Curanex is a developmental stage pharmaceutical company dedicated to discovering, developing and commercializing innovative botanical drugs to treat patients suffering from inflammatory diseases. Our mission is to address significant unmet medical needs and improve patients’ lives by harnessing the power of natural substances. We are dedicated to discovering, developing and commercializing botanical medicines for treating patients with immune and inflammatory diseases and to develop therapies that may offer potential benefits to patients with unmet clinical needs in various fields, such as autoimmune diseases, metabolic diseases and viral infections. Our founders and related research personnel have been devoted to natural substances (“phytomedicine”) since 1996. Based on their knowledge and experience of natural substances and relevant technologies, they developed a proprietary platform for identifying, extracting and optimizing novel anti-inflammatory compounds from medicinal plants. We believe that this platform will allow us to create a pipeline of botanical drug candidates with potentially unique mechanisms of action to address unmet medical needs. Our lead drug candidate, Phyto-N, is a proprietary botanical extract with chemical components and pharmacological activities that harnesses potential anti-inflammatory properties of a medicinal plant with a long history of human use. Phyto-N has a long history of use in Chinese traditional medicine, which focuses on an alternative herbal medical practice, and has shown positive results in animal models of multiple inflammatory diseases. Our objective is to prioritize the development of Phyto-N and its active compounds, to conduct further preclinical and clinical studies to evaluate its therapeutic potential and safety profile, and if warranted, to seek the necessary regulatory approval in order to commercialize Phyto-N. Specifically, we aim to establish proof-of-concept for our botanical drug development platform to bring therapies that will improve life of patients who currently have limited or no effective treatment options and to generate value for our stockholders. Our current drug development pipeline encompasses seven core indications: ulcerative colitis, atopic dermatitis, COVID-19, diabetes, nonalcoholic fatty liver disease (“NAFLD”), and gout. If successfully developed and approved, Phyto-N may improve the lives of many patients worldwide. However, our research to date has been limited to preclinical studies for each of these indications. Our initial business plan is to submit an Investigational New Drug application (“IND”) for the treatment of ulcerative colitis in the first half of 2026. If allowed to proceed by the U.S. Food and Drug Administration (“FDA”), a Phase I trial will be initiated 30 days post-IND submission. If the Phase I trial is completed with positive results, we intend to proceed with a Phase II trial for ulcerative colitis as our lead indication. Contingent upon the success of our ulcerative colitis trials, available funding, and other strategic considerations, Curanex may subsequently initiate additional Phase II trials in other high-value indications such as atopic dermatitis, coronavirus (COVID-19), gout, diabetes, and NAFLD. This multiple indication strategy represents our long-term vision to explore and maximize the value of Phyto-N and build a robust pipeline of botanical drug candidates targeting inflammatory diseases. The successful completion of these clinical trials could position Phyto-N as a potential botanical drug candidate for multiple inflammatory indications, addressing specific unmet medical needs. If approved, Phyto-N could provide patients with new treatment options for various inflammatory conditions. As we progress towards clinical development, we will continue to invest in translational research to further elucidate the mechanisms of action, biomarkers, and patient stratification strategies for Phyto-N. These efforts will support our precision medicine approach and help us optimize the design and execution of our clinical trials to improve the chances of success. However, the process for conducting clinical trials is uncertain and there is no assurance that our clinical development activities will meet our planned timelines. There is also no assurance that we will be successful in obtaining FDA regulatory approval, in obtaining sufficient funds to pursue our growth strategy, and in commercialization of our lead or other product candidates. As a company that is developing botanical drugs, we may face challenges that similar companies experienced in the past with obtaining regulatory approval, as the development and approval process for botanical drugs involves additional challenges, including, but not limited to the complex nature of botanical extracts, which may contain multiple active compounds, making it difficult to identify and characterize all active ingredients, challenges in standardization and quality control due to natural variations in plant materials, difficulties in predicting pharmacokinetics and potential drug interactions due to the complex composition of botanical extracts, and manufacturing complexities in scaling up production while maintaining consistency and quality. Currently only two (2) botanical drugs have received FDA approval, such as Veregen® (sinecatechins), a green tea extract for the treatment of genital and perianal warts, and Fulyzaq®/Mytesi® (crofelemer), derived from the Croton lechleri tree, for managing diarrhea in HIV/AIDS patients on antiretroviral therapy. This limited number of approvals highlights both the innovative nature of our approach and the potential challenges in obtaining regulatory approval. These challenges involve additional costs and may result in delays, or failure to obtain the required FDA regulatory approval. --- Curanex was originally incorporated under the laws of the State of New York on June 1, 2018 under thename “Durand Damiel Health Inc,” focusing on research and development (R&D) of health products and botanical medicines. On October 24, 2023, the Company changed its name to “Fordman Pharma Inc.,” and on November 9, 2023, the Company changed its name to Curanex Pharmaceuticals Inc and changed its focus on discovering, developing and commercializing innovative botanical drugs for major unmet needs to treat patients suffering from inflammatory diseases. Our principal executive offices are located in Jericho, NY.
