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Klotho Neurosciences (NASDAQ:KLTO) Initiates Development of the "Klotho Clock," a Diagnostic Biological Aging and Longevity Clock that Unlocks Health Testing Through Epigenetics and Artificial Intelligence (AI)

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Klotho Neurosciences (NASDAQ:KLTO) is developing two genomics-based diagnostics for longevity research, including a quantitative DNA methylation assay of the alpha-Klotho gene and a multi-gene "Klotho Clock" combining DNA and mRNA analysis.

The company named Dr. Bret Barnes to lead the program and expects a prototype assay in 2026, aiming to use tests in clinical trial stratification and as a revenue-generating service while building a longitudinal database for AI-driven clock improvements.

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Positive

  • Prototype assay expected in 2026
  • Diagnostics intended as an immediate revenue source and database builder
  • Hired industry veteran Dr. Bret Barnes with 18 years at Illumina

Negative

  • Assays are currently in development and unvalidated
  • No regulatory clearances, pricing, or revenue forecasts disclosed

Key Figures

Registered shares: 75,103,879 shares Private placement shares: 34,551,939 shares Private placement warrants: 34,551,939 warrants +5 more
8 metrics
Registered shares 75,103,879 shares Common stock registered for resale under 424B3 dated Feb 24, 2026
Private placement shares 34,551,939 shares Common stock to be sold under Securities Purchase Agreement disclosed Feb 23, 2026
Private placement warrants 34,551,939 warrants Five-year warrants exercisable at $0.2243 per share, pending stockholder approval
Q3 2025 net loss $2,895,585 Net loss for quarter ended September 30, 2025 (10-Q filing)
Cash and equivalents $7,348,034 Cash position at Q3 2025 quarter-end
ATM program size $50,000,000 At-the-market offering capacity disclosed in Q3 2025 10-Q
Shares outstanding 72,536,722 Common shares outstanding as of November 13, 2025
Daily move +62.25% KLTO price change to $0.41 on article date vs prior close

Market Reality Check

Price: $0.4100 Vol: Volume 31,406,637 is 13.5...
high vol
$0.4100 Last Close
Volume Volume 31,406,637 is 13.52x the 20-day average of 2,323,688, indicating unusually heavy trading ahead of this AI/epigenetics announcement. high
Technical At $0.41, shares trade below the 200-day moving average of $0.61 and remain 89.51% under the 52-week high despite a 62.25% daily gain.

Peers on Argus

KLTO gained 62.25% while momentum data flags only IGC on the scanner, up about 8...
1 Up

KLTO gained 62.25% while momentum data flags only IGC on the scanner, up about 8.65%. Other close peers show mixed moves (JSPR and MRSN modestly positive; LSB, LVTX negative), supporting a stock-specific AI/diagnostics reaction rather than a broad biotech move.

Historical Context

5 past events · Latest: Feb 18 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
Feb 18 Patent claims granted Positive +9.3% Granting of <b>18</b> Australian patent claims for secreted Klotho compositions and uses.
Jan 08 Conference presentation Neutral +1.2% CEO presentation at Biotech Showcase 2026 and investor meeting availability.
Nov 07 Industry award Positive -3.2% Win of 2025 BioTech Breakthrough ‘Cell Therapy Innovation of the Year’ award.
Oct 16 Conference attendance Neutral -6.3% Leadership attending Longevity Biotech 2025 and pursuing partnering meetings.
Oct 07 Strategic refocus Positive +14.3% Expiration of LOI with Turn Biotechnologies and renewed focus on Klotho protein pipeline.
Pattern Detected

Recent KLTO news often produced sizable moves, with three positive/neutral items aligning with price gains and two benign or positive updates coinciding with selloffs, indicating somewhat inconsistent but news-sensitive trading.

Recent Company History

Over the last few months, KLTO has highlighted IP expansion, visibility efforts, and strategic focus on its Klotho platform. On Feb 18, 2026, Australian patent claims for secreted Klotho (s‑KL) aligned with a 9.26% rise. Conference and showcase appearances in late 2025 drew modest or negative reactions, while an expired LOI on Oct 7, 2025 coincided with a 14.27% gain as investors refocused on core longevity programs. Today’s AI-driven “Klotho Clock” diagnostics fit that ongoing longevity and neurodegeneration narrative.

Market Pulse Summary

This announcement details KLTO’s move into genomics-based diagnostics, pairing a Klotho DNA methylat...
Analysis

This announcement details KLTO’s move into genomics-based diagnostics, pairing a Klotho DNA methylation assay with an AI-enabled “Klotho Clock” that incorporates DNA and mRNA readouts from Klotho and other longevity genes. The tools aim to stratify neurodegenerative trial patients by biological age and create a potential service revenue stream. In context of prior patent wins and longevity-focused strategy updates, investors may watch future filings, cash metrics, and trial designs to gauge how these diagnostics integrate into the broader Klotho therapeutic platform.

Key Terms

dna methylation, cell-free dna, mRNA, next-generation sequencing, +1 more
5 terms
dna methylation medical
"a quantitative DNA methylation assay that determines the extent of DNA methylation"
A chemical tag added to DNA that acts like a sticky note on a recipe, changing whether a gene is read without altering the underlying genetic code. For investors, DNA methylation matters because these tags can serve as measurable biomarkers for disease diagnosis, risk prediction, and treatment response, and they can be targets for drugs or diagnostic tests—factors that influence clinical value, regulatory approval, and market potential.
cell-free dna medical
"using cell-free DNA isolated through a blood draw as a validated marker"
Fragments of DNA that float freely in the bloodstream after being released by dying or damaged cells, like puzzle pieces carried downstream that hint at what’s happening upstream. Investors care because measuring these fragments enables non‑invasive tests — for example to detect cancer, monitor treatment response, check pregnancy health, or spot organ rejection — so advances, approvals, or reimbursement changes can quickly affect companies that develop the tests and related technologies.
mRNA medical
"measures DNA sequences and the mRNA sequences of Klotho and 8 other genes"
mRNA, short for messenger ribonucleic acid, is a biological molecule that carries instructions from a cell’s genetic blueprint to make specific proteins — like a recipe or software code that tells a kitchen or computer what to produce. Investors care because mRNA is used as a flexible drug and vaccine platform that can be developed and scaled faster than many traditional medicines; its commercial prospects, manufacturing needs, regulatory approval path, and patent position can strongly affect a company’s value.
next-generation sequencing technical
"developing DNA methylation and other bead-based genomics assays in addition to NGS structural variant informatics"
Next-generation sequencing is a set of laboratory techniques that read large amounts of DNA or RNA quickly and cheaply by processing millions of short genetic fragments in parallel, rather than one at a time. For investors, it matters because faster, lower-cost genetic data powers drug discovery, diagnostic tests and personalized medicine, creating scalable revenue opportunities and competitive advantages for companies that own the technology or services.
multiomics technical
"thus creating new, more robust 'multiomics' capabilities"
Multiomics is the combined analysis of different biological data types — such as genes, proteins and small‑molecule chemicals — to build a complete picture of how cells or organisms function. For investors, multiomics matters because it can make drug and diagnostic development more precise and faster by revealing causes, predicting who will benefit from a therapy, and reducing downstream clinical trial surprises — like using multiple camera angles to better understand a complex scene.

AI-generated analysis. Not financial advice.

The Company enlists industry veteran Dr. Bret Barnes to oversee the development of new diagnostic offerings

NEW YORK, Feb. 24, 2026 /PRNewswire/ -- Klotho Neurosciences, Inc. ("Klotho" or the Company) announces the development of two genomics-based diagnostic tests that will be utilized in Klotho's clinical trials and to be provided as a service in the field of longevity and the understanding of the relationships between biological age and chronologic age.  

One genomics test being developed is a quantitative DNA methylation assay that determines the extent of DNA methylation of the anti-aging gene called alpha-Klotho using cell-free DNA isolated through a blood draw as a validated marker of biologic aging.  The second, which the company has named the "Klotho Clock," measures DNA sequences and the mRNA sequences of Klotho and 8 other genes described in the scientific literature as being associated with longevity and healthy lifespan.  Since Klotho induces the expression of several of these genes, Klotho is of primary interest. Complementary with the genetic sequence analysis, the mRNA analysis will provide proof that the proteins are being transcribed and produced by the gene sequences.

 Dr. Joseph Sinkule, Klotho Neurosciences Founder and CEO stated, "This is a unique opportunity to qualify patients with neurodegenerative diseases for our clinical trials to assure that our randomized studies are balanced and stratified based on biologic age and the extent of DNA methylation of the human Klotho gene and promoter.  Similar to many other human genes, the hypermethylation of the Klotho gene and its promoter are key events that occur over time that ultimately silence the gene and lower the Klotho protein levels in all tissues. Balancing the biological age of people going into our randomized studies will minimize the possibility of overloading the placebo group with healthier, 'less biologically aged' people in the placebo arm versus the treatment arm of our studies." 

The Company has enlisted Dr. Bret Barnes to manage the Company's evolving diagnostic program.  Previously he worked at Illumina for 18 years, leading a small team of scientists developing DNA methylation and other bead-based genomics assays in addition to NGS structural variant informatics. Illumina, Inc. is a leading American biotechnology company headquartered in San Diego, specializing in the development, manufacturing, and marketing of integrated systems for large-scale analysis of genetic variation and function.

Dr. Barnes stated, "Unlike other genomic tests on market, Klotho Neurosciences' assay employs novel, cutting-edge probe designs to address underlying human genetic variation, while simultaneously providing increased accuracy at a lower assay cost. The increased information from these novel designs can seamlessly integrate into our AI-based clocks. Besides DNA methylation detection, the software supporting our assay can provide information on Copy Number Variants ('CNVs') and Single Nucleotide Variants ('SNVs'), thus creating new, more robust 'multiomics' capabilities."  

Following the development of the prototype version of the assay, expected in 2026, the Company expects a more efficient and more cost-effective diagnostic product that will serve to provide the company an immediate revenue source and begin to build a database for 'clock' improvements and novel 'clock' discoveries.

About Klotho Neurosciences, Inc.

Klotho Neurosciences, Inc. (NASDAQ: KLTO) is a gene and cell therapy company focused on the development of innovative, disease-modifying cell and gene therapies using a protein derived from the "anti-aging" human Klotho gene (s-KL), tissue-specific promoters, and novel tissue and organ delivery systems to transform and improve the treatment of neurodegenerative disorders such as ALS, Alzheimer's disease, Parkinson's disease and age-related neuronal, ocular, skeletal and muscular pathologies. The "Klotho Clock" will facilitate and integrate our understanding of chronologic age versus biologic age, the relationship between human disease and healthy lifespan, and key factors that may result in extended longevity.

Forward-Looking Statements

This press release contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements generally are identified by the words "believe," "project," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Without limiting the generality of the foregoing, the forward-looking statements in this press release include descriptions of the Company's future commercial operations. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, such as the Company's inability to implement its business plans, identify and realize additional opportunities, or meet or exceed its financial projections and changes in the regulatory or competitive environment in which the Company operates. You should carefully consider the foregoing factors and the other risks and uncertainties described in the documents filed or to be filed by the Company with the U.S. Securities and Exchange Commission (the "SEC") from time to time, which could cause actual events and results to differ materially from those contained in the forward-looking statements. All information provided herein is as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law.

Investor Contact and Corporate Communications:

Jeffrey LeBlanc, CFO
ir@klothoneuro.com 

Website: www.klothoneuro.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/klotho-neurosciences-nasdaqklto-initiates-development-of-the-klotho-clock-a-diagnostic-biological-aging-and-longevity-clock-that-unlocks-health-testing-through-epigenetics-and-artificial-intelligence-ai-302694266.html

SOURCE Klotho Neurosciences, Inc.

FAQ

What is the Klotho Clock announced by Klotho Neurosciences (KLTO) on Feb 24, 2026?

The Klotho Clock is a multiomics diagnostic that measures DNA and mRNA of Klotho and eight longevity genes. According to the company, it combines sequence and expression data to assess biological age and inform clinical trial stratification.

When does Klotho Neurosciences (KLTO) expect a prototype of its methylation assay?

Klotho expects a prototype assay in 2026. According to the company, the prototype launch will precede a more efficient, cost-effective diagnostic aimed at revenue and database growth.

How will Klotho Neurosciences (KLTO) use the new diagnostics in its clinical trials?

The company will use the tests to qualify and stratify trial participants by biologic age and Klotho methylation status. According to the company, this aims to balance randomized arms and reduce bias in outcomes.

Who will lead the diagnostic program at Klotho Neurosciences (KLTO)?

Dr. Bret Barnes will manage the evolving diagnostic program. According to the company, he brings 18 years of experience at Illumina developing methylation assays and NGS informatics.

What technologies does Klotho Neurosciences (KLTO) say its assay will include?

The assay will use novel probe designs, DNA methylation detection, CNV and SNV information, and AI-driven clocks. According to the company, this creates a more robust multiomics capability.

Will the Klotho Clock be available as a service for researchers and clinicians?

Yes, the company plans to offer the diagnostics as a service while using them in trials. According to the company, this dual use is intended to generate revenue and build the clock database.
Klotho Neurosciences, Inc.

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Biotechnology
Biological Products, (no Diagnostic Substances)
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