On December 1, 2025 GSK plc (LSE/NYSE: GSK) reported it will present new data from its haematology portfolio at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (6 – 9 December), reinforcing its potential to redefine outcomes for patients with difficult-to-treat blood cancers.

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New results from the DREAMM programme for belantamab mafodotin further support its potential to extend remission in relapsed or refractory multiple myeloma, with development in newly diagnosed patients underway

Key presentations include:

Updated results from DREAMM-8 (median 35.8 months of follow-up) explore depth of response and sustained benefit for patients with relapsed or refractory multiple myeloma (Abstract #2264)
DREAMM-7 post hoc analysis explores patient characteristics and outcomes associated with duration and depth of response in responders with progression-free survival (PFS) greater than three years (Abstract #2262)
Combined DREAMM-7 and DREAMM-8 subgroup analysis evaluates PFS and minimal residual disease negativity rates following treatment with belantamab mafodotin versus standard of care therapies in patients with functional high-risk relapsed or refractory multiple myeloma, a population with typically poor outcomes (Abstract #5820)
Analyses from DREAMM-9 in transplant-ineligible newly diagnosed multiple myeloma patients assess the potential for higher initial dose intensity to optimise response, followed by dosing schedule extensions to minimise the potential for eye-related side effects (Abstract #5840)
New analyses for momelotinib build on positive MOMENTUM and SIMPLIFY trial results, assessing spleen and anaemia endpoints alongside overall survival, and early results from a first combination trial will be presented

Additional analyses from MOMENTUM and SIMPLIFY-1 highlight the ability of momelotinib to improve haemoglobin levels and achieve a dual response — both transfusion independence and spleen volume reduction — and the association of these outcomes with survival outcomes in myelofibrosis patients with or without prior JAK inhibitor therapy. (Abstract #2023)

Preliminary efficacy and safety results will be shared from the ODYSSEY trial — the first combination trial for momelotinib evaluating it in combination with luspatercept. The trial explores whether momelotinib’s unique dual mechanism, targeting both anaemia and splenomegaly, can serve as a foundational backbone in future combination therapies to deliver deeper, more durable responses. (Abstract #3803).

Additional presentations include:

Post hoc analysis from the MOMENTUM trial assesses the association between increased momelotinib exposure and greater anaemia-related benefits in patients previously treated with JAK inhibitors (Abstract #5580)
Analyses show momelotinib survival results in intermediate- and high-risk patients as defined by the RR6 model following switch from ruxolitinib, a standard of care, at or before 6 months (Abstract #5579)
Full list of GSK’s presentations at ASH (Free ASH Whitepaper):
Belantamab mafodotin
Abstract name Presenter Presentation details
Deep responses and durable outcomes in patients treated with belantamab mafodotin plus pomalidomide and dexamethasone from long-term follow-up of the phase 3 DREAMM-8 study S. Trudel Poster, Abstract #2264
Long-term responders from the phase 3 DREAMM-7 study of belantamab mafodotin plus bortezomib and dexamethasone vs daratumumab plus bortezomib and dexamethasone in relapsed/refractory multiple myeloma V. Hungria Poster, Abstract #2262
Functional high-risk relapsed/refractory multiple myeloma (RRMM) outcomes with belantamab mafodotin (belamaf): DREAMM-7 and DREAMM-8 subgroup analysis M. Mateos Poster, Abstract #5820
Health-related quality of life with belantamab mafodotin in patients with relapsed or refractory multiple myeloma (RRMM): An exploratory analysis of overall quality of life in DREAMM-7 S. Lonial Poster, Abstract #4029
Belantamab mafodotin (Belamaf) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for patients (pts) with transplant-ineligible (TI) newly diagnosed multiple myeloma (NDMM): A focus on treatment efficacy and management/resolution of ocular events in the Phase 1 DREAMM-9 study S. Usmani Poster, Abstract #5840
Patients with relapsed/refractory multiple myeloma who achieved sustained minimal residual disease negativity in the DREAMM-7 trial M. Mateos Poster, Abstract #2265
Impact of belantamab mafodotin–containing regimens on renal function in patients with relapsed/refractory multiple myeloma (RRMM) and mild/moderate renal impairment in the DREAMM-7 and DREAMM-8 trials M. Lacerda Poster, Abstract #2260
Belantamab mafodotin (belamaf) ocular events are manageable and reversible with dose modifications guided by standard assessments S. Lonial Poster, Abstract #4055
An exploratory analysis of health-related quality of life measures with belantamab mafodotin in combination with pomalidomide and dexamethasone (BPd) in patients with relapsed or refractory multiple myeloma (RRMM) enrolled in DREAMM-8 P. Richardson Poster, Abstract #2284
Patient-reported outcomes from DREAMM-7 and DREAMM-8 using the EQ-5D-3L, patient global impression of severity, and patient global impression of change S. Trudel Poster, Abstract #5823
Integrated modeling analyses for belantamab mafodotin in combination with standard of care in patients with relapsed/refractory multiple myeloma (RRMM) From DREAMM-6, DREAMM-7, and DREAMM-8 F. Carreño Poster, Abstract #4043
Years of life lost to multiple myeloma remains high: A targeted literature review A. Bates Poster, Abstract #2804
Life-years and quality-adjusted life-years with belantamab mafodotin, bortezomib, and dexamethasone vs alternative regimens in patients with relapsed/refractory multiple myeloma who received ≥1 prior line of therapy A. Suvannasankha Poster, Abstract #4041
Chimeric antigen receptor T cells in real-world care of multiple myeloma: Patient characteristics and healthcare resource utilization N. Boytsov Poster, Abstract #2787
Bispecific antibodies in real-world care of multiple myeloma: Patient characteristics and healthcare resource utilization N. Boytsov Poster, Abstract #2790
Characteristics of patients with relapsed/refractory multiple myeloma (RRMM) in Europe and the US L. Kalilani ePublication
Indirect treatment comparison of belantamab mafodotin + pomalidomide + dexamethasone Versus comparator regimens in lenalidomide-exposed relapsed/refractory multiple myeloma: A network meta-analysis J. Richter ePublication
Administration- and adverse event-related costs among patients with multiple myeloma treated with B-cell maturation antigen (BCMA)-targeted agents N. Boytsov ePublication
Momelotinib
Abstract name Presenter Presentation details
Dual transfusion independence and spleen volume reduction is associated with overall survival in patients with myelofibrosis treated with momelotinib: Post hoc analyses of SIMPLIFY-1 and MOMENTUM B. Psaila Poster, Abstract #2023
Association between momelotinib exposure and hemoglobin improvement in patients with myelofibrosis and anemia: An exposure-response and time-to-event analysis V. Gupta Poster, Abstract #5580
Preliminary experience from the ODYSSEY trial: Efficacy and safety of momelotinib in combination with luspatercept in patients with transfusion-dependent myelofibrosis P. Bose Poster, Abstract #3803
Survival outcomes in ruxolitinib-treated patients with myelofibrosis following crossover to momelotinib: Application of the response to ruxolitinib at 6 months (RR6) prognostic model to SIMPLIFY-1 R. Rampal Poster, Abstract #5579
Impact of hemoglobin improvement with momelotinib on survival in patients with myelofibrosis and anemia: Post hoc analyses of the SIMPLIFY-1 and MOMENTUM trials P. Vachhani Poster, Abstract #5581
Transfusion independence with momelotinib regardless of baseline erythropoietin levels in the Phase 3 SIMPLIFY-1 trial S. Oh Poster, Abstract #2025
Survival and clinical outcomes in patients with myelofibrosis and new or worsening anemia treated with ruxolitinib: A systematic review and meta-analysis A. Kuykendall Poster, Abstract #2031
Impact of new or worsening anemia and thrombocytopenia on clinical outcomes in JAK inhibitor–naive myelofibrosis patients treated with ruxolitinib V. Gupta Poster, Abstract #3809
Unveiling prognostic subtypes in myelofibrosis through routine blood counts: a population-based analysis of the cytopenic and proliferative phenotypes in andalusia, spain R. Garcia Delgardo ePublication
Discovery of drug combinations with momelotinib to improve myelofibrosis outcomes S. O’Brien ePublication
Momelotinib’s unique polypharmacology supports indication expansion beyond myelofibrosis S. O’Brien ePublication
Full list of Alliance, investigator-initiated studies and supported collaborative studies:
Abstract name Presenter Presentation details
Belantamab mafodotin
Target antigen density impacts clinical response in multiple myeloma patients undergoing treatment with elotuzumab and belantamab mafodotin N. Neparidze ePublication
Can a patient questionnaire (VRAT) reduce the need for ocular examinations with less frequent belantamab mafodotin combined with bortezomib and dexamethasone? The UKMRA PROMMISE D trial R. Popat Poster, Abstract #4065
Belantamab mafodotin, nirogacestat, and pomalidomide in patients with relapsed/refractory multiple myeloma M. Hultcrantz Poster, Abstract #4060
Hematologist-led ocular safety management using the vra tool with belantamab mafodotin plus lenalidomide/dexamethasone in transplant ineligible NDMM: updated results from the RP2D cohort E. Terpos Poster, Abstract #4038
Phase II trial of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone in multiple myeloma following BCMA CAR T-cell therapy B. Derman Poster, Abstract #5832
Momelotinib
Preliminary data from the Phase I/II study of nuvisertib, an oral investigational selective PIM1 inhibitor, in combination with momelotinib showed clinical responses in patients with relapsed/refractory myelofibrosis J. Mascarenhas Oral, Abstract #482
About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.1,2 There are approximately 180,000 new cases of multiple myeloma diagnosed globally each year.3 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.4 Many patients with multiple myeloma, including approximately 70% in the US, are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.5,6,7

About myelofibrosis
Myelofibrosis is a rare blood cancer that disrupts the body’s normal production of blood cells because of dysregulated JAK-signal transducer and activator of transcription protein signalling. The clinical hallmarks of myelofibrosis are splenomegaly (enlarged spleen), severely low blood counts, including anaemia and thrombocytopenia, and debilitating constitutional symptoms, such as fatigue, night sweats and bone pain, attributable to ineffective haematopoiesis and excessive production of proinflammatory cytokines.8,9

About belantamab mafodotin
Belantamab mafodotin is a monoclonal ADC (antibody-drug conjugate) comprising a humanised BCMA (B-cell maturation antigen) conjugated to the cytotoxic agent monomethyl auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

In October 2025, the US FDA approved10 belantamab mafodotin under the brand name Blenrep in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

Belantamab mafodotin in combination with bortezomib and dexamethasone and belantamab mafodotin in combination with pomalidomide and dexamethasone are approved in 2L+ relapsed or refractory multiple myeloma in the European Union11, UK12, Japan13, Canada, Switzerland and Brazil.

Applications are currently under review in other markets globally, including China14 where the application is based on the results of DREAMM-7 and has been granted Breakthrough Therapy Designation and Priority Review.

Indication
In the US, Blenrep is indicated in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

Please see accompanying US Prescribing Information.

About momelotinib
Momelotinib has a differentiated mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, JAK2, and activin A receptor, type I (ACVR1).15,16,17,18 Inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly.15,16,17 Additionally, inhibition of ACVR1 leads to a decrease in circulating hepcidin levels, potentially contributing to anaemia-related benefit.15,16,17,18

In September 2023, the US Food and Drug Administration approved19 momelotinib under the brand name Ojjaara for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythemia), in adults with anaemia.

In January 2024, the European Commission granted marketing authorisation20 for momelotinib for disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib. Momelotinib was also approved21 by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom to treat the symptoms experienced by adult myelofibrosis patients who have moderate or severe anaemia.

In June 2024, the Japan Ministry of Health, Labour and Welfare (MHLW) approved22 momelotinib for the treatment of myelofibrosis. Momelotinib is currently approved in 21 countries and applications are under review in other markets globally.

Important information for momelotinib in the EU
Indication
Momelotinib is indicated for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

Refer to the Omjjara EMA Reference Information for a full list of adverse events and the complete important safety information in the EU.

(Press release, GlaxoSmithKline, DEC 1, 2025, View Source [SID1234661018])

On December 1, 2025 Cleveland Diagnostics, Inc., a pioneering, commercial-stage precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has approved the company’s IsoPSA in vitro diagnostic (IVD) kit through the Premarket Approval (PMA) process. IsoPSA is a blood-based test indicated as an aid in the decision for prostate biopsy for men ≥ 50 years of age with elevated PSA levels.

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"FDA approval of our IsoPSA kit marks a significant milestone in Cleveland Diagnostics’ mission to help physicians and patients detect cancer early when it is most treatable and survivable," shared Arnon Chait, PhD, company president and CEO. "We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide."

FDA approval of the IsoPSA test was based on clinical evidence from a large-scale, prospective study conducted at 14 sites across the U.S. and data from supporting analytical validation studies.

Prostate cancer is the second most common cancer in American men, with 1 in 8 diagnosed during their lifetime. In the U.S., greater than 1 million men undergo prostate biopsies each year, yet up to 75% of those follow-up tests are negative for high-grade disease. This diagnostic gap subjects millions to invasive, costly procedures that can produce physical risks, emotional stress, and significant healthcare costs. IsoPSA helps close this gap, giving clinicians and patients a more accurate risk assessment and greater confidence in biopsy decision-making.

"As a practicing urologist, I see firsthand how the limitations of current PSA testing can lead to unnecessary procedures and anxiety for patients and appreciate the critical need for early and accurate risk assessment and testing," added Dr. Aaron Berger, Chief Medical Officer and Director of Clinical Research at Associated Urological Specialists in Chicago. "IsoPSA represents a meaningful advancement, giving physicians a tool that improves risk assessment and helps us make more informed biopsy decisions with greater confidence."

"FDA approval underscores the value and clinical utility of IsoPSA in distinguishing benign elevations of PSA from those due to high grade cancer," said Dr. Eric Klein, Emeritus Chair of the Glickman Urological & Kidney Institute at Cleveland Clinic and Distinguished Scientist at GRAIL, Inc.* "I’m very pleased to see this milestone achieved; it represents the culmination of extensive study and test development over the past decade."

The IsoPSA IVD kit leverages Cleveland Diagnostics’ IsoClear platform. This proprietary technology investigates protein biomarkers at a structural level in the blood to provide clinically relevant insights into disease state.

Cleveland Diagnostics has offered IsoPSA as a Laboratory-Developed Test (LDT) since 2020, and Medicare and a growing number of commercial payors now cover the test. IsoPSA is included in leading clinical practice guidelines, including the National Comprehensive Cancer Network (NCCN) Prostate Cancer Early Detection Guideline (2025) and the Early Detection of Prostate Cancer: American Urology Association/Society of Urologic Oncology Guideline (2023).

(Press release, Cleveland Diagnostics, DEC 1, 2025, View Source;-Cleveland-Diagnostics-Novel-Blood-Based-Prostate-Cancer-Test [SID1234661034])

On December 1, 2025 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company’s senior management team will participate at the Piper Sandler 37th Annual Healthcare Conference in a fireside chat on Thursday, December 4, 2025 at 10:30 a.m. ET in New York, NY.

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A live webcast of the fireside chat can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source, and will be available for replay following the event.

(Press release, Karyopharm, DEC 1, 2025, View Source [SID1234661019])

On December 1, 2025 SAGA Diagnostics, a pioneer in blood-based cancer detection and precision medicine redefining the standard for ultra-sensitive and early molecular residual disease (MRD) detection, reported it will present five posters—three new studies and two trials in progress—at the 2025 San Antonio Breast Cancer Symposium (SABCS), December 9-12, 2025 in San Antonio, TX.

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The posters build on the TRACER clinical study findings published in Clinical Cancer Research, which demonstrated 100% sensitivity, 100% specificity, and a 13.7-month lead time to recurrence across all subtypes of stage I–III breast cancer. The data presented at SABCS further validates the best-in-class performance of Pathlight, SAGA’s structural-variant (SV)–based MRD test. This clinical validation data provided the basis for a positive coverage determination for Pathlight under the US Centers for Medicare Services MolDx program. SAGA’s collaborating investigators will also present posters introducing a prospective interventional study designed to evaluate clinical utility using Pathlight.

"Building on the very compelling TRACER data, we are advancing into prospective interventional trials to address the critical question of clinical utility," said Dr. David Cescon, Medical Oncologist and Clinician Scientist at Princess Margaret Cancer Centre, University of Toronto. "Our CLAIRE and CATER studies are now enrolling participants to evaluate whether ctDNA-based surveillance and intervention can improve outcomes in early-stage breast cancer. This is an important step toward integrating MRD-guided strategies into standard clinical care."

Updated TRACER Study Analysis

The retrospective analysis of an expanded set of 121 patients with TNBC, HER2+, or ER+/HER2– early breast cancer showed 100% sensitivity, 100% specificity, and a median 12-month lead time from ctDNA detection to clinical recurrence. Rising ctDNA ("molecular progression") preceded radiographic progression in all patients, and baseline SVs were reproducibly detected across longitudinal timepoints in both early-stage and metastatic disease.

Studies Advancing Clinical Utility

Pathlight is being used in two studies to evaluate the impact of MRD detection on clinical decision-making:

Circulating Liquid Biomarkers for Assessment and Identification in Early BREast Cancer (CLAIRE): A multicenter surveillance study using Pathlight every three months for up to five years in intermediate- to high-risk ER+/HER2– early breast cancer, to prospectively characterize the surveillance process and identify candidates for interventional MRD trials.
CApecitabine for Targeted Eradication of Rising ctDNA Molecular Residual Disease in ER+/HER2- Breast Cancer (CATER): An open-label, Phase II study testing whether secondary adjuvant metronomic capecitabine can eradicate ctDNA in patients previously diagnosed with high-risk ER+/HER2– early breast cancer who have detectable MRD despite standard curative intent therapies. Pathlight will be used to assess ctDNA clearance at 16 weeks as the primary endpoint.
Additional posters will be presented focusing on TNBC, including a poster spotlight, highlighting Pathlight’s performance in the neoadjuvant setting.

"The studies presented at SABCS 2025 continue to validate what we consistently see with Pathlight—ultra-sensitive ctDNA detection that can meaningfully improve early breast-cancer management," said Wendy Levin, MD, MS, Chief Clinical Officer of SAGA Diagnostics. "By leveraging truncal SVs, Pathlight provides a dependable signal clinicians can trust. The new prospective studies take us beyond analytical performance into demonstrating true clinical utility."

SAGA Diagnostics also celebrates the recognition of Dr. Mitchell J. Elliott, first author of the TRACER study, who has been selected to receive the prestigious Margaret Foti Foundation Scholar-in-Training Award at SABCS. This award honors outstanding young scientists conducting high-quality cancer research, and Dr. Elliott’s contributions to advancing ultra-sensitive MRD detection in breast cancer exemplify that standard.

Key SAGA Diagnostics presentations during SABCS 2025:

Abstract title

Presentation details

Prevalence and Dynamics of Circulating Tumor DNA Among Patients with Triple-negative Breast Cancer Undergoing Preoperative Systemic Therapy With or Without Immunotherapy

Poster presentation PS2-07-06

Date: December 10, 2025

Time: 5:00-6:30 PM CST

Presenter: Tae-Kyung Robyn Yoo, Asan Medical Center, Seoul, Republic of Korea

Longitudinal ctDNA Tracking in Early and Recurrent Breast Cancer Using an Ultra-Sensitive Structural Variant-Based Assay: An Updated Analysis from the TRACER Study

Poster Presentation PS2-07-08

Date: December 10, 2025

Time: 5:00-6:30 PM CST

Presenter: Mitchell J Elliott, Princess Margaret Cancer Centre, Toronto, ON, Canada

Neo-N (neon) – Three-year Event-free Survival and Ultra-Sensitive ctDNA Dynamics in Early Triple-negative Breast Cancer Treated with Neoadjuvant Carboplatin/Paclitaxel and Nivolumab

Poster Spotlight 7 (PD7-10): Early Triple Negative Breast Cancer—Biomarkers and Novel Approaches

Date: December 11, 2025

Time: 7:00-8:30 AM CST

Presenter: Sherene Loi, Peter MacCallum Cancer Centre, Melbourne, Australia

CLAIRE – a multicenter, prospective single-arm phase II trial, evaluating liquid biopsy guided intensified follow-up surveillance in women with intermediate to high-risk ER+/HER2-negative early-stage breast cancer

Poster Presentation: PS2-07-08

Date: December 12, 2025

Time: 12:30-2:00 PM CST

Presenter: Mitchell J Elliott, Princess Margaret Cancer Centre, Toronto, ON, Canada

CATER-MRD: Capecitabine for Targeted Eradication of ctDNA Molecular Residual Disease in ER-positive/HER2-negative Early-stage Breast Cancer

Poster Presentation: PS5-09-28

Date: December 12, 2025

Time: 12:30-2:00 PM CST

Presenter: Mitchell J Elliott, Princess Margaret Cancer Centre, Toronto, ON, Canada

The full posters will be available on SAGA Diagnostics’ website after they are presented.

(Press release, SAGA Diagnostics, DEC 1, 2025, View Source [SID1234661035])

On November 28, 2025 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), reported 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.

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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 View Source 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 [email protected].

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.

(Press release, Pasithea Therapeutics, NOV 28, 2025, View Source [SID1234660995])