[glenn1919]

KTTA....................................................................p/m

[Psypheri]

That didn't age well. Looks like it was another bull trap, glad I didn't play with this fire

[Trev1966]

Loaded a few k this morning, great news out, GLTA

[subslover]

We have a runaway train!🥰

[glenn1919]

KTTA..................................p/m

[subslover]

Pasithea Therapeutics Reports Positive Pharmacodynamic Results Demonstrating Robust Target Engagement from its Ongoing Phase 1 Clinical Trial of PAS-004
-- PAS-004 shows up to 91% inhibition of pERK, confirming substantial target engagement --

-- One patient in cohort 4A with stage 4 KRAS G12R mutated pancreatic cancer achieves over 5 months of stable disease with tumor volume reduction of -9.8% --

MIAMI, May 06, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor for the treatment of neurofibromatosis type 1 (NF1) and other MAPK pathway driven cancer indications, today announced positive interim pharmacodynamic (PD) data from its ongoing Phase 1 trial of PAS-004 in advanced cancer patients. The data includes results from cohorts 3 and 4A, evaluating 8mg and 15mg capsules, as well as cohort 4B evaluating 4mg tablets, and demonstrates strong target engagement consistent with PAS-004’s favorable pharmacological profile.

Inhibition of ERK phosphorylation (pERK) is widely recognized as a gold-standard PD biomarker for assessing MEK inhibitor activity. To evaluate target engagement, pERK levels were measured in peripheral blood mononuclear cells (PBMCs) collected from patients at baseline and steady-state at day 22.

Preliminary results demonstrate robust pERK inhibition, with reductions in pERK levels of up to 91% even at the 8mg dose level, in line with a previous developed PK/PD model, confirming substantial target engagement in patients receiving PAS-004.

Pharmacodynamic activity is supported by encouraging preliminary clinical observations, with several patients achieving stable disease and tumor shrinkage while on PAS-004 treament. Notably, one patient in cohort 4A (15mg capsule) with stage 4 KRAS G12R-mutated pancreatic cancer, having progressive disease while on three prior lines of therapy, achieved a tumor volume reduction of -9.8% over 5 months of PAS-004 treatment and currently remains on study.

“With today’s update, we are pleased that PAS-004 has demonstrated clinically meaningful reductions in pERK levels at dose levels that are both well-tolerated and safe, with no rash observed,” said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. “We believe PAS-004’s profile offers the potential to finely modulate MAPK pathway activity, enabled by its previously reported long half-life and favorable pharmacokinetic (PK) profile with a Cmax/Cmin ratio below 2. We’re also encouraged by the emerging clinical signals we’re seeing across multiple cancer types and look forward to sharing further safety, PK and PD data in the coming months.”

The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (NCT06299839).

About Pasithea Therapeutics Corp.

Pasithea is a clinical-stage biotechnology company focused on the discovery, research and development of innovative treatments for central nervous system (CNS) disorders, RASopathies and MAPK pathway driven tumors.

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 planned 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 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

[makinezmoney]

$KTTA: Nice.......... tapped $3

Good call.


GO $KTTA

[Monksdream]

KTTA under $2

[subslover]

Pasithea Therapeutics Announces Positive Safety Review Committee (SRC) Recommendation from its Ongoing Phase 1 Clinical Trial of PAS-004 in Advanced Cancer
– SRC recommended that the trial escalate to the next dose level of 30mg capsule –

– No dose-limiting toxicities (DLT’s) or rash observed to date –

MIAMI, April 10, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, today announced that the external Safety Review Committee recommended that the Company’s Phase 1 clinical trial of PAS-004 in advanced cancer should proceed to Cohort 6, 30mg capsule, without modification. This recommendation was based on the review of the safety data from three patients from Cohort 5 and the absence of any dose limiting toxicities (DLT’s). In addition, no rash has been observed to date during the DLT period in any of the first 19 patients in either capsule (15 patients) or tablet (four patients) formulation of PAS-004. Rash is a common adverse event (AE) that is observed at low doses with competitor MEK inhibitors and may lead to the discontinuation rate in real world practice.

“We are seeing substantial enrollment demand and have already identified Cohort 6 patients. In addition, we continue to observe substantial exposure levels of PAS-004, and remain excited about the possibility of delivering relevant pERK inhibition below the no observed adverse effect levels (NOAEL) as we modeled and observed during our previously conducted nine-month chronic toxicity studies. The on label rash rate for both approved MEKi for NF1 exceeds 80% which leads to patients discontinuing who otherwise should remain on treatment for longer periods of time”, stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. “We will provide additional safety, pharmacokinetic (PK) and pharmacodynamic (PD) data over the next several weeks.”

The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (NCT06299839).

[glenn1919]

ktta...................................................P/M

[Viewmont]

$KTTA Added!
https://www.otcmarkets.com/stock/KTTA/news/story?e&id=3205438

[Monksdream]

KTTA, new 52/week low

[Invest-in-America]

KTTAW: Their Warrants just passed Saturn!! (Damn-it!!!)

[subslover]

Pasithea Therapeutics Announces Positive Safety Review Committee (SRC) Recommendation from its ongoing Phase 1 Clinical Trial of PAS-004 in Advanced Cancer
SRC recommended that the trial escalate to the next dose level of 22mg capsule
No dose-limiting toxicities (DLT’s) or rash observed to date in either capsule or tablet formulations
MIAMI, Feb. 05, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, today announced that the external Safety Review Committee recommended that the Company’s Phase 1 clinical trial of PAS-004 in advanced cancer should proceed to cohort 5, 22mg capsule, without modification. This recommendation was based on the review of the safety data from three patients in cohort 4A (15mg capsule) and the absence of any dose limiting toxicities (DLT’s). In addition, no rash has been observed to date in any of the first 14 patients who have been dosed with PAS-004 in either capsule (12 patients) or tablet (2 patients) formulation. Rash is a common adverse event (AE) that is observed at low doses with competitor MEK inhibitors and may lead to the high discontinuation rate in real world practice.

“As we are observing substantial exposure levels of PAS-004, we remain encouraged by the safety profile PAS-004 continues to exhibit,” stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. “With the differentiated profile of PAS-004, we believe it is possible that this highly specific macrocyclic MEK inhibitor with a half life of greater than 60 hours may change the treatment paradigm for patients with NF1 and inoperable plexiform neurofibromas. We are looking forward to presenting updated pharmakokinetic (PK) and pharmacodynamic (PD) data during Q1 2025.”

The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (NCT06299839).

About Pasithea Therapeutics Corp.

[Invest-in-America]

KTTA: Sporting 47% right now, Homeboy --- at least some SUBSTANTIVE news, vs. merely NOT DILUTING their shares today.

[tw0122]

Cancer results $3.85 + 84%

[PennyStockTrader2]

wow once again I turned out to be right, even though I didnt know I would be right. KTTA has almost fully retreated from the spike. I started buying back in the 4s but I would love to buy heavily right here, I just dont have the free cash but if that changes I would be buying simple as that.

[Surfacetite]

Offering and the stock goes up. Huh?

[Awl416]

Pasithea Therapeutics Announces $5 Million Private Placement Priced At-The-Market Under Nasdaq Rules

[PennyStockTrader2]

Absolutely fantastic, timingwise my buyback was excellent, pricewise it was ok, bought back more than I had started with which I definitely hadnt planned for at the time, now have sold some in the pre-market, lets see where this goes, it could completely or partially retreat, trust me on that, hence why you must, I repeat must take some profits, how much profits and at what price is very very difficult to determine, but I use percentage move, 52 week hi/low, news or anticipation of future news, how much cash I need for other purchases etc. I try very hard not to use by lifetime average (profit or loss), its hard not to consider it, but I really try to distance myself from that - the market doesnt care what I paid for any shares and neither should I but still its hard. Look at price and where yu think price is going based on factors mentioned, etc. Where would I be out of the stock completely, possibly in the 9s somewhere, I would have to see how it moves, volume, etc. But let me say this for the Nth time - these biotech stocks retreat and usually there is no more news coming for months to support the price. If you can trade them at the lower end of their price history with any kind of success, you can effectively lower your average to the point that all the shares you have are free or very very cheap.

[tw0122]

$6.40 hitting

[tw0122]

Not bad up 50% now.. We are encouraged that this patient has been treated continuously into the 6th 28-day dosing cycle with no toxicities or AEs observed. While still early in clinical development, we believe PAS-004 is showing early signs of differentiation, indicating PAS-004 has the potential to outperform current MEK inhibitors in terms of safety, reduced administration frequency, and potentially efficacy. Our goal is to provide a once-daily or less frequent dosing treatment with broader application, not only for NF1 but also for other indications.”

Interim Phase 1 Results

Interim Phase 1 Results

Pharmacokinetics (PK)

Plasma exposure increased with an increase in dose and linear PK is observed
Long half-life of approximately 70 hours will allow for once daily dosing or longer intervals
Prolonged systemic exposure with minimal fluctuation in PAS-004 plasma concentration at steady state (Cmax/Cmin ratio of 1.2) indicates a potential to achieve constant target inhibition
PK plasma curve

At steady-state, drug levels peaked at about 5 hours with a geometric mean maximum concentration (Cmax) of 16.2 and 61.3 ng/mL for the 2 mg and 4 mg dose groups, respectively. The mean elimination half-life was 67.9 hours supporting once-daily or less frequent oral dosing.

“PAS-004 has demonstrated distinct properties that we believe are significant advantages for an oral MEK inhibitor. PAS-004 has a significantly longer half-life compared to early-generation MEK inhibitors, particularly those used for the treatment of NF1, which have half-lives of less than 8 hours. The ability to achieve prolonged plasma exposures, as reflected in stable plasma concentrations at steady state, may potentially allow PAS-004 to achieve efficacious doses with a favorable safety profile,” stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea.

Safety & Tolerability

No treatment-related adverse events (TRAEs) or dose limiting toxicities (DLTs) observed to date
In the first 2 dosing cohorts (n=6), PAS-004 was shown to be well-tolerated with a favorable safety profile with no drug-related dose interruptions, reductions or discontinuations. There were no drug-related serious AEs (SAE) in any dose arm and no protocol-defined stopping criteria were met. Importantly, at the 2 and 4 mg dose levels no rash or skin toxicity, gastro-intestinal (GI) toxicity, or ocular toxicity have been observed to date.

The study independent Safety Review Committee has completed its safety review of data from the second dose cohort of 4 mg and the Company has initiated cohort 3 dosing at an increased dose of 8 mg in capsules and has filed a protocol amendment to increase dosing schedule.

PAS-004 Demonstrates a Differentiated MEK Inhibitor Profile

Unlike first-generation MEK inhibitors for the treatment of NF1 that require twice-daily dosing (BID) and exhibit short half-lives (<8 hours), PAS-004 has the potential to achieve prolonged target inhibition due to its long half-life of approximately 70 hours with once-daily dosing (QD). The PK profile shows consistent plasma levels at steady-state, as reflected by a low Cmax to Cmin ratio, potentially reducing the risks for Cmax-related toxicity. These findings provide a compelling rationale for the advancement of PAS-004 into clinical trials for both the treatment of cutaneous and plexiform neurofibromas in NF1, cancer and other MAPK-driven opportunities. The company expects to provide additional trial updates on a periodic basis as the trial progresses.

[Awl416]

Pasithea Therapeutics Announces Positive Initial Safety, Tolerability, Pharmacokinetic (PK), and Preliminary Efficacy Data from its Phase 1 Clinical Trial of PAS-004 in Advanced Cancer

[PennyStockTrader2]

nice spike last couple days, took some profits, and buying back at these prices and below if necessary

[boywonder1]

Dena Greeves, I was never any SPZI. What a liar. Also, I do not know Andrew. Now, go pound the table somewhere else you egoistical moron! I despise your rhetoric as your deception is known in the OTC. The Truth, as no one listens to Dina,anymore. Get your facts straight, and your your hate speech. Dena would be a wonderful drag name, just saying! 98% of OTC markets are scams but there are players like you! STFU, and get on your knees you lippy fool.

[dinogreeves]

You want to talk about deception I see? You are seating on another scam, two names on that ticker that didn't settle with me, one name works for toxic funders in lieu of shares, are you also one of them? Are you working with Sterling too, I got your pump scam SPZ*I, what else did I expose idiot. Get your facts straight, you know nothing.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174812106

[boywonder1]

WRONG on all accounts. Oh, Dina... You should probs ask pound the table for more advice. No, alias here. I know more projections from you. I am fully competent. I do not like deception and all the stock manipulation in the OTC. I call it as I see it! Greed and Californication, not a pretty look.

[dinogreeves]

Now, I think I know who you are, you have a brother (Andrew) that lives in Cali that you hate so much, you actually despise him and you have changed your alias three times since then. How else would you know Dina Greeves. Go figure, the mind of a trader who has false hopes. You need deliverance and a lot of help.

[dinogreeves]

Nah, nah, one last time, cause I think you need help. This is going to run so hard it is going to make you shit your pants. Just watch. One news, the rest will be history. 100% move in one day.

[dinogreeves]

One last time, this is going to run so hard, it will make your head spin, with or without you or in this case Andrew whoever the fuck he is.

[dinogreeves]

Who the fuck is Andrew, you are a lost soul, you need help. But I guarantee you this is going to run big, easy double from here.

[boywonder1]

Please Dina Greeves, no one believes anything you say. You are just like Andrew and the rest!!!!! GET REAL, pretend and greed will not help you. Nefarious, amen....

[dinogreeves]

MS and other psychotic conditions, just needs one awesome news and this will rocket.

[dinogreeves]

One news, this rockets.

[PennyStockTrader2]

shocked at how low this has gone but I stepped up to buy, now we could possibly have bottomed. very bullish here

[PennyStockTrader2]

continuing to add to my position, this should be a real winner

[PennyStockTrader2]

added more up over 1000 shares accumulated. I believe we have something good here just need the right news, but the price is cheap.

[PennyStockTrader2]

did end up making a little $ on KTTA, now my buddy has been pressuring me bigtime to buy as he believes the upside is just huge. Well finally cash freed up to the degree where I felt comfortable taking a position as it has pulled back, and i have an accumulated position of 500 shares around 7 bucks. This better move. or so help me. In any case, its a reasonable entry point here all the way down to 6 dollars (or below but I dont expect that).

Last check they have 16 mill in the bank which will could last them through end of this year.

[Invest-in-America]

Nope, Bro. (But THANKS for heads-up on it right now.)

[TIMGZ]

DID YOU GRAB SOME BCNN ***OTC**** EARLIER TODAY

[Invest-in-America]

Indeed it was!! (I was simple much too LATE to the party.)

[TIMGZ]

IF TRUMP WINS, WHAT DO YOU THING ABOUT THIS****

White House Says President Biden Will Make Clear To Ukraine's Zelenskyy That U.S. Standing Firm On Additional Funding Request

[TIMGZ]

NEWS WAS OUT AT 801AM, ANYTHING AFTER 30% LIKE tw0122,****PLANNING TO EXIT** 100% START WATCHING LIKE AN OWL TO EXIT GRACIOUSLY. THAT WAS BEAUTIFUL RALLY FOR SUCH A PR

[Invest-in-America]

KTTA: Down the toilet. (I got suckered!!) Maybe later it goes back UP.

[TIMGZ]

YOU ARE VERY OBSERVANT MY FRIEND*****JUST BUY FEW AND WAIT ***HOPEFULLY THE ALGO PICK ON THOSE SELECTION.


SOMETIMES AND MOST TIMES, MARKET IS TIMING BUT VERY HARD TO GET IT RIGHT. WE JUST CONTINUE TO LEARN

[Invest-in-America]

KTTA: YEP!! (I hate those stocks that run-up hard 30-days AFTER they got a low-price warning from the NASDAQ, & nothing else to support such a run-up --- e.g., today's @IONM & @NXTP. Can we PLEASE get a stock that runs-up hard behind some SUBSTANTIVE NEWS????)

[TIMGZ]

THE MARKET IS WEIRD, AS LONG AS THE RALLY IS STARTED BIG***THE PR WAS A START****BUT NOT THIS RALLY. EVEN LOOK AT NXTP, IT RALLIED BIG**

WELCOME TO THE NEW NORM, AS LONG NO ONE IS LATE TO THE RALLY

[Invest-in-America]

KTTA: First of all, I GRABBED some of this, & still hold it. (The negative issue is the techno-jargon manner by which they cleverly VEILED the mere 'test tube' and/or 'petri dish' stage of their research regarding the drug in question.)

[madras50]

what is so negative about it?

[Invest-in-America]

KTTA: Despite my negative opinions about their PR, this may nevertheless have a circa 400%-500% RUN UP today.