On May 6, 2025, Pasithea Therapeutics Corp (NASDAQ: KTTA) witnessed a dramatic intraday rally, with its share price soaring from a previous close of $1.40 to a high of $3.79, marking a gain of more than 150%. For a clinical-stage biotech firm that has flown under the radar of most retail investors, such a spike raises a critical question: what’s driving this meteoric rise?

The answer lies in a compelling combination of positive Phase 1 clinical trial data, a strategically timed public offering, and growing investor enthusiasm for targeted cancer therapies in the MEK inhibitor class. This article unpacks the full context behind KTTA’s rally and examines whether the momentum is justified—or overhyped.

Who Is Pasithea Therapeutics?

Pasithea Therapeutics is a U.S.-based biotechnology company focused on the discovery and development of novel therapeutics for neurofibromatosis type 1 (NF1) and other MAPK pathway-driven cancers. Its lead clinical asset, PAS-004, is a next-generation macrocyclic MEK inhibitor, a drug class that has shown promise in targeting a range of cancers associated with mutations in the MAPK pathway, including KRAS-mutated cancers.

The company, which trades on the NASDAQ under the ticker KTTA, is in the early stages of clinical development but has already drawn attention from investors and analysts due to its bold scientific positioning and a pipeline that aims to tackle difficult-to-treat diseases.

The Catalyst: Positive Phase 1 Results for PAS-004

On May 6, 2025, Pasithea announced interim data from its ongoing Phase 1 clinical trial of PAS-004, which triggered the buying frenzy in KTTA stock. The trial is designed to evaluate the safety, tolerability, and early signs of efficacy for PAS-004 in patients with advanced solid tumors.

Key takeaways from the announcement include:

1. Strong Target Engagement

• The trial demonstrated up to 91% inhibition of phosphorylated ERK (pERK), a downstream biomarker used to evaluate MEK inhibitor activity.
• High levels of pERK suppression confirm that PAS-004 is effectively hitting its biological target, a crucial indicator of potential downstream efficacy in cancer treatment.

2. Encouraging Efficacy in Resistant Tumors

• One patient with Stage 4 KRAS G12R-mutated pancreatic cancer achieved over five months of stable disease, along with a 9.8% reduction in tumor volume.
• This result is especially noteworthy because the patient had previously failed three lines of systemic therapy, indicating that PAS-004 may work where other therapies have failed.

3. Favorable Safety Profile

• No serious adverse events were reported during the study period.
• Importantly, patients did not experience common MEK-related toxicities such as skin rash or ocular issues.
• This safety data makes PAS-004 potentially suitable for longer-term dosing, which could increase its value as a future combination therapy.

The Secondary Catalyst: $5 Million Public Offering

Alongside the positive clinical results, Pasithea also announced a $5 million public offering, priced at $1.40 per share—the same as the stock’s prior-day close. This offering includes:

• 3,571,428 shares of common stock
• Accompanying Series C and D warrants for future equity access

This move is particularly important for several reasons:

• Signals strength: The company is raising capital without a deep discount, showing confidence in its valuation.
• Finances future trials: The funds will likely support continued development of PAS-004, including the transition to a Phase 2 study.
• Avoids dilution panic: The offering structure, with warrants and a modest size, didn’t spook the market—rather, it added fuel to the rally.

Market Reaction and Volume Surge

In response to the dual announcement, KTTA shares surged by more than 150% intraday, accompanied by a massive spike in trading volume. Prior to the news, KTTA averaged less than 1 million shares traded per day. On May 6, over 40 million shares changed hands—a staggering increase that reflects:

• Retail investor momentum
• Algorithmic trading triggers
• Coverage by biotech-focused funds and analysts

The move pushed KTTA into the spotlight on retail stock forums, Google Trends, and FinTwit.

Why This Matters: MEK Inhibitors Are a Hot Therapeutic Class

The enthusiasm around PAS-004 isn’t just about a single drug—it’s part of a broader investment trend. MEK inhibitors, which block a key node in the MAPK signaling pathway, are viewed as critical components in treating cancers driven by RAS and RAF mutations.

Approved MEK inhibitors such as Trametinib (Mekinist) and Cobimetinib have shown success, but they are often associated with toxicity issues or limited durability. If Pasithea’s PAS-004 continues to demonstrate strong pERK suppression with minimal side effects, it could become a next-gen option for patients with few alternatives.

Risks and Caveats

Despite the excitement, there are several factors investors must keep in mind:

• Phase 1 Data Is Early: The current results, while promising, come from a small sample size. Phase 2 and 3 trials will be needed to confirm efficacy and safety in a broader population.
• Funding Needs Remain High: Although the company raised $5 million, biotech development is capital-intensive. Additional offerings may be required.
• Regulatory and Competitive Risks: Pasithea is not alone in the MEK inhibitor space. Larger players like Novartis and Roche already have approved products, and other next-gen competitors are in the pipeline.

Pasithea’s Position Going Forward

KTTA’s rally is not unwarranted. The company now stands at a pivotal point:

• It has clinical proof of mechanism (target engagement confirmed)
• It has early proof of concept (stable disease in late-stage cancer)
• It has capital in hand to move forward

The next major milestones will include:

• Completion of the Phase 1 trial
• Initiation of a multi-arm Phase 2 trial
• Additional preclinical publications or partnerships

If these steps go smoothly, KTTA may transition from a micro-cap story to a legitimate clinical-stage biotech with a defined roadmap.

Final Thoughts

The 150% surge in Pasithea Therapeutics (KTTA) stock is not just a speculative spike—it reflects genuine enthusiasm for clinical validation of PAS-004, a MEK inhibitor candidate with early signs of safety and efficacy.

While the road ahead includes funding challenges, regulatory hurdles, and competitive threats, KTTA’s news places it firmly on the radar of biotech watchers, institutional investors, and even big pharma scouts.

For investors willing to tolerate high risk in pursuit of high reward, KTTA is now a stock worth watching—not because of the chart, but because of the science.

Disclaimer

This article is for informational purposes only and should not be construed as financial advice. Investors should perform their own due diligence or consult a licensed financial advisor before making investment decisions.