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New Alert: Klotho Neurosciences, Inc. (Nasdaq: KLTO)
KLTO is our brand new NASDAQ alert.
The company has a chart setup positioning for a potential breakout higher.
Moreover, it has a history of large moves in a short period of time.
In June, the company traded over 3.00…
That's over 250% from here.
But it doesn't have to go up that high to experience double- or triple-digit gains.
KLTO has a 50 day moving average of 1.18, 37% above Friday's close.
Large gaps like this often create big opportunities.
Now might be no different.
The momentum may already be in place.
With a chart setup pointing to a breakout opportunity.
In addition, this morning the company announced breaking news.
KLTO is a NASDAQ listed "biogenetics" and "biotechnology company".
KLTO is "focused on the development of innovative, disease-modifying cell and gene therapies".
KLTO uses "a protein derived from a patented form of the "anti-aging" human Klotho gene (s-KL), and its novel delivery systems".
KLTO objective is "to transform and improve the treatment of neurodegenerative and age-related disorders such as ALS, Alzheimer's disease, and Parkinson's disease".
Amyotrophic Lateral Sclerosis (ALS), or Lou Gehrig's disease, is a "terminal neurodegenerative disorder that results in the progressive loss of both upper and lower motor neurons that normally control voluntary muscle contraction".
Sadly, it's a "Rare Disease with Limited Treatment Options".
ALS "affects fewer than 200,000 people in the US, with around 5,000 new cases diagnosed each year".
In July, the company announced:
- "Klotho Neurosciences, Inc. Granted FDA Orphan Drug Designation for KLTO-202 for Treatment of Amyotrophic Lateral Sclerosis ("ALS" or "Lou Gehrig's Disease")"
Benefits of Orphan Drug Designation:
- "7 Years of Market Exclusivity: No other company can market the same drug for the same indication during this period."
- "Tax Credits: Up to 25% of clinical trial costs can be claimed as tax credits."
- "Waiver of FDA Fees: Application fees for FDA review are waived, saving companies millions of dollars. Grants and Funding: Access to grants to support clinical trial costs."
- "Assistance in Drug Development: Companies receive FDA guidance on the clinical trials and approval process."
As the company further explains:
- "KLTO-202, the company's lead product candidate targeting motor neuron diseases and muscular dystrophies, is composed of a muscle-specific promoter called "desmin," driving the expression of the s-KL gene transcript and s-KL protein, with targeted delivery of the gene therapy to the neuromuscular junction - the interface between the spinal cord and the muscles. At this time, KLTO-202 is not approved for human use by any regulatory authority."
Meanwhile, "Alzheimer's Disease is a progressive, age-related neurodegenerative disease affecting memory, cognition, and behavior. It is the most common cause of dementia, accounting for 60-80% of cases."
Sadly, "Over 6 million Americans are living with Alzheimer's" with "Cost of Care for those patients is over $350 billion".
In addition to its "core programs targeting brain aging and neurodegenerative diseases such as ALS, Alzheimer's, and Parkinson's, the Company is now seeking to expand into adjacent technologies that complement its proprietary anti-aging Klotho platform".
Importantly:
- "The goal is to slow biological aging and reduce the burden of age-related diseases—ultimately promoting a longer, healthier life."
As the company further explains:
"The human Klotho gene is strongly linked to aging and longevity."
"Klotho levels decline with age, contributing to age-related disorders such as cardiometabolic disease, neurodegeneration, cancer, sarcopenia (muscle wasting), osteoporosis, and general fatigue."
"Silencing of the Klotho gene has been shown to accelerate multi-organ deterioration."
The Company's "current portfolio consists of its proprietary cell and gene therapy programs using DNA and RNA as therapeutics and genomics-based diagnostic assays".
KLTO is "managed by a team of individuals and advisors who are highly experienced in biopharmaceutical product development and commercialization".
KLTO has announced multiple accomplishments recently.
In June, the company announced a big accomplishment:
"Klotho Neuroscience, Inc. Announces An Approach To Increase Longevity And Healthy Life Span - Replace A Silenced Gene Called Alpha-Klotho ("Α-Klotho")"
- "Recent clinical and pre-clinical studies and analysis indicates the potential to increase lifespan and reduce age-associated degeneration in multiple organ systems has be realized with a focus on the human gene called Klotho."
In addition, the company also announced multiple big developments:
- "Klotho Neurosciences Raises Over $11 Million, Retires All Debt, And Exceeds Nasdaq Stockholders' Equity Requirement"
- "Klotho Neurosciences, Inc. and the Okinawa Research Center for Longevity Science, Leading Experts on the Okinawa "Blue Zone", Announce a Plan to Study Tissue Levels of the Human Klotho Gene and Protein in the World's Longest-Lived Population"
- "Klotho Neurosciences Moves Forward with Manufacturing Gene Therapy for the Treatment of ALS"
As we previous mentioned, in July, the company announced a big accomplishment:
"Klotho Neurosciences, Inc. Granted FDA Orphan Drug Designation for KLTO-202 for Treatment of Amyotrophic Lateral Sclerosis ("ALS" or "Lou Gehrig's Disease")"
Here are some of the company's comments from this press release:
"Receiving the Orphan Drug Designation for s-KL-AAV.myo for the early treatment of ALS underscores the importance of bringing new treatment options to patients suffering from this rare, universally fatal disease" said Dr. Joseph Sinkule, Klotho's Chief Executive Officer. "My cousin Karen died from this horrific disease. We aim to deliver the first gene replacement therapy addressing the neurologic insult resulting in motor neuron damage and the potential neurologic protection induced by providing therapeutic blood, brain, and muscle concentrations of the s-KL protein. After the FDA's review of the data leading to the Orphan Drug Designation, we believe this ODD designation provides strong validation of our science and our approach to treat this disease" concludes Dr. Sinkule.
In addition, the company also announced:
"Klotho Neurosciences, Inc. Partners with AAVnerGene Inc. to Make Klotho's Gene Therapy Assets"
Here are some of the comments from this press release:
"AAV gene therapy has been proven to be a revolutionary one-time, life-changing treatment, however it is experiencing some crisis caused by high drug price and high dose-related toxicity," said Dr. Daozhan Yu, Founder and CEO of AAVnerGene. "We envisioned these bottleneck problems six years ago and AAVnerGene was founded with the mission to solve them. With the two proprietary platforms, we can dramatically drive down the manufacture cost with the AAVone system and the dose required by the highly efficient and specific tissue-targeting AAVs developed with the ATHENA platform. It's a perfect synergy to partner with Klotho, a neuroscience-driven pathfinder. Neurological disease drug development is always challenging and we need new approaches and mechanisms. Klotho's data on neuron protection and longevity are very impressive and it holds the potential to treat so many devastating diseases. We are very glad to work with the passionate and highly executive team, and strongly believe that the collaboration can bring more affordable and innovative drugs for patients with rare and common diseases."
Dr. Joseph Sinkule concluded "Klotho believes AAVnerGene has conceived a process method that is more cost effective, faster to make, has fewer impurities, shows higher efficacy and lower toxicity because of the higher targeted tissue delivery. KLTO hopes to work with AAVnerGene for manufacturing several of our product candidates composed of a tissue-specific promoter driving our Klotho gene to produce the Klotho protein and elevated concentrations of the protein in specific, targeted tissues and organs affected by these neurologic and neuromuscular diseases."
Plus, the company also announced:
"Klotho Neurosciences, Inc. to Expand Development Programs Beyond Neurology"
Here are some of the company's comments from this press release:
"As announced previously, we've begun manufacturing and development of KLTO-101 and KLTO-202," said Klotho CEO Dr. Joseph Sinkule. "We're also exploring other treatments that could support healthy aging and extend human longevity."
Furthermore:
"The Klotho gene is what we call a master gene," stated Shalom Hirschman, M.D., world-renowned physician and senior consultant to the Company. "The Klotho gene has pleotropic actions modulating many critical cellular pathways including insulin resistance, insulin-like growth factor-1, FOXO3 transcription factors, and Wnt signaling pathways leading to the reduction of inflammatory and mitochondrial oxidative stresses and other cell-damaging mechanisms that can be prevented by two alpha-Klotho protein isoforms – soluble Klotho and secreted-Klotho."
"We're assembling a team of scientists, clinicians, and business leaders focused on identifying key longevity indicators," said Jeffrey LeBlanc, Klotho CFO. "This includes evaluating genes and proteins such as alpha-Klotho, beta-Klotho, FOXO3, anti-myostatin, and their isoforms."
Importantly:
Dr. Sinkule added, "If people don't die of cancer or trauma, they often succumb to age-related diseases of the brain, heart, kidneys, liver, bone, or muscle. Our mission is to identify and develop complementary assets to delay these outcomes through targeted research and intervention."
Last week, on Tuesday, the company announced:
"Klotho Neurosciences, Inc. (KLOTHO) Initiates Manufacturing of KLTO-202 Product Candidate Using AAVnerGene's Platform Technology"
Here are some of the company's comments from this press release:
"Dr. Joseph Sinkule, KLOTHO CEO, stated, "The AAVnerGene technology is a game-changer in manufacturing AAV vectors for intracellular delivery of genes. The initiation of manufacturing is a key milestone in the development of any biotech product, and the manufacturing of gene therapy products presents particular complications. KLOTHO is using AAVnerGene's cutting-edge 'AAVone' platform technology and engineered HEK293 cell line to introduce the plasmid DNA containing our Klotho gene, so that the AAV particles containing our gene are at a higher-than-normal titer concentration, have fewer impurities, and can be optimized and produced faster than the old standard method. We believe that working with AAVnerGene as our development partner has the potential to launch our product candidates into the clinic at a faster pace, lower cost, higher efficacy, and higher purity compared to the current 'triple transfection' manufacturing method.""
In addition, just this morning the company announced breaking news:
"Klotho Neurosciences Provides Shareholder Update Highlighting Recent Milestones as It Prepares to Address $8 Billion Neurodegenerative Disease Market"
- "Key partnerships, regulatory progress, manufacturing advancements, along with significant capital infusion accelerate the development of Klotho-based therapeutics"
KLTO could be positioned for increased growth potential.
Make sure to do your own due diligence.
Sources: Presentation, PR1, PR2, PR3, PR4, PR5, PR6, PR7, PR8, PR9, PR10, Website, Chart
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AwesomeStocks
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