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Pasithea Therapeutics Corp.

For the period ended Jun 30, 2026. Filed Aug 14, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2026 · Filed Aug 14, 2026

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-Q

Period ended 2026-03-31; filed 2026-05-15.

0001213900-26-057837

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-06-30; filed 2026-08-14.

0001213900-26-090146

Item 2. 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 45 previous paragraphs and 48 current paragraphs.

27 unchanged; 16 reworded; 3 added; 2 removed; 0 previous and 2 current paragraphs rearranged.

Tables are not compared: 34 previous and 35 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 (3)

Current report

Our initial planned indication for FDA and other regulatory approval is symptomatic and inoperable NF1-PN in adult and pediatric patients, and it aims to conduct a pediatric Phase 1 trial and registrational trials in both populations.

Current report

General and administrative expenses increased by approximately $365,000, or 22.0%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily driven by increases in (i) insurance expenses of $205,000, (ii) non-cash stock-based expense of approximately $142,000, (iii) accounting and business development of approximately $110,000, (iv) office and other expenses of approximately $44,000, and (v) public company expenses of $30,000. These increases were partially offset by decreases in (i) legal expenses of approximately $138,000, (ii) personnel and board expenses of approximately $24,000, and (iii) non-cash amortization of approximately $4,000.

Current report

General and administrative expenses increased by approximately $349,000, or 9.7%, for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily driven by increases in (i) personnel and board expenses of approximately $285,000, (ii) non-cash stock-based expense of approximately $278,000, (iii) accounting and business development of approximately $87,000, and (iv), public company expenses of approximately $68,000. These increases were partially offset by decreases in (i) legal expenses of approximately $292,000, (ii) office and other expenses of $55,000 (iii) insurance expenses of approximately $14,000, and (iv) non-cash amortization of approximately $8,000.
Removed paragraphs (2)

Previous report

The initial indication we plan to seek FDA marketing approval for PAS-004 is the treatment of symptomatic PNs in both adult and pediatric patients with NF1. As such, we aim to conduct a Phase 1 trial for pediatric NF1-PN patients and ultimately complete registrational clinical trials in both adult and pediatric NF1-PN populations.

Previous report

General and administrative expenses decreased by approximately $16,000, or 0.8%, for the three months ended March 31, 2026, compared to the three months ended March 31, 2025. The decrease was primarily driven by (i) a decrease in income tax expenses and tax credits of approximately $165,000, (ii) a decrease in accounting and business development expenses of approximately $24,000, (iii) a decrease in legal expenses of approximately $154,000, (iv) a decrease in insurance costs of approximately $22,000 and (v) a decrease in board fees of approximately $40,000, offset by (vi) an increase of approximately $240,000 in personnel costs, (vii) an increase in office expenses of approximately $49,000, (viii) an increase in stock-based compensation expense for employees and consultants of approximately $42,000, and (ix) an increase in public company and corporate communication costs of approximately $62,000.
Reworded paragraphs (16)

Previous wording

You should read the following discussion and analysis of financial condition and operating results together with our financial statements and the related notes thereto 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 thereto as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, as filed on March 30, 2026. 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 most recent 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.

Current wording

You should read the following discussion and analysis of financial condition and operating results together with our financial statements and the related notes thereto 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, 2025, as filed on March 30, 2026. 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.

Previous wording

Throughout this report, the terms “our,” “we,” “us,” and the “Company” refer to Pasithea Therapeutics Corp. and its subsidiaries, Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, Pasithea Clinics Inc., Alpha-5 Integrin, LLC, AlloMek Therapeutics, LLC and Pasithea MacroMEK Pty Ltd. Pasithea Clinics Inc., legally dissolved as of September 3, 2025, was 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. Pasithea MacroMEK Pty Ltd is registered in Australia. The operations of Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, and Pasithea Clinics Inc. have been discontinued.

Current wording

Throughout this report, the terms “our,” “we,” “us,” and the “Company” refer to Pasithea Therapeutics Corp. and its subsidiaries, Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, Pasithea Clinics Inc., Alpha-5 Integrin, LLC, AlloMek Therapeutics, LLC and Pasithea MacroMEK Pty Ltd. Pasithea Clinics Inc., legally dissolved as of September 3, 2025, was 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. Pasithea MacroMEK Pty Ltd is registered in Australia. The operations Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, and Pasithea Clinics Inc. have been discontinued.

Previous 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 Advanced Cancer Study”). We are currently conducting the FIH Phase 1 Advanced Cancer Study at four clinical sites in the United States and three additional sites in Eastern Europe. We have completed the initial eight cohorts through 45 mg capsule and have not reached the maximum tolerated dose. We have filed a protocol amendment to continue dose escalation in the FIH Phase 1 Advanced Cancer Study using our tablet formulation of PAS-004 in an effort to continue to explore the safety, PK, and early signals of efficacy at higher dose levels of PAS-004. Simultaneously, a pilot food effect assessment is planned in a subset of patients who agree to participate in this optional component of the study. As such, we expect to complete the trial in 2028.

Current wording

Our lead product candidate, PAS-004, is a next-generation oral once-daily macrocyclic mitogen-activated protein kinase, or MEK inhibitor being developed for the long-term treatment of chronic diseases, including the neurocutaneous manifestations of neurofibromatosis type 1 (“NF1“). Following the U.S. Food and Drug Administration (the “FDA”) clearance of our Investigational New Drug application (the “IND”) in December 2023, we are conducting a Phase 1 open-label, dose escalation trial of PAS-004 in patients with MAPK pathway-driven advanced tumors at sites in the United States and in Eastern Europe.

Previous wording

In May 2025, we initiated our Phase 1/1b multicenter, open-label, dose escalation trial of PAS-004 in adult patients with neurofibromatosis type 1 (“NF1”) with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas (“PN”). We are currently conducting the trial at a total of five sites in the United States, Australia, and South Korea.

Current wording

In May 2025, we initiated a Phase 1/1b open-label, dose escalation trial of PAS-004 in adult patients with NF1 with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas (“PN”) that is being conducting at sites in the United States, Australia, and South Korea.

Previous wording

Additionally, we have one program, PAS-001, in the discovery stage, which we believe addresses limitations in the treatment paradigm for schizophrenia. During the year ended December 31, 2025, we determined to cease further development of our PAS-003 program for ALS due to several factors including the significant capital, resources and time required to develop the program.

Current wording

Additionally, we have one program, PAS-001, in the discovery stage, for treatment of schizophrenia. During the year ended December 31, 2025, we determined to cease further development of our PAS-003 program for ALS due to several factors including the significant capital, resources and time required to develop the program.

Previous wording

Comparison of the Three Months Ended March 31, 2026, and 2025

Current wording

Comparison of the Three and Six Months Ended June 30, 2026, and 2025

Previous wording

Our financial results for the three months ended March 31, 2026, and 2025 are summarized as follows:

Current wording

Our financial results for the three and six months ended June 30, 2026, and 2025 are summarized as follows:

Previous wording

We expect general and administrative expenses to continue to decrease in fiscal year 2026 as compared to fiscal year 2025 primarily due to a decrease in impairment expenses offset by a ramp up in operational activity, public company and corporate communications expenses, and non-cash stock-based compensation.

Current wording

We expect general and administrative expenses to continue to decrease slightly in fiscal year 2026 as compared to fiscal year 2025 primarily due to a decrease in impairment expenses offset by a ramp up in operational activity, public company and corporate communications expenses, and non-cash stock-based compensation.

Previous wording

Research and development expenses relate to activities primarily focused on the development of PAS-004 for the three months ended March 31, 2026 and 2025.

Current wording

Research and development expenses relate to activities primarily focused on the development of PAS-004 for the three and six months ended June 30, 2026 and 2025.

Previous wording

Research and development expenses increased by approximately $1,212,000, or 70.1%, for the three months ended March 31, 2026, compared to the three months ended March 31, 2025. The increase was primarily due to (i) an increase in clinical trial and regulatory expenses of approximately $472,000, (ii) an increase in chemistry, manufacturing and controls (“CMC”) expenses of approximately $507,000, (iii) an increase in preclinical research expense of approximately $130,000, and (iv) an increase in non-clinical research and development expense of approximately $109,000, offset by (vi) a decrease in other expenses of approximately $5,000.

Current wording

Research and development expenses increased by approximately $1,537,000, or 71.5%, for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. The increase was primarily due to (i) an increase in clinical trial and regulatory expenses of approximately $299,000, (ii) an increase in chemistry, manufacturing and controls (“CMC”) expenses of approximately $877,000, (iii) an increase in non-clinical research and development expense of approximately $199,000, (iv) an increase in preclinical research expense of approximately $144,000 and (v) non-cash stock expense of approximately $33,000. These increases were partially offset by a decrease in other expenses of approximately $15,000.

Previous wording

We expect research and development expenses to continue to increase in fiscal year 2026 as compared to fiscal year 2025 primarily due to (i) an increase in clinical trial and regulatory expenses related to our ongoing clinical trials for PAS-004, (ii) an increase in CMC costs related to PAS-004 drug product and drug supply for our clinical trials, as well as the development of a liquid formation of PAS-004, (iii) the initiation of non-clinical absorption, distribution, metabolism and excretion (“ADME”) studies, non-clinical developmental and reproductive toxicology studies, and clinical human ADME studies, (iv) an increase in preclinical research for PAS-004, and (v) an increase in personnel costs related to anticipated new workforce hires to support our research and development activities.

Current wording

We expect research and development expenses to continue to increase in fiscal year 2026 as compared to fiscal year 2025 primarily due to (i) an increase in clinical trial and regulatory expenses related to our ongoing clinical trials for PAS-004, (ii) an increase in CMC costs related to PAS-004 drug product and drug supply for our clinical trials, as well as the development of a liquid formation of PAS-004, (iii) the ongoing non-clinical absorption, distribution, metabolism and excretion (“ADME”) studies, and non-clinical developmental and reproductive toxicology studies, (iv) the initiation of clinical human ADME studies, (v) an increase in preclinical research for PAS-004, and (vi) an increase in personnel costs related to new workforce hires to support our research and development activities.

Previous wording

For the three months ended March 31, 2026, other income, net increased by approximately $1,890,000, or 1,616.4%, as compared to the three months ended March 31, 2025. The increase during the three months ended March 31, 2026, was primarily driven by (i) an approximate $1,465,000 increase in the change of the fair value of warrant liabilities during the three months ended March 31, 2026, (ii) an increase in interest and dividends, net of approximately $403,000, (iii) a decrease in foreign currency gain of approximately $9,000, (iv) an increase in other income of approximately $24,000, and (v) an increase in realized foreign currency translation loss from dissolution of subsidiaries of approximately $7,000 due to the fact that it did not exist this quarter.

Current wording

For the six months ended June 30, 2026, other income, net increased by approximately $2,235,000, or 1,055.8%, as compared to the six months ended June 30, 2025. The increase during the six months ended June 30, 2026, was primarily driven by (i) an approximate $1,494,000 increase in the change of the fair value of warrant liabilities, (ii) an increase in interest and dividends, net of approximately $759,000, (iii) a decrease in other income of approximately $43,000, and (iv) an increase in realized foreign currency translation loss from dissolution of subsidiaries of approximately $7,000, offset by (v) a decrease in foreign currency gain of approximately $69,000.

Previous wording

Working capital decreased by approximately $245,000 from December 31, 2025, to March 31, 2026, due primarily to net cash used to fund operations for the three months ended March 31, 2026, offset by the December 2025 Placement Agents Warrant liabilities reclassified to equity.

Current wording

Working capital decreased by approximately $5,078,000 from December 31, 2025, to June 30, 2026, due primarily to net cash used to fund operations for the six months ended June 30, 2026, offset by the December 2025 Placement Agents Warrant liabilities reclassified to equity.

Previous wording

Cash, cash equivalents and restricted cash decreased by approximately $4.8 million for the three months ended March 31, 2026, compared to a decrease of approximately $1.6 million for the three months ended March 31, 2025. The decrease for the three months ended March 31, 2026, was primarily attributable to cash used to fund operations and an increase in prepaid expenses. The decrease for the three months ended March 31, 2025, was primarily attributable to cash used to fund operations which was partially offset by at-the-market sales of common stock of approximately $1.7 million.

Current wording

Cash, cash equivalents and restricted cash decreased by approximately $9.5 million for the six months ended June 30, 2026, compared to an increase of approximately $0.3 million for the six months ended June 30, 2025. The decrease for the six months ended June 30, 2026, was primarily attributable to cash used to fund operations, an increase in prepaid expenses and a decrease in other current assets and accounts payable and accrued liabilities. The increase in cash and cash equivalents for the six months ended June 30, 2025 was primarily attributable to cash provided by financing activities related to proceeds from at-the-market sales of common stock of $2.0 million, proceeds from the issuance of common stock through a May 2025 Public Offering of $4.2 million and proceeds from the exercise of warrants of $1.3 million, which was partially offset by payments on director and officer insurance of $0.3 million.

Previous wording

As of March 31, 2026, we had approximately $50.4 million in operating bank accounts and money market funds, with working capital of approximately $51.2 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.

Current wording

As of June 30, 2026, we had approximately $45.7 million in operating bank accounts and money market funds, with working capital of approximately $46.4 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.

Previous wording

Our critical accounting estimates, which include (1) stock-based compensation and (2) fair value measurements, are more fully described in the Notes to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed on March 30, 2026. During the three months ended March 31, 2026, there were no material changes to our critical accounting policies and estimates from those described in our most recent Annual Report on Form 10-K.

Current wording

Our critical accounting estimates, which include (1) stock-based compensation and (2) fair value measurements, are more fully described in the Notes to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed on March 30, 2026. During the six months ended June 30, 2026, there were no material changes to our critical accounting policies and estimates from those described in our most recent Annual Report on Form 10-K.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

Research and development expenses increased by approximately $2,749,000, or 70.9%, for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. The increase was primarily due to (i) an increase in clinical trial and regulatory expenses of approximately $771,000, (ii) an increase in chemistry, manufacturing and controls (“CMC”) expenses of approximately $1,290,000, (iii) an increase in non-clinical research and development expense of approximately $401,000, and (iv) an increase in preclinical research expense of approximately $272,000, and (v) non-cash stock expense of approximately $35,000 offset by (vi) a decrease in other expenses of approximately $20,000.

Current report — wording carried from elsewhere

For the three months ended June 30, 2026, other income, net increased by approximately $344,000, or 363.8%, as compared to the three months ended June 30, 2025. The increase during the three months ended June 30, 2026, was primarily driven by (i) an increase in interest and dividends, net of approximately $356,000, (ii) a decrease in other income of approximately $19,000, (iii) an approximate $29,000 increase in the change of the fair value of warrant liabilities, offset by (iv) a increase in foreign currency gain of approximately $59,000.