Core Points - Pasithea Therapeutics Corp. is a clinical-stage biotechnology company focused on developing PAS-004, a next-generation macrocyclic MEK inhibitor for treating RASopathies and MAPK pathway-driven tumors [2] - The company will present at the H.C. Wainwright 27 Annual Global Investment Conference on September 8, 2025, at 5:00 PM ET [1][2] - PAS-004 is currently undergoing a Phase 1 clinical trial for advanced cancer patients and a Phase 1/1b clinical trial for adult patients with neurofibromatosis type 1-associated plexiform neurofibromas [2] Event Details - The presentation will take place at the Lotte New York Palace Hotel during the H.C. Wainwright 27 Annual Global Investment Conference [2] - Management will be available for one-on-one meetings throughout the event [2]

Core Insights - Pasithea Therapeutics Corp. is participating in the H.C. Wainwright 27 Annual Global Investment Conference scheduled for September 8-10, 2025, in New York City [1][2] - The CEO, Dr. Tiago Reis Marques, will present the company and is available for one-on-one meetings during the event [2] - Pasithea is focused on developing PAS-004, a next-generation macrocyclic MEK inhibitor, currently in Phase 1 clinical trials for advanced cancer and neurofibromatosis type 1 [2] Company Overview - Pasithea Therapeutics is a clinical-stage biotechnology company dedicated to researching and developing PAS-004 for treating RASopathies, MAPK pathway-driven tumors, and other diseases [2] - PAS-004 is being tested in two clinical trials: a Phase 1 trial for advanced cancer patients (NCT06299839) and a Phase 1/1b trial for adult patients with NF1-associated plexiform neurofibromas (NCT06961565) [2]

PART I. FINANCIAL INFORMATION [ITEM 1. Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) Pasithea Therapeutics Corp.'s unaudited condensed consolidated financial statements, covering balance sheets, operations, equity, cash flows, and accounting notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights | Metric | June 30, 2025 (Unaudited) ($) | December 31, 2024 ($) | |:---|:---|:---| | Cash and cash equivalents | $7,217,052 | $6,922,729 | | Total current assets | $8,636,599 | $7,368,315 | | Total assets | $17,009,142 | $16,064,719 | | Total current liabilities | $1,736,956 | $1,119,871 | | Total liabilities | $1,830,697 | $1,282,043 | | Total stockholders' equity | $15,178,445 | $14,782,676 | - Cash and cash equivalents **increased by** approximately **$294,323** from December 31, 2024, to June 30, 2025[11](index=11&type=chunk) - Total assets **increased by** approximately **$944,423**, while total liabilities **increased by** approximately **$548,654** during the six months ended June 30, 2025[11](index=11&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations and Comprehensive Loss Highlights | Metric | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | |:---|:---|:---|:---|:---|\n| General and administrative | $1,662,223 | $1,587,060 | $3,612,551 | $3,878,706 | | Research and development | $2,148,676 | $2,357,974 | $3,878,527 | $4,107,102 | | Loss from operations | $(3,810,899) | $(3,945,034) | $(7,491,078) | $(7,985,808) | | Net loss | $(3,716,157) | $(3,866,249) | $(7,279,395) | $(7,727,089) | | Basic and diluted loss per share | $(0.66) | $(3.71) | $(1.85) | $(7.41) | | Comprehensive loss | $(3,710,526) | $(3,869,161) | $(7,273,764) | $(7,730,621) | - Net loss **decreased by** **$150,092** (**3.9%**) for the three months ended June 30, 2025, compared to the same period in 2024[12](index=12&type=chunk) - Basic and diluted loss per share **significantly decreased** from **$(3.71)** to **$(0.66)** for the three months ended June 30, 2025, primarily due to an **increase in weighted-average common shares outstanding**[12](index=12&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Key Changes in Stockholders' Equity (Six Months Ended June 30, 2025) | Item | Amount ($) | |:---|:---|\n| Balance at January 1, 2025 | $14,782,676 | | Stock-based compensation (stock options) | $96,985 | | Stock-based compensation (warrants) | $1,573 | | Issuance of common stock under ATM agreement, net | $1,652,745 | | Issuance of common stock from pre-funded warrants exercise, net | $871 | | Realized foreign currency translation loss | $7,171 | | Net loss | $(3,563,238) | | Issuance of common stock under ATM agreement, net (Q2) | $358,037 | | Issuance of common stock in May 2025 public offering, net | $4,214,506 | | Issuance of common stock from warrants exercise, net | $1,280,000 | | Foreign currency translation | $5,631 | | Net loss (Q2) | $(3,716,157) | | Balance at June 30, 2025 | $15,178,445 | - Total stockholders' equity **increased by** from **$14,782,676** at January 1, 2025, to **$15,178,445** at June 30, 2025, primarily driven by **significant capital raises through common stock issuances**[13](index=13&type=chunk) - The company issued **7,443,577 shares** of common stock as of June 30, 2025, a **substantial increase** from **1,394,263 shares** at December 31, 2024, due to ATM sales, pre-funded warrant exercises, and a public offering[13](index=13&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows Highlights | Cash Flow Activity | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | |:---|:---|:---|\n| Net cash used in operating activities | $(6,924,643) | $(8,359,951) | | Net cash provided by financing activities | $7,213,335 | $- | | Effect of foreign currency translation on cash | $5,631 | $(3,532) | | Net change in cash | $294,323 | $(8,363,483) | | Cash - End of period | $7,217,052 | $7,967,569 | - Net cash used in operating activities **decreased by** approximately **$1.4 million** for the six months ended June 30, 2025, compared to the same period in 2024[15](index=15&type=chunk) - The company generated **$7,213,335** in cash from financing activities in the first six months of 2025, a **significant increase** from zero in the prior year, primarily from common stock sales and warrant exercises[15](index=15&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [NOTE 1 – NATURE OF THE ORGANIZATION AND BUSINESS](index=8&type=section&id=NOTE%201%20%E2%80%93%20NATURE%20OF%20THE%20ORGANIZATION%20AND%20BUSINESS) - Pasithea Therapeutics Corp. is a clinical-stage biotechnology company focused on treatments for CNS disorders, RASopathies, MAPK pathway-driven tumors, and other diseases[17](index=17&type=chunk) - The primary focus is on PAS-004, a MEK inhibitor, with a Phase 1 dose escalation trial ongoing in the US and Eastern Europe, expected to complete in 2026[18](index=18&type=chunk) - A Phase 1/1b trial for PAS-004 in adult NF1-PN patients was initiated in May 2025 in Australia, with plans for trials in South Korea and the US[19](index=19&type=chunk) - The company has discovery-stage programs for ALS (PAS-003) and schizophrenia (PAS-001)[21](index=21&type=chunk) - As of June 30, 2025, the company had **$7.2 million** in cash and cash equivalents and **$6.9 million** in working capital, but management believes **additional funding is required** to meet needs for the next twelve months, raising substantial doubt about its ability to continue as a **going concern**[25](index=25&type=chunk)[26](index=26&type=chunk) [NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=9&type=section&id=NOTE%202%20%E2%80%93%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) - The company prepares its financial statements in accordance with U.S. GAAP and is an 'emerging growth company,' electing to use the extended transition period for new accounting standards[23](index=23&type=chunk)[24](index=24&type=chunk) - Research and development costs are **expensed as incurred**, with grant income of approximately **$43,000** recorded as a contra expense for the six months ended June 30, 2025[31](index=31&type=chunk)[32](index=32&type=chunk) - Warrant liabilities (IPO Warrants) are classified as **derivative liabilities and re-measured at fair value** each balance sheet date, with changes recognized in the statements of operations[38](index=38&type=chunk) Fair Value Measurements of Financial Instruments | Item | June 30, 2025 Fair Value ($) | December 31, 2024 Fair Value ($) | Level 1 (June 30, 2025) ($) | Level 3 (June 30, 2025) ($) | |:---|:---|:---|:---|:---|\n| Cash equivalents | $6,207,926 | $6,093,044 | $6,207,926 | $- | | Public warrant liabilities | $88,000 | $152,240 | $88,000 | $- | | Representative warrant liabilities | $5,741 | $9,932 | $- | $5,741 | - The company adopted ASU 2023-07, Segment Reporting, as of January 1, 2024, resulting in additional disclosures of significant segment expenses[65](index=65&type=chunk) [NOTE 3 – PROPERTY AND EQUIPMENT, NET](index=17&type=section&id=NOTE%203%20%E2%80%93%20PROPERTY%20AND%20EQUIPMENT,%20NET) Property and Equipment, Net | Category | June 30, 2025 ($) | December 31, 2024 ($) | |:---|:---|:---|\n| Property and equipment, gross | $161,503 | $164,696 | | Less: accumulated depreciation | $(47,939) | $(42,353) | | Property and equipment, net | $113,564 | $122,343 | - Net property and equipment **decreased by** approximately **$8,779** from December 31, 2024, to June 30, 2025[66](index=66&type=chunk) - Depreciation expense was approximately **$8,000** for the six months ended June 30, 2025, compared to **$9,000** for the same period in 2024[66](index=66&type=chunk) [NOTE 4 – LEASES](index=18&type=section&id=NOTE%204%20%E2%80%93%20LEASES) - The company's laboratory lease in South San Francisco expired in June 2024[67](index=67&type=chunk) - As of June 30, 2025, the company had **no recognized ROU assets and lease liabilities**, down from approximately **$332,000** at inception of the operating lease[68](index=68&type=chunk)[69](index=69&type=chunk) Operating Lease Expense | Metric | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | |:---|:---|:---|:---|:---|\n| Operating lease expense | $- | $79,587 | $- | $122,103 | [NOTE 5 – INTANGIBLE ASSETS](index=18&type=section&id=NOTE%205%20%E2%80%93%20INTANGIBLE%20ASSETS) Intangible Assets, Net | Category | June 30, 2025 Net ($) | December 31, 2024 Net ($) | |:---|:---|:---|\n| In-process research and development | $2,900,000 | $2,900,000 | | Patents and intellectual property | $4,096,068 | $4,411,150 | | Intangible assets, net | $6,996,068 | $7,311,150 | - Net intangible assets **decreased by** approximately **$315,082** from December 31, 2024, to June 30, 2025, primarily due to amortization of patents and intellectual property[71](index=71&type=chunk) Future Expected Amortization Expense of Intangible Assets | Year | Amount ($) | |:---|:---|\n| 2025 (remaining) | $315,082 | | 2026 | $630,164 | | 2027 | $630,164 | | 2028 | $630,164 | | 2029 | $630,164 | | Thereafter | $1,260,330 | | Total | $4,096,068 | [NOTE 6 – STOCKHOLDERS' EQUITY](index=19&type=section&id=NOTE%206%20%E2%80%93%20STOCKHOLDERS'%20EQUITY) - The company had **7,443,577 shares** of Common Stock outstanding at June 30, 2025, a **significant increase** from **1,394,263 shares** at December 31, 2024[73](index=73&type=chunk) - On January 1, 2025, shares available under the 2023 Stock Incentive Plan automatically **increased by** **41,828 shares**, totaling **264,221 available shares** as of June 30, 2025[78](index=78&type=chunk) - During the six months ended June 30, 2025, all **871,000** September 2024 Pre-Funded Warrants were exercised, resulting in the issuance of **871,000 shares** of Common Stock[86](index=86&type=chunk) - The company sold **692,600 shares** of Common Stock under the ATM Agreement for net proceeds of **$2,010,782** during the six months ended June 30, 2025[89](index=89&type=chunk) - The May 2025 Public Offering closed on May 7, 2025, generating approximately **$4.2 million** in net proceeds (excluding warrant exercises) and involved the sale of **3,571,428 shares** of Common Stock (or pre-funded warrants) and accompanying Series C and D Common Warrants[90](index=90&type=chunk)[93](index=93&type=chunk) - Simultaneously with the May 2025 Public Offering, investors exercised Series D Common Warrants for **914,286 shares**, generating an additional **$1.3 million** in gross proceeds[91](index=91&type=chunk) [NOTE 7 – STOCK OPTIONS](index=24&type=section&id=NOTE%207%20%E2%80%93%20STOCK%20OPTIONS) - For the six months ended June 30, 2025, **27,379 stock options** vested, and **30,716 stock options** were forfeited[100](index=100&type=chunk) Stock-Based Compensation Expense Related to Stock Options | Period | 2025 ($) | 2024 ($) | |:---|:---|:---|\n| Three Months Ended June 30 | $58,000 | $135,000 | | Six Months Ended June 30 | $155,000 | $432,000 | - As of June 30, 2025, **151,318 stock options** were outstanding with a weighted-average exercise price of **$23.58** and a remaining unamortized compensation expense of approximately **$139,000**[103](index=103&type=chunk) [NOTE 8 – WARRANTS](index=25&type=section&id=NOTE%208%20%E2%80%93%20WARRANTS) - As of June 30, 2025, the fair value of Public Warrants was approximately **$0.40** per warrant, and Representative Warrants was approximately **$0.416** per warrant[104](index=104&type=chunk) Outstanding Warrants as of June 30, 2025 | Exercise Price ($) | Number of Warrants | Weighted-Average Remaining Contractual Term (years) | |:---|:---|:---|\n| $1.40 | 6,228,570 | 3.36 | | $1.75 | 250,000 | 4.85 | | $3.85 | 2,439,026 | 2.51 | | $5.13 | 85,366 | 4.26 | | $8.13 | 1,500 | 8.67 | | $20.00 | 433,999 | 1.40 | | $37.60 | 100,001 | 2.13 | | $120.00 | 13,800 | 1.21 | | $125.00 | 220,000 | 1.21 | | Total | 9,772,262 | 3.04 | - During the three and six months ended June 30, 2025, the company issued warrants to purchase **7,392,856 shares** of Common Stock in connection with the May 2025 Public Offering[105](index=105&type=chunk) - Series D Common Warrants to purchase **914,286 shares** were exercised for approximately **$1.28 million** in gross proceeds during the three and six months ended June 30, 2025[106](index=106&type=chunk) [NOTE 9 – COMMITMENTS AND CONTINGENCIES](index=25&type=section&id=NOTE%209%20%E2%80%93%20COMMITMENTS%20AND%20CONTINGENCIES) - The company is **not currently a party to any legal proceedings that would have a material adverse effect on its business, results of operations, financial condition, or cash flows**[109](index=109&type=chunk)[110](index=110&type=chunk) [NOTE 10 – RELATED PARTY TRANSACTIONS](index=26&type=section&id=NOTE%2010%20%E2%80%93%20RELATED%20PARTY%20TRANSACTIONS) - Prof. Lawrence Steinman receives **$25,000 per quarter** for consulting and advisory services related to clinical and commercial development of product candidates[111](index=111&type=chunk) [NOTE 11 – INCOME TAXES](index=26&type=section&id=NOTE%2011%20%E2%80%93%20INCOME%20TAXES) - The company is evaluating the potential impacts of the newly enacted One Big Beautiful Bill Act on U.S. federal tax law but has not yet recorded any material adjustments[112](index=112&type=chunk)[113](index=113&type=chunk) - As of June 30, 2025, and December 31, 2024, a **full valuation allowance was established** against deferred tax assets related to net operating losses, resulting in a zero balance[39](index=39&type=chunk) [NOTE 12 – SEGMENT INFORMATION](index=26&type=section&id=NOTE%2012%20%E2%80%93%20SEGMENT%20INFORMATION) - The company operates and manages its business as a **single operating and reportable segment** focused on the research and development of innovative treatments for CNS disorders, RASopathies, MAPK pathway-driven tumors, and other diseases[114](index=114&type=chunk) Significant Segment Expenses | Expense Category | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | |:---|:---|:---|:---|:---|\n| General and administrative | $1,460,723 | $1,300,277 | $3,157,148 | $3,197,996 | | Pre-clinical research | $103,343 | $796,595 | $165,336 | $1,226,979 | | CMC | $99,413 | $420,951 | $324,010 | $798,771 | | Clinical development | $1,928,275 | $1,068,655 | $3,363,079 | $1,894,772 | | Depreciation and amortization | $161,746 | $162,257 | $323,454 | $324,514 | | Share based compensation expense | $57,645 | $160,952 | $156,203 | $507,429 | [NOTE 13 – SUBSEQUENT EVENTS](index=27&type=section&id=NOTE%2013%20%E2%80%93%20SUBSEQUENT%20EVENTS) - The company has evaluated events subsequent to June 30, 2025, and found **no material reportable subsequent events**[117](index=117&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion and analysis of financial condition and operations, including company summary, recent developments, expense analysis, and liquidity outlook [Company Summary](index=30&type=section&id=Company%20Summary) - Pasithea is a clinical-stage biotechnology company focused on CNS disorders, RASopathies, MAPK pathway-driven tumors, and other diseases, with PAS-004 as its lead product candidate[123](index=123&type=chunk)[124](index=124&type=chunk) - The company expects to incur **significant operating losses and expenses** for the foreseeable future as it advances product candidates through development and clinical trials, requiring **continued financing through equity, debt, or collaborations**[128](index=128&type=chunk)[129](index=129&type=chunk) [Recent Developments](index=31&type=section&id=Recent%20Developments) - Clinical updates for PAS-004 include completion of enrollment and initial dosing for cohort 6 in the FIH Phase 1 Dose Escalation Study (April 2025) and initiation of a Phase 1/1b clinical trial in adult NF1-PN patients (May 2025)[130](index=130&type=chunk) - The May 2025 Public Offering closed on May 7, 2025, generating total gross proceeds of approximately **$6.3 million**, including warrant exercises[131](index=131&type=chunk) - The company received a **Nasdaq deficiency notice** on June 23, 2025, for **not meeting the $1.00 minimum bid price requirement** and is considering options, including a reverse stock split, to regain compliance[132](index=132&type=chunk)[133](index=133&type=chunk) - Inflation has led to **higher costs** across the business, including employee compensation and outside services, and is expected to continue impacting the company throughout 2025[134](index=134&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Operating Results Comparison (Three Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change ($) | % Change | |:---|:---|:---|:---|:---|\n| General and administrative | $1,662,223 | $1,587,060 | $75,163 | **4.7%** | | Research and development | $2,148,676 | $2,357,974 | $(209,298) | **(8.9%)** | | Loss from operations | $(3,810,899) | $(3,945,034) | $134,135 | **(3.4%)** | | Net loss | $(3,716,157) | $(3,866,249) | $150,092 | **(3.9%)** | Operating Results Comparison (Six Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change ($) | % Change | |:---|:---|:---|:---|:---|\n| General and administrative | $3,612,551 | $3,878,706 | $(266,155) | **(6.9%)** | | Research and development | $3,878,527 | $4,107,102 | $(228,575) | **(5.6%)** | | Loss from operations | $(7,491,078) | $(7,985,808) | $494,730 | **(6.2%)** | | Net loss | $(7,279,395) | $(7,727,089) | $447,694 | **(5.8%)** | [General and administrative](index=33&type=section&id=General%20and%20administrative) - G&A expenses **increased by** approximately **$75,000** (**5%**) for the three months ended June 30, 2025, driven by increases in accounting, business development, personnel, and other income, partially offset by decreases in office, stock-based, and public company expenses[137](index=137&type=chunk) - G&A expenses **decreased by** approximately **$266,000** (**7%**) for the six months ended June 30, 2025, primarily due to reduced legal, stock-based, public company, and office expenses, partially offset by increases in accounting, business development, personnel, and other income[138](index=138&type=chunk) - The company expects a slight **decrease in G&A expenses** for fiscal year 2025 compared to 2024, mainly due to reduced legal and public company expenses[139](index=139&type=chunk) [Research and Development](index=33&type=section&id=Research%20and%20Development) - R&D expenses **decreased by** approximately **$209,000** (**9%**) for the three months ended June 30, 2025, primarily due to de-prioritization of discovery programs, reduced consulting, stock compensation, and manufacturing expenses, partially offset by a **significant increase** in clinical trials expense for PAS-004[141](index=141&type=chunk) - R&D expenses **decreased by** approximately **$229,000** (**6%**) for the six months ended June 30, 2025, driven by similar factors as the three-month period, with a **substantial increase** in clinical trials expense for PAS-004 being the main offset[142](index=142&type=chunk) - R&D expenses are expected to **increase** throughout fiscal year 2025 due to increased clinical research for PAS-004 and manufacturing costs for clinical trials, partially offset by decreases in pre-clinical research and workforce reduction[143](index=143&type=chunk) [Other income, net](index=33&type=section&id=Other%20income,%20net) - Other income, net, **increased by** approximately **$16,000** (**20%**) for the three months ended June 30, 2025, mainly due to foreign currency transaction gains, fair value changes in warrant liabilities, and other income, partially offset by **decreased interest and dividends**[144](index=144&type=chunk) - Other income, net, **decreased by** approximately **$47,000** (**18%**) for the six months ended June 30, 2025, primarily due to **decreased interest and dividends** and a realized foreign currency translation loss, partially offset by increased fair value of warrant liabilities, foreign currency gains, and other income[145](index=145&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) [Working Capital](index=35&type=section&id=Working%20Capital) Working Capital | Metric | June 30, 2025 ($) | December 31, 2024 ($) | |:---|:---|:---|\n| Current assets | $8,636,599 | $7,368,315 | | Current liabilities | $1,736,956 | $1,119,871 | | Working capital | $6,899,643 | $6,248,444 | - Working capital **increased by** approximately **$0.6 million** between December 31, 2024, and June 30, 2025, primarily due to cash received from the May 2025 Public Offering[146](index=146&type=chunk) [Liquidity and Financial Condition](index=35&type=section&id=Liquidity%20and%20Financial%20Condition) Cash Flow Summary (Six Months Ended June 30) | Cash Flow Activity | 2025 ($) | 2024 ($) | |:---|:---|:---|\n| Net cash used in operating activities | $(6,924,643) | $(8,359,951) | | Net cash provided by financing activities | $7,213,335 | $- | | Net change in cash | $294,323 | $(8,363,483) | | Cash - End of period | $7,217,052 | $7,967,569 | - Cash and cash equivalents **increased by** approximately **$0.3 million** for the six months ended June 30, 2025, a **significant improvement** from an **$8.4 million** decrease in the prior year, driven by financing activities[147](index=147&type=chunk) - Financing activities provided **$7.2 million** in cash, primarily from ATM sales (**$2.0 million**), the May 2025 Public Offering (**$4.2 million**), and warrant exercises (**$1.3 million**)[147](index=147&type=chunk) [Liquidity & Capital Resources Outlook](index=35&type=section&id=Liquidity%20%26%20Capital%20Resources%20Outlook) - Management believes the company will **not have sufficient working capital** to meet its needs for the next twelve months without raising additional capital, indicating a **going concern uncertainty**[148](index=148&type=chunk) - The company's public float is below **$75.0 million**, restricting it from raising more than one-third of its public float through primary public offerings using shelf registration statements in any twelve-month period (**baby shelf rules**)[149](index=149&type=chunk) - Future funding requirements are highly dependent on the scope, timing, and results of R&D, clinical trials, manufacturing costs, potential collaborations, intellectual property costs, and commercialization activities[151](index=151&type=chunk)[152](index=152&type=chunk) [Contractual Obligations](index=37&type=section&id=Contractual%20Obligations) - Contractual obligations are summarized in Note 9 – Commitments and Contingencies[153](index=153&type=chunk) [Off-Balance Sheet Arrangements](index=37&type=section&id=Off-Balance%20Sheet%20Arrangements) - The company did not have any **no off-balance sheet arrangements** during the periods presented[154](index=154&type=chunk) [Critical Accounting Estimates](index=37&type=section&id=Critical%20Accounting%20Estimates) - There were **no material changes to the company's critical accounting estimates** (stock-based compensation and fair value measurements) during the three months ended June 30, 2025, from those described in its Form 10-K[155](index=155&type=chunk) [Recent Accounting Pronouncements](index=37&type=section&id=Recent%20Accounting%20Pronouncements) - A description of recent accounting pronouncements applicable to the financial statements is provided in Note 2 – Summary of Significant Accounting Policies[156](index=156&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures about Market Risk](index=38&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Pasithea Therapeutics Corp. is exempt from market risk disclosures - The company is **exempt from providing market risk disclosures** as a smaller reporting company[158](index=158&type=chunk) [ITEM 4. Controls and Procedures](index=38&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control - The CEO and CFO evaluated and concluded that the company's disclosure controls and procedures were **effective as of June 30, 2025**[159](index=159&type=chunk) - **No changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting** during the three months ended June 30, 2025[161](index=161&type=chunk) PART II. OTHER INFORMATION [ITEM 1. Legal Proceedings](index=39&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is not involved in legal proceedings with a material adverse effect on its business or financial condition - The company is **not a party to any legal proceedings that are believed to have a material adverse effect on its business, results of operations, financial condition, or cash flows**[164](index=164&type=chunk) [ITEM 1A. Risk Factors](index=39&type=section&id=ITEM%201A.%20Risk%20Factors) Updated risk factors highlight Nasdaq minimum bid price non-compliance and potential delisting, affecting stock price and capital raising - The company received a Nasdaq notice on June 23, 2025, for **non-compliance with the $1.00 minimum bid price requirement**, with a compliance period until December 22, 2025[166](index=166&type=chunk) - **Failure to regain compliance could lead to delisting**, **negatively affecting stock liquidity, financing ability, and investor confidence**; a reverse stock split is being considered as an option[167](index=167&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported during the period - **None to report**[168](index=168&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=39&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - **None to report**[169](index=169&type=chunk) [ITEM 4. Mine Safety Disclosures](index=39&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - **Not applicable**[170](index=170&type=chunk) [ITEM 5. Other Information](index=39&type=section&id=ITEM%205.%20Other%20Information) No other material information was reported, including no changes in Rule 10b5-1 trading arrangements - **No director or officer adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement** during the fiscal quarter ended June 30, 2025[172](index=172&type=chunk) [ITEM 6. Exhibits](index=41&type=section&id=ITEM%206.%20Exhibits) Exhibits filed as part of the Form 10-Q include warrants, securities purchase agreements, and certifications - **Exhibits include forms of May 2025 Pre-Funded Warrant, Series C/D Common Warrant, May 2025 Placement Agent Warrant, May 2025 Securities Purchase Agreement, and certifications by the CEO and CFO**[173](index=173&type=chunk) [SIGNATURES](index=42&type=section&id=SIGNATURES) - The report is **signed by Tiago Reis Marques, Chief Executive Officer, and Daniel Schneiderman, Chief Financial Officer, on August 14, 2025**[178](index=178&type=chunk)

– Initial interim safety, tolerability, biomarker, and preliminary efficacy data expected in Q1 2026 – MIAMI, July 31, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor for the treatment of neurofibromatosis type 1 (NF1) and other MAPK pathway driven indications, today announced the Company has completed enrollment and initial dosing of three subjects in Coh ...

Core Viewpoint - Pasithea Therapeutics Corp. has appointed Dr. James Lee to its scientific advisory board to guide the development of PAS-004, a next-generation macrocyclic MEK inhibitor, for treating ETS2 pathway inflammatory diseases such as inflammatory bowel disease (IBD) [1][3] Company Overview - Pasithea Therapeutics is a clinical-stage biotechnology company focused on developing PAS-004, which targets RASopathies, MAPK pathway-driven tumors, and other diseases [5] - The company is currently conducting a Phase 1 clinical trial of PAS-004 in advanced cancer patients and a Phase 1/1b trial in adult patients with neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas [5] Dr. James Lee's Expertise - Dr. Lee is recognized for his research on the ETS2 pathway in inflammatory diseases and has published significant findings in prestigious journals like Nature [2][4] - His clinical research has the potential to lead to transformative therapies for patients with IBD, and his guidance is expected to expand PAS-004's development to additional indications beyond NF1 [3] Research and Development Focus - The company aims to fund the development of PAS-004 through non-dilutive financing, including grants and strategic collaborations [3]

Core Insights - Pasithea Therapeutics Corp. announced promising interim results for PAS-004, a next-generation macrocyclic MEK inhibitor, in a Phase 1 clinical trial targeting advanced cancer patients with MAPK pathway-driven tumors [1][6] Group 1: Clinical Trial Overview - The ongoing Phase 1 study employs a multi-center, open-label, dose escalation design to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PAS-004 [1] - As of April 2, 2025, 21 patients have been enrolled across six cohorts, with pancreatic cancer (28.6%), colorectal cancer (28.6%), and melanoma (23.8%) being the most common diagnoses [2] Group 2: Efficacy and Safety - PAS-004 demonstrated a dose-dependent PK profile and preliminary clinical activity, with 10 out of 16 efficacy evaluable patients achieving stable disease at some point during the trial [5] - One patient with stage 4 BRAF-mutated melanoma showed a tumor volume reduction of -14.9% and has maintained stable disease for over 5 months [1][5] - All treatment-related adverse events were grade 1 or 2, with no known MEK inhibitor class-related adverse events observed [3] Group 3: Pharmacokinetics - Preliminary PK analysis indicates a linear PK profile with an estimated half-life exceeding 60 hours, and sufficient exposures for target engagement were achieved [4] - The peak to trough ratio was below 2 at steady state across all dose levels, supporting the potential for effective treatment [4] Group 4: Future Outlook - The CEO of Pasithea highlighted the potential of PAS-004 as a best-in-class MEK inhibitor, emphasizing its high selectivity and sustained pathway suppression, which may benefit both monotherapy and combination therapy [6] - The company is also conducting a Phase 1/1b clinical trial for PAS-004 in adult patients with neurofibromatosis type 1-associated plexiform neurofibromas [7]

Core Insights - Pasithea Therapeutics Corp. has announced new preclinical data indicating that PAS-004, a next-generation macrocyclic MEK inhibitor, demonstrates superior inhibition of ETS2-driven inflammatory responses compared to the FDA-approved MEK inhibitor selumetinib in a human macrophage model of chronic inflammation [1][3] Group 1: Study Findings - The study conducted at the Francis Crick Institute shows that PAS-004 consistently outperforms selumetinib across all tested doses (0.01 μM, 0.1 μM, and 1 μM), indicating more robust and durable MEK inhibition under inflammatory conditions [2][3] - PAS-004 exhibits superior suppression of ETS2 signaling, with greater downregulation of ETS2-regulated genes than selumetinib at all doses tested [3][4] - PAS-004 significantly reduces ETS2-dependent macrophage functions such as cytokine production, phagocytosis, and reactive oxygen species (ROS) generation, which are central to chronic inflammation [4] Group 2: Mechanistic Insights - Gene Set Enrichment Analysis reveals that PAS-004's effects closely mirror ETS2 knockout profiles, showing a higher normalized enrichment score (-3.96 vs -3.56) and greater statistical significance (1.2 x 10⁻²⁵⁰ vs 3.7 x 10⁻⁷⁴) compared to selumetinib [4] - The ability of PAS-004 to block ETS2 signaling suggests it may target multiple cytokines, including TNFα, IL-23, and IL-1β, which are critical in chronic inflammatory diseases [4] Group 3: Future Potential - The company believes that PAS-004 has the potential to be a new oral treatment option for inflammatory diseases such as inflammatory bowel disease (IBD), based on low adverse events and tolerable safety data observed in Phase 1 clinical trials [4][5] - The preclinical results suggest that PAS-004's ability to block ETS2 signaling and target multiple cytokines opens the potential for testing in large market inflammatory indications [5]

Financial Performance - The net loss for the three months ended March 31, 2025, was $3,563,238, a decrease of $297,602, or 7.7%, compared to the net loss of $3,860,840 for the same period in 2024[121] - Net loss for the three months ended March 31, 2025, was $3,563,238, an improvement from a net loss of $3,860,840 for the same period in 2024[130] - Other income, net decreased by approximately $63,000, or 35%, for the three months ended March 31, 2025, primarily due to a decrease in interest and dividends[128] Expenses - For the three months ended March 31, 2025, general and administrative expenses decreased by approximately $341,000, or 15%, compared to the same period in 2024[121] - Research and development expenses decreased by approximately $19,000, or 1%, for the three months ended March 31, 2025, primarily due to decreases in preclinical research and consulting expenses[126] - The company anticipates an increase in research and development expenses in fiscal year 2025 due to ongoing clinical trials for PAS-004[127] - The primary use of cash is to fund operating expenses, primarily general and administrative and research and development expenditures[134] Cash Flow and Working Capital - Working capital decreased by approximately $1.7 million from $6,248,444 as of December 31, 2024, to $4,530,046 as of March 31, 2025, primarily due to cash used to fund operations[129] - Cash and cash equivalents decreased by approximately $1.6 million for the three months ended March 31, 2025, compared to a decrease of approximately $4.3 million for the same period in 2024[130] - As of March 31, 2025, the company had approximately $5.3 million in operating bank accounts and money market funds, with a working capital of approximately $4.5 million[132] - The company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities to continue operations and execute development plans[132] - Future funding requirements will depend on various factors, including the costs of clinical trials and business development activities, with no committed sources of capital currently available[135] Regulatory and Development Updates - The company received FDA clearance for the Investigational New Drug application for PAS-004 in December 2023[114] - The ongoing FIH Phase 1 Dose Escalation Study of PAS-004 is being conducted at four clinical sites in the United States and three additional sites in Eastern Europe[114] - The company plans to seek marketing approval for PAS-004 in specific patient populations, including adults and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas[114] Public Offering and Capital Restrictions - The company completed a public offering on May 7, 2025, raising total gross proceeds of approximately $6.3 million[119] - The calculated public float as of March 31, 2025, is below $75 million, restricting the company from raising more than one-third of its public float through primary public offerings in any twelve-month period[133] Accounting Policies - There were no material changes to the company's critical accounting policies and estimates during the three months ended March 31, 2025[139] - The company has no off-balance sheet arrangements during the periods presented[138]

Core Insights - Pasithea Therapeutics Corp. has initiated a Phase 1/1b clinical trial for PAS-004, a macrocyclic MEK inhibitor, targeting adult patients with neurofibromatosis type 1 (NF1) and symptomatic plexiform neurofibromas, with the first patient expected to be dosed in Q2 2025 [1][4] Group 1: Clinical Trial Details - The trial aims to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PAS-004 in adult NF1 patients [1][5] - The first clinical trial site is located at the Royal North Shore Hospital in Sydney, Australia, with additional sites planned in Australia, South Korea, and the United States [2][6] - The study will be conducted in two parts, with Part A focusing on dose exploration and Part B on determining the recommended phase 2 dose (RP2D) [8][9] Group 2: Financial and Operational Aspects - Pasithea has selected Novotech (Australia) Pty Limited as its clinical research organization (CRO) for the trial and anticipates eligibility for an Australian R&D Tax Incentive, which could provide a cash refund of up to 48.5% of eligible trial costs [3][6] - The company is funded to produce initial interim patient data in NF1 following recent financing activities, including the exercise of certain warrants [4] Group 3: Expert Commentary - Dr. Rebecca Brown, a member of Pasithea's Scientific Advisory Board, expressed optimism about the safety profile of PAS-004 based on previous data from advanced cancer patients and highlighted the importance of patient compliance due to the once-daily dosing regimen [4] - Dr. Tiago Reis Marques, CEO of Pasithea, emphasized the significance of this trial as a milestone for both the company and patients with NF1-related plexiform neurofibromas [4]

Core Viewpoint - Pasithea Therapeutics has successfully closed a public offering, raising a total of approximately $6.3 million, which will be utilized for various corporate purposes including ongoing research and clinical trials [1][4]. Group 1: Offering Details - The company closed a public offering of 3,571,428 shares of common stock at a price of $1.40 per share, along with Series C and Series D warrants [1][2]. - The Series C warrants have an exercise price of $1.40 and expire in five years, while the Series D warrants also have an exercise price of $1.40 and expire in 18 months [2]. - The total gross proceeds from the offering were $5.0 million, with additional proceeds of approximately $1.3 million from the exercise of Series D warrants [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated for general corporate purposes, including ongoing research, clinical trials, and the development of new technologies [4]. - The company plans to invest in or acquire synergistic companies and engage in licensing activities related to its current and future product candidates [4]. Group 3: Company Overview - Pasithea Therapeutics is a clinical-stage biotechnology company focused on developing innovative treatments for central nervous system disorders and RASopathies [7].