Klotho Neurosciences, Inc. Stock Price, News & Analysis

Klotho Neurosciences (NASDAQ: KLTO) announced plans to expand beyond its core neurology focus to pursue technologies targeting muscle strength, bone health, and longevity indicators. The company is evaluating acquisitions of complementary technologies to support its proprietary anti-aging Klotho platform, while continuing the development of KLTO-101 and KLTO-202.

The expansion focuses on addressing the decline of Klotho levels with age, which contributes to various age-related disorders including cardiometabolic disease, neurodegeneration, cancer, sarcopenia, and osteoporosis. The company is assembling a scientific team to evaluate genes and proteins such as alpha-Klotho, beta-Klotho, FOXO3, and anti-myostatin to develop interventions for age-related diseases.

Klotho Neurosciences (NASDAQ: KLTO) has announced a strategic partnership with AAVnerGene Inc. to manufacture its gene therapy candidates using AAVnerGene's advanced AAV manufacturing and tissue-targeted delivery technologies.

The collaboration aims to accelerate the development of KLTO's three key candidates: KLTO-101 for Alzheimer's and Parkinson's diseases, KLTO-202 for ALS and motor neuron diseases, and KLTO-303 for aging-related pathologies. AAVnerGene's proprietary platforms - AAVone system and ATHENA platform - promise to deliver more cost-effective, faster manufacturing with higher efficacy, purity, and lower toxicity through improved tissue targeting.

Klotho Neurosciences (NASDAQ:KLTO), a gene and cell therapy company focused on neurodegenerative and aging-related diseases, has regained full compliance with NASDAQ's listing requirements. The company has met both the minimum $1.00 bid price requirement and the minimum stockholders' equity threshold of $2.5 million.

While KLTO will maintain its NASDAQ listing, the exchange will continue monitoring the company's compliance with stockholders' equity requirements for one year. If KLTO falls below the minimum equity threshold during this period, it could face delisting but would have the opportunity to request a hearing.

Klotho Neurosciences (NASDAQ:KLTO) has received FDA Orphan Drug Designation for KLTO-202, its novel secreted-Klotho promoter gene therapy for treating Amyotrophic Lateral Sclerosis (ALS). This designation provides significant benefits including tax credits for clinical trials, GDUFA User Fee waivers, and 7 years of market exclusivity.

KLTO-202 targets motor neuron diseases using a muscle-specific promoter called "desmin" to express the s-KL gene and protein, specifically delivering therapy to the neuromuscular junction. The company has completed proof of concept studies in two animal models and is initiating manufacturing while planning regulatory meetings with the FDA and EMA.

Klotho Neurosciences (NASDAQ: KLTO) announced advancement in manufacturing and process development for KLTO-202, its investigational gene therapy treatment for amyotrophic lateral sclerosis (ALS). The company has licensed a unique RNA splice variant of the human alpha-Klotho gene from the Autonomous University of Barcelona for developing advanced gene therapies.

The company's research has demonstrated that overexpression of secreted alpha-Klotho (s-KL) using gene therapy has shown positive therapeutic outcomes in multiple animal studies, including mouse and non-human primate models. The timeline for development indicates approximately 8 months for manufacturing and 4-6 months for regulatory processes, with Phase I/II clinical trials expected to begin by Q3 2026.

KLTO plans to collaborate with contract research organizations (CROs) to manage manufacturing and clinical trials, maintaining operational efficiency without significant staff expansion. The company aims to use an AAV vector to deliver the s-KL gene directly to motor neurons affected by ALS, a disease that typically leads to paralysis and death within 2-3 years of diagnosis.

Klotho Neurosciences (NASDAQ: KLTO) has announced a partnership with the Okinawa Research Center for Longevity Science (ORCLS) to study tissue levels of the human Klotho gene and protein in Okinawa's centenarian population. The research focuses on understanding how the alpha-Klotho protein may contribute to healthy longevity and lifespan.

The collaboration will analyze blood samples from ORCLS's extensive centenarian study database to investigate the role of Klotho protein in promoting longevity and reducing risks of neurodegenerative diseases. KLTO's preliminary data suggests that maintaining optimum blood levels of Klotho protein in later life correlates with longevity, while lower levels are associated with premature aging and neurological disorders.

The company's patent-protected secreted s-KL protein isoform shows promise for treating conditions like ALS, Alzheimer's, Parkinson's, and other age-related disorders including sarcopenia, osteoporosis, diabetes, and cardiovascular conditions.

Klotho Neurosciences (NASDAQ: KLTO) has announced the mutual termination of its Share Exchange Agreement with SkyBell Technologies, originally signed on March 26, 2025. The termination, formalized on June 13, 2025, prevents substantial shareholder dilution that would have resulted in SkyBell owning 90% of KLTO. The decision allows Klotho to maintain its strategic focus on developing therapeutic and longevity programs, particularly targeting neurodegenerative and age-related diseases. CEO Dr. Joseph Sinkule emphasized the company's commitment to developing anti-aging gene and biologic therapies aimed at slowing the aging process and reducing mortality from age-related organ failure. The termination agreement includes no liability for either party.

Klotho Neurosciences (NASDAQ: KLTO) has successfully raised over $11 million through the exercise of existing warrants by investors over a ten-day period, with Chardan Capital Markets serving as the exclusive financial advisor. The biogenetics company has strategically utilized $3.1 million of the raised funds to fully extinguish all outstanding debt, achieving a debt-free balance sheet. This financial restructuring has positioned KLTO to exceed the stockholders' equity thresholds required for maintaining NASDAQ listing compliance, addressing a critical regulatory requirement.

Klotho Neurosciences (NASDAQ: KLTO) has announced breakthrough findings in longevity research centered on the Klotho gene. The company has secured exclusive worldwide licenses for s-KL protein technology, building on Professor Makoto Kuro-O's 1997 discovery linking Klotho blood levels to mammalian lifespan. Recent studies published in Molecular Therapy demonstrated that genetic overexpression of Klotho increased mouse lifespan by 30-40%, while the secreted form (s-KL) showed a 20% lifespan increase. The research revealed s-KL's potential in addressing age-related conditions including cognitive decline, neuroinflammation, sarcopenia, and osteoporosis. KLTO plans to develop s-KL treatments focusing on neurodegenerative diseases like ALS, Alzheimer's, and Parkinson's, supported by patents in the USA, Europe, and China.