Pasithea Therapeutics Corp. (KTTA) Bundle
When you look at Pasithea Therapeutics Corp. (KTTA), are you seeing a small-cap biotech with a $4.51 million market capitalization, or a nimble player on the cusp of a major clinical breakthrough?
This clinical-stage company operates with a dual focus, pioneering ketamine-based treatments while aggressively developing its lead candidate, PAS-004, a next-generation MEK inhibitor for neurofibromatosis and oncology.
The market's attention is defintely on the recent positive Phase 1 data from November 2025, which showed a compelling 71.4% initial Disease Control Rate in patients with BRAF-mutated tumors, a critical signal that could re-rate the stock from its current $0.72 per share price.
While the trailing twelve months (TTM) net loss of -$13.49 million is a reality for drug development, understanding how their hybrid business model-combining clinical services and drug pipeline-converts clinical success into a sustainable revenue stream is the key to your investment decision.
Pasithea Therapeutics Corp. (KTTA) History
You're looking for the bedrock of Pasithea Therapeutics Corp., and honestly, it's a story of rapid evolution in the high-risk, high-reward world of biotech. The company's trajectory, from a dual-focus startup to a clinical-stage entity centered on its lead drug candidate, PAS-004, has been incredibly fast.
Given Company's Founding Timeline
Pasithea Therapeutics was launched to tackle the significant unmet medical needs in central nervous system (CNS) disorders, especially where the immune system plays a role. It was a clear, focused starting point, blending clinical service with drug discovery.
Year established
The company was incorporated as a Delaware corporation on May 12, 2020.
Original location
The headquarters are in Miami Beach, Florida, specifically at 1111 Lincoln Road, Suite 500.
Founding team members
The company was co-founded by two distinguished figures: Dr. Tiago Reis Marques, a renowned neuroscientist who serves as Chief Executive Officer, and Dr. Lawrence Steinman, a distinguished immunologist and entrepreneur who is the Executive Chairman.
Initial capital/funding
The earliest documented capital raise was a Seed funding round of $250K on January 26, 2021, quickly followed by a Series A round of $1.21 million on March 18, 2021. This was a crucial early validation before the public market debut.
Given Company's Evolution Milestones
The company's history is best tracked by its funding and its clinical pipeline advancements. The shift from a broader focus to aggressively pursuing the MEK inhibitor PAS-004 is the most important development.
| Year | Key Event | Significance |
|---|---|---|
| 2020 | Incorporated in Delaware (May) | Formal establishment of the corporate entity to begin operations. |
| 2021 | Seed Round Funding: $250K (Jan) | Secured initial capital to fund early research and development efforts. |
| 2021 | Initial Public Offering (IPO) on NASDAQ (Sep) | Raised capital with plans for a $17 million offering, providing significant funding for the drug pipeline and clinic expansion. |
| 2024 | $5 Million Private Placement (Sep) | Raised approximately $5 million in gross proceeds to bolster working capital and advance the PAS-004 program. |
| 2025 | $6.3 Million Public Offering Closed (May) | Secured approximately $6.3 million in gross proceeds from an offering and warrant exercises, extending the cash runway for clinical trials. |
| 2025 | Positive PAS-004 Phase 1 Interim Data (Nov) | Reported a 71.4% Disease Control Rate (DCR) in BRAF-mutated tumors from the PAS-004 trial, demonstrating monotherapy clinical activity. |
Given Company's Transformative Moments
The most transformative moment wasn't a single event, but a clear strategic pivot toward oncology and RASopathies, anchored by the acquisition and aggressive development of PAS-004, a next-generation macrocyclic MEK inhibitor.
This shift is visible in the financials. For the quarter ended September 30, 2025, the company reported a net loss of approximately $3.0 million, reflecting the high burn rate typical of a clinical-stage biotech focused on R&D. This investment is a bet on the pipeline.
- The Clinical Pipeline Focus: Initially having a dual focus on ketamine clinics for depression and drug development, the company has increasingly prioritized its clinical-stage asset, PAS-004, for neurofibromatosis type 1 (NF1) and advanced solid tumors. This is where the capital is now flowing.
- Global Clinical Expansion in 2025: The expansion of the PAS-004 Phase 1/1b trial into new sites in Eastern Europe and South Korea in 2025 was a crucial move to accelerate patient enrollment and broaden data collection. This is defintely a marker of commitment to the asset.
- The Financial Reality Check: As of September 30, 2025, the company's cash and cash equivalents were only $4.1 million, with an accumulated deficit of about $59.9 million. This tight cash position necessitates continuous, successful capital raises, which are transformative in their own right, as they keep the science moving.
- Positive Data Validation: The November 2025 announcement of positive interim Phase 1 data for PAS-004, showing a favorable safety profile and monotherapy activity, is the most recent, critical validation point, supporting its potential as a differentiated candidate for NF1 treatment.
To understand the 'why' behind these actions, you need to look at the foundational principles driving the team: Mission Statement, Vision, & Core Values of Pasithea Therapeutics Corp. (KTTA).
Pasithea Therapeutics Corp. (KTTA) Ownership Structure
Pasithea Therapeutics Corp. (KTTA) is governed by a relatively small but experienced leadership team, with the majority of the stock held by retail and public shareholders, a common structure for a clinical-stage biotech company. This structure means that while institutional influence is present, the stock's price and strategic direction are highly sensitive to retail investor sentiment and key clinical trial data, like the recent positive results for PAS-004.
Given Company's Current Status
As of November 2025, Pasithea Therapeutics Corp. is a publicly traded, clinical-stage biotechnology company, trading on the Nasdaq stock exchange under the ticker symbol KTTA. The company is focused on developing treatments for central nervous system (CNS) disorders and RASopathies, with its lead candidate, PAS-004, a next-generation MEK inhibitor, currently in Phase 1/1b trials.
The company's financial health, as reflected in its Q3 2025 report, shows a strong liquidity position with a current ratio of 4.02 and no debt, but it is not yet profitable, reporting an Earnings Per Share (EPS) of -$5.09. This is typical for a biotech firm that is burning cash on research and development, but it means the pressure to deliver on clinical milestones is defintely high. You can dive deeper into these numbers here: Breaking Down Pasithea Therapeutics Corp. (KTTA) Financial Health: Key Insights for Investors
Given Company's Ownership Breakdown
The ownership structure is heavily weighted toward public investors, which increases volatility but also offers greater potential for price movement on positive news. Institutional ownership is low, which suggests a lack of broad endorsement from major funds, but it also means there's room for significant buying if the clinical data continues to impress.
| Shareholder Type | Ownership, % | Notes |
|---|---|---|
| Retail/Public Investors | 73.38% | Calculated as the residual, this group drives much of the stock's daily trading volume. |
| Institutional Investors | 23.92% | Includes funds like AdvisorShares Investments LLC, which held 3.46% as of November 2025. |
| Insiders (Executives & Directors) | 2.70% | Relatively low insider stake, which can be a point of concern for long-term alignment. |
Given Company's Leadership
The company is steered by a small, scientifically-focused executive team and board, prioritizing clinical development over commercial operations, which makes sense for a Phase 1/1b company. The key decision-makers are:
- Dr. Tiago Reis Marques, Chief Executive Officer (CEO) and Director: Serving since August 2020, Dr. Marques is a psychiatrist and senior clinical fellow at Imperial College London. His leadership is centered on the scientific and clinical strategy. His base salary for 2025 was recently increased to $533,000.
- Daniel Schneiderman, Chief Financial Officer (CFO): An experienced finance executive focused on capital markets and financial operations, he joined as CFO in October 2022. His 2025 base salary was raised to $391,000.
- Dr. Lawrence Steinman, Co-Founder and Board Member: A highly respected figure in the neuroscience field, his presence lends significant scientific credibility to the board.
The board recently approved a compensation change for the executives, increasing their base salaries but also adjusting their target bonus percentages-the CEO's target bonus is 55% of his base salary, while the CFO's is 40%. This links a substantial portion of their potential earnings to performance metrics, a crucial factor for a company in the high-stakes clinical trial phase.
Pasithea Therapeutics Corp. (KTTA) Mission and Values
Pasithea Therapeutics Corp. operates with a clear, patient-centric mission: to tackle debilitating neurological and psychiatric conditions where current treatments are defintely inadequate. This purpose drives their dual strategy of clinical service expansion and rigorous drug development, even as the company operates with a substantial financial loss, reporting an estimated EBITDA of -$11 million for the past fiscal year.
Given Company's Core Purpose
As a clinical-stage biotechnology company, Pasithea's core purpose moves beyond simple profit, focusing instead on scientific breakthroughs for underserved patient populations. This is the cultural DNA you need to understand when evaluating their long-term value.
Official mission statement
While a single, formal mission statement isn't explicitly published, the company's stated focus is on addressing significant unmet medical needs by bringing novel treatments to patients suffering from complex and debilitating disorders. Their work is fundamentally centered on the central nervous system (CNS) disorders and RASopathies (a group of genetic conditions) where treatment options are limited or have severe side effects.
- Focus on CNS disorders, including Neurofibromatosis type 1 (NF1) and Amyotrophic Lateral Sclerosis (ALS).
- Prioritize drug candidates like PAS-004, a next-generation MEK inhibitor.
- Commit to scientific inquiry and improving patient outcomes.
Vision statement
The company's vision is best understood through its strategic direction-a roadmap for how they plan to achieve their mission and grow beyond their current stock price of approximately $0.33 per share as of November 2025. It's a two-pronged approach that blends clinical service delivery with an aggressive drug pipeline. You can read more about their strategic focus here: Mission Statement, Vision, & Core Values of Pasithea Therapeutics Corp. (KTTA).
- Advance Drug Pipeline: Accelerate CNS drug candidates to achieve key clinical milestones.
- Expand Clinical Services: Increase the network of partner clinics for therapies like ketamine-based treatments.
- Sustainability Goals: Adopt environmentally sustainable practices in operations and research.
Given Company slogan/tagline
Pasithea Therapeutics Corp. does not use a formal, publicly-advertised slogan or tagline. Their identity is instead communicated through their scientific positioning: a biotechnology company at the forefront of research into mental health and brain disorders. This emphasis on being a research-driven, clinical-stage entity is their real-world tagline.
Pasithea Therapeutics Corp. (KTTA) How It Works
Pasithea Therapeutics Corp. operates a dual-pronged business model: it is a clinical-stage biotechnology company developing novel drug candidates for neurological disorders, and it also runs a network of hybrid mental health clinics. The company primarily creates value by advancing its lead drug, PAS-004, through clinical trials, while the clinics provide a secondary, immediate revenue stream from specialized mental health treatments.
Pasithea Therapeutics Corp.'s Product/Service Portfolio
| Product/Service | Target Market | Key Features |
|---|---|---|
| PAS-004 (MEK Inhibitor) | Adult patients with Neurofibromatosis Type 1 (NF1)-associated plexiform neurofibromas; Advanced solid tumor patients with MAPK pathway-driven mutations. | Next-generation macrocyclic oral MEK inhibitor in Phase 1/1b trials; interim data shows a 71.4% Disease Control Rate (DCR) in BRAF-mutated tumors as of November 2025; long half-life of approximately 57 hours. |
| Specialized Mental Health Clinics (Pasithea Clinics) | Patients with treatment-resistant mental health disorders, primarily depression. | Hybrid model offering both in-person and at-home intravenous (IV) ketamine infusions; in-clinic access to repeated transcranial magnetic stimulation (rTMS). |
Pasithea Therapeutics Corp.'s Operational Framework
The company's operations are heavily weighted toward research and development (R&D) for its drug pipeline, which is typical for a clinical-stage biotech. To be fair, this focus is why the reported revenue for the trailing 12 months ending June 30, 2025, was $0.00, as commercial drug sales haven't started yet. The clinical operations are structured to drive future value.
- Drug Development: Focuses on advancing PAS-004, a next-generation macrocyclic MEK inhibitor, through clinical trials, with a new Phase 1/1b trial site activated at the University of Alabama at Birmingham in November 2025.
- Clinical Trial Management: Manages multi-center, open-label studies (like the Phase 1 trial for advanced cancer, NCT06299839) to assess safety, pharmacokinetics (PK), and preliminary efficacy.
- Capital Deployment: Utilizes proceeds from financing, such as the $5 million public offering in May 2025, to fund ongoing R&D and clinical trials.
- Clinic Service Delivery: Operates a network of clinics to provide specialized, non-traditional treatments like ketamine and rTMS, which helps address immediate patient needs while the drug pipeline matures.
Here's the quick math: the company's current earnings (loss) of approximately -$13.5 million reflects the high cost of running concurrent clinical trials and R&D programs. That's the cost of chasing a breakthrough drug.
For a deeper dive into the numbers, you should check out Breaking Down Pasithea Therapeutics Corp. (KTTA) Financial Health: Key Insights for Investors.
Pasithea Therapeutics Corp.'s Strategic Advantages
Pasithea's market success hinges on the clinical profile of its lead candidate, PAS-004, and its differentiated approach to mental health care. Their strategy is defintely a high-risk, high-reward biotech play combined with a service-based hedge.
- Differentiated Drug Profile: PAS-004, as a macrocyclic oral MEK inhibitor, has shown a favorable safety profile in Phase 1 trials, with all treatment-related adverse events being Grade 1 or 2, and notably, no ocular or cardiovascular toxicities observed to date. This is a crucial distinction from some older MEK inhibitors.
- Long Half-Life: The long half-life of ~57 hours for PAS-004 suggests potential for once-daily dosing, which can significantly improve patient compliance and convenience in chronic conditions like NF1.
- Hybrid Clinic Model: The combination of in-person clinics offering rTMS and at-home mobile clinics for IV ketamine infusions provides a broader, more flexible service offering for treatment-resistant depression patients, expanding their geographic reach and patient access.
- Targeting High Unmet Need: The focus on NF1, a condition with limited treatment options, positions the company to potentially capture a significant market share if PAS-004 is approved.
Pasithea Therapeutics Corp. (KTTA) How It Makes Money
Pasithea Therapeutics Corp. is a clinical-stage biotechnology company, meaning it does not currently generate revenue from selling a commercialized drug or service. Instead, the company's financial engine is entirely dependent on securing capital to fund its research and development (R&D) pipeline, primarily through equity financing.
The company essentially makes money by selling a piece of its future potential to investors, using that cash to advance its lead drug candidate, PAS-004, through costly clinical trials, a high-risk, high-reward model common in early-stage biotech.
Given Company's Revenue Breakdown
As of the nine months ended September 30, 2025, Pasithea Therapeutics Corp. reported zero revenue from product sales or services. Therefore, the company's operational funding breakdown is not a revenue mix but a capital-raising mix. The table below reflects the primary source of cash inflow used to sustain operations, which is financing, not sales.
| Revenue Stream (Source of Capital) | % of Total | Growth Trend |
|---|---|---|
| Product Sales/Service Revenue | 0% | Stable (at zero) |
| Capital Raising (Equity/Warrants) | ~100% of Operating Cash Inflow | Increasing (via dilutive financing) |
The reality is simple: for a company like this, revenue is zero. The money to operate comes from capital raises. In the nine months ending September 30, 2025, the company successfully secured approximately $7.5 million in financing, primarily through equity sales, which is the lifeblood of the business right now. This aggressive strategy resulted in a massive 531% increase in common shares outstanding, exploding the share count from 1.4 million to 7.4 million, which is a major dilution risk for current shareholders.
Business Economics
The economics of Pasithea Therapeutics Corp. are defined by its burn rate (operating expenses) versus its cash runway. The company's primary expense is R&D, focused on advancing the lead candidate, PAS-004, a macrocyclic MEK inhibitor for conditions like Neurofibromatosis Type 1 (NF1).
- Cost Structure: The company ruthlessly streamlined operations to focus capital. Clinical development expenses surged 51% to $4.3 million for the nine months ended September 30, 2025, directly funding the acceleration of the PAS-004 Phase 1 studies.
- Strategic Cuts: To finance this clinical acceleration, pre-clinical R&D expenses were cut by 77%, decreasing to just $0.3 million for the same nine-month period. This move concentrates the entire enterprise risk onto the success of PAS-004.
- Pricing Strategy: The company has no current product pricing strategy because it has no commercial product. Its future profitability hinges entirely on the successful completion of clinical trials, regulatory approval, and then establishing a premium price point for a novel therapy in its target markets, such as NF1, which has high unmet medical need.
The core economic fundamental is the high fixed cost of drug development, which is currently being funded by highly dilutive equity sales. You can dig deeper into the investor sentiment around this financing activity by Exploring Pasithea Therapeutics Corp. (KTTA) Investor Profile: Who's Buying and Why?
Given Company's Financial Performance
The financial performance for Pasithea Therapeutics Corp. is characterized by significant losses, reflecting its clinical-stage status and high R&D investment. The numbers from the third quarter (Q3) and nine months ended September 30, 2025, paint a clear picture of a company facing a liquidity cliff.
- Net Loss: The net loss for the nine months ended September 30, 2025, was $10.32 million, a slight improvement from the $10.73 million loss a year prior. The Q3 2025 net loss alone was $3.04 million.
- Liquidity Crisis: The company holds only $4.1 million in cash against an average operating cash burn of approximately $1.1 million per month. This confirms a cash runway of less than four months, a critical 'Going Concern Uncertainty' that management explicitly acknowledged.
- Capital Structure: The balance sheet shows a strong current ratio of 4.02 and a quick ratio of 2.99, which usually signals good liquidity, but this is deceptive; it simply means their current assets (mostly cash) are high relative to current liabilities, but the cash is depleting fast. Importantly, the company maintains a debt-free balance sheet with a debt-to-equity ratio of 0.
- Share Dilution: The aggressive financing strategy has led to a major overhang: 9.8 million outstanding warrants, a number that exceeds the current 7.4 million common shares, which guarantees substantial future shareholder erosion. This is a defintely a factor to weigh when assessing the stock's value.
Pasithea Therapeutics Corp. (KTTA) Market Position & Future Outlook
Pasithea Therapeutics Corp. is at a critical inflection point, moving from pure research to generating initial clinical data for its lead candidate, PAS-004. While the company holds a 0% commercial market share due to its clinical-stage status and 2025 fiscal year revenue of zero, its future outlook is entirely dependent on the successful, non-toxic progression of its MEK inhibitor pipeline in high-value, unmet-need areas like Neurofibromatosis Type 1 (NF1) and advanced cancers.
Competitive Landscape
In the biotechnology sector, especially for a clinical-stage company, competition is less about current sales and more about pipeline differentiation and speed to market. Pasithea Therapeutics is competing for mindshare and capital against other small-cap biotechs with early-stage assets, even those in slightly different therapeutic areas, as they all vie for the same investor dollars and partnership opportunities. The broader MEK inhibitor market is already validated and significant, with established products generating billions.
| Company | Market Share, % | Key Advantage |
|---|---|---|
| Pasithea Therapeutics Corp. | 0% | Next-gen macrocyclic MEK inhibitor (PAS-004) with favorable safety profile in early trials. |
| KALA BIO, Inc. | <1% (Estimated) | Focus on ocular surface diseases and retinal disorders (e.g., dry eye, retinal vein occlusion). |
| Revelation Biosciences, Inc. | <1% (Estimated) | Novel therapeutic approach for infectious diseases and inflammatory conditions (e.g., chronic kidney disease). |
Opportunities & Challenges
You need to see Pasithea Therapeutics as a call option on its pipeline, not a stable business. The opportunity is massive, but so is the inherent risk of clinical-stage biotech. The immediate opportunity lies in the positive data for PAS-004, but the market's reaction to the latest Phase 1 results was less than stellar, with the stock plummeting 25% on November 20, 2025.
| Opportunities | Risks |
|---|---|
| PAS-004's long half-life (~57 hours) and favorable safety profile (no ocular/cardio toxicities) could differentiate it from older MEK inhibitors. | Clinical-stage company with zero revenue and negative EPS of -$5.09, requiring continuous capital raises. |
| Targeting NF1-associated plexiform neurofibromas, an orphan indication with an established multi-billion dollar market for MEK inhibitors. | High stock volatility (82.17) and trading near its 52-week low of $0.33, indicating poor investor sentiment. |
| Expansion of the NF1 trial with the new UAB site activation in November 2025, accelerating patient enrollment. | Piotroski F-Score of 2 suggests poor near-term business operations and potential financial distress. |
Industry Position
Pasithea Therapeutics is a micro-cap player in the highly specialized biotechnology industry, currently valued at a market capitalization of approximately $2.46 million. It is a high-risk, high-reward proposition. The company's financial health is characterized by a strong balance sheet with a debt-to-equity ratio of 0 and a cash ratio of 2.99, meaning it has good liquidity and no debt. This is crucial because it gives them runway to execute on the clinical trials, but it doesn't change the fact that they are burning cash with a Net Income (TTM) of approximately -$13.49 million.
Here's the quick math: the company is a pure-play clinical development engine. Its value is tied directly to the success of PAS-004 in a Phase 1/1b setting. The recent positive pharmacokinetic (PK) data is a necessary, but not sufficient, step for success. What this estimate hides is the massive dilution risk if a larger, non-dilutive partnership isn't secured soon.
- Focus on neurofibromatosis and CNS disorders gives a clear, defensible niche.
- Lead candidate PAS-004 is a macrocyclic MEK inhibitor, a structurally distinct approach from competitors.
- Current valuation is low, with the Price-to-Book ratio at 0.2, reflecting a market that is not yet convinced of its pipeline's commercial viability.
For a detailed breakdown of the company's core philosophy, you can review its Mission Statement, Vision, & Core Values of Pasithea Therapeutics Corp. (KTTA).
Next step: Closely monitor the enrollment and safety data from the UAB site for the NF1 trial, as that will defintely be the next major catalyst.

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