Accessibility StatementSkip Navigation NEW YORK and PALO ALTO, Calif., Sept. 30, 2025 /PRNewswire/ --Â Klotho Neurosciences, Inc. (Nasdaq: KLTO, "Klotho" or "the Company") today announced it has signed a Letter of Intent (LOI) to acquire select assets from Turn Biotechnologies, Inc. ("Turn"), a leader in induced pluripotent stem cells (iPSC) and cellular reprogramming. The proposed cash and stock transaction is subject to completion of due diligence, execution of a definitive agreement, and customary closin ...

Core Insights - Klotho Neurosciences, Inc. is focused on developing Klotho-based therapeutics aimed at treating neurodegenerative diseases [1] - The company's CEO and Chairman, Dr. Joseph Sinkule, will participate in the Inaugural Klotho Conference & Scientific Seminar [1] Company Overview - Klotho Neurosciences, Inc. is listed on NASDAQ under the ticker KLTO [1] - The company specializes in biotechnology with a specific emphasis on neurodegenerative disease treatments [1]

Core Insights - Klotho Neurosciences, Inc. is advancing Klotho-based therapeutics for neurodegenerative diseases, targeting a market estimated at over $8 billion annually for conditions like ALS, Alzheimer's, and Parkinson's disease [1][2] Group 1: Company Achievements - In 2025, Klotho Neurosciences achieved critical strategic and operational milestones, executing a focused strategy to advance Klotho-based therapeutics from preclinical development toward clinical evaluation [2] - The company has enhanced its operational and scientific foundations through strategic partnerships, expanded research capabilities, and the addition of key talent [2] - Klotho is positioned to pursue key objectives that build on its 2025 successes, aiming to create long-term value for shareholders [2] Group 2: Product Development - Klotho Neurosciences focuses on innovative, disease-modifying cell and gene therapies derived from the human Klotho gene, targeting neurodegenerative and age-related disorders [3] - The current portfolio includes proprietary cell and gene therapy programs using DNA and RNA as therapeutics, along with genomics-based diagnostic assays [3] Group 3: Future Plans - The company plans to accelerate preclinical and IND-enabling studies for its KLTO-202 program [5] - Klotho aims to evaluate complementary technologies and acquisitions to enhance its pipeline breadth in brain health, organ function, and longevity [5] - The company will continue to expand internal capabilities to strengthen R&D, manufacturing, and clinical readiness [5]

PART I. FINANCIAL INFORMATION This section presents the unaudited condensed consolidated financial statements, management's analysis, market risk disclosures, and controls and procedures [ITEM 1. Financial Statements](index=3&type=section&id=ITEM%201.%20Financial%20Statements) The financial statements show a significant increase in cash and assets due to financing, a higher net loss, and a going concern uncertainty [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to **$10.8 million** from **$2.5 million**, driven by a substantial rise in cash and cash equivalents Condensed Consolidated Balance Sheet Highlights (Unaudited) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $8,430,946 | $63,741 | | Total current assets | $8,546,332 | $157,811 | | Total assets | $10,845,886 | $2,457,365 | | **Liabilities & Equity** | | | | Total current liabilities | $62,962 | $1,247,534 | | Total liabilities | $195,409 | $1,272,020 | | Total stockholders' equity | $10,650,477 | $1,185,345 | [Unaudited Condensed Consolidated Statements of Operations](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a significantly widened net loss of **$6.3 million** for the six months ended June 30, 2025, due to increased operating and interest expenses Comparison of Operations (Unaudited) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Total operating expenses | $1,892,852 | $395,607 | $3,479,820 | $817,652 | | Net operating loss | $(1,892,852) | $(395,607) | $(3,479,820) | $(817,652) | | Net loss | $(4,093,231) | $(451,639) | $(6,327,213) | $(1,123,683) | | Net loss per share | $(0.12) | $(0.03) | $(0.21) | $(0.07) | [Unaudited Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash and cash equivalents increased by **$8.37 million** for the six months ended June 30, 2025, primarily from **$11.89 million** in financing activities Cash Flow Summary for the Six Months Ended June 30 | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,522,178) | $(929,399) | | Net cash used in investing activities | $0 | $(123,497) | | Net cash provided by financing activities | $11,889,383 | $1,895,424 | | **Net Change in Cash** | **$8,367,205** | **$842,528** | | Cash - End of period | $8,430,946 | $845,336 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's business, reverse merger, accounting policies, going concern doubt, equity transactions, and FDA Orphan Drug Designation - The company develops medicines for chronic diseases, including cancer and neurodegenerative disorders, and recently changed its name from ANEW Medical, Inc. to Klotho Neurosciences, Inc. to reflect its strategic focus[19](index=19&type=chunk)[21](index=21&type=chunk) - Management has substantial doubt about the Company's ability to continue as a going concern for the next twelve months due to significant operating losses, negative cash flows, and the need to raise additional capital[30](index=30&type=chunk) - During Q2 2025, holders of common stock warrants exercised **11.0 million** warrants for gross proceeds of **$11.4 million** after the company initiated an inducement program, reducing the exercise price from **$3.49** to **$1.35**[89](index=89&type=chunk) - Subsequent to the quarter end, on July 3, 2025, the FDA granted Orphan Drug Designation to the company's gene therapy candidate KLTO-202 for the treatment of ALS[105](index=105&type=chunk) - The company regained compliance with Nasdaq listing requirements on July 14, 2025, after receiving deficiency notices in 2024 regarding minimum market value and bid price[97](index=97&type=chunk)[100](index=100&type=chunk)[109](index=109&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses increased operating expenses and net loss, improved liquidity from financing, and ongoing going concern doubt [Results of Operations](index=27&type=section&id=Results%20of%20Operations) The company reported no revenue and a net loss of **$6.3 million** for the first half of 2025, significantly higher than the prior year Comparison of Operating Results | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $0 | $0 | $0 | $0 | | Operating Expenses | $1,892,852 | $395,607 | $3,479,820 | $817,652 | | Net Loss | $4,093,231 | $451,639 | $6,327,213 | $1,123,683 | [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) Cash increased to **$8.4 million** due to **$11.9 million** from financing activities, but substantial doubt about going concern remains without further funding - Cash position increased to **$8.4 million** as of June 30, 2025, primarily due to **$11.9 million** raised from financing activities in the first six months of the year[128](index=128&type=chunk)[130](index=130&type=chunk) - The company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities to continue operations, and without it, there is substantial doubt about its ability to continue as a going concern[131](index=131&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures about Market Risk](index=29&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Klotho Neurosciences is exempt from providing market risk disclosures - As a smaller reporting company, Klotho Neurosciences is not required to make disclosures under this item[135](index=135&type=chunk) [ITEM 4. Controls and Procedures](index=30&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were ineffective due to material weaknesses in accounting resources and segregation of duties - Management concluded that disclosure controls and procedures were ineffective as of the end of the reporting period[136](index=136&type=chunk) - The ineffectiveness is due to material weaknesses related to inadequate accounting resources and a lack of segregation of duties, stemming from the company's small size[137](index=137&type=chunk) - There were no changes in internal controls during the most recent fiscal quarter that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[143](index=143&type=chunk) PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, other information, and a list of exhibits filed with the report [ITEM 1. Legal Proceedings](index=31&type=section&id=ITEM%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - None[146](index=146&type=chunk) [ITEM 1A. Risk Factors](index=31&type=section&id=ITEM%201A.%20Risk%20Factors) As a smaller reporting company, the company is not required to provide disclosures under this item - As a smaller reporting company, disclosures under this item are not required[147](index=147&type=chunk) [ITEM 5. Other Information](index=31&type=section&id=ITEM%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the quarter - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during the quarter[151](index=151&type=chunk) [ITEM 6. Exhibits](index=31&type=section&id=ITEM%206.%20Exhibits) This section lists the various exhibits filed as part of the Quarterly Report, including officer certifications and XBRL data - The report includes various exhibits, such as officer certifications (31.1, 31.2, 32.1, 32.2) and Inline XBRL data files (101 series)[153](index=153&type=chunk)

Core Insights - Klotho Neurosciences, Inc. has signed a binding agreement with AAVnerGene Inc. to initiate the manufacturing and development of its KLTO-202 gene therapy candidate using AAVnerGene's platform technology [1] - The collaboration aims to leverage AAVnerGene's innovative AAV manufacturing and tissue-targeted delivery technologies to enhance the efficacy and safety of Klotho's gene therapy products [2][6] Company Overview - Klotho Neurosciences, Inc. focuses on developing disease-modifying cell and gene therapies derived from the patented "anti-aging" Klotho gene, targeting neurodegenerative and age-related disorders such as ALS, Alzheimer's, and Parkinson's disease [4] - The company’s portfolio includes proprietary cell and gene therapy programs utilizing DNA and RNA therapeutics, along with genomics-based diagnostic assays [4] Technology and Development - AAVnerGene's AAVone platform technology simplifies the AAV production process by using a one-plasmid system, which increases production efficiency and reduces impurities compared to the traditional triple transfection method [3] - The ATHENA platform technology developed by AAVnerGene enables precise tissue targeting, which is expected to enhance the safety profile of Klotho's gene therapy candidates by minimizing liver-related side effects [2][6] Strategic Importance - The initiation of manufacturing is considered a key milestone in the biotech product development process, particularly for gene therapy products, which often face complex manufacturing challenges [2] - The partnership with AAVnerGene is anticipated to accelerate the clinical development of Klotho's product candidates, potentially leading to faster market entry at lower costs and higher efficacy [2]

Core Insights - Klotho Neurosciences, Inc. is pursuing the acquisition of technologies to enhance brain function, muscle strength, bone health, and other longevity indicators [1] - The company aims to expand its focus beyond neurodegenerative diseases to include complementary technologies that support its anti-aging Klotho platform [2] - Klotho gene is linked to aging and longevity, with its levels declining with age, contributing to various age-related disorders [3] Company Developments - Klotho has initiated the manufacturing and development of its products KLTO-101 and KLTO-202, while also exploring additional treatments for healthy aging [3] - The company is assembling a team of experts to identify key longevity indicators, including evaluating specific genes and proteins related to aging [4] - Klotho's mission is to develop assets that can delay the onset of age-related diseases affecting various organs [4] Business Focus - Klotho Neurosciences specializes in biogenetics, focusing on innovative cell and gene therapies derived from the human Klotho gene to treat neurodegenerative and age-related disorders [4] - The company's portfolio includes proprietary cell and gene therapy programs utilizing DNA and RNA as therapeutics, along with genomics-based diagnostic assays [4]

Core Insights - Klotho Neurosciences, Inc. is evaluating the acquisition of complementary technologies to enhance brain function, organ health, and longevity [1][2] - The company aims to expand its focus beyond neurodegenerative diseases to include technologies that support healthy aging and reduce age-related diseases [2][3] Company Developments - Klotho is currently manufacturing and developing clinical treatments KLTO-101 and KLTO-202, while also exploring additional therapies for healthy aging [3] - The Klotho gene is identified as a "master gene" linked to aging and longevity, with its levels declining with age, contributing to various age-related disorders [3][4] Scientific Focus - The company is assembling a team to identify key longevity indicators, evaluating genes and proteins such as alpha-Klotho, beta-Klotho, and FOXO3 [4] - The mission is to develop complementary assets to delay the onset of age-related diseases affecting the brain, heart, kidneys, liver, bone, and muscle [4] Company Profile - Klotho Neurosciences, Inc. specializes in innovative, disease-modifying cell and gene therapies derived from the human Klotho gene, targeting neurodegenerative and age-related disorders [4] - The company’s portfolio includes proprietary cell and gene therapy programs utilizing DNA and RNA as therapeutics [4]

Core Insights - Klotho Neurosciences, Inc. has partnered with AAVnerGene Inc. to enhance the manufacturing of its gene therapy candidates, aiming for faster, cost-effective, and higher efficacy treatments for neurodegenerative diseases [1][2] - The collaboration focuses on several product candidates, including KLTO-101 for Alzheimer's and Parkinson's diseases, KLTO-202 for ALS, and KLTO-303 for age-related pathologies [2] Company Overview - Klotho Neurosciences, Inc. specializes in innovative cell and gene therapies derived from the human Klotho gene, targeting neurodegenerative and age-related disorders [3] - The company is managed by a team experienced in biopharmaceutical product development and commercialization [3] AAVnerGene Overview - AAVnerGene is a biotechnology company that focuses on next-generation AAV vector technologies, including the AAVone system for cost-effective AAV production and the ATHENA platform for precise tissue targeting [2] - The company aims to provide affordable and scalable gene therapy solutions to accelerate clinical development across various therapeutic areas [2]

Core Points - Klotho Neurosciences has regained compliance with NASDAQ listing requirements, including a minimum bid price of $1.00 and stockholders' equity of at least $2.5 million [1][2] - The company is focused on developing gene and cell therapies for neurodegenerative and aging-related diseases, utilizing a patented form of the "anti-aging" human Klotho gene [4] - Klotho will be monitored for compliance with the stockholders' equity requirement for one year, with potential delisting if it falls out of compliance [3] Company Overview - Klotho Neurosciences specializes in innovative, disease-modifying therapies for conditions such as ALS, Alzheimer's, and Parkinson's disease [4] - The company's portfolio includes proprietary cell and gene therapy programs using DNA and RNA, as well as genomics-based diagnostic assays [4] - The management team consists of experienced individuals in biopharmaceutical product development and commercialization [4]

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].