Pasithea Therapeutics Corp. (NASDAQ:KTTA) is a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments for central nervous system (CNS) disorders and cancers driven by the MAPK signaling pathway, including RASopathies such as neurofibromatosis type 1 (NF1). Founded in 2020 and headquartered in Miami, Florida, the company was built around a deep scientific commitment to addressing unmet needs in neuro-oncology, neuroinflammation, and psychiatric conditions. Pasithea is guided by a multidisciplinary leadership team with expertise in drug discovery, CNS biology, translational research, and clinical development, and has rapidly established a focused, high-impact pipeline with the potential to disrupt stagnant therapeutic categories.
The company’s flagship drug candidate, PAS-004, is a next-generation, brain-penetrant, macrocyclic MEK inhibitor that selectively targets the MEK1/2 proteins in the MAPK pathway. PAS-004 is being developed for the treatment of NF1 and other advanced solid tumors harboring MAPK mutations. Unlike older MEK inhibitors, PAS-004 is designed to offer enhanced selectivity, reduced off-target toxicity, and superior pharmacokinetics. These properties position it as a potentially best-in-class agent in diseases where MEK signaling is a core driver of pathology. The drug is currently undergoing a Phase 1 dose-escalation trial, and early data has shown excellent tolerability and target engagement. With no dose-limiting toxicities reported through multiple cohorts and a clean safety profile, PAS-004 is drawing attention as a promising candidate in a space where therapeutic innovation is urgently needed.
In addition to PAS-004, Pasithea is advancing a diverse pipeline that includes PAS-003 for amyotrophic lateral sclerosis (ALS) and PAS-001 for schizophrenia. These programs reflect the company’s broader commitment to addressing high-burden CNS disorders through novel mechanisms and brain-penetrant molecules. The acquisition of Alpha-5 Integrin LLC further expanded Pasithea’s research footprint, adding a novel antibody platform focused on treating neuroinflammatory and degenerative CNS conditions. This move was in line with the company’s strategy of building a portfolio of differentiated CNS assets with strong preclinical proof of concept and potential for rapid clinical translation. Each of these programs complements the company’s core strengths in CNS drug development and positions Pasithea to pursue multiple regulatory and commercial pathways.
Pasithea’s growth strategy is grounded in scientific rigor, efficient capital allocation, and strategic optionality. In May 2025, the company raised $5 million through a public offering that included common stock and Series C and D warrants priced at $1.40 per share. The financing was led by H.C. Wainwright & Co. and structured to minimize dilution while providing ample runway to support the ongoing clinical advancement of PAS-004 and other pipeline programs. The net proceeds are expected to fund research and development, preclinical studies, licensing activities, and potential acquisitions of synergistic technologies or companies. This financing milestone reflects investor confidence in the company’s pipeline and execution, and positions Pasithea to scale its operations as it transitions from early-stage trials to mid-phase development.
Pasithea operates with a capital-efficient model, leveraging external research collaborations and a streamlined internal team to maintain flexibility and speed. The company’s clinical progress, scientific direction, and financial strategy collectively underscore its ambition to build a next-generation CNS therapeutics platform. As it advances PAS-004 through clinical trials and continues to develop its additional pipeline assets, Pasithea stands at the intersection of precision medicine and neuroscience—poised to deliver impactful therapies that could redefine standards of care for patients with complex and underserved conditions.
PAS-004: A Next-Generation MEK Inhibitor with Broad Potential
At the heart of Pasithea’s pipeline is PAS-004, a highly selective and brain-penetrant macrocyclic MEK1/2 inhibitor. Unlike first-generation MEK inhibitors that often suffer from dose-limiting toxicities and off-target effects, PAS-004 was engineered for enhanced tolerability, superior pharmacokinetics, and long-term efficacy. The drug is currently being studied in a Phase 1 dose-escalation trial for patients with advanced solid tumors harboring MAPK pathway mutations, including NF1-related tumors. Importantly, PAS-004 has been well tolerated across multiple dose levels with no reported dose-limiting toxicities, according to preliminary results shared at the 2025 ASCO Annual Meeting.
The program recently completed enrollment of Cohort 6 in its dose-escalation phase, marking a significant milestone that has energized the investor community. The stock rallied over 7% on the announcement, reflecting growing confidence in PAS-004’s potential to redefine treatment for a broad range of MEK-driven tumors. The company expects to complete full enrollment in the Phase 1 trial by year-end 2025, after which dose expansion cohorts will commence for target indications such as NF1, low-grade gliomas, and melanoma. As an orally available agent that crosses the blood-brain barrier and demonstrates target engagement with minimal toxicity, PAS-004 could emerge as a best-in-class MEK inhibitor with broad oncologic applications.
CHECK THIS OUT: Exact Sciences (EXAS) Just Made Cancer Detection 100x Easier! and Soleno Therapeutics (SLNO): The Biotech Company That Could Make You Rich.
Diversifying the Pipeline with CNS and Rare Disease Targets
Pasithea’s innovation doesn’t stop with PAS-004. The company is simultaneously expanding its research footprint into neurodegenerative and psychiatric indications with two preclinical assets, PAS-003 and PAS-001. PAS-003 is being developed for the treatment of amyotrophic lateral sclerosis (ALS), while PAS-001 is focused on schizophrenia and other treatment-resistant psychotic disorders. Both programs represent high unmet medical needs with enormous commercial potential and fit squarely within Pasithea’s expertise in CNS biology and drug delivery. In addition, the company’s acquisition of Alpha-5 Integrin LLC added an antibody platform targeting inflammatory CNS disorders, further enhancing the therapeutic breadth of its pipeline.
The decision to broaden its focus beyond oncology and into neuroinflammatory and psychiatric conditions reflects the company’s long-term ambition to become a platform-driven innovator in CNS therapeutics. By balancing high-risk, high-reward cancer targets with chronic CNS indications, Pasithea is building a multi-asset portfolio with diversified clinical and commercial upside.
$5 Million Public Offering Bolsters Balance Sheet and Fuels Expansion
On May 6, 2025, Pasithea announced the pricing of a $5 million public offering, consisting of 3,571,428 shares of common stock (or pre-funded warrants) and accompanying Series C and Series D common stock purchase warrants. Shares and warrants were priced at $1.40 per unit, with Series C warrants exercisable immediately and expiring in five years, while Series D warrants expire in 18 months. The offering was led exclusively by H.C. Wainwright & Co., a trusted name in life sciences capital markets, and is expected to close around May 7, 2025, pending customary closing conditions.
This raise comes at a pivotal time as the company prepares to accelerate enrollment, expand clinical sites, and initiate dose expansion cohorts in its PAS-004 program. The net proceeds are earmarked for general corporate purposes including R&D activities, licensing opportunities, preclinical development, and potential acquisitions that align with the company’s technology platforms. By structuring the raise to include long-dated warrants, Pasithea has successfully raised non-restrictive capital without excessive dilution—preserving future upside for shareholders while extending operational runway into 2026.
A Unique Value Proposition in a Market Starved for Innovation
Pasithea is operating in a space where very few small-cap biotech companies dare to compete. Brain-penetrant kinase inhibitors are notoriously hard to design, and regulatory pathways for RASopathies like NF1 are rigorous. Yet, Pasithea is executing across multiple fronts: progressing a well-tolerated MEK inhibitor in humans, expanding into psychiatric and neuroinflammatory conditions, and strengthening its balance sheet with strategic, minimally dilutive funding. The potential for PAS-004 to become a pipeline-in-a-product is enormous, given the wide range of MEK-driven tumors and CNS diseases it could address.
In a recent wave of market enthusiasm, shares of KTTA surged on trial progress and momentum from ASCO data. Despite the rally, the company’s market capitalization remains deeply discounted relative to its clinical positioning and scientific potential. With a float of under 10 million shares and positive sentiment from both institutional and retail investors, KTTA could experience rapid revaluation as trial data matures and partnerships develop.
Catalysts on the Horizon and a Clear Growth Trajectory
The second half of 2025 is set to be catalytic for Pasithea. Full enrollment in the PAS-004 Phase 1 trial will be completed, and data readouts could validate its differentiation versus existing MEK inhibitors. Dose expansion cohorts in NF1 and glioma may begin shortly thereafter, setting the stage for potential FDA designations such as Fast Track or Orphan Drug. Additionally, updates on PAS-003 and PAS-001 could bring new visibility to the company’s non-oncology programs and solidify its CNS-focused brand.
Investors should also monitor the potential for strategic partnerships or licensing deals. Given the complexity and cost of developing kinase inhibitors for rare tumors, larger biotech firms could view PAS-004 as an ideal acquisition or co-development opportunity. The dual warrant structure in the recent raise also provides optionality for future capital inflows without pressuring the stock in the near term.
Conclusion: Pasithea Is Building Something Bigger Than Just a Drug
Pasithea Therapeutics is not just a clinical-stage company testing a molecule. It is building a new framework for CNS drug discovery—where molecules are smarter, trials are more focused, and diseases long ignored by Big Pharma finally get the attention they deserve. From its brain-penetrant MEK inhibitor to its efforts in ALS and schizophrenia, Pasithea is positioning itself as a lean, innovative engine for high-impact medical breakthroughs.
The recent $5 million raise, the strength of its clinical updates, and its expanding pipeline give KTTA shareholders plenty to look forward to in 2025 and beyond. For investors seeking asymmetric biotech opportunities with real clinical programs, solid IP, and competent management, Pasithea offers one of the most compelling setups in the micro-cap space today.
READ ALSO: Johnson & Johnson (JNJ) can be the Next Trillion-Dollar Stock and Boston Scientific (BSX) Just Signed a $45M Deal—Here’s What It Means for Investors.
