PennyStockTrader2
6月前
well, I took a lot of profits, I dont liken how this is trading, we now know there will be massive dilution at 80 cents, so the upside in theory should be limited as people dont want the lenders to make a lot of money, granted they are big biotech funds that wont be selling, nonetheless I would rather take profits and buy back at lower prices if they come, and they very well could come, it could easily go back to a buck or lower dont fool yourselves, I repeat again do not fool yourselves. If it keeps moving up, I keep selling, thats it, its that simple.
subslover
6月前
Pasithea Therapeutics Announces Pricing of $60 Million Public Offering of Common Stock
Extends cash runway through at least the first half of 2028
Led by Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners, and Squadron Capital Management
MIAMI, Nov. 28, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (“Pasithea” or the “Company”) (Nasdaq: KTTA; KTTAW), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), today announced the pricing of a public offering of 80,000,000 shares of the Company’s common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.75 per share of common stock (or per pre-funded warrant in lieu thereof). The public offering was led by healthcare-dedicated investors, including Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners, and Squadron Capital Management.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
The closing of the offering is expected to occur on or about December 1, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds to the Company from the offering are expected to be approximately $60 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes. The Company’s cash position following the closing will extend its cash runway through at least the first half of 2028. Such corporate purposes include, without limitation, ongoing research and pre-clinical studies, clinical trials, the development of new biological and pharmaceutical technologies, investing in or acquiring companies that are synergistic with or complementary to the Company’s technologies, licensing activities related to its current and future product candidates, and to the development of emerging technologies, investing in or acquiring companies that are developing emerging technologies, licensing activities, or the acquisition of other businesses and working capital.
The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-291611) originally filed with the Securities and Exchange Commission (“SEC”) on November 18, 2025, as amended on November 26, 2025, and declared effective on November 28, 2025. The offering is being made only by means of a prospectus, which is part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. When available, electronic copies of the final prospectus may be obtained for free on the SEC’s website located at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.
This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
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).
subslover
6月前
Pasithea Therapeutics Announces $1 Million Award by ALS Association to Study the Efficacy, Safety, and Tolerability of PAS-004 for Treatment of ALS
-- The ALS Association is the world's leading funder of amyotrophic lateral sclerosis (ALS) research --
-- The Hoffman ALS Clinical Trial Awards Program was created to fund early- to mid-stage biomarker-driven clinical trials of novel or repurposed therapeutics for ALS --
MIAMI, Nov. 25, 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, today announced that the ALS Association has awarded a Hoffman ALS Clinical Trial Award grant worth ~$1 million to study PAS-004 in ALS patients. The award was given to study the “Efficacy, safety and tolerability of PAS-004 for the treatment of ALS”.
“We are honored that the ALS Association recognizes the promise of PAS-004,” said Dr. Lawrence Steinman, Chairman of Pasithea. “Its support enables the initiation of the first clinical trial of PAS-004 in individuals living with ALS, which is a significant milestone for Pasithea as we look to provide proof-of-concept that PAS-004 may be the best-in-class MEK inhibitor for the treatment of many indications. I am delighted to continue working on the development of potentially effective treatments for ALS. PAS-004 targets a critical molecule in the pathophysiology of motor neuron disease and has delivered significant and promising results in the ALS gold standard SOD mouse model. PAS-004, already in the clinic for neurofibromatosis and advanced cancers, is showing a promising safety profile and initial monotherapy efficacy signal. We are excited for PAS-004 to enter the clinic for ALS, a disease in great need of advances in therapy."
“The ALS Association’s Hoffman Clinical Trial Awards Program supports early-stage clinical trials of potential new treatments that hold promise for those living with ALS,” said Dr. Kuldip Dave, Senior Vice President of Research at the ALS Association. “We are pleased to support the first dosing of PAS-004 in people living with ALS. By funding programs at this critical stage, we are working to accelerate the development of therapeutic candidates that can help make ALS a livable disease until we can cure it.”
Dr. Tiago Reis Marques, CEO of Pasithea, commented: “Inflammation and the aggregation of a protein called TDP-43 are well-recognized contributors to the development and progression of ALS. Two enzymes, mitogen-activated protein kinase (MAPK) and extracellular signal-regulated kinase (MEK), have been shown to play a role in TDP-43–related neurodegeneration and neuroinflammation, suggesting they represent promising therapeutic targets. This Phase 1 study, awarded to a leading ALS institution in the US, will evaluate PAS-004 in twelve patients with ALS enrolled across three sequential dose cohorts and followed for approximately 28 weeks. In addition to assess safety and tolerability, the study will measure changes in the ALS Functional Rating Scale–Revised (ALSFRS-R) scores and neurofilament light chain (NfL) levels to explore potential early signals of clinical activity.”
PennyStockTrader2
6月前
while this has been painful, I am averaging down as heavily as possible. When this does recover, and I dont think it will be long, it will be breathtaking. the news is out, the risks are minimal, everything is going according to plan per all these PRs, and the potential for the company is thru the roof, $5 - $20, anything is possible. I'd like to see some biotech hedge funds step up to the plate and not leave us little guys doing all the work. In the meantime I have started to do some short term trading but honestly, its safer to buy and hold, but with buying so much stock down here, its ok to trade a little in case the volatility remains. Absolute steal at this price, and under 30 cents I have no words.
subslover
1年前
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
subslover
1年前
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).
subslover
1年前
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.