10-Q 1 f10q0923_pasithea.htm QUARTERLY REPORT

 

 

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 September 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 November 9, 2023, there were 20,836,623 shares of the registrant’s common stock outstanding.

 

 

 

 

  

PASITHEA THERAPEUTICS CORP.

FORM 10-Q

For the Quarter ended September 30, 2023

 

  Page
   
PART I. FINANCIAL INFORMATION
     
ITEM 1. Financial Statements 1
     
  Condensed Consolidated Balance Sheets at September 30, 2023 (unaudited) and December 31, 2022 1
     
  Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) for the Three and Nine Months Ended September 30, 2023 and 2022 2
     
  Condensed Consolidated Statements of Changes in Stockholders’ Equity (unaudited) for the Three and Nine Months Ended September 30, 2023 and 2022 3
     
  Condensed Consolidated Statements of Cash Flows (unaudited) for the Nine Months Ended September 30, 2023 and 2022 4
     
  Notes to Unaudited Condensed Consolidated Financial Statements 5
     
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 16
     
ITEM 3. Quantitative and Qualitative Disclosures about Market Risk 22
     
ITEM 4. Controls and Procedures 22
     
PART II. OTHER INFORMATION
     
ITEM 1. Legal Proceedings 23
     
ITEM 1A. Risk Factors 23
     
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 23
     
ITEM 3. Defaults Upon Senior Securities 23
     
ITEM 4. Mine Safety Disclosures 23
     
ITEM 5. Other Information 23
     
ITEM 6. Exhibits 23
     
SIGNATURES 24

 

i

 

 

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements 

PASITHEA THERAPEUTICS CORP.

CONDENSED CONSOLIDATED BALANCE SHEETS

 

   September 30,
2023
   December 31,
2022
 
   (Unaudited)     
ASSETS        
Current assets:        
Cash and cash equivalents  $19,584,690   $33,087,864 
Amount due from sale of assets   95,000    
-
 
Prepaid expenses   985,067    562,375 
Other current assets   106,511    262,992 
Current assets of discontinued operations   
-
    163,462 
Total current assets   20,771,268    34,076,693 
Property and equipment, net   145,924    125,197 
Right of use asset- operating lease   378,453    500,428 
Intangibles, net   8,098,855    8,571,478 
Goodwill   1,262,911    1,262,911 
Non-current assets of discontinued operations   
-
    643,382 
Total assets  $30,657,411   $45,180,089 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable and accrued liabilities  $1,869,458   $1,481,393 
Lease liability- short term portion   174,471    160,362 
Current liabilities of discontinued operations   
-
    235,879 
Total current liabilities   2,043,929    1,877,634 
           
Non-current liabilities          
Lease liability   210,817    344,021 
Warrant liabilities   29,059    140,611 
Non-current liabilities of discontinued operations   
-
    319,575 
Total non-current liabilities   239,876    804,207 
Total liabilities   2,283,805    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; 20,836,623 and 26,043,406 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively   17,466    17,987 
Additional paid-in capital   58,634,236    61,837,802 
Accumulated other comprehensive loss   (7,717)   (661)
Accumulated deficit   (30,270,379)   (19,356,880)
Total stockholders’ equity   28,373,606    42,498,248 
Total liabilities and stockholders’ equity  $30,657,411   $45,180,089 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

1

 

 

PASITHEA THERAPEUTICS CORP.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

 

   For the Three Months Ended
September 30,
   For the Nine Months Ended
September 30,
 
   2023   2022   2023   2022 
                 
Operating expenses:                
Selling, general and administrative   $2,164,560   $2,576,802   $6,081,362   $7,267,239 
Research and development    1,624,766    1,278,922    4,749,217    1,278,922 
Loss from operations    (3,789,326)   (3,855,724)   (10,830,579)   (8,546,161)
                     
Other income (expense):                     
Change in fair value of warrant liabilities    44,996    (335,317)   111,552    871,680 
Interest and dividends, net    131,740    
-
    242,543    
-
 
Other income (expense), net    176,736    (335,317)   354,095    871,680 
                     
Loss before income taxes    (3,612,590)   (4,191,041)   (10,476,484)   (7,674,481)
Provision for income taxes    
-
    
-
    
-
    
-
 
Net loss from continuing operations  $(3,612,590)  $(4,191,041)  $(10,476,484)  $(7,674,481)
                     
Net loss from discontinued operations, net of tax   
-
    (395,089)   (437,015)   (1,144,283)
Net loss   $(3,612,590)  $(4,586,130)  $(10,913,499)  $(8,818,764)
                     
Weighted-average common shares outstanding, basic and diluted
   25,160,994    26,548,688    25,784,010    24,415,888 
Basic and diluted loss per share from continuing operations
  $(0.14)  $(0.16)  $(0.41)  $(0.31)
Basic and diluted loss per share from discontinuing operations
  $-   $(0.01)  $(0.02)  $(0.05)
                     
Comprehensive loss:                     
Net loss  $(3,612,590)  $(4,586,130)  $(10,913,499)  $(8,818,764)
Foreign currency translation    (4,256)   (82,514)   (7,056)   (136,012)
Comprehensive loss  $(3,616,846)  $(4,668,644)  $(10,920,555)  $(8,954,776)

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

2

 

 

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 
Stock-based compensation:                              
-restricted share units   16,667    1    24,174    
-
    
-
    24,175 
-options   -    
-
    102,499    
-
    
-
    102,499 
Stock repurchase   (5,323,451)   (532)   (3,725,884)   
-
    
-
    (3,726,416)
Foreign currency translation   -    
-
    
-
    (4,256)   
-
    (4,256)
Net loss   -    -    
-
    
-
    (3,612,590)   (3,612,590)
Balance at September 30, 2023   20,836,623   $17,466   $58,634,236   $(7,717)  $(30,270,379)  $28,373,606 
                               
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   -    
-
    101,480    
-
    
-
    101,480 
-restricted stock   279,447    28    282,213    
-
    
-
    282,241 
-common stock   -    
-
    
-
    
-
    
-
    
-
 
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   26,548,688   $18,038   $57,814,993   $(64,059)  $(6,447,139)  $51,321,833 
Stock-based compensation expense:                              
-restricted share units   -    
-
    24,176    
-
    
-
    24,175 
-options   -    
-
    111,451    
-
    
-
    111,451 
-restricted stock   -    
-
    
-
    
-
    
-
    
-
 
Warrants issued for acquisition   -    
-
    
-
    
-
    
-
    
-
 
Common shares issued for acquisition   -    
-
    
-
    
-
    
-
    
-
 
Foreign currency translation   -    
-
    
-
    (82,514)   
-
    (82,514)
Net loss   -    
-
    
-
    -    (4,586,130)   (4,586,130)
Balance at September 30, 2022   26,548,688   $18,038   $57,950,620   $(146,573)  $(11,033,269)  $46,788,816 

  

See accompanying notes to the unaudited condensed consolidated financial statements.

 

3

 

 

PASITHEA THERAPEUTICS CORP.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   For the Nine Months Ended
September 30,
 
   2023   2022 
         
CASH FLOWS FROM OPERATING ACTIVITIES:        
Net loss from continuing operations  $(10,476,484)  $(7,674,481)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation   13,610    956 
Amortization expense   472,623    
-
 
Stock-based compensation   522,329    678,890 
Change in fair value of warrant liabilities   (111,552)   (871,680)
Non-cash lease expense   2,880    
-
 
Gain on sale of assets   (65,048)   
-
 
Changes in operating assets and liabilities:          
Prepaid expenses   (422,692)   (669,627)
Other assets   156,481    (621,279)
Accounts payable and accrued liabilities   388,064    465,606 
Lease liabilities   
-
    (17,564)
Net cash used in operating activities   (9,519,789)   (8,709,179)
           
CASH FLOWS FROM INVESTING ACTIVITIES:          
Purchase of property and equipment   (34,337)   (14,376)
Net cash proceeds from sale of assets   55,000    
-
 
Acquisition of business, net of cash acquired   
-
    56,579 
Net cash provided by investing activities   20,663    42,203 
           
CASH FLOWS FROM FINANCING ACTIVITIES:          
Note payable proceeds   392,354    
-
 
Principal payments on note payable   (392,354)   
-
 
Repurchase of common stock   (3,726,416)   
-
 
Net cash used in financing activities   (3,726,416)   
-
 
           
Effect of foreign currency translation on cash   (7,056)   (129,521)
Net cash used in operating activities of discontinued operations   (594,383)   (1,026,911)
Net cash provided by (used in) investing activities of discontinued operations   323,807    (698,790)
Net cash provided by (used in) financing activities of discontinued operations   
-
    
-
 
           
NET CHANGE IN CASH  $(13,503,174)  $(10,522,198)
Cash and cash equivalents - Beginning of period   33,087,864    52,901,962 
Cash and cash equivalents - End of period  $19,584,690   $42,379,764 
           
Supplemental disclosure of cash flow information:          
Lease liabilities arising from obtaining right-of-use assets  $
-
   $410,392 
Amount due from sale of assets  95,000  
-
 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

4

 

 

PASITHEA THERAPEUTICS CORP.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS 

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 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.

 

As of June 30, 2023, the at home services in New York, NY as well as in the U.K had been discontinued and we sold and disposed of our assets associated with the Clinics operations in Los Angeles, CA, and the U.K. The lease associated with the related property in Los Angeles was assumed by the buyer in the transaction.

 

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, , 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”).

 

5

 

 

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 September 30, 2023, the Company had approximately $19.6 million of cash and cash equivalents and working capital of approximately $18.7 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 unaudited 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.

 

6

 

 

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 and 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, classified as trading securities. The Company had cash equivalents of $10.3 million as of September 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 September 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.

 

7

 

 

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, September 30, 2023  $10,253,735   $10,253,735   $
             -
   $
               -
 
                     
Liabilities:                    
Public warrant liabilities, September 30, 2023  $27,280   $27,280   $
-
   $
-
 
Representative warrant liabilities, September 30, 2023  $1,779   $
-
   $
-
   $1,779 
                     
Liabilities:                    
Public warrant liabilities, December 31, 2022  $132,000   $132,000   $
-
   $
-
 
Representative warrant liabilities, December 31, 2022  $8,611   $
-
   $
-
   $8,611 

 

The following table presents a reconciliation of the Level 3 Representative Warrants liabilities:

 

    Three months ended
September 30,
 
    2023     2022  
Representative warrant liabilities, July 1   $ 4,535     $ 18,600  
Issuances     -       -  
Exercises     -       -  
Change in fair value     (2,757 )     23,882  
Representative warrant liabilities, September 30   $ 1,779     $ 42,482  

 

    Nine months ended
September 30,
 
    2023     2022  
Representative warrant liabilities, January 1   $ 8,611     $ 106,205  
Issuances     -       -  
Exercises     -       -  
Change in fair value     (6,833 )     (63,723 )
Representative warrant liabilities, September 30   $ 1,779     $ 42,482  

 

8

 

 

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 September 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 September 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:

 

   Nine months ended
September 30,
 
   2023   2022 
Stock options   1,980,000    1,000,000 
Warrants   15,356,000    13,600,000 
Restricted stock units   83,332    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.

 

9

 

 

The relevant translation rates are as follows:

 

   As of
September 30,
2023
   As of
December 31,
2022
 
Closing rate, British Pound (GBP) to $USD at period end   1.2207    1.2039 
Average rate, GBP to $USD for the period ended   1.2444    1.2362 
Closing rate, Euro (EUR) to $USD at period end   1.0589    0.9367 
Average rate, EUR to $USD for the period ended   1.0833    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 September 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 September 30,
2023
   As of December 31,
2022
 
Leasehold improvements  $3,193   $3,193 
Medical equipment   155,363    99,220 
Office equipment   6,140    26,343 
Property and equipment, gross   164,696    128,756 
Less: accumulated depreciation   (18,772)   (3,559)
Property and equipment, net  $145,924   $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%.

 

10

 

 

As of September 30, 2023, the Company recognized total ROU assets and lease liabilities as follows:

 

   As of September 30,
2023
   As of December 31,
2022
 
Non-current leases - right of use assets  $378,453   $500,428 
Current liabilities - operating lease liabilities  $174,471   $160,362 
Non-current liabilities - operating lease liabilities  $210,817   $344,021 
           
Operating lease expense  $188,206   $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 September 30, 2023:

 

2023 (remaining)  $65,169 
2024   199,872 
2025   183,216 
Total future minimum lease payments  $448,257 
Amount representing interest   (62,969)
Present value of net future minimum lease payments  $385,288 

 

NOTE 5 – INTANGIBLE ASSETS AND GOODWILL

 

Intangible assets, net consists of the following:

 

    September 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     5,671,478       (472,623 )     5,198,855       5,671,478       -       5,671,478  
Intangible assets, net   $ 8,571,478     $ (472,623 )   $ 8,098,855     $ 8,571,478     $ -     $ 8,571,478  

 

As of September 30, 2023, future expected amortization expense of Intangible assets was as follows:

 

2023 (remaining)

  $157,541 
2024   630,164 
2025   630,164 
2026   630,164 
2027   630,164 
Thereafter   5,420,658 
Remaining future amortization expense  $8,098,855 

 

There were no changes to goodwill for the nine months ended September 30, 2023.

 

11

 

 

NOTE 6 – STOCKHOLDERS’ EQUITY

 

Common Stock

 

The Company had 20,836,623 and 26,548,688 shares of its Common Stock issued and outstanding at September 30, 2023 and 2022, respectively.

  

Common Stock Issuances for the Three and Nine Months Ended September 30, 2023

 

During the three and nine months ended September 30, 2023, the Company issued 16,667 and 116,668 shares of common stock, respectively, due to the vesting of restricted stock units (“RSUs”), and recognized approximately $24,175 and $71,736, 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 September 30, 2023, the remaining unamortized RSU stock-based compensation expense was approximately $117,000.

 

The Company did not grant any RSUs or restricted stock awards during the three and nine months ended September 30, 2023.

 

Tender Offer (Common Stock Repurchase)

 

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 and it expired on September 8, 2023.

 

On September 14, 2023, the Company disclosed the results of the Tender Offer. A total of 5,323,451 shares of the Company’s common stock (the “Tender Offer Shares”) were validly tendered and not properly withdrawn at a purchase price of $0.70 per for an aggregate purchase price of $3,726,416, including fees and expenses relating to the Tender Offer. The Company had 20,819,956 shares of common stock outstanding following payment for the shares of common stock purchased in the Tender Offer. The Tender Offer Shares were retired and cancelled following the closing of the Tender Offer.

 

NOTE 7 – STOCK OPTIONS

 

Stock Options Issued, Vested and Cancelled

 

During the three months ended September 30, 2023, no stock options were issued. During the three months ended September 30, 2023, stock options to purchase an aggregate of 279,167 shares of Common Stock, subject to time-based milestone vesting conditions, vested.

 

During the nine months ended September 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 nine months ended September 30, 2023, stock options to purchase an aggregate of 629,168 shares of Common Stock, subject to time-based milestone vesting conditions, vested. During the nine months ended September 30, 2023, stock options to purchase an aggregate of 200,000 shares of Common Stock were cancelled.

 

12

 

 

Stock-Based Compensation

 

For the three months ended September 30, 2023 and 2022, total stock-based compensation expense related to the Company’s stock options was approximately $102,000 and approximately $111,000, respectively. For the three months ended September 30, 2023, the Company recognized approximately $81,000 of stock-based compensation related to its options within selling, general and administrative expense, and approximately $21,000 within research and development expense. For the three months ended September 30, 2022, all stock-based compensation expense was recorded within selling, general and administrative expense.

 

For the nine months ended September 30, 2023 and 2022, total stock-based compensation expense related to the Company’s stock options was approximately $451,000 and approximately $307,000, respectively. For the nine months ended September 30, 2023, the Company recognized approximately $349,000 of stock-based compensation related to its options within selling, general and administrative expense, and approximately $102,000 within research and development expense. For the nine months ended September 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 nine months ended September 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    9.41    
-
 
Expired/Cancelled   (200,000)   
-
    -    
-
 
Exercised   
-
    
-
    
-
    
-
 
Outstanding, September 30, 2023   1,980,000   $1.62    8.81    
-
 
Exercisable, September 30, 2023   845,835   $2.63    8.52   $
-
 

 

As of September 30, 2023, the remaining unamortized stock-based compensation expense related to the stock options was approximately $479,000.

 

NOTE 8 – WARRANTS

 

As of September 30, 2023, the fair value of the Public Warrants was approximately $0.01 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 $0.01 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    3.88      
$3.50    8,680,000    3.15      
$6.00    276,000    2.96      
$6.25    4,400,000    2.96      
      15,356,000    3.19   $4.12 

 

No warrants were granted, expired/cancelled, or exercised during the three and nine months ended September 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.

 

13

 

 

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

 

As of June 30, 2023, we sold and disposed of our assets associated with the Clinics operations in Los Angeles, CA and disposed of our services in the U.K. The lease associated with the related property in Los Angeles was assumed by the buyer in the transaction. 

 

As of September 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 nine months ended September 30, 2023 and 2022, have been reflected in the condensed consolidated statements of operations and consist of the following:

 

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2023   2022   2023   2022 
Revenues  $
-
   $218,608   $
-
   $245,847 
Cost of services   
-
    86,465    
-
    114,503 
Gross margin   
-
    132,143    
-
    131,344 
Selling, general and administrative   
-
    527,232    502,063    1,320,627 
Research and Development   
-
    
-
    
-
    
-
 
Loss from discontinued operations   
-
    (395,089)   (502,063)   (1,189,283)
Gain on sale of accounts payable   
-
    
-
    
-
    45,000 
Gain on sale of assets   
-
    
-
    65,048    
-
 
Gain (loss) from discontinued operations, before income tax   
-
    (395,089)   (437,015)   (1,144,283)
Income tax expense   
-
    
-
    
-
    
-
 
Net loss from discontinued operations, net of tax  $
-
   $(395,089)  $(437,015)  $(1,144,283)
Weighted-average common shares outstanding, basic and diluted
   25,160,994    26,548,688    25,784,010    24,415,888 
Basic and diluted loss per share from discontinued operations
  $(0.00)  $(0.01)  $(0.02)  $(0.05)

 

14

 

 

The following table presents the gain on the sale of assets in Los Angeles, CA:

 

   As of
September 30,
2023
 
Cash proceeds  $55,000 
Proceeds to receive in installments   95,000 
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:

 

   Nine months
ended
September 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  $95,000 

 

NOTE 11– NOTE PAYABLE

 

Directors and Officers 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 $0 at September 30, 2023 and December 31, 2022, respectively.

 

15

 

 

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.

 

There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:

 

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;

 

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;

 

16

 

 

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 α5β1 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.

 

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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

 

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 and it expired on September 8, 2023, subject to the terms and conditions of the Tender Offer. The Tender Offer resulted in the Company purchasing 5,323,451 shares of its common stock for an aggregate purchase price of approximately $3.7 million, excluding fees and expenses relating to the Tender Offer. For more information on the Tender Offer, see “Note 6 – Stockholders’ Equity” in the Notes to Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this Form 10-Q.

 

Selection of PAS-003 Lead Candidate

 

On November 9, 2023, we announced that we selected our PAS-003 lead development candidate, a humanized monoclonal antibody with optimal properties that targets α5β1 integrin for the treatment of both sporadic and familial ALS. PAS-003 is now ready for manufacturing and IND enabling studies.

 

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.

 

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Results of Operations

 

Comparison of the Three and Nine Months Ended September 30, 2023 and 2022

 

Our financial results for the three and nine months ended September 30, 2023 and 2022 are summarized as follows:

 

   For the Three Months Ended
September 30,
         
   2023   2022   Change   % Change 
Selling, general and administrative  $2,164,560   $2,576,802   $(412,242)   (16.0)%
Research and development   1,624,766    1,278,922    345,844    27.0%
Loss from operations   (3,789,326)   (3,855,724)   66,398    1.7%
Other income (expense), net   176,736    (335,317)   512,053    152.7%
Net loss from continuing operations   (3,612,590)   (4,191,041)   578,451    13.8%
Net loss from discontinued operations, net of tax   -    (395,089)   395,089    100.0%
Net loss  $(3,612,590)  $(4,586,130)  $973,540    21.2%

 

   For the Nine Months Ended
September 30,
         
   2023   2022   Change   % Change 
Selling, general and administrative  $6,081,362   $7,267,239   $(1,185,877)   (16.3)%
Research and development   4,749,217    1,278,922    3,470,295    271.3%
Loss from operations   (10,830,579)   (8,546,161)   (2,284,418)   (26.7)%
Other income, net   354,095    871,680    (517,585)   (59.4)%
Net loss from continuing operations   (10,476,484)   (7,674,481)   (2,802,003)   (36.5)%
Net loss from discontinued operations, net of tax   (437,015)   (1,144,283)   707, 268    61.8%
Net loss  $(10,913,499)  $(8,818,764)  $(2,094,735)   (23.8)%

 

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 nine months ended September 30, 2023, selling, general and administrative expenses were approximately $2.2 million and $6.1 million, respectively. Selling, general and administrative expenses decreased for the three and nine months ended September 30, 2023 compared to the three and nine months ended September 30, 2022 primarily due to the discontinued Clinics operations in 2023.

 

We expect selling, general, and administrative expenses to remain relatively flat throughout the rest of 2023.

 

Research and Development

 

Research and development expenses relate to our activities performed by our Therapeutics segment, which is primarily focused on the development of PAS-004, our lead product candidate, and PAS-003, our most advanced discovery candidate.

 

For the three and nine months ended September 30, 2023, research and development expenses were approximately $1.6 million and $4.7 million, respectively. Research and development expenses increased for the three and nine months ended September 30, 2023 compared to the three and nine months ended September 30, 2022 primarily due to the commencement and expansion of our drug development activities related to PAS-004 and PAS-003. 

 

We expect research and development expenses to continue to increase throughout the rest of 2023 primarily due to manufacturing, regulatory and clinical development of PAS-004.

 

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Other income (expense), net

 

For the three months ended September 30, 2023, other income (expense), net increased by approximately $512 thousand compared to the three months ended September 30, 2022. The increase in other income, net is due primarily to the 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 September 30, 2023, compared to a larger increase in the fair value of the Public Warrants and the Representative Warrants that occurred during the three months ended September 30, 2022. See “Note 2 – Summary of Significant Accounting Policies” in the Notes to Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this Form 10-Q for more information on the accounting treatment of the Public Warrants and the Representative Warrants. The remaining increase in other income (expense), net is due to dividend income of $142 thousand during the three months ended September 30, 2023.

 

For the nine months ended September 30, 2023, other income, net decreased by approximately $517 thousand compared to the nine months ended September 30, 2022. The decrease is primarily due to the decrease of approximately $67 thousand that occurred during the nine months ended September 30, 2023, compared to a $1.4 million decrease in the fair value of our Public Warrants and Representative Warrants that occurred during the nine months ended September 30, 2022, partially offset by an increase in dividend income of $253 thousand during the nine months ended September 30.

 

Working Capital

 

   As of
September 30,
2023
   As of
December 31,
2022
(1)
 
Current assets  $20,771,268   $33,913,231 
Current liabilities   2,043,929    1,641,755 
Working capital  $18,727,339   $32,271,476 

 

(1)the numbers for December 31, 2022, exclude the discontinued operation

 

Working capital decreased by approximately $13.5 million between December 31, 2022 and September 30, 2023 due primarily to cash used to repurchase shares of our common stock in the Tender Offer and to fund operations for the nine months ended September 30, 2023.

 

Liquidity and Financial Condition

 

   Nine Months Ended
September 30,
 
   2023   2022 
Net loss  $(10,913,499)  $(8,818,764)
           
Net cash used in operating activities  $(9,519,789)  $(8,709,179)
Net cash provided by investing activities   20,663    42,203 
Net cash used in financing activities   (3,726,416)   - 
Effect of foreign currency translation   (7,056)   (129,521)
Net cash used in discontinued operations   (270,576)   (1,725,701)
           
Decrease in cash and cash equivalents  $(13,503,174)  $(10,522,198)

 

Cash and cash equivalents decreased by approximately $13.5 million for the nine months ended September 30, 2023, compared to a decrease of approximately $10.5 million for the nine months ended September 30, 2022, which was primarily attributable to cash used to repurchase shares of our common shares in the Tender Offer during the period and cash used to fund operations, partially offset by a decrease of approximately $271 thousand in net cash used in discontinued operations, compared to a decrease of approximately $1.7 million in the corresponding period of 2022.

 

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Liquidity & Capital Resources Outlook

 

As of September 30, 2023, we had approximately $19.6 million in operating bank accounts and money market funds, with working capital of approximately $18.7 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 continues to be satisfied through the net proceeds from the Initial Public Offering, the private placement we consummated 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.

 

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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 nine months ended September 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 September 30, 2023 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

 

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not presently a party to any legal proceedings that, if determined adversely to us, we believe would individually or in the aggregate have a material adverse effect on our business, results of operations, financial condition or cash flows. 

 

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

 

Exhibit No.

  Description
31.1*   Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*   Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**   Certification of the Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**   Certification of the Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS*   Inline XBRL Instance Document.
101.SCH*   Inline XBRL Taxonomy Extension Schema Document
101.CAL*   Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB*   Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*   Inline XBRL Taxonomy Extension Presentation Linkbase Document
101.DEF*   Inline XBRL Taxonomy Extension Definition Linkbase Document
104   Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)

 

* Filed herewith.

** Furnished, not filed.

+ 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.

 

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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: November 13, 2023

 

 

By: /s/ Daniel Schneiderman  
  Daniel Schneiderman  
  Chief Financial Officer  
  (Principal Financial Officer and
Principal Accounting Officer)
 
   
 

Date: November 13, 2023

 

 

 

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