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NEW YORK - Klotho Neurosciences, Inc. (NASDAQ:KLTO), a biotechnology company with a current market capitalization of $45.33 million, has received Orphan Drug Designation from the FDA for its KLTO-202 candidate for the treatment of Amyotrophic Lateral Sclerosis (ALS), the company reported Monday.
The biotechnology firm has also entered a binding agreement with AAVnerGene, Inc. to manufacture and develop the KLTO-202 gene therapy candidate, with manufacturing already underway.
Klotho has raised over $11 million in financing this year to advance its programs focused on neurodegenerative diseases. While the company has eliminated all debt and regained full compliance with Nasdaq listing requirements, InvestingPro data shows its current ratio stands at 0.29, indicating potential liquidity challenges. The company’s financial health score is currently rated as WEAK, with short-term obligations exceeding liquid assets.
"We are executing a focused and disciplined strategy to advance our Klotho-based therapeutics from preclinical development toward clinical evaluation," said CEO Dr. Joseph Sinkule in the press release.
The company has expanded its research capabilities by launching a research center in Okinawa, Japan, and strengthening its internal development team.
Following the mutual termination of its collaboration with SkyBell, Klotho now retains full global rights to its Klotho programs, which target neurodegenerative conditions including ALS, Alzheimer’s disease, and Parkinson’s disease. The stock has shown remarkable momentum, posting a 115% return over the past six months, though InvestingPro analysis indicates high price volatility. Get access to 8 more exclusive ProTips and comprehensive financial metrics with an InvestingPro subscription.
The company plans to accelerate preclinical and IND-enabling studies for KLTO-202 while evaluating complementary technologies and potential acquisitions to enhance its pipeline breadth in brain health, organ function, and longevity.
Klotho Neurosciences develops therapies using a protein derived from the human Klotho gene, targeting a neurodegenerative disease market that industry research estimates at over $8 billion annually. According to InvestingPro’s Fair Value analysis, the stock appears to be trading above its Fair Value, with a price-to-book ratio of 70.96x reflecting investor optimism about the company’s potential in this substantial market.
In other recent news, Klotho Neurosciences, Inc. has announced several significant developments. The company has regained compliance with NASDAQ’s continued listing requirements, meeting the necessary bid price and stockholders’ equity thresholds. In addition, Klotho Neurosciences received Orphan Drug Designation from the FDA for its KLTO-202 gene therapy candidate for Amyotrophic Lateral Sclerosis (ALS), which provides benefits such as tax credits and market exclusivity. The company has also entered into a partnership with AAVnerGene Inc. to manufacture gene therapy candidates, utilizing AAVnerGene’s proprietary technologies for enhanced production and delivery. Furthermore, Klotho Neurosciences is evaluating the acquisition of complementary technologies to expand beyond neurological treatments, focusing on healthy brain function and longevity. This expansion aligns with their proprietary anti-aging Klotho platform. The company has initiated manufacturing of its KLTO-202 gene therapy candidate using AAVnerGene’s platform, aiming for higher efficiency and fewer impurities in production. These developments reflect Klotho Neurosciences’ strategic efforts to advance its pipeline and broaden its technological reach.
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