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

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

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Pasithea Therapeutics Announces Pricing of $60 Million Public Offering of Common Stock Pasithea Therapeutics (Nasdaq: KTTA) priced a public offering of 80,000,000 shares (or pre-funded warrants) at $0.75 per share, expected to close on or about December 1, 2025, with gross proceeds of approximately $60 million before fees. The offering was led by healthcare investors including Vivo Capital and Janus Henderson Investors, with H.C. Wainwright & Co. as placement agent.The company said net proceeds will be used for general corporate purposes and that pro forma cash will extend the cash runway through at least the first half of 2028. Securities are offered under an effective Form S-1 (File No. 333-291611).

#KTTA #KTTAW Pasithea Therapeutics Announces Pricing of $60 Million Public Offering of Common Stock

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Pasithea Therapeutics Announces $1 Million Award by ALS Association to Study the Efficacy, Safety, and Tolerability of PAS-004 for Treatment of ALS Pasithea Therapeutics (NASDAQ: KTTA) announced on November 25, 2025 that the ALS Association awarded a Hoffman ALS Clinical Trial Award grant of approximately $1 million to support a Phase 1 study of PAS-004 in ALS patients.The funded study will enroll 12 patients across three sequential dose cohorts with about 28 weeks of follow-up. Endpoints include safety, tolerability, ALS Functional Rating Scale–Revised (ALSFRS-R) changes and neurofilament light chain (NfL) levels. Pasithea notes prior efficacy in the SOD mouse model and that PAS-004 is already in clinic for neurofibromatosis and advanced cancers with a promising safety profile.

#KTTA #KTTAW Pasithea Therapeutics Announces $1 Million Award by ALS Association to Study the Efficacy, Safety, and Tolerability of PAS-004 for Treatment of ALS

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Pasithea Therapeutics Announces Positive PAS-004 Tablet Pharmacokinetic (PK) Data in Ongoing Phase 1/1b Trial in Adult NF1 Patients -- Tablet steady state showing Cmax/Cmin ratio

#KTTA #KTTAW Pasithea Therapeutics Announces Positive PAS-004 Tablet Pharmacokinetic (PK) Data in Ongoing Phase 1/1b Trial in Adult NF1 Patients

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10,000 NF1 Patients: Pasithea's Next-Gen MEK Inhibitor Trial Launches at Korea's Largest Hospitals Biotech firm Pasithea launches Phase 1/1b trial of PAS-004 MEK inhibitor at ASAN and Severance hospitals, targeting 10,000 NF1 patients in South Korea. First patient dosed in key expansion.

#KTTA #KTTAW Pasithea Therapeutics Announces Activation of Clinical Trial Sites in South Korea for Phase 1/1b Trial of PAS-004 in Adult NF1 Patients

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Clinical-Stage Biotech Pasithea Therapeutics Announces Updated Schedule for H.C. Wainwright Conference Pasithea Therapeutics (NASDAQ: KTTA) CEO Dr. Tiago Reis Marques to present at H.C. Wainwright Conference on Sept 8 at 5:00 PM ET. Company developing PAS-004 MEK inhibitor.

#KTTA #KTTAW Pasithea Therapeutics Updates Time of Presentation at the H.C. Wainwright 27th Annual Global Investment Conference

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Revolutionary Once-Daily NF1 Treatment Begins Phase 1/1b Trial: First Patients Successfully Dosed Novel once-daily MEK inhibitor shows promising early safety profile in NF1 treatment. Key efficacy data expected Q1 2026. Learn more about this potential breakthrough.

#KTTA #KTTAW Pasithea Therapeutics Completes Enrollment and Initial Dosing of First Cohort from its Phase 1/1b Clinical Trial of PAS-004 in Adult NF1 Patients

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Pasithea Therapeutics Presents Updated Interim Data from Ongoing Phase 1 Study of PAS-004 at the ASCO Annual Meeting 2025 Pasithea Therapeutics has presented updated interim data from its Phase 1 study of PAS-004, a next-generation macrocyclic MEK inhibitor, at ASCO 2025. The study enrolled 21 patients with MAPK pathway-driven advanced solid tumors across six dosing cohorts. Key findings show PAS-004 demonstrating preliminary clinical activity in heavily pre-treated patients, with notable results in cohort 4A (15mg capsule). A stage 4 BRAF-mutated melanoma patient achieved stable disease with -14.9% tumor reduction after 5+ months. The drug showed favorable pharmacokinetics with a half-life exceeding 60 hours and maintained good tolerability with only grade 1 or 2 adverse events. Of 16 evaluable patients, 10 achieved stable disease, with progression-free survival up to 159 days and overall survival up to 253 days. The results suggest PAS-004's potential as a best-in-class MEK inhibitor for various MAPK pathway-driven tumors.

#KTTA #KTTAW Pasithea Therapeutics Presents Updated Interim Data from Ongoing Phase 1 Study of PAS-004 at the ASCO Annual Meeting 2025

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Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-004 in Adult NF1 Patients and Activation of First Clinical Trial Site Pasithea Therapeutics (NASDAQ: KTTA) has initiated a Phase 1/1b open-label study for PAS-004, their next-generation macrocyclic MEK inhibitor, in adult patients with neurofibromatosis type 1 (NF1). The trial will begin at Royal North Shore Hospital in Sydney, Australia, with patient dosing expected in Q2 2025. The study will evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy of PAS-004 in treating both plexiform and cutaneous neurofibromas, starting with a 4mg daily tablet dosage. The company plans to expand to additional sites in Australia, South Korea, and the U.S. Notably, Pasithea expects to receive up to 48.5% cash refund on eligible R&D activities through Australian tax incentives. The company is now funded to produce initial interim patient data, with PAS-004 showing promising safety profiles in previous cancer trials.

#KTTA #KTTAW Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-004 in Adult NF1 Patients and Activation of First Clinical Trial Site

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Pasithea Therapeutics Announces Pricing of $5 Million Public Offering Pasithea Therapeutics (NASDAQ: KTTA) has announced the pricing of a $5 million public offering consisting of 3,571,428 shares of common stock (or pre-funded warrants) at $1.40 per share. The offering includes accompanying Series C warrants (5-year expiration) and Series D warrants (18-month expiration), both with an exercise price of $1.40 per share.H.C. Wainwright & Co. is serving as the exclusive placement agent, with the offering expected to close around May 7, 2025. The company plans to use the proceeds for general corporate purposes, including research, clinical trials, technology development, potential acquisitions, and working capital. Pasithea is developing PAS-004, a next-generation macrocyclic MEK inhibitor for neurofibromatosis type 1 and other cancer indications.

#KTTA #KTTAW Pasithea Therapeutics Announces Pricing of $5 Million Public Offering

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Pasithea Therapeutics Reports Positive Pharmacodynamic Results Demonstrating Robust Target Engagement from its Ongoing Phase 1 Clinical Trial of PAS-004 Pasithea Therapeutics (NASDAQ: KTTA) reported positive interim pharmacodynamic data from its Phase 1 trial of PAS-004, a next-generation macrocyclic MEK inhibitor. The trial evaluated doses of 8mg, 15mg capsules, and 4mg tablets in advanced cancer patients. Key findings include up to 91% inhibition of pERK, demonstrating robust target engagement. Notably, a stage 4 pancreatic cancer patient with KRAS G12R mutation achieved tumor volume reduction of -9.8% over 5 months of treatment. The drug shows a favorable safety profile with no rash observed. PAS-004 aims to treat neurofibromatosis type 1 (NF1) and other MAPK pathway driven cancers. The ongoing Phase 1 trial (NCT06299839) is designed to evaluate safety, tolerability, and preliminary efficacy in patients with MAPK pathway driven advanced solid tumors.

#KTTA #KTTAW Pasithea Therapeutics Reports Positive Pharmacodynamic Results Demonstrating Robust Target Engagement from its Ongoing Phase 1 Clinical Trial of PAS-004

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Pasithea Therapeutics Announces Completion of Enrollment and Initial Dosing of Patients in Cohort 6 from its Phase 1 Trial of PAS-004 in Advanced Cancer Patients Pasithea Therapeutics (NASDAQ: KTTA) has reached a significant milestone in its Phase 1 clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor. The company has successfully completed enrollment and initial dosing of three subjects in Cohort 6, administering 30 mg capsules of PAS-004. The ongoing trial is designed as a multi-center, open-label, dose escalation 3+3 study, focusing on patients with MAPK pathway driven advanced solid tumors. The study specifically targets patients with documented RAS, NF1, or RAF mutations, or those who have not responded to BRAF/MEK inhibition. CEO Dr. Tiago Reis Marques expressed satisfaction with the rapid recruitment and enrollment pace, projecting complete trial enrollment by the end of 2025. The study aims to evaluate multiple aspects of PAS-004, including: Safety and tolerability Pharmacokinetics (PK) Pharmacodynamics (PD) Preliminary efficacy

#KTTA #KTTAW Pasithea Therapeutics Announces Completion of Enrollment and Initial Dosing of Patients in Cohort 6 from its Phase 1 Trial of PAS-004 in Advanced Cancer Patients

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Pasithea Therapeutics Announces Positive Safety Review Committee (SRC) Recommendation from its Ongoing Phase 1 Clinical Trial of PAS-004 in Advanced Cancer Pasithea Therapeutics (NASDAQ: KTTA) announced positive progress in its Phase 1 clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor for treating neurofibromatosis type 1 (NF1) and other cancers. The Safety Review Committee recommended advancing to Cohort 6 with a 30mg capsule dose following review of Cohort 5 data.Key highlights include:No dose-limiting toxicities (DLTs) observed across 19 patientsZero instances of rash reported during the DLT periodStrong enrollment demand with Cohort 6 patients already identifiedThe trial (NCT06299839) is a multi-center, open-label, dose escalation study evaluating PAS-004's safety, tolerability, and preliminary efficacy in patients with MAPK pathway driven advanced solid tumors. The company plans to release additional safety, pharmacokinetic, and pharmacodynamic data in the coming weeks.

#KTTA #KTTAW Pasithea Therapeutics Announces Positive Safety Review Committee (SRC) Recommendation from its Ongoing Phase 1 Clinical Trial of PAS-004 in Advanced Cancer

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Clinical Trial Breakthrough: Cancer Drug Shows Unprecedented Safety Profile in Phase 1 Pasithea's Phase 1 trial of PAS-004 progresses to 22mg dose, demonstrating superior safety with no rash side effects in 14 patients - a key advantage over competing MEK inhibitors.

#KTTA #KTTAW Pasithea Therapeutics Announces Positive Safety Review Committee (SRC) Recommendation from its ongoing Phase 1 Clinical Trial of PAS-004 in Advanced Cancer

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Pasithea Therapeutics Expands Phase 1 Cancer Trial to Europe, Advances PAS-004 Testing Pasithea adds sites in Romania and Bulgaria for PAS-004 cancer drug trial, completes Cohort 4A dosing. Seven total sites now active with interim data expected Q1 2025.

#KTTA #KTTAW Pasithea Therapeutics Announces Opening of European Clinical Trial Sites and Completes Initial Dosing of Cohort 4

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#KTTA #KTTAW Pasithea Therapeutics Announces Positive Safety Review Committee (SRC) Recommendation from its ongoing Phase 1 Clinical Trial of PAS-004 in Advanced Cancer

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