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Pasithea Therapeutics Corp.

For the period ended Dec 31, 2024. Filed Mar 24, 2025.

View on SEC.gov

About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2024 · Filed Mar 24, 2025

KTTA$0.58+11.3%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-K

Period ended 2023-12-31; filed 2024-03-29.

0001213900-24-027508

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Current report: 10-K

Period ended 2024-12-31; filed 2025-03-24.

0001013762-25-001646

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 49 previous paragraphs and 51 current paragraphs.

34 unchanged; 9 reworded; 7 added; 5 removed; 1 previous and 1 current paragraphs rearranged.

Tables are not compared: 14 previous and 14 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (7)

Current report

Additionally, we have two programs that are in the discovery stage, which we believe address limitations in the treatment paradigm of the indications we plan to address with these programs, which are currently amyotrophic lateral sclerosis (“ALS”) for PAS-003 and schizophrenia for PAS-001. During the year ended December 31, 2023, we determined to cease further development of our PAS-002 program for multiple sclerosis due to several factors including the significant capital, resources and time required to develop the program, and the current and projected availability of effective treatment options for MS patients, among others.

Current report

During the year ended December 31, 2023, we also discontinued providing business support services to anti-depression clinics (the “Clinics” segment) in the U.K. and in the United States, previously conducted through partnerships with healthcare providers. During the year ended December 31, 2023, the at home services in New York, NY as well as in the U.K were discontinued and the Company sold and disposed of the assets associated with the Clinics operations in Los Angeles, CA. The lease associated with the related property in Los Angeles was assumed by the buyer in the transaction.

Current report

General and administrative expenses decreased by approximately $827,000, or 10.5%, for the year ended December 31, 2024 compared to the year ended December 31, 2023. The decrease was primarily driven by (i) a decrease of $530,000 in professional fees, of which approximately $271,000 was related to public company and corporate communications expenses, approximately $127,000 was related to business development, and approximately $132,000 was related to personnel, office expenses or other professional fees (ii) a decrease in legal fees of approximately $461,000, (iii) a decrease in accounting fees of approximately $57,000, offset by (iv) an increase of approximately $147,000 in stock compensation expenses, and (v) an increase of approximately $74,000 in consulting fees.

Current report

We expect general and administrative expenses to decrease slightly in fiscal year 2025 as compared to fiscal year 2024 primarily due to reduced legal and public company and corporate communications expenses.

Current report

Research and development expenses decreased by approximately $903,000, or 11.1%, for the year ended December 31, 2024 compared to the year ended December 31, 2023. The decrease was primarily due to (i) a decrease of approximately $2,019,000 of pre-clinical research related to our discovery programs, (ii) a decrease of approximately $1,141,000 in manufacturing costs related to PAS-004 due to the bulk manufacturing of GMP materials to support our clinical trials in fiscal year 2023, (iii) a decrease of approximately $167,000 in consulting fees, (iv) a decrease in compensation and stock compensation expenses of approximately $200,000 in connection with the reduction in workforce related to the closure of our research laboratory, offset by (v) an increase of approximately $2,624,000 in clinical research related to the ongoing FIH Phase 1 Dose Escalation Study.

Current report

In September 2024, we entered into a securities purchase agreement with an institutional investor for the issuance and sale in a private placement (the “September 2024 Private Placement”) of (i) pre-funded warrants to purchase up to 1,219,513 shares of our Common Stock, at an exercise price of $0.001 per share, (ii) Series A warrants (the “Series A Warrants”) to purchase up to 1,219,513 shares of Common Stock, at an exercise price of $3.85 per share, and (iii) Series B warrants (the “Series B Warrants” and together with the Series A Warrants, the “September 2024 Warrants” ) to purchase up to 1,219,513 shares of Common Stock with an exercise price of $3.85 per share. The combined purchase price per Pre-Funded Warrant and accompanying September 2024 Warrants was $4.099. The net proceeds to us from the Private Placement were approximately $4.5 million, after deducting placement agent fees and estimated offering expenses.

Current report

We are able to sell securities on a shelf registration statement pursuant to the ATM Agreement with H.C. Wainwright & Co., LLC. Under current Securities and Exchange Commission regulations, if at any time our public float is less than $75.0 million, and for so long as our public float remains less than $75.0 million, the amount we can raise through primary public offerings of securities in any twelve-month period using shelf registration statements is limited to an aggregate of one-third of our public float, which is referred to as the baby shelf rules. As of December 31, 2024, our calculated public float is below $75.0 million and we will be restricted from selling more than an aggregate of one-third of our public float pursuant to a shelf registration statement in any twelve-month period, so long as the aggregate market value of our Common Stock held by non-affiliates is less than $75.0 million.
Removed paragraphs (5)

Previous report

We are also focused on the development of our discovery programs through lead identification of drug candidates, including PAS-003, a monoclonal antibody targeting a5b1 integrin for the treatment of ALS and PAS-001, a small molecule targeting the complement component 4A(C4A) gene for the treatment of schizophrenia.

Previous report

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.

Previous report

General and administrative expenses decreased by approximately $2.0 million, or 21%, for the year ended December 31, 2023 compared to the year ended December 31, 2022. The decrease was primarily driven by (i) a decrease of $1.6 million in professional fees associated with being a public company and non-recurring corporate communication costs associated with a dissident shareholder campaign that were incurred in 2022, of which approximately $1.2 million was related to public relations and communications, approximately $236,000 was related to investor relations, research, and other professional fees, and approximately $171,000 was related to the transfer agent and proxy fees (ii) a decrease in consulting and legal fees of approximately $1.6 million due to the non-recurring costs of a dissident shareholder campaign, litigation settlements, hiring of contractors, and the acquisition of Alpha-5 during 2022, (iii) a decrease in accounting and valuation fees of approximately $159,000 due to higher fees related to the acquisition in 2022, offset by (iv) an increase of approximately $655,000 in personnel expenses related to the hiring of employees, (v) an increase of approximately $278,000 in non-cash expenses, primarily related to the amortization of intangible assets, (vi) an increase of approximately $388,000 in office and other expenses related to director fees, insurance, IT administration, utilities, travel, and (business development.

Previous report

We expect general and administrative expenses to decrease in fiscal year 2024 as compared to fiscal year 2023 due to the non-recurring expenses that were incurred in 2023 related to the unsolicited, non-binding proposal to acquire all outstanding shares of the Company from a third party and the tender offer we completed in September 2023.

Previous report

Research and development expenses increased by approximately $5.4 million, or 204%, for the year ended December 31, 2023 compared to the year ended December 31, 2022. The increase is due to the expansion of our drug development activities related to the research of our product candidates, the manufacturing and clinical development of PAS-004, and increased consulting fees.
Reworded paragraphs (9)

Previous wording

Throughout this report, the terms “our,” “we,” “us,” and the “Company” refer to Pasithea Therapeutics Corp. and its subsidiaries, Pasithea Therapeutics Limited (UK), Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, Pasithea Clinics Inc., Alpha-5 Integrin, LLC, and AlloMek Therapeutics, LLC. Pasithea Therapeutics Limited (UK) is a private limited Company, registered in the United Kingdom (UK). Pasithea Clinics Inc. is incorporated in Delaware, Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, a private limited Company, registered in Portugal, and Alpha-5 Integrin, LLC and AlloMek Therapeutics, LLC, are both Delaware limited liability companies.

Current wording

Throughout this report, the terms “our,” “we,” “us,” and the “Company” refer to Pasithea Therapeutics Corp. and its subsidiaries, Pasithea Therapeutics Limited (UK), Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, Pasithea Clinics Inc., Alpha-5 Integrin, LLC, AlloMek Therapeutics, LLC and Pasithea MacroMEK Pty Ltd. Pasithea Therapeutics Limited (UK) is a private limited Company, registered in the United Kingdom (UK). Pasithea Clinics Inc. is incorporated in Delaware, Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, a private limited Company, registered in Portugal, and Alpha-5 Integrin, LLC and AlloMek Therapeutics, LLC, are both Delaware limited liability companies. Pasithea MacroMEK Pty Ltd is registered in Australia.

Previous wording

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 are focused on developing our lead therapeutic candidate, PAS-004, a next-generation macrocyclic MEK inhibitor for potential use in a range of indications, including neurofibromatosis type 1--associated plexiform neurofibromas and certain oncology indications that we acquired from AlloMek Therapeutics, LLC (“AlloMek”) in October 2022.

Current wording

We are a clinical-stage biotechnology company focused on the discovery, research and development of innovative treatments for central nervous system (CNS) disorders and other diseases, including RASopathies.

Previous wording

In December 2023, the U.S. Food and Drug Administration (the “FDA”) cleared our Investigational New Drug application (the “IND”) for PAS-004 and we received a study may proceed letter from the FDA for our Phase 1 multicenter, open-label trial of PAS-004 in patients with MAPK pathway-driven advanced tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition. The Company is currently conducting the Phase 1 clinical trial. Our clinical development plan for PAS-004 following the Phase 1 study is to begin a Phase 1b/2 clinical trial in neurofibromatosis type 1 (NF1)-associated plexiform neurofibroma pediatric and adult patients.

Current wording

Our primary operations (the “Therapeutics” segment) are focused on developing our lead product candidate, PAS-004, a next-generation macrocyclic mitogen-activated protein kinase, or MEK inhibitor that we believe may address the limitations and liabilities associated with existing drugs targeting a similar mechanism of action. In December 2023, the U.S. Food and Drug Administration (the “FDA”) cleared our Investigational New Drug application (the “IND”) for PAS-004 and we received a study may proceed letter from the FDA for our Phase 1 multicenter, open-label, dose escalation trial of PAS-004 in patients with MAPK pathway-driven advanced tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (the “FIH Phase 1 Dose Escalation Study”). We are currently conducting the FIH Phase 1 Dose Escalation Study at four clinical sites in the United States and three additional sites in Eastern Europe. Our clinical development plan for PAS-004 is to advance PAS-004 into a Phase 1/1b clinical trial in adult NF1-PN patients followed by pediatric NF1-PN patients and ultimately complete registrational clinical trials in these patient populations, which are the initial indications that the Company plans to seek marketing approval of PAS-004 for.

Previous wording

Research and development expenses for the years ended December 31, 2023 and 2022 relates to activities primarily focused on the development of PAS-001, PAS-003 and PAS-004.

Current wording

Research and development expenses for the years ended December 31, 2024 and 2023 relates to activities primarily focused on the development of PAS-004, PAS-003 and PAS-001.

Previous wording

We expect research and development expenses to increase in fiscal year 2024 as compared to fiscal year 2023 primarily due to the clinical development of PAS-004 as well as PAS-004 CMC activities.

Current wording

We expect research and development expenses to increase in fiscal year 2025 as compared to fiscal year 2024 primarily due to (i) an increase in clinical research for PAS-004 related to the ongoing FIH Phase 1 Dose Escalation Study and the upcoming phase 1/1b clinical trial of PAS-004 in adult NF1-PN patients, and (ii) an increase in manufacturing costs related to the drug supply for our clinical trials, offset by decreases in pre-clinical research and the reduction in workforce related to the closure of our research laboratory.

Previous wording

For the year ended December 31, 2023, other income, net decreased by approximately $389,000, or 45%, as compared to the year ended December 31, 2022. The decrease was primarily driven by a $1.8 million decrease in gains associated with changes in the fair value of our warrant liabilities, offset by interest and dividends of approximately $415,000 during the year ended December 31, 2023 that did not occur in the prior year and non-recurring litigation settlements of $1.0 million paid during the year ended December 31, 2022.

Current wording

For the year ended December 31, 2024, other income, net decreased by approximately $126,000, or 26.8%, as compared to the year ended December 31, 2023. The decrease was primarily driven by a $126,000 increase in the fair value of our warrant liabilities during the year ended December 31, 2024.

Previous wording

Working capital decreased by $18.2 million between December 31, 2023 and December 31, 2022 due primarily to cash used to repurchase shares of our Common Stock in the Tender Offer and to fund operations for the year ended December 31, 2023.

Current wording

Working capital decreased by $7.8 million between December 31, 2024 and December 31, 2023 due primarily to cash used to fund operations for the year ended December 31, 2024.

Previous wording

Cash and cash equivalents decreased by approximately $16.8 million for the year ended December 31, 2023 compared to a decrease of approximately $19.8 million for the year ended December 31, 2022, which was primarily attributable to cash used to repurchase shares of our common shares in the Tender Offer during the year and cash used to fund operations, partially offset by a decrease of approximately $287,000 in net cash used in discontinued operations, compared to a decrease of approximately $2.4 million during the year ended December 31, 2022.

Current wording

Cash and cash equivalents decreased by approximately $9.4 million for the year ended December 31, 2024 compared to a decrease of approximately $16.8 million for the year ended December 31, 2023, which was primarily attributable to cash used to fund operations, partially offset by an increase of approximately $4.5 million in net cash from financing activities from the private placement offering in September 2024.

Previous wording

As of December 31, 2023, we had approximately $16.3 million in operating bank accounts and money market funds, with working capital of approximately $14.1 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 not have sufficient working capital to meet our needs through twelve months from the issuance date of the financial statements included in this annual report, without raising additional capital.

Current wording

As of December 31, 2024, we had approximately $6.9 million in operating bank accounts and money market funds, with working capital of approximately $6.2 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 placements we consummated in November 2021 and September 2024 and the receipt of cash upon the prior exercise of our outstanding warrants. Based on the foregoing, management believes that we will not have sufficient working capital to meet our needs through twelve months from the issuance date of the financial statements included in this annual report, without raising additional capital.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

Throughout this report, the terms “our,” “we,” “us,” and the “Company” refer to Pasithea Therapeutics Corp. and its subsidiaries, Pasithea Therapeutics Limited (U.K.), Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, Pasithea Clinics Inc., Alpha-5 Integrin, LLC (“Alpha-5”), AlloMek Therapeutics, LLC (“AlloMek”) and Pasithea MacroMEK Pty Ltd. Pasithea Therapeutics Limited (U.K.), legally dissolved as of January 2, 2024 was 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 Inc. is incorporated in Delaware. Alpha-5 and AlloMek are both Delaware limited liability companies. Pasithea MacroMEK Pty Ltd is registered in Australia. The operations of Pasithea Therapeutics Limited (U.K.), Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, and Pasithea Clinics Inc. have been discontinued.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

During the year ended December 31, 2023, we discontinued our support services to anti-depression clinics in the U.K. and related at-home services in New York, NY. We also discontinued our clinical operations in Los Angeles, CA and disposed of the related property. Accordingly, as of December 31, 2023, we have discontinued the operations of our support services to clinics provided by our subsidiaries and remain focused on the research and development of our therapeutic product candidates.