On track for initial interim safety and PK data release in Q3 2024

2024年第三季度发布初始临时安全和PK数据

MIAMI, June 13, 2024 (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 indications, announced today that an independent Safety Review Committee (SRC) has completed its safety review of data from the first dose cohort (2mg) treated in the ongoing Phase 1 clinical trial (NCT06299839) 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..

迈阿密，2024年6月13日（环球通讯社）--Pasithea Therapeutics Corp.（纳斯达克：KTTA）（“Pasithea”或“公司”），一家临床阶段生物技术公司，开发下一代大环MEK抑制剂PAS-004，用于治疗1型神经纤维瘤病（NF1）和其他适应症，今天宣布，一个独立的安全审查委员会（SRC）已经完成了对PAS-004正在进行的1期临床试验（NCT06299839）中治疗的第一剂量队列（2mg）数据的安全性审查，这些数据来自MAPK途径驱动的晚期实体瘤患者，这些患者有RAS，NF1或RAF突变或BRAF/失败MEK抑制。。

Based on these findings, the SRC recommended that the trial escalate to the next dose level (4mg) without modifications. This recommendation was based on the absence of any dose limiting toxicities (DLT’s) or clinically relevant treatment-emergent adverse events in the initial cohort of 3 patients. The Company has now completed enrollment and initial dosing of 3 patients in the second cohort..

基于这些发现，SRC建议将试验升级至下一剂量水平（4mg），无需修改。这项建议是基于在最初的3名患者队列中没有任何剂量限制性毒性（DLT）或临床相关的治疗紧急不良事件。该公司现已完成第二组中3名患者的登记和初始给药。。

Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea stated, 'We are pleased to have rapidly enrolled and completed first dosing of the participants in the second cohort following the SRC's positive recommendation to advance to 4mg of PAS-004. We look forward to continuing to develop PAS-004 as a potential treatment for solid tumors as well as cutaneous and plexiform neurofibromas in NF1 patients.

Pasithea首席执行官Tiago Reis Marques博士表示，“我们很高兴在SRC积极建议将PAS-004剂量提高到4mg后，迅速登记并完成了第二组参与者的首次给药。我们期待着继续开发PAS-004作为NF1患者实体瘤以及皮肤和丛状神经纤维瘤的潜在治疗方法。

We remain on track to present our initial safety and pharmacokinetic (PK) data in the third quarter of 2024.'.

我们将继续在2024年第三季度提供我们的初始安全性和药代动力学（PK）数据。”。

The Phase 1 trial is a multicenter, open-label, dose escalation study evaluating the safety, tolerability, and pharmacokinetics (PK) and pharmacodynamics (PD) 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.

第一阶段试验是一项多中心，开放标签，剂量递增研究，评估PAS-004在MAPK途径驱动的晚期实体瘤患者中的安全性，耐受性，药代动力学（PK）和药效学（PD），其中记录了RAS，NF1或RAF突变或BRAF/MEK抑制失败的患者。

The primary objective of the study is to assess the safety and tolerability of PAS-004, with secondary objectives including PK and PD parameters, an evaluation of the preliminary anticancer activity (efficacy) of PAS-004 and defining the preliminary recommended Phase 2 dose(s)..

该研究的主要目的是评估PAS-004的安全性和耐受性，次要目标包括PK和PD参数，评估PAS-004的初步抗癌活性（功效），并确定初步推荐的2期剂量。。

About Pasithea Therapeutics Corp.

关于Pasithea Therapeutics Corp。

Pasithea is a biotechnology company focused on the discovery, research and development of innovative treatments for central nervous system (CNS) disorders and RASopathies. With an experienced team of experts in the fields of neuroscience, translational medicine, and drug development, Pasithea is developing new molecular entities for the treatment of neurological disorders, including Neurofibromatosis type 1 (NF1), Solid Tumors, and Amyotrophic Lateral Sclerosis (ALS)..

Pasithea是一家生物技术公司，专注于发现、研究和开发中枢神经系统（CNS）疾病和RASopathies的创新治疗方法。Pasithea拥有神经科学、转化医学和药物开发领域经验丰富的专家团队，正在开发用于治疗神经疾病的新分子实体，包括1型神经纤维瘤病（NF1）、实体瘤和肌萎缩侧索硬化症（ALS）。。

Forward Looking Statements

前瞻性声明

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 all 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, preclinical studies and clinical trials, clinical and regulatory timelines, market opportunity, competitive position, potential growth opportunities and other statements that are predictive in nature.

本新闻稿包含的声明构成根据1995年《私人证券诉讼改革法》安全港条款所作的“前瞻性声明”。这些前瞻性陈述包括除历史事实陈述外的所有关于公司对其业务未来事件的当前观点和假设的陈述，以及关于公司计划、假设、期望、信念和目标、公司当前和未来业务战略的成功、产品开发、临床前研究和临床试验、临床和监管时间表、市场机会、竞争地位、潜在增长机会和其他预测性陈述的其他陈述。

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.

前瞻性陈述受到许多条件的限制，其中许多条件超出了公司的控制范围。虽然公司认为这些前瞻性陈述是合理的，但不应过度依赖任何此类前瞻性陈述，这些前瞻性陈述是基于公司在本发布之日可获得的信息。

These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including 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).

这些前瞻性陈述基于当前的估计和假设，并受到各种风险和不确定性的影响，包括公司最新的10-K表年度报告、10-Q表季度报告以及向美国证券交易委员会（SEC）提交的其他文件中规定的因素。

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..

因此，实际结果可能会有很大不同。除法律要求外，本公司无义务在本发布日期后更新这些报表，无论是由于新信息、未来事件还是其他原因。。

Contact

联系人

Patrick Gaynes

Patrick Gaynes

Corporate Communications

公司通信

pgaynes@pasithea.com

pgaynes@pasithea.com