, 2021. All sales have fixed pricing and there are currently no variable components included in the Company’s revenue.
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 similar to 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:
Three months ended March 31, | ||||||||
2022 | 2021 | |||||||
Stock options | ||||||||
Warrants | ||||||||
Restricted stock units |
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.
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The relevant translation rates are as follows:
March 31, 2022 | December 31, 2021 | |||||||
Closing rate, British Pound (GBP) to US$ at period end | ||||||||
Average rate, GBP to US$ for the period ended | ||||||||
Closing rate, Euro (EUR) to US$ at period end | ||||||||
Average rate, EUR to US$ for the period ended |
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 March 31, 2022 and December 31, 2021, 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.
NOTE 3 – INITIAL PUBLIC OFFERING
Pursuant
to the Initial Public Offering, on September 17, 2021, the Company sold
The Company classifies each warrant as a liability at its fair value and the warrants were allocated a portion of the proceeds from the issuance of the Units equal to its fair value determined by the Black-Scholes model.
In connection
with the Initial Public Offering, the Company granted the underwriters an option for a period of 45 days to purchase up to an additional
NOTE 4 – COMMITMENTS AND CONTINGENCIES
Integrated Research and Development Agreement – Aptuit (Verona) Srl, an Evotec Company
In February 2022, the Company entered into an
integrated research and development agreement with Aptuit (Verona) Srl, an Evotec Company (“Evotec”), with the goal of delivering
a treatment for schizophrenia.
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Medical Office Lease – West Hollywood, California
On March 11, 2022, the Company entered into an agreement
to lease a medical office in West Hollywood, California. The lease commencement date will be the later of
Consulting Agreement – Yassine Bendiabdallah
Effective November 1, 2021, the Company entered into
a Consulting Agreement with Yassine Bendiabdallah to act as the Head of Pasithea Therapeutic U.K., manage all Pasithea U.K. clinics and
aid in E.U. expansion. The Consulting Agreement provides an annual salary of $
Service Agreement – The University of Texas at Austin
On September 21, 2021, the Company entered into a
Service Agreement with the University of Texas at Austin (“UTA”), a university of higher education in the State of Texas,
to act as the Chair of the Scientific Advisory Board, holding three scientific advisory board meetings per year and providing incidental
monthly consults. The Company pays UTA $
Collaboration Agreement – Zen Baker Street Clinic (U.K.)
On August 4, 2021, the Company entered into an Amended
and Restated Collaboration Agreement with Portman Health Ltd (“Portman”), whereby both parties have agreed to collaborate
on the provision of ketamine infusion treatments and any other treatments agreed to by the parties from time to time (the “Treatments”)
at Portman’s London based clinic. The Company has agreed, among other things, market the Treatments to the extent permitted under
law, arrange and pay for the fit-out of the consulting room, provide equipment necessary for the Treatments, develop, operate and maintain
a booking website for the Treatments, make bookings and take payments, and employ or engage customer services advisers to liaise with
clinical staff and pay certain staff costs. Portman has agreed provide consulting and treatment rooms, apply for and maintain CQC registrations,
employ or engage licensed and qualified staff, assess patient and, if appropriate, administer the Treatments, maintain equipment and
provide all ketamine and other pharmaceuticals necessary for the Treatments. All revenues from such Treatments (less certain staff costs)
shall be allocated
Collaboration Agreement – Zen Knightsbridge Clinic (U.K.)
On August 4, 2021, the Company entered into an Amended
and Restated Collaboration Agreement with Purecare Limited (“Purecare”), whereby both parties have agreed to collaborate
on the provision of Treatments at Purecare’s London based clinic. The Company has agreed, among other things, market the Treatments
to the extent permitted under law, arrange and pay for the fit-out of the consulting room, provide equipment necessary for the Treatments,
develop, operate and maintain a booking website for the Treatments, make bookings and take payments, and employ or engage customer services
advisers to liaise with clinical staff and pay certain staff costs. Purecare has agreed provide consulting and treatment rooms, apply
for and maintain CQC registrations, employ or engage licensed and qualified staff, assess patient and, if appropriate, administer the
Treatments, maintain equipment and provide all ketamine and other pharmaceuticals necessary for the Treatments. All revenues from such
Treatments (less certain staff costs) shall be allocated
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Business Support Services Subcontract – The IV Doc
On April 9, 2021, Pasithea Clinics, an affiliate
of the Company, entered into a Business Support Services Subcontract (the “Subcontract”) with The IV Doc, pursuant to which
The IV Doc provides certain non-clinical administrative, back office, and other business support services to one or more professional
medical practices in the State of New York. During the term of the Subcontract, which shall be effective for
Employment Agreement – Dr. Tiago Reis Marques
On July 13, 2020, we entered into an employment agreement
with Dr. Tiago Reis Marques to serve as our Chief Executive Officer. The initial term of Dr. Marques’ employment commenced on the
closing of our initial business combination and ended on the first anniversary of the commencement date. After the initial term, the
employment agreement automatically renewed for additional one-year periods, unless the Company or Dr. Marques provided the other party
with at least 60 days’ prior written notice of its desire not to renew. Pursuant to the employment agreement, we agreed to pay
Dr. Marques an annual base salary of $
In December 2021, we entered into a new executive
employment agreement (the “2021 Employment Agreement”) with Dr. Marques to serve as our Chief Executive Officer, effective
January 1, 2022.
Subject to the approval by the Board of Directors,
Dr. Marques was eligible to receive an equity grant of
On December 20, 2021, the Board of Directors approved the stock option and RSU grants to Dr. Marques as described above. See Note 5 for further information about stock option and RSU awards.
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NOTE 5 – STOCKHOLDERS’ EQUITY
The Company is authorized to issue an aggregate of
(i) 495,000,000 shares of common stock having a par value of $0.0001 per share and (ii) 5,000,000 shares of preferred stock having a par value of $0.0001 per share.
Effective April 8, 2021, we amended our certificate of incorporation to effect a 1-for-20 reverse stock split of our outstanding shares of Common Stock. No fractional shares were issued as a result of the reverse stock split. Any fractional shares resulting from the reverse stock split were paid in cash. The reverse stock split did not otherwise affect any of the rights currently accruing to holders of our common stock. All share information presented in these financial statements has been retroactively adjusted to reflect the reduced number of shares outstanding.
During 2021, the Company entered into various subscription
agreements in connection with a private placement seeking to raise up to $
During 2021, the Company entered into various subscription
agreements in connection with a second private placement seeking to raise up to $
November 2021 Private Placement
On November 24, 2021, the Company entered into a
purchase agreement with institutional investors to issue
The investors may exercise the warrants on a cashless
basis if the warrant shares are not then registered pursuant to an effective registration statement. The investors have contractually
agreed to restrict their ability to exercise the warrants such that the number of shares of common stock held by the investors and any
of their affiliates after such exercise does not exceed either
In connection with the Purchase Agreement, the Company entered into a registration rights agreement (the “Registration Rights Agreement”) with the investors. Pursuant to the Registration Rights Agreement, the Company is required to file a resale registration statement with the Securities and Exchange Commission (the “SEC”) to register for resale the shares and the warrant shares and to have such Registration Statement declared effective within 60 days after the date of the Purchase Agreement, or 90 days of the date of the Purchase Agreement in the event the Registration Statement is subject to a “full review” by the SEC. The Company is obligated to pay certain liquidated damages to the investor if it fails to file the resale registration statement when required, fail to cause the Registration Statement to be declared effective by the SEC when required, or if it fails to maintain the effectiveness of the Registration Statement.
Pursuant to a Placement Agent Agreement (the “Placement
Agent Agreement”), dated as of November 24, 2021, by and between us and EF Hutton, division of Benchmark Investments, LLC (“EF
Hutton”), the Company engaged EF Hutton to act as its exclusive placement agent in connection with the November 2021 Private Placement.
Pursuant to the Placement Agent Agreement, the Company paid EF Hutton a cash fee of
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On November 29, 2021, the Company consummated the
November 2021 Private Placement, pursuant to which it issued
A total of
Stock Options
Stock option activity for the three months ended March 31, 2022 was as follows:
Weighted- average | ||||||||
Number of | Exercise Price per | |||||||
Options | Share | |||||||
Outstanding, January 1, 2022 | $ | |||||||
Granted | ||||||||
Expired | ||||||||
Exercised | ||||||||
Outstanding, March 31, 2022 | $ | |||||||
Exercisable, March 31, 2022 | $ |
These options had a weighted average remaining life
of
Under the terms of Dr. Marques’ 2021 Employment
Agreement (Note 4), Dr. Marques was granted
Restricted Stock Units
Under the terms of Dr. Marques’ 2021 Employment
Agreement (Note 4), Dr. Marques was granted
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Restricted Stock
The Company recognized $
NOTE 6 – WARRANT LIABILITIES
On September 17, 2021, the Company consummated its
Initial Public Offering of
Simultaneously with the consummation of the closing
of the Initial Public Offering, the Company issued the underwriters a total of
The Company evaluated the Public and Representative Warrants (collectively, the “Warrants”) as either equity-classified or liability-classified instruments based on an assessment of the warrants’ specific terms and applicable authoritative guidance in ASC 480, “Distinguishing Liabilities from Equity” (“ASC 480”) and ASC 815, “Derivatives and Hedging” (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock, among other conditions for equity classification. Pursuant to such evaluation, the Company further evaluated the Warrants under ASC 815-40, Derivatives and Hedging — Contracts in Entity’s Own Equity, and concluded that the Warrants do not meet the criteria to be classified in stockholders’ equity.
Certain adjustments to the settlement amount of the Warrants are based on a variable that is not an input to the fair value of an option as defined under ASC 815 — 40, and thus the Warrants are not considered indexed to the Company’s own stock and not eligible for an exception from derivative accounting. The accounting treatment of derivative financial instruments requires that the Company record a derivative liability upon issuance of the Warrants at the closing of the Initial Public Offering. Accordingly, the Company classifies each Warrant as a liability at its fair value, with subsequent changes in their respective fair values recognized in the statement of operations and comprehensive income (loss) at each reporting date.
During November 2021,
As of March 31, 2022, the fair value of the Public
Warrants was approximately $
As of December 31, 2021, the fair value of the Public
Warrants was approximately $
NOTE 7 – SUBSEQUENT EVENTS
The Company has evaluated events and transactions subsequent to March 31, 2022, through the date these condensed consolidated financial statements were included in this Quarterly Report on Form 10-Q and filed with the SEC. Other than the below, there are no subsequent events identified that would require disclosure in these condensed consolidated financial statements.
Restricted Stock Grants to Service Providers
On May 5, 2022, the Company’s Board of Directors
approved grants of restricted common stock pursuant to agreements with certain consultants and service providers. An aggregate of
Stock Option Grant to Consultant
On May 5, 2022, the Company’s Board of Directors approved a grant
to a consultant of
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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, 2021. 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) and Pasithea Clinics Inc. Pasithea Therapeutics Limited (UK) is a private limited Company, registered in the United Kingdom (UK). Pasithea Clinics Inc. is incorporated in Delaware.
The full extent to which the COVID-19 pandemic may directly or indirectly impact our business, results of operations and financial condition, will depend on future developments that are uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national and international customers and markets. We have made estimates of the impact of COVID-19 within our financial statements, and although there is currently no major impact, there may be changes to those estimates in future periods. Actual results may differ from these estimates.
Company Summary
We are a biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders. Epidemiological data indicate neuropsychiatric disorders as being some of the most prevalent, devastating, and yet poorly treated illnesses. We believe that the current treatments for these disorders, such as depression, are inadequate and that conventional medicines have low success rates in long-term treatment. According to an article published by PLOS One, randomized, double-blind, placebo-controlled clinical trials of antidepressants were only effective for 42-51% of patients with MDD. For example, current pharmacotherapies for MDD and bipolar depression (BDep) have a distinct lag of onset that can generate further distress and impairment in patients. According to an article published in 2000 by The Journal of Clinical Psychiatry and an article published in 2010 by Pharmaceuticals (Basel), available antidepressant medications usually take several weeks before patients display significant therapeutic benefit. This delayed onset of treatment can result in increased morbidity and increased risk for suicidal behavior. This has been reported in a base population study including 159,810 users of 4 antidepressant drugs showing that the risk of suicidal behavior increased in the first month after starting antidepressants, and in particular during the first 1 to 9 days, regardless of the chemical class of antidepressant. This study was published in a 2004 article published by The Journal of the American Medical Association. Similarly, other studies including a 2006 article published by The American Journal of Psychiatry have shown a significantly higher risk of suicide attempts during the first week of antidepressant treatment compared to subsequent weeks. Furthermore, depressive symptoms are commonly known to affect the ability of patients to function across multiple domains, impacting self-esteem, motivation and cognitive function. Delayed onset of antidepressants contributes to ongoing functional impairment and may interfere with integration back into daily life, in turn delaying full functional recovery. Furthermore, according to a 2012 article published by Biological Psychiatry and a 2013 article published by Brain Stimulation, the continued presence of depressive symptoms may promote chronic neuronal loss and suppress neurogenesis in the hippocampus.
Traditional psychiatric drugs can also cause side effects. Furthermore, the approval of psychotropic drugs with novel mechanisms of action has been rare in recent years. Our biotech operations focus on developing drugs that target the pathophysiology underlying such disorders rather than symptomatic treatments, with the goal of developing new pharmacological agents that display significant advantages over conventional therapies with respect to efficacy and tolerability. We particularly focus on the cross-talk between the immune system and brain disorders and how immune dysregulation affects CNS function.
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Our secondary operations in the U.K., and our intended secondary operations in the United States, are focused on providing business support services to anti-depression clinics. Our operations in the U.K. involve providing business support services to registered healthcare providers who assess patients, and if appropriate, administer intravenous infusions of ketamine, and our intended operations in the United States involve providing business support services to entities that furnish similar services to patients who personally pay for those services. Operations initially take place across the United States and the U.K. through partnerships with healthcare companies, including Zen Healthcare and The IV Doc. Our operations in the U.K. are, and our intended operations in the United States will be, limited to providing business support services to healthcare companies. In the United States, certain of these business support services will be subcontracted to The IV Doc through a Business Support Services Subcontract. We do not provide professional medical services, establish or own anti-depression clinics, provide psychiatric assessments, or be responsible for the administration of intravenous infusions of ketamine in the United States. Furthermore, we do not obtain or administer ketamine, nor do we maintain any license or registration to own, maintain or dispense controlled substances in the U.K. or in the United States. We provide business support services to properly authorized companies that provide clinical services of the type described above to self-pay patients, and we subcontract certain of these business support services to The IV Doc.
Company Strategy
Our core strategy is to become a leader in solving psychiatric and neurological disorders, one of the world’s biggest clinical problems, through research, development, and commercialization of novel CNS drugs. Key elements of our business strategy are as follows:
● | Research new drugs or the treatment of CNS disorders targeting the pathophysiology underlying the disease and with different mechanisms of action than conventional psychiatric and neurological drugs. Research will be conducted under the leadership of Professor Lawrence Steinman, a renowned neurologist and immunologist based at Stanford University, and Dr. Tiago Reis Marques, a psychiatrist and neuroscientist at Imperial College and King’s College London; |
● | Partner with reputable and successful healthcare companies and clinics to provide and support the intravenous administration of ketamine to treat treatment-resistant depression and PTSD; |
○ | Create a capital efficient revenue stream with significant client bases across the United States and the U.K., including in Los Angeles, New York City, London; and |
○ | Create a diversified revenue stream by establishing and supporting clinics to provide greater visibility of revenue and EBITDA. |
Results of Operations
Three Months Ended March 31, 2022 and 2021
Our financial results for the three months ended March 31, 2022 and 2021 are summarized as follows:
Three Months Ended | ||||||||
March 31, | ||||||||
2022 | 2021 | |||||||
Revenues | $ | 13,658 | $ | - | ||||
Cost of servicesd | 12,937 | |||||||
Selling, general and administrative expenses | 2,405,258 | 549,609 | ||||||
Loss from operations | (2,404,537 | ) | (549,609 | ) | ||||
Other income (expense), net | 830,297 | - | ||||||
Loss before income taxes | $ | (1,574,240 | ) | $ | (549,609 | ) |
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Revenues for the three months ended March 31, 2022 relate to our operations in the U.K. providing business support services to registered healthcare providers who assess patients, and if appropriate, administering intravenous infusions of ketamine. The increase in our loss before income taxes for the three months ended March 31, 2022 compared to the same period of 2021 is mainly attributable to increased selling, general and administrative expenses as a result of further expansion of operations following the receipt of proceeds from our initial public offering and private placement offering in November 2021, partially offset by a decrease in the fair value of our warrant liabilities of $785,297.
Working Capital
As of | ||||||||
March 31, 2022 | December 31, 2021 | |||||||
Current assets | $ | 50,949,946 | $ | 53,300,457 | ||||
Current liabilities | 433,684 | 447,280 | ||||||
Working capital | $ | 50,516,262 | $ | 52,853,177 |
Working capital decreased by $2,336,915 between December 31, 2021 and March 31, 2022 due primarily to cash used to fund our loss from operations for the three months ended March 31, 2022.
Liquidity and Financial Condition
Three
Months Ended | Three Months Ended March 31, 2021 | |||||||
Net loss | $ | (1,574,240 | ) | $ | (549,609 | ) | ||
Net cash (used in) operating activities | (2,527,478 | ) | (381,845 | ) | ||||
Net cash (used in) investing activities | (113,867 | ) | - | |||||
Net cash provided by financing activities | - | 1,208,926 | ||||||
Effect of foreign currency translation | (4,155 | ) | - | |||||
Increase (decrease) in cash and cash equivalents | $ | (2,645,500 | ) | $ | 827,081 |
Cash and cash equivalents decreased by $2,645,500 for the three months ended March 31, 2022, which was primarily attributable to cash used to fund our loss from operations and make equipment purchases during the period.
Liquidity & Capital Resources Outlook
As of March 31, 2022, we had $50,321,206 in our operating bank accounts and working capital of $50,516,262. Our liquidity needs prior to the consummation of the Initial Public Offering had been satisfied through proceeds from the issuance of common stock in private placements. Subsequent to the consummation of the Initial Public Offering and the November 2021 Private Placement, our liquidity was and will continue to be satisfied through the net proceeds from the consummation of the Initial Public Offering and the November 2021 Private Placement. 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.
Contractual Obligations
See Note 4 – 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.
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Off-Balance Sheet Arrangements
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, which include (1) revenue recognition, (2) stock-based compensation and (3) fair value measurements, are more fully described in the notes to our financial statements included in our 10-K for the fiscal year ended December 31, 2021. 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. |
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
The Company has established a Disclosure Controls Committee that assists the Chief Executive Officer and Chief Financial Officer in their evaluation of the Company’s disclosure controls and procedures. Our Chief Executive Officer and Chief Financial Officer 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.
There have been no changes in the Company’s internal control over financial reporting during the three months ended March 31, 2022 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
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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, 2021. 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 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.
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Item 6. Exhibits
+ | Indicates a management contract or any compensatory plan, contract or arrangement. |
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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: May 16, 2022 | ||
By: | /s/ Stanley M. Gloss | |
Stanley M. Gloss | ||
Chief Financial Officer | ||
(Principal Financial Officer and Principal Accounting Officer) | ||
Date: May 16, 2022 |
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