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Greenland Mines Ltd

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Business Summary

Greenland Mines Ltd (formerly Klotho Neurosciences, Inc.) is a company focused on developing essential medicines for chronic diseases, specifically cancer, cardiovascular, and neurodegenerative disorders. The company operates through two primary licensed platforms: a generic drug portfolio and a biosimilar biologics platform for cancer treatment, and a proprietary, patented gene therapy platform utilizing the "Klotho" protein to treat neurodegenerative diseases. A significant strategic development occurred in March 2026, subsequent to the reported fiscal year, with the acquisition of Greenland Mines Corp., expanding the company's operations into the development and mining of critical and precious minerals. This acquisition is noted as a material step in the company's strategic growth and positioning .

The company's core business model revolves around the research, development, and eventual commercialization of pharmaceutical products. Currently, the company is in a pre-revenue stage and does not generate revenue from product sales . Revenue generation is anticipated upon successful completion of development, regulatory approval, and commercialization of its product candidates . The company relies on a mix of in-licensed technologies and internal development capabilities. Key customer segments, once products are commercialized, are expected to be patients suffering from chronic diseases such as cancer, Alzheimer's, and ALS.

The company's product and service lines are primarily divided into two platforms. The first is a cell and gene therapy platform, which includes a proprietary gene therapy program utilizing the "Klotho" protein to treat neurodegenerative diseases and other age-related conditions. This platform is based on exclusive, worldwide, royalty-bearing licenses from the Autonomous University of Barcelona (UAB) for the commercialization of the α-Klotho sequence (s-KL) and related know-how for gene and cell therapy against neurodegenerative diseases . The gene therapy product candidates, KLTO-101 for Alzheimer's disease and KLTO-202 for Amyotrophic Lateral Sclerosis (ALS), are currently in the pre-clinical stage of development . The second platform consists of clinical-stage generic/biosimilar technologies, including an off-patent portfolio of generic drugs and off-patent biosimilar biologics in-licensed from Reliance Life Sciences (RLS) . This includes five market-approved anti-cancer drugs for sale in Germany, comprising components of the "FOLFOX" and "FOLFIRI" multi-drug regimens for metastatic colorectal and gastric cancer, and two drugs for metastatic lung cancer . Additionally, the company acquired two off-patent bio generic antibodies from RLS, biosimilars to Roche's rituximab (MabThera®/Rituxan®), trastuzumab (Herceptin®), and bevacizumab (Avastin®) .

For the fiscal year ended December 31, 2025, Greenland Mines Ltd reported no revenue . Total operating expenses were $7,146,265 , resulting in a net operating loss of $(7,146,265) . The company incurred a net loss of $(10,551,674) , with basic and diluted EPS of $(0.22) . Cash and cash equivalents at year-end were $7,176,615 . Total current liabilities were $76,764 , and the company reported a net working capital of $7,216,922 . The accumulated deficit as of December 31, 2025, was approximately $(21.1) million .

Comparing fiscal year 2025 to 2024, total operating expenses increased by $1,606,029, from $5,540,236 in 2024 to $7,146,265 in 2025 . This increase was primarily driven by a $1,381,590 increase in general and administrative expenses, a $634,187 increase in research and development expense, and a $674,613 increase in professional fees, partially offset by a $1,084,361 decrease in stock-based compensation expense . The net loss widened from $(6,150,372) in 2024 to $(10,551,674) in 2025 , primarily due to increased operating expenses, a $1,957,358 increase in interest expense, a $1,178,000 settlement expense, and a $26,553 change in fair value of warrant liability, partially offset by a $366,638 increase in other income . Net cash used in operating activities increased from $(2,946,512) in 2024 to $(5,889,254) in 2025 . Net cash provided by financing activities significantly increased from $3,130,942 in 2024 to $13,002,128 in 2025 , primarily due to proceeds from sales of stocks and warrants, convertible promissory notes, and At-the-Market sales of common shares.

During the reported period, the company engaged in several significant operational developments. In March 2026, subsequent to the fiscal year-end, the company completed the acquisition of Greenland Mines Corp., expanding into critical and precious minerals mining . The company also terminated a Share Exchange Agreement to acquire SB Security Holdings, LLC on June 13, 2025 . In terms of financing, the company initiated a warrant exercise inducement program in 2025, reducing the exercise price from $3.49 to $1.35 for certain outstanding warrants, leading to the exercise of 11.0 million warrants for gross proceeds of $11.4 million . Additionally, the company entered into a sales agreement with A.G.P./Alliance Global Partners on July 3, 2025, to sell up to $50,000,000 of common stock through an At-the-Market facility, selling 2,206,930 shares for gross proceeds of $1,112,745 during 2025 .

Business Outlook

Management explicitly states that the company expects to continue incurring significant operating and net losses, as well as negative cash flows from operations, for the foreseeable future as it continues to develop its gene therapy product candidates and prepares for potential future regulatory approvals and commercialization of its products . The company has not generated any revenue to date and does not expect to generate product revenue unless and until it successfully completes development and obtains regulatory approval for at least one of its gene therapy product candidates . Furthermore, the current cash and cash equivalents balance will not be sufficient to complete all necessary development activities and commercially launch its products .

A major growth area for Greenland Mines Ltd is the advancement of its cell and gene therapy product candidates for age-associated neurologic diseases, including rare "orphan diseases" and larger patient populations . The company is working with UAB scientists to advance programs focused on neurodegenerative and age-related disorders such as Alzheimer's and ALS, all based on the Klotho gene and the s-KL protein . The two lead gene therapy product candidates are KLTO-101 (AAV9-CMV-sKL) for Alzheimer's disease and KLTO-202 (AAVmyo-Des-sKL) for ALS . Within the next 12 months, the company plans to complete the animal toxicology package for KLTO-202 and submit an Investigational New Drug (IND) application to the FDA in 2025 for a first-in-human Phase I "Compassionate Use" study in late-stage ALS patients . The pre-clinical development program for KLTO-101 is expected to follow KLTO-202 by six to nine months . The company also plans to find a corporate partner for the development of KLTO-101 for Alzheimer's disease . Additionally, the company may pursue clinical trials for the recombinant s-KL protein to evaluate its safety and efficacy through infusion in healthy volunteers and select patient populations .

Another growth area involves the development of new in vitro assays to detect and measure different isoforms and metabolites of Klotho, which is crucial for the R&D program of its gene therapy products . The company plans to develop and validate one or more assays to separate and individually measure the three Klotho protein isoforms (s-KL, m-KL, p-KL) and the two metabolites (KL1 and KL2) . If this assay, developed as a research test method, becomes a clinical biomarker of disease, the company intends to introduce it as a commercial diagnostic .

The company expects net cash used in operating activities to increase in the future until its products are able to produce meaningful revenue . The company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities to continue executing its development plans and operations . Without additional funding, there is substantial doubt about the company's ability to continue as a going concern for the next twelve months from the date of the financial statements .

Regarding capital allocation, the company's plans are focused on its important gene therapy programs, with new programs potentially evolving from this core technology . Much of the work on building a platform of next-generation gene and cell delivery technologies to optimize AAV-based, Lentivirus-based, and lipid-based gene therapies will be funded by a Sponsored Research Agreement with UAB in Barcelona, which has a two-year budget of 623,100 euros . The company has not paid dividends on its common shares since its formation and does not anticipate paying dividends in the foreseeable future, intending to retain any future earnings for business operations .

Management explicitly flagged several structural headwinds and execution risks. The company will require substantial additional funding to meet its financial obligations and pursue business objectives . There is significant uncertainty regarding the time and cost of product candidate development and obtaining regulatory approval for its new gene transfer technology . The regulatory approval process for novel product candidates like gene therapies can be more expensive and take longer than for other, better-known products . Clinical development of gene therapy candidates will require the development and use of new in vitro assays, and delays in this could impede timely development . Regulatory requirements governing gene therapy products have changed frequently and may continue to change, potentially lengthening the regulatory review process, increasing development costs, or delaying approval .

Geographic, regulatory, and macro factors also pose constraints. The company faces the risk of not obtaining approval for its gene therapy product candidates in jurisdictions outside the United States, which would limit their full market potential . Approval processes vary among countries and can involve additional testing and administrative review periods . Furthermore, the company received a delinquency notification from Nasdaq on September 19, 2025, for failing to maintain a minimum bid price of $1 per share for 30 consecutive business days . While an additional six-month extension until September 14, 2026, was granted, failure to regain compliance could lead to delisting from Nasdaq .

Risk Factors

Greenland Mines Ltd faces substantial risks across macroeconomic, competitive, regulatory, and operational dimensions. Macroeconomic risks include the need for substantial additional funding to meet financial obligations and pursue business objectives, as the company expects to incur significant operating and net losses and negative cash flows for the foreseeable future . Competitive risks are intense, particularly in biosimilar biologics where the company will face established competition from innovator brands and other approved biosimilars from major players like Pfizer Inc., Mylan Inc., Amgen Inc., Teva Pharmaceutical Industries LTD, and Celltrion Healthcare Co. LTD . In gene therapy, while direct competition for human s-KL Klotho gene or protein is limited, other companies like Unity Biotechnology and Klothea BIO are pursuing related approaches . Regulatory risks are significant due to the lengthy, rigorous, and unpredictable approval processes by the FDA, EMA, and other foreign authorities for both biosimilar and gene therapy product candidates . The evolving nature of gene therapy regulations, including potential changes in requirements and increased scrutiny, could delay or prevent commercialization . Operational risks include high dependence on key executives and personnel, the need to attract and retain qualified staff, and reliance on third parties for manufacturing, quality control, and clinical trials . The company's manufacturing facilities or those of its CDMOs may not continue to meet regulatory requirements or supply demands, potentially leading to sanctions or production suspension . Furthermore, the company's common stock is at risk of delisting from Nasdaq if it fails to maintain a minimum bid price of $1 per share by September 14, 2026 .

Management Priorities

Management's message to shareholders emphasizes the company's strategic pivot and ongoing development efforts despite being in a pre-revenue stage with significant losses. The overall tone reflects a commitment to advancing its pharmaceutical pipeline, particularly in gene therapy, while also highlighting a recent, material strategic shift into critical and precious minerals mining. Management explicitly states that the company expects to incur significant operating and net losses and negative cash flows from operations for the foreseeable future, and that current cash and cash equivalents are insufficient to complete all necessary development and commercialization activities . The three strategic priorities emphasized are the advancement of the cell and gene therapy platform, specifically KLTO-101 for Alzheimer's and KLTO-202 for ALS, with a plan to complete the animal toxicology package for KLTO-202 and submit an IND application to the FDA in 2025 ; the development and validation of new in vitro assays for Klotho isoforms and metabolites to support gene therapy development ; and the recent acquisition of Greenland Mines Corp. in March 2026, which expands operations into critical and precious minerals mining, signaling a diversification strategy .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Overview
  2. [2] Item 7, MD&A — Results of Operations
  3. [3] Item 1A, Risk Factors — We currently have no products that are approved for commercial sale and may never be able to develop marketable products.
  4. [4] Item 1, Business — Cell and Gene Therapy — α-Klotho gene
  5. [5] Item 1, Business — Our two lead gene therapy product candidates are KLTO-101 (AAV9-CMV-sKL) for the treatment or prevention of Alzheimer’s disease, and KLTO-202 (AAVmyo-Des-sKL) gene therapy product for treatment and prevention of Lou Gehrig’s disease (amyotrophic lateral sclerosis or “ALS”).
  6. [6] Item 1, Business — Our Research Pipeline
  7. [7] Item 1, Business — Overview
  8. [8] Item 1, Business — Biosimilars Program
  9. [9] Item 7, MD&A — Revenue
  10. [10] Item 7, MD&A — Operating Expenses
  11. [11] Item 7, MD&A — Net operating loss
  12. [12] Item 7, MD&A — Net Loss
  13. [13] Item 8, Consolidated Statements of Operations — Net loss per share: Basic and Diluted
  14. [14] Item 7, MD&A — Liquidity and Capital Resources Outlook
  15. [15] Item 8, Consolidated Balance Sheets — Total current liabilities
  16. [16] Item 7, MD&A — Working Capital
  17. [17] Item 7, MD&A — Liquidity and Capital Resources Outlook
  18. [18] Item 7, MD&A — Operating Expenses
  19. [19] Item 7, MD&A — Operating Expenses
  20. [20] Item 7, MD&A — Net Loss
  21. [21] Item 7, MD&A — Net Loss
  22. [22] Item 7, MD&A — Operating Activities
  23. [23] Item 7, MD&A — Financing Activities
  24. [24] Item 1, Business — Overview
  25. [25] Item 10, Commitments and Contingencies — Termination of acquisition agreement of SB Security Holdings, LLC
  26. [26] Item 9, Stockholder's Equity — Warrants
  27. [27] Item 9, Stockholder's Equity — At-the-Market Sales Agreement
  28. [28] Item 1A, Risk Factors — We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of our product candidates.
  29. [29] Item 1A, Risk Factors — We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of our product candidates.
  30. [30] Item 1A, Risk Factors — We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of our product candidates.
  31. [31] Item 1, Business — Our primary focus is the advancement of a sustainable portfolio of cell and gene therapy product candidates for age-associated neurologic diseases, both rare “orphan diseases” as well as diseases in larger patient populations.
  32. [32] Item 1, Business — We are working with UAB scientists to advance our programs focused on neurodegenerative and age-related disorders — Alzheimer’s and ALS — all based on the Klotho gene and the s-KL protein.
  33. [33] Item 1, Business — Our two lead gene therapy product candidates are KLTO-101 (AAV9-CMV-sKL) for the treatment or prevention of Alzheimer’s disease, and KLTO-202 (AAVmyo-Des-sKL) gene therapy product for treatment and prevention of Lou Gehrig’s disease (amyotrophic lateral sclerosis or “ALS”).
  34. [34] Item 1, Business — Within the next 12 months, we plan to complete the animal toxicology package for KLTO-202 and the submission of an Investigational New Drug application (IND) to the FDA in 2025 for permission to start the first-in-human Phase I “Compassionate Use” study of KLTO-202 in late-stage ALS patients.
  35. [35] Item 1, Business — Likewise, the pre-clinical development program for KLTO-101, similar to that of KLTO-202, will follow behind the development of KLTO-202 by six to nine months.
  36. [36] Item 1, Business — We plan to find a corporate partner to help in the development of KLTO-101 for the Alzheimer’s disease indication.
  37. [37] Item 1, Business — We may also bring the recombinant s-KL protein into clinical trials to evaluate the safety and efficacy of infusing the protein into normal healthy volunteers for pharmacology (“PK/PD”) and safety, and then in select patient populations.
  38. [38] Item 1A, Risk Factors — Clinical development of our gene therapy candidates will require the development and use of new in vitro assays that can detect and measure different isoforms and metabolites of Klotho.
  39. [39] Item 1, Business — Therefore, as part of the research and development (R&D) program, we plan to develop and validate an assay to separate and individually measure all Klotho isoforms and metabolites of p-KL.
  40. [40] Item 1, Business — If the assay developed as a research test method (e.g., ELISA, SDS/Western blot, capillary electrophoresis) becomes a clinical biomarker of disease, the Company will attempt to introduce this test as a commercial diagnostic.
  41. [41] Item 7, MD&A — Operating Activities
  42. [42] Item 7, MD&A — Liquidity & Capital Resources Outlook
  43. [43] Item 7, MD&A — Liquidity & Capital Resources Outlook
  44. [44] Item 1, Business — Our plans are focused on these important programs, but new programs may evolve from this core technology, such as gene-based therapy delivering other proteins of interest.
  45. [45] Item 1, Business — Much of this work will be funded by the Sponsored Research Agreement with UAB in Barcelona, having a two year budget of 623,100 euros.
  46. [46] Item 5, Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities — Dividend Policy
  47. [47] Item 1A, Risk Factors — We will need substantial additional funding to meet our financial obligations and to pursue our business objectives.
  48. [48] Item 1A, Risk Factors — Our AAV-based gene therapy product candidates and our lentiviral-based gene therapy product candidate are based on new gene transfer technology, which makes it difficult to predict the time and cost of product candidate development and of subsequently obtaining regulatory approval.
  49. [49] Item 1A, Risk Factors — The regulatory approval process for novel product candidates such as ours can be more expensive and take longer than for other, better known or more extensively studied product candidates.
  50. [50] Item 1A, Risk Factors — Clinical development of our gene therapy candidates will require the development and use of new in vitro assays that can detect and measure different isoforms and metabolites of Klotho.
  51. [51] Item 1A, Risk Factors — Regulatory requirements governing gene therapy products have changed frequently and may continue to change in the future.
  52. [52] Item 1A, Risk Factors — Even if we obtain FDA approval for our gene therapy product candidates in the United States, we may never obtain approval for or commercialize them in any other jurisdiction, which would limit our ability to realize their full market potential.
  53. [53] Item 1A, Risk Factors — Approval processes vary among countries and can involve additional product testing and validation and additional administrative review periods.
  54. [54] Item 1A, Risk Factors — If we fail to comply with the continued listing requirements of Nasdaq, specifically, Nasdaq Listing Rule 5450(a)(2), we may face possible delisting, which would result in a limited public market for our shares and make obtaining future debt or equity financing more difficult for us.
  55. [55] Item 1A, Risk Factors — If the Company fails to timely regain compliance with the Bid Price Rule for 10 consecutive business days by September 14, 2026, the Company’s common stock will be subject to delisting from Nasdaq.
  56. [56] Item 1A, Risk Factors — We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of our product candidates.
  57. [57] Item 1A, Risk Factors — Biosimilar Competition
  58. [58] Item 1, Business — Competition
  59. [59] Item 1A, Risk Factors — The evolving regulatory approval processes of the FDA, EMA and comparable foreign authorities are lengthy, time-consuming, rigorous, and inherently unpredictable.
  60. [60] Item 1A, Risk Factors — Regulatory requirements governing gene therapy products have changed frequently and may continue to change in the future.
  61. [61] Item 1A, Risk Factors — We are highly dependent on the services of our key executives and personnel, including our Chief Executive Officer, Dr. Joseph Sinkule (Pharm. D.) and if we are not able to retain these members of our management or recruit additional management, clinical and scientific personnel, our business will suffer.
  62. [62] Item 1A, Risk Factors — We and RLS, and our gene therapy CDMO, are subject to significant regulation with respect to manufacturing our product candidates. RLS and the CDMO’s manufacturing facilities may not continue to meet regulatory requirements or may not be able to meet supply demands.
  63. [63] Item 1A, Risk Factors — If the Company fails to timely regain compliance with the Bid Price Rule for 10 consecutive business days by September 14, 2026, the Company’s common stock will be subject to delisting from Nasdaq.
  64. [64] Item 7, MD&A — Liquidity & Capital Resources Outlook
  65. [65] Item 1, Business — Our two lead gene therapy product candidates are KLTO-101 (AAV9-CMV-sKL) for the treatment or prevention of Alzheimer’s disease, and KLTO-202 (AAVmyo-Des-sKL) gene therapy product for treatment and prevention of Lou Gehrig’s disease (amyotrophic lateral sclerosis or “ALS”). Within the next 12 months, we plan to complete the animal toxicology package for KLTO-202 and the submission of an Investigational New Drug application (IND) to the FDA in 2025 for permission to start the first-in-human Phase I “Compassionate Use” study of KLTO-202 in late-stage ALS patients.
  66. [66] Item 1, Business — Therefore, as part of the research and development (R&D) program, we plan to develop and validate an assay to separate and individually measure all Klotho isoforms and metabolites of p-KL.
  67. [67] Item 1, Business — In March 2026, the Company completed the acquisition of Greenland Mines Corp., in a transaction that expands the Company’s operations into the development and mining of critical and precious minerals.

Analysis on 5/21/2026