Greenland Mines Ltd (GRML) Business Analysis — Annual Report Summary, Outlook & Risks

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Greenland Mines Ltd (GRML)

Business Summary

Greenland Mines Ltd (formerly Klotho Neurosciences, Inc.) is a company focused on developing essential medicines for chronic diseases, including 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 for neurodegenerative diseases. A significant strategic development occurred in March 2026, subsequent to the reported fiscal year, with the acquisition of Greenland Mines Corp., expanding operations into the development and mining of critical and precious minerals. The company's common stock and warrants trade on the Nasdaq under the symbols "GRML" and "GRMLW" respectively.

The core business model revolves around the research, development, and eventual commercialization of pharmaceutical products. This includes a mix of generic drugs, biosimilar biologics, and novel gene therapies. The primary customer segments, once products are commercialized, would be patients suffering from chronic diseases such as cancer, Alzheimer's disease, and Amyotrophic Lateral Sclerosis (ALS). The company currently generates no revenue, indicating a pre-commercialization stage business model heavily reliant on successful R&D and regulatory approvals.

The company's product and service lines are segmented into three main areas. First, a generic drug portfolio includes five market-approved anti-cancer drugs, four of which are part of the "FOLFOX" and "FOLFIRI" multi-drug regimens for metastatic colorectal and gastric cancer, and two used for metastatic lung cancer. These drugs are approved for sale in Germany ¹. Second, a biosimilar biologics platform, in-licensed from Reliance Life Sciences (RLS), focuses on "off-patent" biosimilar versions of Roche's rituximab (MabThera®/Rituxan®), trastuzumab (Herceptin®), and bevacizumab (Avastin®) for cancer, autoimmune diseases, and neovascularization diseases ². The licensed territory for these biosimilars is North America, Europe, and Israel ³. Third, a proprietary, patented gene therapy platform utilizes a gene therapy approach to introduce the therapeutic protein "Klotho" to treat neurodegenerative diseases and other age-related disorders. This platform includes two lead product candidates: KLTO-101 (AAV9-CMV-sKL) for Alzheimer's disease and KLTO-202 (AAVmyo-Des-sKL) for ALS ⁴. The company also holds a license for a "Needleless Syringe" technology ⁵.

For the fiscal year ended December 31, 2025, Greenland Mines Ltd reported no revenue ⁶. The company incurred a net loss of $10,551,674 ⁷. Operating expenses totaled $7,146,265 ⁸. Cash and cash equivalents stood at $7,176,615 ⁹, with total current assets of $7,293,686 ¹⁰ and total current liabilities of $76,764 ¹¹, resulting in a working capital of $7,216,922 ¹². The accumulated deficit as of December 31, 2025, was approximately $21.1 million ¹³.

Comparing fiscal year 2025 to 2024, the company's operating expenses increased by $1,606,029 ¹⁴, from $5,540,236 in 2024 ¹⁵ to $7,146,265 in 2025 ¹⁶. This increase was primarily driven by a $1,381,590 rise in general and administrative expenses ¹⁷, a $634,187 increase in research and development expense ¹⁸, and a $674,613 increase in professional fees ¹⁹, partially offset by a $1,084,361 decrease in stock-based compensation expense ²⁰. The net loss widened from $6,150,372 in 2024 ²¹ to $10,551,674 in 2025 ²². Net cash used in operating activities increased by $2,942,742 ²³, from $2,946,512 in 2024 ²⁴ to $5,889,254 in 2025 ²⁵. Cash and cash equivalents increased significantly from $63,741 in 2024 ²⁶ to $7,176,615 in 2025 ²⁷, primarily due to $13,002,128 ²⁸ in net cash provided by financing activities in 2025, compared to $3,130,942 in 2024 ²⁹.

During the reported period, the company made several operational developments. It initiated a warrant exercise inducement program, reducing the exercise price from $3.49 to $1.35 for certain outstanding warrants ³⁰. This resulted in the exercise of 11.0 million warrants for gross proceeds of $11.4 million ³¹. The company also entered into a securities purchase agreement with an accredited investor, issuing 6,250,000 shares of common stock at $0.08 per share for gross proceeds of $500,000 ³². Additionally, 500 preferred B shares were issued for $500,000 and subsequently converted into 6,250,000 common shares ³³. The company also entered into an At-the-Market sales agreement to sell up to $50,000,000 of common stock, selling 2,206,930 shares for gross proceeds of $1,112,745 in 2025 ³⁴. A Share Exchange Agreement to acquire SB Security Holdings, LLC was terminated on June 13, 2025 ³⁵.

Business Outlook & Financial Sufficiency

Management explicitly states that 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 ³⁶. The company expects to continue to incur 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 prepare for potential future regulatory approvals and commercialization of its products ³⁷. The current cash and cash equivalents balance will not be sufficient to complete all necessary development activities and commercially launch products ³⁸.

A major growth area for the company is its proprietary, patented gene therapy platform, which uses a gene therapy approach to introduce the therapeutic protein "Klotho" to treat neurodegenerative diseases. The two lead product candidates are KLTO-101 (AAV9-CMV-sKL) for Alzheimer's disease and KLTO-202 (AAVmyo-Des-sKL) for Amyotrophic Lateral Sclerosis (ALS) ³⁹. 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 ⁴⁰. The pre-clinical development program for KLTO-101 is expected to follow KLTO-202 by six to nine months ⁴¹. The company intends to seek market approval in countries where it has issued and/or pending patents, including the U.S., Canada, Europe, China, and other viable markets ⁴². Furthermore, the company plans to find a corporate partner for the development of KLTO-101 for Alzheimer's disease ⁴³. There is also a plan to develop and validate new in vitro assays to separate and individually measure the three Klotho protein isoforms (s-KL, m-KL, p-KL) and two metabolites (KL1 and KL2) as part of the research and development program ⁴⁴.

Another growth area is the biosimilar biologics platform, which includes "off-patent" biosimilar versions of rituximab, trastuzumab, and bevacizumab for cancer and other diseases ⁴⁵. The company has initiated preparatory activities for its confirmatory Phase 3 clinical trial of bevacizumab-anew (Avastin) biosimilar candidate and rituximab-anew (Rituxan/Mabthera) candidate ⁴⁶. The company expects it may be several years before these Phase 3 clinical trials are completed and a product candidate is ready for market approval ⁴⁷.

The company expects net cash used in operating activities to increase in the future until its products are able to produce meaningful revenue ⁴⁸. 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 ⁴⁹. Without additional funding, there is substantial doubt about the company's ability to continue as a going concern for the twelve months from the date of the financial statements ⁵⁰.

Regarding capital allocation, the company has an Equity Incentive Plan, and during 2025, it granted 180,000 stock options at a weighted average fair value of $0.38 ⁵¹ and 408,691 shares at $1.34 per share to a member of management ⁵². In 2024, 1,000,000 stock options were granted at a weighted average fair value of $0.37 ⁵³. The company also entered into an At-the-Market sales agreement to sell up to $50,000,000 of common stock, intending to use the net proceeds for working capital and general corporate purposes ⁵⁴.

The company faces structural headwinds and execution risks, including the need for substantial additional funding to meet financial obligations and pursue business objectives ⁵⁵. It is highly dependent on collaborations with Universitat Autònoma de Barcelona (UAB) for preclinical R&D programs ⁵⁶. Negative public opinion of gene therapy and increased regulatory scrutiny may adversely impact development or commercial success ⁵⁷. The company faces significant competition in biosimilar biologics from other biotechnology and pharmaceutical companies ⁵⁸. There is also a risk that other companies may have property rights to the AAV and lentiviral vectors and lipid nanoparticles used for gene therapies, which the company may need to license ⁵⁹. The company currently has no products approved for commercial sale and may never be able to develop marketable products ⁶⁰.

Management Sentiments & Priorities

Management's message to shareholders emphasizes the company's focus on developing essential medicines for chronic diseases, particularly through its gene therapy platform for neurodegenerative disorders and biosimilar biologics for cancer. They acknowledge the significant strategic shift with the recent acquisition of Greenland Mines Corp. in March 2026, expanding into critical and precious mineral mining, which is noted as a "significant step in the Company's strategic growth and positioning" ⁷¹. However, the financial discussion in the 10-K does not reflect the impact of this acquisition. Management explicitly states that the company has not generated any operating revenues 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 ⁷². They anticipate continued significant operating and net losses and negative cash flows for the foreseeable future ⁷³. A key strategic priority is the advancement of the cell and gene therapy product candidates, specifically KLTO-101 for Alzheimer's disease and KLTO-202 for ALS, with plans to complete the animal toxicology package for KLTO-202 and submit an IND application to the FDA in 2025 for a Phase I "Compassionate Use" study ⁷⁴. Another priority is to find a corporate partner for the development of KLTO-101 ⁷⁵. Management also highlights the ongoing development of a new assay method to differentiate Klotho protein isoforms as part of the R&D program ⁷⁶. They also note the need for substantial additional funding to meet financial obligations and pursue business objectives, indicating that current cash and cash equivalents are insufficient to complete all necessary development and commercialization activities ⁷⁷.

Risk Factors

Greenland Mines Ltd faces substantial risks across macroeconomic, competitive, regulatory, and operational dimensions. Macroeconomic risks include the company's reliance on outside financing and cash from operations, with no assurance of securing timely additional financing on favorable terms, or at all, which could significantly limit its ability to grow or support its business ⁶¹. Operationally, the company has incurred significant losses since its inception and expects to continue incurring losses and negative cash flows for the foreseeable future, raising substantial doubt about its ability to continue as a going concern without additional funding ⁶². The company is highly dependent on its key executives and personnel, and the loss of any of these individuals could seriously harm its business ⁶³. Furthermore, the company relies on third parties for manufacturing, quality control testing, and conducting preclinical and clinical trials, and any failure by these third parties to comply with regulations or meet supply demands could harm the business ⁶⁴. In terms of competitive risks, the company expects to enter highly competitive pharmaceutical markets, facing numerous companies with substantially greater financial, technical, and other resources, including larger R&D staff and experienced marketing and manufacturing organizations ⁶⁵. Specifically, for biosimilars, there are already at least four approved bevacizumab biosimilars and three approved rituximab biosimilars on the market, which could materially harm the company's ability to gain market share ⁶⁶. Regulatory risks are significant, as the evolving regulatory approval processes for biologics and gene therapies are lengthy, time-consuming, rigorous, and inherently unpredictable, with no guarantee of obtaining approval for any product candidates ⁶⁷. The company's gene therapy product candidates are based on new gene transfer technology, making it difficult to predict the time and cost of development and regulatory approval ⁶⁸. Negative public opinion and increased regulatory scrutiny of gene therapy and genetic research may damage public perception or adversely affect the ability to conduct business or obtain regulatory approvals ⁶⁹. The company also faces a NASDAQ delisting risk due to its common stock failing to maintain a minimum bid price of $1 per share for 30 consecutive business days, with an extension granted until September 14, 2026, to regain compliance ⁷⁰.

View Source Annual Report on SEC.gov ↗

References

[1] Item 1, Business — Overview
[2] Item 1, Business — Our Research Pipeline
[3] Item 1, Business — Biosimilars Program
[4] 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”).
[5] Item 4, Intangible Assets — Needleless Syringe License
[6] Item 7, MD&A — Revenue
[7] Item 7, MD&A — Net Loss
[8] Item 7, MD&A — Operating Expenses
[9] Item 7, MD&A — Liquidity and Capital Resources
[10] Item 8, Consolidated Balance Sheets — Total current assets
[11] Item 8, Consolidated Balance Sheets — Total current liabilities
[12] Item 7, MD&A — Working Capital
[13] Item 2, Summary of Significant Accounting Policies — Going Concern
[14] Item 7, MD&A — Operating Expenses
[15] Item 7, MD&A — Operating Expenses
[16] Item 7, MD&A — Operating Expenses
[17] Item 7, MD&A — Operating Expenses
[18] Item 7, MD&A — Operating Expenses
[19] Item 7, MD&A — Operating Expenses
[20] Item 7, MD&A — Operating Expenses
[21] Item 7, MD&A — Net Loss
[22] Item 7, MD&A — Net Loss
[23] Item 7, MD&A — Operating Activities
[24] Item 7, MD&A — Operating Activities
[25] Item 7, MD&A — Operating Activities
[26] Item 7, MD&A — Liquidity and Capital Resources
[27] Item 7, MD&A — Liquidity and Capital Resources
[28] Item 7, MD&A — Financing Activities
[29] Item 7, MD&A — Financing Activities
[30] Item 9, Stockholder's Equity — Warrants
[31] Item 9, Stockholder's Equity — Warrants
[32] Item 9, Stockholder's Equity — Investor Share Purchase
[33] Item 9, Stockholder's Equity — Preferred B Shares
[34] Item 9, Stockholder's Equity — At-the-Market Sales Agreement
[35] Item 10, Commitments and Contingencies — Termination of acquisition agreement of SB Security Holdings, LLC
[36] Item 1A, Risk Factors — We currently have no products that are approved for commercial sale and may never be able to develop marketable products.
[37] 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.
[38] 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.
[39] 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”).
[40] 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”).
[41] 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”).
[42] Item 1, Business — The Company plans to seek market approval in countries where we have issued and/or pending patents, to include the U.S., Canada, Europe, China, and other viable markets.
[43] Item 1, Business — We plan to find a corporate partner to help in the development of KLTO-101 for the Alzheimer’s disease indication.
[44] 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.
[45] Item 1, Business — Our clinical-stage generic/biosimilar technologies consist of (a) “off-patent” portfolio of generic drugs (b) and “off-patent” biosimilar biologics (in-licensed from RLS).
[46] Item 1A, Risk Factors — If we are unable to obtain regulatory approval for, or successfully commercialize, bevacizumab-anew, or rituximab-anew, our business will be harmed.
[47] Item 1A, Risk Factors — If we are unable to obtain regulatory approval for, or successfully commercialize, bevacizumab-anew, or rituximab-anew, our business will be harmed.
[48] Item 7, MD&A — Operating Activities
[49] Item 2, Summary of Significant Accounting Policies — Going Concern
[50] Item 2, Summary of Significant Accounting Policies — Going Concern
[51] Item 9, Stockholder's Equity — Equity Incentive Plan
[52] Item 9, Stockholder's Equity — Equity Incentive Plan
[53] Item 9, Stockholder's Equity — Equity Incentive Plan
[54] Item 9, Stockholder's Equity — At-the-Market Sales Agreement
[55] Item 1A, Risk Factors — We will need substantial additional funding to meet our financial obligations and to pursue our business objectives.
[56] Item 1A, Risk Factors — We currently primarily rely on our collaborations with Universitat Autònoma de Barcelona (“UAB”) for our preclinical research and development programs.
[57] Item 1A, Risk Factors — Negative public opinion of gene therapy and increased regulatory scrutiny of gene therapy and genetic research may adversely impact the development or commercial success of our current and future product candidates.
[58] Item 1A, Risk Factors — We face significant competition in the area of biosimilar biologics from other biotechnology and pharmaceutical companies.
[59] Item 1A, Risk Factors — We use AAV and lentiviral vectors, and lipid nanoparticles to deliver some gene therapies, but others may have property rights to these vectors that we may need to license.
[60] Item 1A, Risk Factors — We currently have no products that are approved for commercial sale and may never be able to develop marketable products.
[61] Item 1A, Risk Factors — We may need additional capital in the future, which may not be available to us on favorable terms, and may dilute your ownership of our common stock.
[62] Item 1A, Risk Factors — We have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or maintain profitability.
[63] 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.
[64] Item 1A, Risk Factors — We will rely on third parties to manufacture and quality control test our product candidates, to conduct our preclinical and clinical trials, and perform other tasks for us.
[65] Item 1A, Risk Factors — We face intense competition and rapid technological change and the possibility that our competitors may develop therapies that are similar, more advanced, more effective, or less expensive than ours.
[66] Item 1A, Risk Factors — We face intense competition and rapid technological change and the possibility that our competitors may develop therapies that are similar, more advanced, more effective, or less expensive than ours.
[67] 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. If we and our collaboration partners are ultimately unable to obtain regulatory approval for our product candidates, our business will be harmed.
[68] 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.
[69] Item 1A, Risk Factors — Negative public opinion and increased regulatory scrutiny of gene therapy and genetic research may damage public perception of our product candidates or adversely affect our ability to conduct our business or obtain regulatory approvals for our product candidates.
[70] 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.
[71] Item 1, Business — Overview
[72] Item 7, MD&A — Overview
[73] Item 7, MD&A — Overview
[74] 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”).
[75] Item 1, Business — We plan to find a corporate partner to help in the development of KLTO-101 for the Alzheimer’s disease indication.
[76] 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.
[77] 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.

Analysis on 5/21/2026

Recent Material Events

Jun 29, 2026Material Event

Greenland Mines Ltd. dismissed its independent registered public accounting firm, BCRG Group, following BCRG's attest business being acquired by Simon & Edward LLP (S&E) on June 15, 2026. The Audit Committee approved the appointment of S&E as the new independent auditor on June 23, 2026. Previous audit reports for fiscal years 2024 and 2025 included an explanatory paragraph regarding substantial doubt about the company's ability to continue as a going concern. There were no disagreements with BCRG regarding accounting principles or auditing procedures, though material weaknesses in internal control over financial reporting were previously disclosed. Greenland Mines Ltd. is a mining company.

Jun 25, 2026Material Event

Greenland Mines Ltd. completed a private placement on June 18, 2026, issuing 15,000,000 shares of common stock to purchasers for approximately $3,750,000 in gross proceeds. The issuance was made under Section 4(a)(2) of the Securities Act of 1933 and Rule 506 of Regulation D. Greenland Mines Ltd. is a mining company operating in the mining industry.

Jun 22, 2026Material Event

Greenland Mines Ltd. entered into a Share Exchange Agreement with AnorTech Inc. to acquire 19,958,503 common shares of AnorTech, representing approximately 9.9% of AnorTech's outstanding common shares. On June 22, 2026, the Company issued 12,400,000 shares of its own common stock to AnorTech in exchange for the AnorTech shares. The Company also holds an option to acquire up to 25,168,669 additional AnorTech shares at a price per share of at least CAD$0.30 or the last closing price on the TSXV. Greenland Mines Ltd. operates in the mining industry and focuses on mineral exploration and extraction.

Jun 22, 2026Material Event

Greenland Mines Ltd. stockholders at a special meeting held on June 18, 2026, approved a proposal to amend the Certificate of Incorporation to allow for one or more reverse stock splits of common stock with an exchange ratio between 1-for-2 and 1-for-50, with an aggregate exchange ratio not exceeding 1-for-60. Greenland Mines Ltd. is a mining company operating in the mining industry.

Jun 17, 2026Material Event

Greenland Mines Ltd. entered into a Securities Purchase Agreement on June 15, 2026, to issue and sell 15,000,000 shares of common stock to three investors for $3,750,000 in total proceeds. The company intends to use the net proceeds for working capital and general corporate purposes, with the closing expected to occur on or before June 25, 2026. Greenland Mines Ltd. is a mining company operating in the mining industry.

Greenland Mines Ltd (GRML)

Business Summary

Business Outlook & Financial Sufficiency

Management Sentiments & Priorities

Risk Factors

View Source Annual Report on SEC.gov ↗

References

[1] Item 1, Business — Overview
[2] Item 1, Business — Our Research Pipeline
[3] Item 1, Business — Biosimilars Program
[4] 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”).
[5] Item 4, Intangible Assets — Needleless Syringe License
[6] Item 7, MD&A — Revenue
[7] Item 7, MD&A — Net Loss
[8] Item 7, MD&A — Operating Expenses
[9] Item 7, MD&A — Liquidity and Capital Resources
[10] Item 8, Consolidated Balance Sheets — Total current assets
[11] Item 8, Consolidated Balance Sheets — Total current liabilities
[12] Item 7, MD&A — Working Capital
[13] Item 2, Summary of Significant Accounting Policies — Going Concern
[14] Item 7, MD&A — Operating Expenses
[15] Item 7, MD&A — Operating Expenses
[16] Item 7, MD&A — Operating Expenses
[17] Item 7, MD&A — Operating Expenses
[18] Item 7, MD&A — Operating Expenses
[19] Item 7, MD&A — Operating Expenses
[20] Item 7, MD&A — Operating Expenses
[21] Item 7, MD&A — Net Loss
[22] Item 7, MD&A — Net Loss
[23] Item 7, MD&A — Operating Activities
[24] Item 7, MD&A — Operating Activities
[25] Item 7, MD&A — Operating Activities
[26] Item 7, MD&A — Liquidity and Capital Resources
[27] Item 7, MD&A — Liquidity and Capital Resources
[28] Item 7, MD&A — Financing Activities
[29] Item 7, MD&A — Financing Activities
[30] Item 9, Stockholder's Equity — Warrants
[31] Item 9, Stockholder's Equity — Warrants
[32] Item 9, Stockholder's Equity — Investor Share Purchase
[33] Item 9, Stockholder's Equity — Preferred B Shares
[34] Item 9, Stockholder's Equity — At-the-Market Sales Agreement
[35] Item 10, Commitments and Contingencies — Termination of acquisition agreement of SB Security Holdings, LLC
[36] Item 1A, Risk Factors — We currently have no products that are approved for commercial sale and may never be able to develop marketable products.
[37] 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.
[38] 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.
[39] 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”).
[40] 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”).
[41] 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”).
[42] Item 1, Business — The Company plans to seek market approval in countries where we have issued and/or pending patents, to include the U.S., Canada, Europe, China, and other viable markets.
[43] Item 1, Business — We plan to find a corporate partner to help in the development of KLTO-101 for the Alzheimer’s disease indication.
[44] 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.
[45] Item 1, Business — Our clinical-stage generic/biosimilar technologies consist of (a) “off-patent” portfolio of generic drugs (b) and “off-patent” biosimilar biologics (in-licensed from RLS).
[46] Item 1A, Risk Factors — If we are unable to obtain regulatory approval for, or successfully commercialize, bevacizumab-anew, or rituximab-anew, our business will be harmed.
[47] Item 1A, Risk Factors — If we are unable to obtain regulatory approval for, or successfully commercialize, bevacizumab-anew, or rituximab-anew, our business will be harmed.
[48] Item 7, MD&A — Operating Activities
[49] Item 2, Summary of Significant Accounting Policies — Going Concern
[50] Item 2, Summary of Significant Accounting Policies — Going Concern
[51] Item 9, Stockholder's Equity — Equity Incentive Plan
[52] Item 9, Stockholder's Equity — Equity Incentive Plan
[53] Item 9, Stockholder's Equity — Equity Incentive Plan
[54] Item 9, Stockholder's Equity — At-the-Market Sales Agreement
[55] Item 1A, Risk Factors — We will need substantial additional funding to meet our financial obligations and to pursue our business objectives.
[56] Item 1A, Risk Factors — We currently primarily rely on our collaborations with Universitat Autònoma de Barcelona (“UAB”) for our preclinical research and development programs.
[57] Item 1A, Risk Factors — Negative public opinion of gene therapy and increased regulatory scrutiny of gene therapy and genetic research may adversely impact the development or commercial success of our current and future product candidates.
[58] Item 1A, Risk Factors — We face significant competition in the area of biosimilar biologics from other biotechnology and pharmaceutical companies.
[59] Item 1A, Risk Factors — We use AAV and lentiviral vectors, and lipid nanoparticles to deliver some gene therapies, but others may have property rights to these vectors that we may need to license.
[60] Item 1A, Risk Factors — We currently have no products that are approved for commercial sale and may never be able to develop marketable products.
[61] Item 1A, Risk Factors — We may need additional capital in the future, which may not be available to us on favorable terms, and may dilute your ownership of our common stock.
[62] Item 1A, Risk Factors — We have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or maintain profitability.
[63] 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.
[64] Item 1A, Risk Factors — We will rely on third parties to manufacture and quality control test our product candidates, to conduct our preclinical and clinical trials, and perform other tasks for us.
[65] Item 1A, Risk Factors — We face intense competition and rapid technological change and the possibility that our competitors may develop therapies that are similar, more advanced, more effective, or less expensive than ours.
[66] Item 1A, Risk Factors — We face intense competition and rapid technological change and the possibility that our competitors may develop therapies that are similar, more advanced, more effective, or less expensive than ours.
[67] 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. If we and our collaboration partners are ultimately unable to obtain regulatory approval for our product candidates, our business will be harmed.
[68] 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.
[69] Item 1A, Risk Factors — Negative public opinion and increased regulatory scrutiny of gene therapy and genetic research may damage public perception of our product candidates or adversely affect our ability to conduct our business or obtain regulatory approvals for our product candidates.
[70] 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.
[71] Item 1, Business — Overview
[72] Item 7, MD&A — Overview
[73] Item 7, MD&A — Overview
[74] 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”).
[75] Item 1, Business — We plan to find a corporate partner to help in the development of KLTO-101 for the Alzheimer’s disease indication.
[76] 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.
[77] 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.

Analysis on 5/21/2026

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