Revenue - The Company reported no revenue for the three months ended September 30, 2025 and 2024[114] Operating Expenses - Operating expenses decreased to $1,853,304 for the three months ended September 30, 2025, down from $2,870,932 in the same period of 2024, a reduction of approximately 35.4%[115] - For the nine months ended September 30, 2025, operating expenses increased to $5,333,124 from $3,688,584 in the same period of 2024, an increase of approximately 44.6%[118] Net Loss - The net loss for the three months ended September 30, 2025 was $2,895,585, compared to a net loss of $2,959,426 for the same period in 2024, reflecting a decrease of about 2.2%[116] - The net loss for the nine months ended September 30, 2025 was $9,222,798, compared to $4,083,109 for the same period in 2024, representing an increase of approximately 126.4%[119] Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2025 was $4,610,390, compared to $2,002,358 for the same period in 2024, an increase of approximately 130.5%[121] - The Company had cash and cash equivalents of $7,348,034 as of September 30, 2025, with an accumulated deficit of approximately $19.8 million[127] - Net cash provided by financing activities for the nine months ended September 30, 2025 was $11,894,683, significantly higher than $2,173,942 for the same period in 2024[123][124] Future Outlook - The Company expects to continue incurring significant professional costs to remain publicly traded and requires additional working capital funding to execute its business plans[125][127] - The Company has no off-balance sheet arrangements as of September 30, 2025[128]

Core Insights - Klotho Neurosciences, Inc. has been awarded the Fifth Annual BioTech Breakthrough Award in the "Cell Therapy Innovation of the Year" category for its innovative gene and cell therapies targeting neurodegenerative diseases [1][2]. Company Overview - Klotho Neurosciences focuses on developing transformative therapies using a patented form of the human Klotho gene (s-KL) to treat conditions such as ALS, Alzheimer's disease, and Parkinson's disease [2][4]. - The company's therapies aim to address the underlying mechanisms of neuronal aging, potentially slowing, halting, or reversing disease progression [2]. Industry Context - The BioTech Breakthrough Awards recognize innovation in the life sciences and biotechnology sectors, highlighting excellence in biopharma, therapeutics, genomics, diagnostics, and research tools [3]. - As the global population ages, there is an increasing demand for therapies that target the root causes of age-related diseases, positioning Klotho to meet this challenge [3].

Core Insights - Klotho Neurosciences, Inc. will participate in the Longevity Biotech 2025 conference in Boston on October 22-23, 2025, focusing on advancing longevity therapeutics [1][2] - The company aims to engage in one-on-one meetings with investors and potential partners during the event to discuss collaborations and therapeutic programs [2] - Klotho specializes in developing innovative cell and gene therapies targeting neurodegenerative and age-related disorders, leveraging a patented form of the "anti-aging" human Klotho gene [3] Company Overview - Klotho Neurosciences, Inc. is a biogenetics company listed on NASDAQ (KLTO) [3] - The company focuses on disease-modifying therapies for conditions such as ALS, Alzheimer's disease, and Parkinson's disease [3] - Klotho's portfolio includes proprietary cell and gene therapy programs utilizing DNA and RNA therapeutics, along with genomics-based diagnostic assays [3]

Core Insights - Klotho Neurosciences, Inc. has allowed its Letter of Intent with Turn Biotechnologies to expire, as the proposed transaction did not align with the company's long-term strategic plan [1][2] - The company will redirect its focus and resources towards advancing its Klotho anti-aging protein research pipeline and developing treatments that promise the greatest value for patients and shareholders [2] Company Overview - Klotho Neurosciences, Inc. is a biogenetics company dedicated to developing innovative, disease-modifying cell and gene therapies utilizing a protein derived from the patented "anti-aging" human Klotho gene [4] - The company aims to transform the treatment of neurodegenerative and age-related disorders, including ALS, Alzheimer's disease, and Parkinson's disease, through its proprietary cell and gene therapy programs [4] Market Context - The longevity medicine market is one of the fastest-growing global sectors, driven by an aging population projected to reach 2.1 billion by 2050 [3] - Healthcare costs are currently at 10% of global GDP and are expected to exceed $47 trillion by 2030, highlighting the significant opportunity in the longevity sector [3]

Core Insights - Klotho Neurosciences, Inc. has signed a Letter of Intent to acquire select assets from Turn Biotechnologies, positioning itself as a leader in longevity therapeutics [1][4] - The acquisition includes Turn's ERA platform and eTurna RNA delivery system, aimed at rejuvenating somatic cells for various regenerative therapies [2][4] - Klotho will also gain a partnership with a South Korean pharmaceutical company valued at up to $300 million, highlighting the commercial potential of Turn's technology [3][4] Company Overview - Klotho Neurosciences focuses on developing innovative cell and gene therapies derived from the "anti-aging" Klotho gene, targeting neurodegenerative and age-related disorders [7] - The company aims to expand its therapeutic reach by integrating Turn's technologies, which utilize RNA molecules to reset cellular age [4][5] - Klotho plans to rebrand post-transaction to reflect its broadened mission in addressing aging and related diseases [4] Market Context - The longevity medicine market is rapidly growing, driven by an aging global population projected to reach 2.1 billion by 2050, significantly impacting healthcare costs [5] - Klotho aims to address aging at the cellular level, which is seen as a root cause of various age-related health issues [5]

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]