Pasithea Therapeutics Provides Outlook on PAS-004 Clinical Programs and Data Release Timelines

Rhea-AI Summary

Pasithea Therapeutics (NASDAQ: KTTA) updated timelines for PAS-004 clinical programs and reported a $60 million gross public offering completed December 2025 to fund operations through at least H1 2028. The company completed enrollment of 12 adult NF1-PN patients across four dose cohorts (4, 8, 12, 18 mg) in Part A and plans to present safety, tolerability, PK and six-month efficacy data in H2 2026. For the advanced cancer Phase 1 study, Pasithea expects longer-term follow-up from Cohort 4–8 (15–45 mg) in Q2 2026. Prior results included a partial response and a 71.4% disease control rate in efficacy-evaluable BRAF-mutated tumors.

Positive

• Raised $60 million gross proceeds in December 2025
• Completed enrollment of 12 NF1-PN patients in Part A
• Plans NF1 six-month efficacy data release in H2 2026
• Advanced cancer follow-up data expected in Q2 2026
• 71.4% disease control rate in BRAF-mutated efficacy-evaluable patients

Negative

• Small NF1-PN cohort: only 12 patients enrolled to date
• Funding runway through at least H1 2028 implies cash limits beyond that

News Market Reaction

-3.26%

2 alerts

-3.26% News Effect

-11.0% Trough Tracked

-$704K Valuation Impact

$21M Market Cap

0.0x Rel. Volume

On the day this news was published, KTTA declined 3.26%, reflecting a moderate negative market reaction. Argus tracked a trough of -11.0% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $704K from the company's valuation, bringing the market cap to $21M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

NF1-PN Part A enrollment: 12 patients NF1-PN dose cohorts: 4, 8, 12, 18 mg tablets Advanced cancer cohorts: 15–45 mg capsules (Cohorts 4–8) +5 more

8 metrics

NF1-PN Part A enrollment 12 patients Phase 1/1b adult NF1-PN trial Part A

NF1-PN dose cohorts 4, 8, 12, 18 mg tablets First 4 dose cohorts in Part A

Advanced cancer cohorts 15–45 mg capsules (Cohorts 4–8) Ongoing Phase 1 cancer trial

Disease control rate 71.4% Efficacy-evaluable BRAF-mutated tumors, prior MEK inhibitor

Public offering proceeds $60 million Gross proceeds from December 2025 public offering

Cash runway Through at least H1 2028 Runway guidance post $60M offering

NF1-PN efficacy horizon 6-month timepoint Planned efficacy readout window for NF1-PN study

Key development year 2025 Described as pivotal year with early safety and activity signals

Market Reality Check

Price: $0.9099 Vol: Volume 140,720 is 0.32x t...

low vol

$0.9099 Last Close

Volume Volume 140,720 is 0.32x the 20-day average of 436,165, suggesting limited pre-news positioning. low

Technical Shares at 0.905 are trading slightly below the 200-day MA of 0.91 and 76.49% below the 3.85 52-week high.

Peers on Argus

Peers in Biotechnology showed mixed moves, with SXTP up 4.39% and ADTX up 3.17% ...

Peers in Biotechnology showed mixed moves, with SXTP up 4.39% and ADTX up 3.17% while PALI, TTNP and TNFA were down between 3.96% and 9.72%, indicating stock-specific factors for KTTA.

Historical Context

5 past events · Latest: Dec 02 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 02	Equity offering close	Neutral	+2.6%	Closing of $60M public offering at $0.75 per share.
Nov 28	Equity offering pricing	Negative	+38.7%	Pricing of $60M offering of 80M shares/pre-funded warrants.
Nov 25	ALS trial grant	Positive	+14.8%	Approx. $1M ALS Association grant for PAS-004 Phase 1 study.
Nov 24	Cancer trial update	Positive	+45.3%	Completion of Cohort 7 in PAS-004 cancer trial with positive safety/PK/PD.
Nov 21	NF1 PK data	Positive	-29.6%	Positive tablet PK data in NF1-PN Phase 1/1b with higher exposure.

Pattern Detected

The stock has reacted positively to several financings and clinical updates, but there are instances where positive clinical PK data coincided with a sharp selloff, indicating inconsistent reactions to ostensibly favorable news.

Recent Company History

Over the past few months, Pasithea focused on financing and advancing PAS-004. In November 2025, it reported positive PK and PD data in advanced cancer and NF1-PN, plus an ALS grant of about $1 million, with generally strong share reactions except for one PK update that sold off. Late November and early December saw a major $60 million equity offering around $0.75 per share, which extended cash runway to at least the first half of 2028 and was met with positive price responses.

Market Pulse Summary

This announcement details PAS-004’s clinical trajectory, including completion of 12 NF1-PN patients ...

Analysis

This announcement details PAS-004’s clinical trajectory, including completion of 12 NF1-PN patients in Part A, planned six‑month efficacy readouts, and longer-term oncology follow-up. It also reiterates prior signals such as a 71.4% disease control rate in BRAF‑mutated tumors and the $60 million financing that extended runway into at least H1 2028. Investors may watch upcoming 2026 data presentations, safety consistency across higher doses, and continued capital discipline.

Key Terms

macrocyclic mek inhibitor, neurofibromatosis type 1, pharmacokinetic (pk), phase 1/1b, +4 more

8 terms

macrocyclic mek inhibitor medical

"PAS-004, a next-generation oral macrocyclic MEK inhibitor for the treatment..."

A macrocyclic MEK inhibitor is a type of cancer drug built around a large ring-shaped molecule that blocks the MEK protein, a key switch in a cell growth pathway often hijacked by tumors. For investors, these drugs matter because they can slow or stop tumor growth where that pathway is active, so clinical results, safety issues, and regulatory decisions can quickly change a biotech’s value—think of it as cutting the fuel line to an engine driving tumor growth.

neurofibromatosis type 1 medical

"for the treatment of neurofibromatosis type 1 associated plexiform neurofibromas..."

A genetic condition that causes noncancerous tumors to grow on nerves and can lead to skin changes, pain, learning challenges and other complications; severity varies widely from mild to serious. Investors track it because treatments, diagnostics and care pathways for this distinct patient group can drive clinical trial outcomes, regulatory approvals and long‑term revenue, much like a niche market where the size, unmet need and treatment complexity determine potential returns.

pharmacokinetic (pk) medical

"expected to include safety, tolerability and pharmacokinetic (PK) data."

Pharmacokinetic (pk) describes how a substance, such as a medication or chemical, moves through and is processed by the body over time. It includes how the substance is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps assess the potential effectiveness, safety, and market success of new drugs or treatments.

phase 1/1b medical

"Ongoing Phase 1/1b clinical trial in adult patients with NF1-PN..."

Phase 1/1b describes early-stage clinical testing in humans where researchers first assess a drug’s safety, tolerable dose range and how the body processes it; phase 1b often means small expansion groups to explore the best dose and look for initial signs the treatment might work. For investors, these studies are like the first road tests of a new product—positive results reduce risk and increase value potential, while negative or unclear results raise uncertainty about future development.

disease control rate medical

"including a partial response and an initial disease control rate of 71.4%..."

The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy can meaningfully limit disease, which matters to investors assessing a drug’s potential efficacy and commercial value.

braf-mutated tumors medical

"among efficacy evaluable patients with BRAF-mutated tumors..."

Tumors described as BRAF-mutated carry a specific change in the BRAF gene that helps cancer cells grow and survive; this genetic change can appear in multiple cancer types. For investors, the presence of a BRAF mutation matters because it identifies patients who may respond to targeted drugs or diagnostic tests—like a lock that fits a particular key—so clinical trial results, approvals, or new tests can materially affect a drug’s market potential and company valuation.

dose escalation medical

"first-in-human dose escalation advanced cancer study of PAS-004..."

Dose escalation is the process of gradually increasing the amount of a treatment or substance over time. In finance, it can refer to slowly raising investments or commitments to manage risk and assess performance. For investors, understanding dose escalation helps gauge how companies or strategies adjust their approaches, which can impact future growth or stability.

me k inhibitor medical

"our potentially best-in-class macrocyclic MEK inhibitor"

A MEK inhibitor is a type of drug that blocks a specific enzyme (MEK) involved in a cell’s growth signaling pathway, slowing or stopping the uncontrolled growth of cancer cells. For investors, MEK inhibitors matter because their effectiveness, safety, regulatory approvals, and role in combination treatments can drive a drug’s commercial value and affect the financial prospects of companies developing or selling targeted cancer therapies — think of it as cutting a key wire in a malfunctioning electrical circuit.

AI-generated analysis. Not financial advice.

MIAMI, Jan. 13, 2026 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation oral macrocyclic MEK inhibitor for the treatment of neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN), today provided updated timelines on its ongoing clinical trials in advanced cancer and adult NF1-PN patients.

Ongoing Phase 1/1b clinical trial in adult patients with NF1-PN (NCT06961565):

• Pasithea has completed enrollment of 12 patients through the first 4 dose cohorts (4, 8, 12 and 18 mg tablets) in Part A of the study.   
  
  
• The Company plans to present data in the second half of 2026, including available efficacy data through the six-month timepoint for both plexiform and cutaneous neurofibromas. The planned data release is also expected to include safety, tolerability and pharmacokinetic (PK) data.
  

Ongoing Phase 1 clinical trial in advanced cancer patients (NCT06299839):

• Pasithea expects to present longer-term follow-up data from patients in Cohort 4 (15mg capsule) through Cohort 8 (45mg capsule) in the second quarter of 2026.
  

“2025 was a pivotal year for Pasithea, highlighted by early evidence of a differentiated safety and tolerability profile and initial signals of clinical activity in our first-in-human dose escalation advanced cancer study of PAS-004, our potentially best-in-class macrocyclic MEK inhibitor,” said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. “In November 2025, we announced encouraging results in patients previously treated with a MEK inhibitor, including a partial response and an initial disease control rate of 71.4% among efficacy evaluable patients with BRAF-mutated tumors and met our planned milestone of providing initial NF1-relevant data through the presentation of pharmacokinetic results in the first two cohorts of our NF1 study. We believe these findings from our advanced cancer study support the development of PAS-004 for the treatment of NF1-PN patients. Additionally, in December 2025, we successfully raised $60 million in gross proceeds through a public offering, enabling us to advance PAS-004 through several key milestones and support operations through at least the first half of 2028. We remain steadfast in our mission to deliver safe, tolerable and effective therapies to patients with significant unmet need, especially in indications requiring chronic dosing.”

About Pasithea Therapeutics Corp.

Pasithea is a clinical-stage biotechnology company primarily focused on the research and development of its lead drug candidate, PAS-004, a next-generation macrocyclic MEK inhibitor intended for the treatment of RASopathies, MAPK pathway-driven tumors, and other diseases. The Company is currently testing PAS-004 in a Phase 1 clinical trial in advanced cancer patients (NCT06299839), and a Phase 1/1b clinical trial in adult patients with neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas (NCT06961565).

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the Company’s ongoing Phase 1 clinical trial of PAS-004 in advanced cancer patients, the Company’s ongoing Phase 1/1b clinical trial of PAS-004 in adult NF1 patients, and the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD) and preliminary efficacy of PAS-004, as well as all other statements, other than statements of historical fact, regarding the Company’s current views and assumptions with respect to future events regarding its business, as well as other statements with respect to the Company’s plans, assumptions, expectations, beliefs and objectives, the success of the Company’s current and future business strategies, product development, pre-clinical studies, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth and financing opportunities and other statements that are predictive in nature. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including risks that future clinical trial results may not match results observed to date, may be negative or ambiguous, or may not reach the level of statistical significance required for regulatory approval, as well as other factors set forth in the Company’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other filings made with the U.S. Securities and Exchange Commission (SEC). Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.

Pasithea Therapeutics Contact

Patrick Gaynes
Corporate Communications
pgaynes@pasithea.com

FAQ

What PAS-004 NF1-PN data will Pasithea (KTTA) release in H2 2026?

Pasithea plans to release safety, tolerability, PK and six-month efficacy data for NF1-PN Part A in H2 2026.

When will Pasithea (KTTA) present advanced cancer follow-up data for PAS-004?

Longer-term follow-up data from Cohort 4–8 (15–45 mg) is expected in Q2 2026.

How much capital did Pasithea (KTTA) raise in December 2025 and what is the runway?

Pasithea raised $60 million gross proceeds in December 2025, funding operations through at least H1 2028.

What were the clinical activity signals reported for PAS-004 in 2025?

Reported signals include a partial response and a 71.4% disease control rate in BRAF-mutated efficacy-evaluable patients.

How many NF1-PN patients were enrolled in PAS-004 Part A as of Jan 13, 2026?

Enrollment of 12 adult NF1-PN patients across four dose cohorts (4, 8, 12, 18 mg) was completed.