공시 • Sep 18
Curatis Holding AG Announces FDA Minutes Confirm Positive Outcome of Meeting on 9. September 2025 - Corticorelin on Track for Phase 3 Curatis Holding AG received the official minutes from the FDA meeting which took place on 9. September. Based on the totality of the feedback and discussions, Curatis can proceed as planned with the clinical development of corticorelin. Corticorelin is under development as a novel treatment intended to reduce or even eliminate steroid use and associated toxicities thereby potentially impacting the quality of life of patients suffering from peritumoral brain edema (PTBE) associated with metastatic (secondary) brain tumors. The virtual meeting with the FDA provided the opportunity to discuss the clinical development plan for corticorelin and encompassed CMC (Chemistry, Manufacturing and Control), nonclinical and clinical aspects. The offical FDA minutes which Curatis received after publication of the half year results reflect the positive outcome. Curatis may proceed without delay to a regulatory submission supporting a pivotal study in patients suffering from PTBE secondary to solid tumor brain metastases. The Phase 3 will utilize an adaptive trial design consisting of a dose optimization lead-in and confirmatory segment. PTBE occurs in association with many primary and metastatic (secondary) brain tumors, often in connection with metastases caused by lung cancer, breast cancer, melanoma and colorectal cancer. PTBE results in impairment of brain function due to the accumulation of extracellular fluid around the tumor and can cause symptoms such as headaches, vomiting and neurological dysfunction such as paralysis, speech disorders, visual problems and altered mental status. Standard of care treatment for PTBE is the use of corticosteroids which frequently have serious side effects such as severe myopathy, impared glucose metabolism, muscle wasting, abnormal weight gain, oeoporosis, gastritis, gastrointestinal bleeding, hypertension and personality changes. Additionally, corticosteroids can also counteract certain cancer therapies such as chemotherapy or emerging immunotherapies. In the US alone, more than 150,000 patients suffer from PTBE. 공시 • May 23
Curatis Holding AG Announces Executive Changes Curatis Holding AG announced strengthening the team with Kirsty Crame, MD, as Chief Medical Officer and Timm Trenktrog, PhD, as Head of Chemistry, Manufacturing and Controls (CMC). Kirsty Crame, MD, was educated at the University of Amsterdam as a Doctor of Medicine. She has more than 12 years of experience in clinical development, of which more than 10 years have been in the field of immuno-oncology in a variety of indications for rare and non-rare diseases. Kirsty was previously a member of the Executive Committee and Vice President of Clinical Strategy and Development at Medigene, a German biotech company specializing in the development of highly innovative, T-cell receptor-directed cancer therapies. Prior to that, she was Director of Clinical Development at Gadeta, a Dutch company specializing in the development of novel immunotherapies. Kirsty will support Curatis in the preparation and conduct of the pivotal Phase 3 study with C-PTBE-01 and also brings extensive experience in regulatory affairs. Timm Trenktrog, PhD, worked for Actelion Pharmaceuticals Ltd. in Switzerland for more than 19 years, most recently as Vice President and Head of Technical Operations on the Executive Board. As a leading pharmaceutical expert, he lectured for over 10 years at the ETH Zurich on quality, production and technical development. Timm will support Curatis in the area of technical development and manufacturing (CMC) for C-PTBE-01 to ensure smooth production and the highest quality of the active ingredient, dosage form and final product. 공시 • Mar 11
Curatis Announces Formation of Distinguished Advisory Board Curatis Holding announced the formation of an Advisory Board comprised of four internationally recognized experts across multiple medical and scientific disciplines. The board brings together leaders in pediatric oncology, neurology, drug development, and biochemistry to guide Curatis's research initiatives and strategic direction. The Advisory Board includes: Stewart Goldman, MD – An internationally renowned pediatric oncologist who serves as Chair of the Department of Child Health at the University of Arizona College of Medicine - Phoenix and Senior Vice President of Research at Phoenix Children's. Dr. Goldman oversees more than 700 research studies and is an accomplished leader in brain tumor research with over 170 peer-reviewed publications. Previously, he spent 23 years at Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine. Prof. Dr. Andreas Gantenbein – Past-president of the Swiss Headache Society and a distinguished neurologist whose research focuses on clinical studies including medication overuse headache, menstrual migraine, and CGRP-antibodies. Prof. Gantenbein began his career as a clinical research fellow in the Headache Group at Queen Square, London, and has since published more than 100 articles in peer-reviewed journals. He currently runs a private practice in Bülach after serving as Chief Physician of Neurology at the rehabilitation center RehaClinic Bad Zurzach. Dr. Anthony Man, B.Med Sci, MB, BS, FRCP (UK) – A physician with over 35 years of experience in international clinical research and drug development across multiple therapeutic areas. Dr. Man has contributed to more than 30 successful new drug applications and has held senior management positions at pharmaceutical companies including Lederle, Roche, Ciba Geigy, and Novartis. He also served as Chief Development Officer and Chief Executive Officer of Basilea Pharmaceutica from 2000-2013. Prof. Dr. Arnim Pause, M.Sc., Ph.D. – A Professor of Biochemistry at McGill University'sGoodman Cancer Institute and the Department of Biochemistry in Montreal, Canada. Prof. Pause is also Senior Director of Research at Kreamedica Inc. and has authored over 90 high-impact peer-reviewed publications, book chapters, and patents. With experience in both academia and industry, his research expertise spans molecular medicine with a focus on cancer biology. 공시 • Nov 14
Curatis Holding AG to Apply for A Biologic License for C-PTBE-01 in the USA Curatis Holding AG has explored in detail which regulatory pathway should be pursued in view of a possible approval of C-PBTE-01 in the USA. The detailed clarifications in collaboration with a renowned US law firm and their regulatory experts have shown that C-PTBE-01 meets the criteria for a Biologic License Application (BLA). If approved in the USA, this would result in a market protection of 12 years, significantly longer than the 7 years market protection under orphan drug status. This would extend the market protection for C-PTBE-01 in the USA by 70% or 5 years. 공시 • May 31
Curatis Holding AG, Annual General Meeting, Jun 21, 2024 Curatis Holding AG, Annual General Meeting, Jun 21, 2024, at 14:00 W. Europe Standard Time. Location: pratteln Switzerland 공시 • Jan 29
Curatis AG entered into a transaction agreement to acquire Kinarus Therapeutics Holding AG (SWX:KNRS) in a reverse merger transaction. Curatis AG entered into a transaction agreement to acquire Kinarus Therapeutics Holding AG (SWX:KNRS) in a reverse merger transaction on January 29, 2024. Under the terms of the Transaction Agreement, shareholders of Curatis shall exchange each outstanding Curatis share (into one newly issued Kinarus Holding share, whereby the consideration consists of approx. 14x the number of outstanding Kinarus shares (the “Consideration Shares”). Kinarus Holding shall be renamed to Curatis Holding AG with a proposed change of ticker symbol to (“CURE”) and the domicile of the Company be moved to Liestal, Basel-Landschaft. All shareholders of Curatis shall contribute and exchange their Curatis Shares (as a contribution in kind in an ordinary capital increase of Kinarus Holding) into Consideration Shares in the context of this contemplated transaction. In addition to the Combination Transaction, Kinarus Holding and Curatis have placed an offer with the bankruptcy administrator ("Konkursverwaltung") of Basel-Stadt to purchase selected assets (patents, products and precursor, intellectual property as well as data of Kinarus AG in Liquidation relating to their lead product candidate, KIN001) from the bankruptcy estate of Kinarus AG in Liquidation, a 100% subsidiary of Kinarus Holding. Concurrently, also subject to approval by the Extraordinary General Meeting of Kinarus Holding, the Company will reduce the nominal value of the New Kinarus Shares from CHF 44.80 post Reserve Share Split to CHF 0.10 with a swap of CHF 44.70 in nominal amount per New Kinarus Share from share capital into statutory capital reserves. As a result, the nominal value per New Kinarus Shares will be CHF0.10. The final details of the Reverse Share Split transaction are expected to be announced together with the invititation to the Extraordinary General Meeting of Kinarus Holding in February 2024. As a result of all these transactions, the currently outstanding share capital of Kinarus Holding will be aggregated in the ratio 4,480:1, leading to 292,450 New Kinarus Shares post Reverse Share Split. In the context of the closing of the Combination Transaction, 4,093,916 New Kinarus Shares will be issued and used to settle the Combination Transaction with a share exchange ratio 1:1 for Curatis shares. Post the implementation of the Transaction, Kinarus Holding is expected to have an issued share capital of CHF438,636.60, divided into 4,386,366 New Kinarus Holding shares with nominal value CHF0.10 each. In addition, Kinarus Holding will have a maximum of approx. 850,000 options outstanding to third parties to purchase New Kinarus Shares so that the maximum total amount of fully diluted number of New Kinarus Shares outstanding is approximately 5,250,000. In the context of the Combination Transaction, it is envisaged that an up to CHF 5.5 milllion financing transaction in the form of a Mandatory Exchangeable Loan Note issued by Curatis (the “Financing Round”) is implemented. The closing of the Transaction is subject to various conditions Approval by the courts of Basel-Stadt to revert bankruptcy for Kinarus Holding, Approval of all proposed resolutions to the Extraordinary General Meeting of Kinarus Holding, being scheduled for on or around end of February or early March 2024, Approval by the SIX Swiss Exchange of the listing of the newly issued shares of Kinarus Holding in the frame of the Transaction and Approval by the bankruptcy administrator ("Konkursverwaltung") of Basel-Stadt to sell the assets, patents, IP and data relating to KIN001 in line with the submitted offer by Kinarus Holding and Curatis. The Transaction is expected to close in Q2 2024. 
