Core Viewpoint - Klotho Neurosciences, Inc. has received Orphan Drug Designation from the FDA for its gene therapy product KLTO-202, aimed at treating ALS, highlighting the company's commitment to developing innovative treatments for rare neurodegenerative diseases [1][3][5]. Group 1: Company Overview - Klotho Neurosciences, Inc. focuses on gene and cell therapies for neurodegenerative and aging-related diseases, utilizing a patented form of the "anti-aging" human Klotho gene [7]. - The company is developing KLTO-202, which targets motor neuron diseases and muscular dystrophies through a muscle-specific promoter and aims to deliver therapeutic concentrations of the s-KL protein [6][7]. Group 2: Orphan Drug Designation - The FDA's Orphan Drug Designation is granted to treatments for rare diseases affecting fewer than 200,000 people in the U.S., providing incentives such as tax credits and seven years of market exclusivity [2]. - The designation for KLTO-202 validates the scientific approach of Klotho Neurosciences in addressing ALS, a disease with significant unmet medical needs [2][3]. Group 3: ALS Context - ALS, also known as Lou Gehrig's disease, affects fewer than 200,000 people in the U.S., with approximately 5,000 new cases diagnosed annually [4]. - The disease is characterized by motor neuron damage, leading to severe physical decline and is universally fatal [3][4]. Group 4: Development Progress - Klotho Neurosciences has completed proof of concept studies in animal models and is initiating manufacturing of KLTO-202, with plans for further discussions with the FDA and EMA regarding development [5].

NEW YORK, June 30, 2025 /PRNewswire/ -- Klotho Neurosciences, Inc. (NASDAQ: KLTO) today announced that it is moving forward with manufacturing and process development work in preparation for clinical trials of KLTO-202, its investigational gene therapy for amyotrophic lateral sclerosis (ALS).A unique RNA splice variant of the human gene called alpha-Klotho has been licensed by the Company from the Autonomous University of Barcelona ("UAB") including patents, patent applications, research, knowhow and other ...

Core Insights - Klotho Neuroscience, Inc. is partnering with leading researchers from the Okinawa Research Center for Longevity Science to explore the role of the Klotho gene in promoting longevity and reducing neurodegenerative diseases [1][2][3] Company Overview - Klotho Neuroscience, Inc. (NASDAQ: KLTO) focuses on developing cell and gene therapies targeting neurological conditions such as ALS, Alzheimer's Disease, and Parkinson's Disease [1][4] - The company utilizes a patented form of the Klotho gene, specifically the secreted alpha-Klotho protein isoform (s-KL), in its innovative therapies [4] Research and Development - Preliminary data from ORCLS suggests that the alpha-Klotho gene and its protein isoform may contribute to healthy longevity, with decreased levels correlating with various age-related diseases [2][3] - The partnership will analyze blood samples from centenarians to assess the Klotho protein's role in longevity and its potential protective effects against neurodegenerative disorders [3][4] Historical Context - Okinawa is recognized as the original Blue Zone, known for its high concentration of centenarians, validated by extensive research from ORCLS over the past five decades [2][3] - ORCLS has a history of significant discoveries in human aging, including the identification of longevity genes and their translation from model organisms to humans [3]

Core Insights - Klotho Neurosciences, Inc. has terminated its Share Exchange Agreement with SkyBell Technologies, allowing the company to focus on its core R&D programs and enhance shareholder value [2][3] Company Overview - Klotho Neurosciences, Inc. is a biogenetics company specializing in innovative, disease-modifying cell and gene therapies derived from the anti-aging human Klotho gene, targeting neurodegenerative and age-related disorders such as ALS, Alzheimer's, and Parkinson's disease [4] Strategic Implications - The termination of the agreement eliminates the need to issue new common stock to SkyBell, which would have resulted in SkyBell owning 90% of Klotho, thereby preventing significant dilution of existing shareholders [7] - The company will not incur any liability as a result of this termination, allowing it to refocus its strategy and allocate resources towards advancing its primary therapeutic and longevity programs [7]