BRAF

MIAMI, April 29, 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 the Company has completed enrollment and initial dosing of three subjects in Cohort 6 with 30 mg capsules of PAS-004. “We are pleased to have recruited, enrolled and commenced dosing of the initial three subjects in Cohort 6 more rapidly than anticipated and we currently expect to complete enrollment of all patients in the trial by the end of 2025,” said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (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 subject to various risks and uncertainties, including risks that future clinical trial results may not match results observed to date, may be negative or ambiguous, or may not reach the level of statistical significance required for regulatory approval, as well as other 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). 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. Pasithea Therapeutics Contact Patrick Gaynes Corporate Communications pgaynes@pasithea.com Released April 29, 2025

LUT014 Gel Shows Statistically Significant Reductions of Acneiform Rash in the Intention-to- Treat and Per-Protocol Patient Analyses as Compared to Placebo Patients Randomized to LUT014 Had Lower Rates of Interruption of Anti-EGFRI Therapy Due to Acneiform Rash Study Presented at the Clinical Trials Plenary Session TEL AVIV, Israel, April 28, 2025 /PRNewswire/ -- Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing cutaneous dose limiting toxicity, presented data from its recently completed double-blind, placebo-controlled phase 2 randomized clinical trial of lead therapy, LUT014 gel, demonstrating statistically-significant reductions in dose-limiting acneiform rash in patients treated with epidermal growth factor receptor (EGFR) inhibitor therapy. This new clinical data, showing that Lutris' topically-applied novel B-Raf inhibitor gel is optimized for paradoxical MAPK activation, was presented yesterday in an oral presentation at the Clinical Trials Plenary Session at the American Association for Cancer Research (AACR) Annual Meeting 2025. Presentation Details: Presentation Title: A double-blind placebo-controlled randomized phase 2 clinical trial to assess the efficacy of a topical BRAF inhibitor for acneiform rash toxicities from anti-EGFR therapies Presenting Author: Anisha B. Patel, MD, Associate Professor, Department of Dermatology, University of Texas MD Anderson Cancer Center, Houston, TX Abstract Number: CT018 Session Title: New Frontiers in Precision Oncology "Due to the widespread use of EGFR inhibitors for cancer treatment and the frequent occurrence of dermal toxicities, many patients do not receive optimal cancer therapy. This is often because the toxicity leads to dose reductions or complete discontinuation of treatment," stated Benjamin W. Corn, M.D., Chief Medical Officer of Lutris Pharma. "By reversing the inhibitory effect of anti-EGFR therapy on downstream signaling in skin cells, we firmly believe LUT014 has the potential to be a key therapeutic, offering significant benefits to patients with no other effective treatment options. In the trial, as we expected, LUT014 demonstrated statistically significant improvement in acneiform rash compared to placebo, with highly successful outcomes in both intention-to-treat and per-protocol patient analyses. LUT014 was also shown to be safe and well tolerated, with fewer adverse events reported than in the placebo group, with the majority of adverse events being mild." "This was the first placebo-controlled randomized clinical trial demonstrating the benefit and safety of an agent for the treatment of the acneiform rash associated with anti-EGFR therapy. Therefore, having these overwhelmingly positive results for LUT014 selected for an oral presentation at the prestigious AACR Annual Meeting, is a testament to the potential of our lead asset and a significant milestone for the company," added Noa Shelach, Ph.D., Chief Operating Officer of Lutris Pharma. "In addition, our successful $30 million financing, completed in January 2025, allows us to continue advancing our clinical development program as we pursue our goal of commercializing LUT014 which will align with our mission to enhance the effectiveness of anti-cancer therapies and significantly improve the quality of life for patients." The trial enrolled 118 colorectal cancer patients from 23 clinical sites, all of whom had developed grade 2 or non-infected grade 3 acneiform rash while receiving cetuximab or panitumumab. Participants were randomized in a 1:1:1 ratio to receive either LUT014 gel 0.03%, LUT014 gel 0.1%, or a placebo gel. The gel was applied daily for 28 days. The primary endpoint was the proportion of patients who achieved treatment success, measured by an improvement of at least one grade in Common Terminology Criteria for Adverse Events (CTCAE) scoring or an improvement of at least 5 points in the Functional Assessment of Cancer Therapy (FACT)-EGFRI-18 HRQoL skin-specific assessment. The study employed both an intention-to-treat (ITT) analysis and a Per-Protocol (PP) analysis (i.e., patients who dropped out or did not discontinue their EGFR inhibitor for reasons unrelated to the rash, such as disease progression were excluded from the analysis). Sample size calculation was based on an expected treatment success of 20% for the placebo group and 50% for one of the treatment groups. A total of 117 patients were required for a two group ꭕ2 test with a 0.05 two-sided significance and 80% power. Efficacy is shown in the table below. In the ITT as well as the PP, the composite endpoint demonstrated statistically significant rates of success for the high dose LUT014 group, compared to placebo. About EGFR Inhibitor-Induced Rash EGFR is a receptor on the surface of cells which is expressed in many normal epithelial tissues, including skin. The EGFR signaling pathway is one of the key pathways that regulate growth, survival, proliferation, and differentiation of cells. B-Raf is a protein encoded by the BRAF gene and is a downstream effector component of the EGFR signaling pathway. EGFR has been shown to be over-activated in various human cancers, including colorectal, lung, head and neck, urinary bladder, pancreatic and breast cancers, eliciting downstream phosphorylation and activation of the MAP Kinase pathway. EGFR inhibitors can block the EGFR signal responsible for cell growth. Among the various types of pharmacological therapies for cancer, EGFR inhibitors are increasingly being used both as primary therapy as well as in patients who have progressed on prior chemotherapy treatments. Although effective as an anti-cancer therapy leading to tumor shrinkage, EGFR inhibitors have many adverse reactions associated with their use. The majority of patients treated with EGFR inhibitors will experience adverse dermatological side effects typically manifested as a papulopustular skin rash, also known as acneiform lesions, which can impact quality of life and affect adherence to therapy. About LUT014 LUT014 is a novel B-Raf inhibitor which is applied topically to the skin. When the B-Raf protein is mutated, as is the case in some human cancers such as melanoma, blocking this pathway leads to apoptosis of the cells and tumor shrinkage. However, when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAPK pathway is activated, and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses the paradoxical effect of B-Raf Inhibitors in order to enhance cell proliferation and balance cell destruction, typical to radiation dermatitis. About Lutris Pharma Lutris Pharma is a clinical stage biopharmaceutical company focused on improving anti-cancer therapy effectiveness and quality of life for patients who are being treated with EGFR (Epidermal Growth Factor Receptor) inhibitors or with radiation, where dermal toxicity often leads to a reduction of anti-cancer therapy compliance. The company aims to provide novel topical therapies in order to mitigate these side effects. Lutris Pharma's lead asset, LUT014, a B-Raf Inhibitor, is a proprietary, first-in-class, small molecule formulated as a topical gel, has recently been studied in a phase 2 clinical trial in metastatic colorectal cancer patients with EGFR inhibitor induced acneiform lesions and previously had successfully completed a phase 1/2 study for the treatment of radiation-induced dermatitis in breast cancer patients. For more information, please visit . Contacts: Lutris Pharma Noa Shelach, Ph.D. Chief Operating Officer [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] SOURCE Lutris Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHANGHAI, April 25, 2025 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the supplemental new drug application (“NDA”) for toripalimab (trade name: TUOYI®) as the first-line treatment for unresectable or metastatic melanoma has been approved by the National Medical Products Administration (“NMPA”). This marks the approval of toripalimab’s 12th indication in the Chinese mainland. Melanoma is the most malignant type of skin cancer. According to GLOBOCAN 2022 statistics, approximately 332,000 new melanoma cases and 59,000 deaths were recorded globally that year. Though melanoma is relatively uncommon in China, its mortality rate is high (approximately 5,000 deaths amongst approximately 9,000 new cases in 2022) and its incidence rate is rising year by year. Since 2018, anti-PD-1 monoclonal antibodies have been approved for the second-line or later treatment of advanced melanoma in China and are widely used clinically. However, the first-line standard treatment for advanced melanoma is still dominated by traditional chemotherapy or targeted therapy (limited to patients with BRAF V600 mutation). Until now, no domestic anti-PD-1 monoclonal antibody had been approved for advanced melanoma in China, creating an urgent clinical need for first-line immunotherapy options. The supplemental NDA approval is based on data from the MELATORCH study (NCT03430297). MELATORCH is a multicenter, randomized, open-label, positive-controlled Phase 3 clinical study, and is also the first pivotal registrational clinical study of a PD-(L)1 inhibitor as the first-line treatment for advanced melanoma that has yielded positive results. Led by Professor Jun GUO from Peking University Cancer Hospital as the Principal Investigator, the study was conducted in 11 clinical centers across the country. The study was designed to compare the efficacy and safety of toripalimab versus dacarbazine for the systemic anti-tumor treatment-naive patients with unresectable or metastatic melanoma. Prior to this, the results of the MELATORCH study made its debut at the 27th National Clinical Oncology Conference and 2024 Chinese Society of Clinical Oncology (CSCO) Annual Meeting. The results showed that compared with the dacarbazine group (N=128), the progression-free survival (“PFS”) assessed by Blinded Independent Central Review (BICR) of the toripalimab group (N=127) was significantly prolonged, with the median PFS of the two groups being 2.3 months vs. 2.1 months respectively, and the disease progression or mortality risk was reduced by 29.2% (hazard ratio [HR]=0.708, 95% CI: 0.526-0.954; P=0.0209). The sensitivity analysis of median overall survival (“OS”), corrected for the impact of subsequent anti-tumor treatment, showed that compared with the dacarbazine group, the toripalimab treatment group showed a significant trend towards survival benefit, with the median OS being 15.1 months vs. 9.4 months (HR=0.680, 95% CI: 0.486-0.951) respectively. Toripalimab has a good safety profile that is consistent with previous studies with no new safety signals identified. Professor Jun GUO from Peking University Cancer Hospital said, “Melanoma is a highly aggressive cancer. Due to its low sensitivity to traditional radiotherapy and chemotherapy, patients are often faced with poor survival outcomes. However, thanks to melanoma’s high immunogenicity, immunotherapies such as toripalimab have significantly improved patient survival in recent years. In China, advanced melanoma patients—including those in second-line and later—have gained broad access to these treatments through national medical insurance. Now, toripalimab has been extended to first-line treatment of advanced melanoma. Compared to traditional chemotherapy, toripalimab has demonstrated significant advantages in PFS, ORR, and DoR, as well as a clear trend toward improved OS. Notably, this approval was based on the MELATORCH study, which exclusively enrolled Chinese patients. The trial design aligned closely with clinical practice in China, and thus the findings were more relevant to Chinese melanoma patients. We hope that China’s independently developed immunotherapies like toripalimab can provide a comprehensive treatment solution for advanced melanoma and offer new hope to more patients.” Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, also shared her enthusiasm: “Within a month, toripalimab has secured approvals for two new indications—liver cancer and melanoma. This milestone achievement was, without a doubt, made possible by the selfless and dedicated collaboration of researchers, participating patients, and R&D teams. Seven years ago, toripalimab had just pioneered breakthroughs in second-line melanoma treatment, becoming China’s first domestically developed anti-PD-1 monoclonal antibody and starting a new era of immunotherapy in China; today, toripalimab is again reaching new heights as it becomes the first Chinese-developed first-line immunotherapy for melanoma. Not only does this demonstrate toripalimab’s exceptional clinical value, it also reflects China’s growing strength and innovation in immuno-oncology. Moving forward, we will remain committed to advancing world-class therapies to benefit patients across the world!” About Toripalimab Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are twelve approved indications for toripalimab in the Chinese mainland: unresectable or metastatic melanoma after failure of standard systemic therapy;recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC);in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC);in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) patients;first-line treatment for unresectable or metastatic melanoma. The first 10 indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China. Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia, Singapore and other countries and regions. In addition, toripalimab BLAs are under review in many countries or regions around the globe. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com. Junshi Biosciences Contact InformationIR Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800 PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86 021-6105 8800