Pasithea Therapeutics Corp. (KTTA): Business Model Canvas [Dec-2025 Updated]

You're digging into Pasithea Therapeutics Corp.'s business model, and honestly, for a clinical-stage outfit like this, the canvas tells a dual story: developing the novel MEK inhibitor PAS-004 while running the mental health clinics. Right now, the focus is clearly on the capital structure, as evidenced by that recent $60 million equity raise needed to fund trials, which sits against a trailing net loss of about $13.5 million as of late 2025. So, what does this hybrid structure-part drug developer, part service provider-actually look like when you map out its key activities and revenue streams? Let's break down the nine blocks below to see where the real value creation lies for Pasithea Therapeutics Corp. right now.

Pasithea Therapeutics Corp. (KTTA) - Canvas Business Model: Key Partnerships

When you look at the capital structure and clinical execution for Pasithea Therapeutics Corp. as of late 2025, the key partnerships are clearly centered around financing major clinical milestones and securing non-dilutive funding for pipeline expansion.

The company recently closed a significant financing event that really shores up the balance sheet. This was a public offering that brought in substantial cash to fund operations through at least the first half of 2028. This kind of runway extension is crucial for a clinical-stage biotech.

Here's a breakdown of the major players involved in that recent capital raise and research support:

• - Institutional Healthcare Investors: This group provided the backbone for the financing. Key participants included Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners, and Squadron Capital Management.
• - H.C. Wainwright & Co.: This firm acted as the exclusive placement agent for the late 2025 public offering.
• - ALS Association: This organization provided non-dilutive support, awarding a grant to advance PAS-004 into a new indication.
• - Clinical Research Organizations (CROs): These are essential for executing the multi-center Phase 1/1b trials globally, such as those currently running for PAS-004 in Neurofibromatosis type 1-associated plexiform neurofibromas and advanced cancer.
• - ZEN Healthcare: Partnership for management support of UK-based mental health clinics.

The recent financing activity is best summarized in a table, showing the scale of the commitment from the institutional partners and the role of the placement agent.

The $1 million grant from the ALS Association is specifically earmarked to fund a Phase 1 study of PAS-004 in twelve ALS patients over approximately 28 weeks, marking the first clinical trial of that MEK inhibitor in ALS patients. This non-dilutive capital is a smart way to de-risk pipeline expansion.

The $60 million offering, priced at $0.75 per share, is expected to extend the company's cash runway through at least the first half of 2028, which is a very concrete number for planning purposes. Net proceeds are designated for general corporate purposes, including ongoing research, pre-clinical studies, and clinical trials.

The reliance on CROs is implicit in the execution of multi-center trials across different geographies, like the Phase 1/1b trial in adult NF1 patients with sites activated in South Korea. You need those specialized organizations to manage the logistics of global clinical execution; that's just how the industry works.

Pasithea Therapeutics Corp. (KTTA) - Canvas Business Model: Key Activities

You're looking at the core engine driving Pasithea Therapeutics Corp. right now-the things they absolutely must execute on to move forward. It's all about the drug candidate and keeping the lights on while the science plays out. Here's the quick math on what they're actively doing as of late 2025.

The primary focus remains the research and development (R&D) of the lead candidate, PAS-004, which is a next-generation macrocyclic MEK inhibitor. This effort is directly tied to funding secured through strategic capital raising.

The company recently executed a major capital raise, closing a public offering on December 1, 2025, which brought in approximately $60 million in gross proceeds. This offering involved 80,000,000 shares or pre-funded warrants priced at $0.75 per share. Management expects this influx of capital to extend the cash runway through at least the first half of 2028. To be fair, the company's enterprise value was noted at $117 million with a price-to-book value of 0.65 around the same time, showing a mix of investor confidence and underlying operational challenges.

Execution of clinical trials for PAS-004 is a critical activity, spanning two main indications. The data coming out of these trials definitely shapes investor perception.

Pasithea Therapeutics Corp. is also actively expanding PAS-004's utility. They announced a $1 million award from the ALS Association on November 25, 2025, specifically to study the efficacy, safety, and tolerability of PAS-004 for the treatment of ALS.

The company continues operating its Pasithea Clinics for IV ketamine and rTMS therapy in the US and UK. While the search results confirm the historical intent to develop these U.S. and UK clinics, specific revenue or operational statistics for these clinics in late 2025 weren't immediately available for this section.

Key operational metrics supporting the clinical development include a robust current ratio of 4 and a debt-to-equity ratio of zero. However, efficiency metrics show significant challenges, with a return on equity of -89.9% and a return on assets of -83.64%.

The company is defintely focused on moving these assets forward.

• Research and development (R&D) of lead candidate PAS-004 (MEK inhibitor).
• Execution of Phase 1/1b clinical trials for NF1 and advanced cancer patients.
• Strategic capital raising, like the recent $60 million public offering.
• Operating Pasithea Clinics for IV ketamine and rTMS therapy in the US and UK.
• Expanding PAS-004's utility into new indications like ALS, supported by a $1 million award.

Finance: review the burn rate against the new $60 million runway projection by end of Q1 2026.

Pasithea Therapeutics Corp. (KTTA) - Canvas Business Model: Key Resources

You're looking at the core assets Pasithea Therapeutics Corp. (KTTA) relies on to drive value, and right now, the balance sheet is getting a significant boost. As of September 30, 2025, the company held $4.1 million in cash and cash equivalents. This liquidity position is set to be bolstered by the late 2025 financing event; Pasithea Therapeutics announced the pricing of a $60 million public offering, which was expected to close on or about December 1, 2025. That capital is earmarked to support the ongoing development of PAS-004 and extend the cash runway through at least the first half of 2028.

Here's a quick look at some of the hard numbers underpinning the current resource base:

The most critical tangible asset is the Intellectual Property (IP) tied to PAS-004, the next-generation macrocyclic MEK inhibitor. This IP is being validated through two active Phase 1 programs. The data coming out of the advanced cancer trial (NCT06299839) is showing tangible results, so you can see the IP is translating into clinical signals.

The clinical data from the ongoing Phase 1 trials provides the necessary evidence to advance the compound. For instance, in the advanced cancer study, interim data through Cohort 4A showed stable disease (SD) by RECIST 1.1 in 10 out of 16 efficacy evaluable patients. Specifically, one patient with stage 4 BRAF-mutated melanoma achieved over 5 months of stable disease with a tumor volume reduction of -14.9%. More recently, Cohort 7 (37mg capsules) of that same trial reported zero treatment-related adverse events during the DLT period. The Pharmacodynamic (PD) results from that cohort supported sustained pathway suppression, inhibiting pERK at approximately 80% near Cmax and maintaining inhibition above 60% at Cmin (24-hour postdose). Based on this, the Safety Review Committee recommended escalation to Cohort 8, which is 45mg capsules.

You also have the operational expertise embedded in the Pasithea Clinics segment. This requires the specialized human capital of board-certified medical professionals to manage and execute the clinical service component of the business model.

Finally, the balance sheet structure itself is a key resource, specifically the absence of external liabilities. The company maintains a strong balance sheet with a debt-to-equity ratio of zero.

Pasithea Therapeutics Corp. (KTTA) - Canvas Business Model: Value Propositions

You're looking at the core value Pasithea Therapeutics Corp. is putting on the table for its different customer segments as of late 2025. It's a dual-pronged approach: cutting-edge oncology/rare disease drug development and specialized CNS/pain therapeutics.

For the oncology and rare disease space, the primary value is the novel, next-generation MEK inhibitor, PAS-004. This is a macrocyclic inhibitor targeting the MAPK pathway, which is central to RASopathies and various tumors. The clinical data supports this value proposition:

• Interim Phase 1 data showed a disease control rate of 71.4% in patients with BRAF-mutated tumors.
• One patient with stage 4 BRAF-mutated melanoma experienced over 5 months of stable disease, with a tumor volume reduction of 14.9%.
• Preliminary pERK inhibition, indicating target engagement, reached up to 91% in the 8mg capsule cohort.
• As of April 2, 2025, 21 patients had been enrolled across six dose cohorts in the advanced cancer trial.

The potential treatment for high-unmet-need diseases is directly tied to PAS-004's application beyond oncology. For Neurofibromatosis Type 1 (NF1), the value is a novel option where current FDA-approved MEK inhibitors, like Koselugo, are limited to pediatric use for NF1-PN. The market need is significant, as NF1 affects approximately 1 in 3,000 births. Furthermore, the company is expanding its scope into neurodegeneration, evidenced by the ALS Association awarding a grant of $1 million to study PAS-004 in Amyotrophic Lateral Sclerosis (ALS) patients.

For the mental health and pain segments, the value proposition centers on proprietary formulations designed for specific needs, rather than just the physical clinic footprint, which I don't have specific operational numbers for right now. You have:

• PAS001: A novel psychedelic therapeutic leveraging N,N-Dimethyltryptamine (DMT) aimed at treatment-resistant depression, offering potential advantages in rapid onset and short duration for efficient administration.
• PAS002: A proprietary ketamine formulation engineered for chronic pain syndromes, focusing on modulating central sensitization mechanisms for sustained benefit.

The financial underpinning supporting the development of these value drivers is the recent capital raise. Pasithea Therapeutics Corp. priced a public offering of 80 million shares at $0.75 per share in December 2025, securing $60 million in net proceeds. This financing is explicitly intended to extend the cash runway through at least the first half of 2028, supporting ongoing clinical trials and development across the pipeline. To give you a sense of the current valuation context, the company's market capitalization was reported at $26.21 million following the offering period.

Here's a quick look at the key pipeline assets and their associated data points:

The company's financial position, as of the Q3 2025 filing, showed a current ratio of 4.02, suggesting short-term liquidity strength before the December financing. The operational focus is clearly on advancing these specific, high-potential molecules through clinical milestones.

Pasithea Therapeutics Corp. (KTTA) - Canvas Business Model: Customer Relationships

You're looking at the relationships Pasithea Therapeutics Corp. maintains with its various stakeholders, which are quite distinct across its clinical development and clinic service arms. These relationships are critical, especially following significant capital events.

High-touch, personalized care model for Pasithea Clinics patients

Pasithea Therapeutics Corp. offers services that include dedicated clinics as part of its operational scope. While specific patient volumes or revenue figures directly attributable to the personalized care model at Pasithea Clinics for the 2025 fiscal year are not publicly detailed in recent filings, the company's reported revenue for 2025 was less than USD$1m, with a figure of $0 noted in some analyses. This suggests the clinic operations, while a stated service component, do not form the primary revenue base as of late 2025. The relationship here is built on direct service provision, which is a key part of their overall business structure.

Intensive Investor Relations (IR) to manage sentiment following dilutive financing

Investor relationships are currently dominated by the need to manage sentiment following a major equity event. Pasithea Therapeutics Corp. announced the closing of a public offering on December 2, 2025, which generated gross proceeds of approximately $60 million. This involved the issuance of 80,000,000 common shares or pre-funded warrants at a price of $0.75 per share. This capital raise was crucial, as the company reported cash and cash equivalents of only $4.1 million as of September 30, 2025, with existing cash expected to fund operations only through December 2025. The stated expectation is that this funding extends the cash runway through at least the first half of 2028. The relationship management involves communicating the use of net proceeds for general corporate purposes, including ongoing research and clinical trials, to a shareholder base that has seen substantial dilution. The stock price on December 1, 2025, was $1.16 / share, down 60.94% from December 2, 2024.

Here's a quick look at the key figures from the late 2025 financing event:

Direct relationships with Principal Investigators and clinical trial sites

The relationships with clinical sites are directly tied to the development of the lead candidate, PAS-004. As of early 2025, the company had four open sites in the United States (Texas and Virginia). By January 2025, Pasithea Therapeutics Corp. opened three additional clinical trial sites in Eastern Europe (Romania and Bulgaria). Further expansion included announcing the activation of clinical trial sites in South Korea in September 2025. The company is collaborating in the U.S. with NEXT Oncology, led by Dr. Anthony Tolcher M.D., and Dr. Ildefonso Rodriguez M.D. acts as principal investigator for the San Antonio, TX site. The completion of Cohort 7 in the Phase 1 trial for advanced cancer patients was announced on November 24, 2025.

The network of clinical engagement includes:

• Four U.S. sites activated as of January 2025.
• Three European sites opened in Romania and Bulgaria by January 2025.
• Site activation announced in South Korea in September 2025.
• Completion of Cohort 7 in Phase 1 trial reported November 2025.

Regulatory engagement with the FDA for drug development milestones

Engagement with the U.S. Food and Drug Administration (FDA) is foundational for the PAS-004 program. This relationship was marked by the FDA approval of the Investigational New Drug (IND) application for PAS-004. Furthermore, the FDA reviewed the protocol for the Phase 1 multicenter, open-label trial. The objective of this trial is to assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and to define the preliminary recommended Phase 2 dose. The company also announced a $1 million award from the ALS Association in November 2025 to study PAS-004 for ALS treatment.

Pasithea Therapeutics Corp. (KTTA) - Canvas Business Model: Channels

The distribution and access strategy for Pasithea Therapeutics Corp. (KTTA) centers on clinical development pathways and direct patient access through its subsidiary clinics, leveraging both physical presence and scientific communication.

The primary channel for advancing the lead candidate, PAS-004, is through a multi-center clinical trial network. As of early 2025, this network was strategically expanded to cover key geographies for patient recruitment and data diversity.

This expansion to seven total clinical sites-four in the US and three in Eastern Europe-was designed to accelerate patient enrollment for the ongoing Phase 1 study of PAS-004.

For direct patient engagement, the wholly owned subsidiary, Pasithea Clinics, utilizes physical locations for in-person treatments. In London, the Company had existing locations in Marylebone and Knightsbridge and planned to open three new clinics by mid-2022, with each clinic projected to contribute an estimated USD$5 million annually in revenue based on 2022 projections. The Company's headquarters is listed in Miami Beach, FL.

Regarding mobile/at-home services, the search results confirm the offering of ketamine therapy at the UK clinic locations, but specific operational details, such as the number of major US cities covered (e.g., NYC, LA, Florida) or associated patient volumes for mobile/at-home IV ketamine services in the US as of late 2025, are not present in the latest filings reviewed.

Dissemination of trial data and corporate visibility is achieved through scientific publications and key industry events. Pasithea Therapeutics Corp. management presented at the H.C. Wainwright 27th Annual Global Investment Conference in New York City between September 8-10, 2025. Furthermore, the Company announced plans to present interim safety and pharmacokinetic (PK) data from PAS-004 Cohorts 4A and 4B in Q1 2025. A significant non-dilutive channel for validation was the $1 Million Award by ALS Association announced on November 25, 2025.

The Channels strategy relies on these distinct avenues:

• - Multi-center clinical trial sites in the US and Eastern Europe for PAS-004, totaling 7 active sites as of January 2025.
• - Pasithea Clinics: Physical locations, including established sites in London (e.g., Marylebone, Knightsbridge) with a projected annual revenue benchmark of USD$5 million per planned new clinic from 2022 estimates.
• - Mobile/At-home IV ketamine services in major US cities (e.g., NYC, LA, Florida), for which specific 2025 operational metrics are not detailed.
• - Scientific publications and conferences (e.g., H.C. Wainwright) to disseminate trial data, with management presenting at the September 2025 conference.

Pasithea Therapeutics Corp. (KTTA) - Canvas Business Model: Customer Segments

You're looking at the core groups Pasithea Therapeutics Corp. (KTTA) serves or relies on as of late 2025. It's a mix of patients needing novel therapies and the capital markets that fund the science.

The patient segments are defined by the indications for their lead candidate, PAS-004, a next-generation macrocyclic oral MEK inhibitor.

The investor base that participated in the late 2025 financing is specific, showing institutional focus on the clinical-stage assets.

• Healthcare-dedicated investors leading the December 2025 offering included Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners, and Squadron Capital Management.
• The $60 million gross proceeds from the offering are intended to extend the cash runway through at least the first half of 2028.
• The offering price was set at $0.75 per share of common stock or pre-funded warrant.

For the patient populations, the clinical trial enrollment provides concrete numbers on the initial addressable market being tested.

• In the advanced cancer trial, the efficacy evaluable population was n=16 as of the April 2, 2025 cut-off date.
• One patient with KRAS G12R-mutated pancreatic cancer achieved a tumor diameter reduction of -9.8%.

The academic segment is directly evidenced by the recent grant activity.

• The $1 million ALS Association award supports studying PAS-004 in ALS, expanding the pipeline into a third neurological indication.

Pasithea Therapeutics Corp. (KTTA) - Canvas Business Model: Cost Structure

You're looking at the cost side of Pasithea Therapeutics Corp. (KTTA), and honestly, for a clinical-stage biotech, it's almost entirely driven by the science and the corporate infrastructure needed to support it. The numbers we have, based on the nine months ending September 30, 2025, show where the cash is going before any product revenue starts flowing in.

The biggest chunk of your spending is definitely tied up in the development pipeline, specifically for PAS-004. This is where the money goes to run the clinical trials, which are the make-or-break moments for any drug candidate. You have to fund the science, no way around it.

Here's a quick look at the major operating expenses for the nine months ended September 30, 2025, which gives you a clear picture of the burn rate:

The General and Administrative (G&A) costs are substantial, reflecting the necessary overhead to operate as a publicly traded entity on NASDAQ. This includes everything from executive salaries to compliance, legal fees, and maintaining that public listing status. It's the cost of being a company, not just a lab.

For the network of Pasithea Clinics, their operating costs-staffing, rent, and supplies for patient care and potentially clinical trial support-are embedded within these reported figures, primarily within the G&A structure, as a separate operating cost line item isn't broken out in the latest filings. You're paying for the infrastructure that supports the CNS disorder focus.

To put the overall financial performance in context, the company was operating at a significant loss, which is typical for this stage of development. The net loss for the trailing 12 months ending September 30, 2025, was approximately -$13.5 million. That's the bottom line you need to cover with financing.

Speaking of financing, you should note the recent capital raise. Pasithea Therapeutics Corp. priced a public offering of 80 million shares at $0.75 each in late November 2025, bringing in around $60 million. This cash infusion is explicitly intended to fund the PAS-004 development and clinical trials, aiming to extend the cash runway through at least mid-2028. That new capital directly offsets the current cost structure by providing a longer operational runway.

Key components driving the R&D spend include:

• Significant Research and Development (R&D) expenses for PAS-004 clinical trials.
• Funding Phase 1 studies for the MEK inhibitor.
• Costs associated with CNS disorder and RASopathies research translation.

The G&A costs cover the corporate necessities:

• Costs associated with maintaining NASDAQ listing compliance.
• Corporate overhead and executive compensation.
• General operational and administrative staffing.

Finance: draft the projected monthly cash burn based on the 9-month operating expense run rate by end of day Tuesday.

Pasithea Therapeutics Corp. (KTTA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Pasithea Therapeutics Corp. (KTTA) as of late 2025, and honestly, it's what you'd expect from a clinical-stage biotech heavily focused on drug development. The primary financial inflows right now aren't from product sales; they are from financing activities and targeted research support. This is a company funding its pipeline, not yet selling a commercial product.

The most significant recent cash infusion came from the capital markets. Pasithea Therapeutics Corp. priced a public offering of common stock in late November 2025, which closed on December 2, 2025. This move generated gross proceeds of approximately \$60 million before accounting for placement agent fees and other expenses. That capital is key; the company stated the net proceeds are intended to extend its cash runway through at least the first half of 2028.

Beyond equity raises, non-dilutive funding provides crucial, non-equity-cost support for specific research initiatives. For instance, Pasithea Therapeutics Corp. secured a Hoffman ALS Clinical Trial Award grant from the ALS Association worth approximately \$1 million in November 2025. This grant is earmarked specifically to study their lead candidate, PAS-004, in patients with Amyotrophic Lateral Sclerosis.

Here's a quick look at how these major funding events stack up against the company's reported operational revenue status:

The company maintains a revenue stream from its clinical operations, which are separate from the drug development pipeline. This involves the Pasithea Clinics segment. The revenue here is generated from fees for IV ketamine and rTMS mental health services from Pasithea Clinics. Still, the overall picture for the drug development side remains pre-commercial, which is reflected in the official filings.

The official financial reporting confirms the pre-commercial status of the primary business focus. Current trailing 12-month revenue ending June 30, 2025, was reported as \$0.00. This \$0.00 figure is typical for a clinical-stage biotechnology firm whose primary value driver is its pipeline assets, not current sales volume.

To summarize the key components of the Revenue Streams block for Pasithea Therapeutics Corp. as of late 2025, you see a reliance on non-operating income to fuel operations:

• - Capital raising through equity offerings, generating $60 million gross proceeds in late 2025.
• - Non-dilutive grant funding, such as the $1 million from the ALS Association.
• - Fees for IV ketamine and rTMS mental health services from Pasithea Clinics.
• - Current trailing 12-month revenue ending June 30, 2025, was reported as $0.00, reflecting pre-commercial status.