Greenland Mines (GRML) risk factors, 2026 10-K

Risks Related to Our Business and Operations

1. 01Our business is subject to a number of risks of which you should be aware before making the decision to invest in our common stock
2. 02We are dependent on the success of our biosimilar and gene therapy product candidates, which are still in early stages of development
3. 03We 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
4. 04We are unable to estimate the actual funds that we will require for development and any approved marketing and commercialization activities
5. 05We may be required to make significant payments to third parties under the agreements pursuant to which we acquired our gene therapy and biosimilar product candidates
6. 06We need to attract and retain key personnel
7. 07Our employees, independent contractors, principal investigators, consultants, commercial collaborators, manufacturers, service providers and other vendors, or those of our affiliates, may engage in misconduct or other improper activities
8. 08Operation of our business internationally exposes us to business, regulatory, political, operational, financial, and economic risks associated with doing business in various jurisdictions globally

Risks Related to Development of Biosimilar Biologics and Cell and Gene Therapies

1. 09If we are unable to obtain regulatory approval for, or successfully commercialize, bevacizumab-anew, or rituximab-anew, our business will be harmed
2. 10The 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
3. 11The results of previous clinical trials may not be predictive of future results, and the results of our future clinical trials may not satisfy the requirements of the FDA, EMA or other foreign regulatory agencies
4. 12Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval
5. 13If we receive approval, regulatory agencies require that we report certain information about adverse medical events
6. 14If other biosimilars of bevacizumab (Avastin) or rituximab-anew (Rituxan/Mabthera) are determined to be interchangeable and our biosimilar product candidates for these reference products are not, our business would suffer
7. 15If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our current or future product candidates, and our insurance coverage may not be sufficient to satisfy any liability that may arise
8. 16Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory scrutiny
9. 17If a regulatory agency discovers previously unknown problems with an approved product, they may impose restrictions on that product
10. 18We 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
11. 19Many of our competitors have substantially greater financial, technical and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations
12. 20If an improved version of a reference product, such as Avastin, is developed or if the market for the reference product significantly declines, sales or potential sales of our biosimilar product candidates may suffer
13. 21We currently have no marketing and sales organization. If we are unable to establish sales and marketing capabilities in jurisdictions for which we choose to retain commercialization rights, we may be unable to generate any revenue
14. 22We may need to enter into agreements with other companies that can provide capabilities and funds for the development and commercialization of our product candidates. If we are unsuccessful in forming or maintaining these agreements on favorable terms, our business could be harmed
15. 23The third-party coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue
16. 24Our biosimilar product candidates, if approved, will face price competition from both the respective reference products and other biosimilars
17. 25Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control
18. 26Our 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
19. 27Clinical 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
20. 28Regulatory requirements governing gene therapy products have changed frequently and may continue to change in the future
21. 29The FDA, NIH and the EMA have each expressed interest in further regulating biotechnology, including gene therapy and genetic testing
22. 30Even 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
23. 31Even if our product candidates receive marketing approval, they may fail to achieve market acceptance by physicians, patients, third-party payors, or others in the medical community necessary for commercial success
24. 32Negative 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
25. 33Increasing demand for compassionate use or expanded access of our unapproved therapies could negatively affect our reputation and harm our business

Risks Related to Our Reliance on Third Parties

1. 34We 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
2. 35We expect to depend on third parties for the commercialization of our biosimilar and gene therapy product candidates in certain major markets outside the United States, and their failure to commercialize in those markets could harm our business and operating results
3. 36We 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

Risks Related to Intellectual Property

1. 37If we infringe or are alleged to infringe intellectual property rights of third parties, our business could be harmed. Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts
2. 38There may be third-party patents or patent applications with claims to compositions, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates
3. 39Third parties could bring claims against us that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial monetary damages
4. 40The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history
5. 41We may become involved in lawsuits to protect or enforce any future patents, which could be expensive, time-consuming, and unsuccessful
6. 42We may be unable to obtain and maintain effective patent rights for our product candidates or any future product candidates
7. 43We may not be able to protect our intellectual property rights throughout the world

Risks Related to Our Business Operations

1. 44We may not be successful in our efforts to identify, develop or commercialize additional product candidates
2. 45If any of these events occur, we may be forced to abandon our development efforts for a program or programs or we may not be able to identify, develop or commercialize additional product candidates, which would harm our business and could potentially cause us to cease operations
3. 46If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business

General Risks

1. 47If our security measures are compromised now, or in the future, or the security, confidentiality, integrity, or availability of, our information technology, software, services, communications or data is compromised, limited or fails, it could result in material harm to our business
2. 48There is no assurance that we will be able to reach and service customers in a profitable manner
3. 49We may in the future issue more shares that could cause a loss of control by our present management and current stockholders
4. 50The elimination of personal liability of director and officers under Delaware law and the existence of indemnification rights held by our directors, officers and employees may result in substantial expenses
5. 51We may undertake one or more significant corporate transactions that may not achieve their intended results, may adversely affect our financial condition and our results of operations, or result in unforeseeable risks to our business
6. 52The JOBS Act permits “emerging growth companies” like us to take advantage of certain exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies
7. 53If large amounts of our common shares held by our existing stockholders are sold in the future, the market price of our common shares could decline
8. 54Investors may suffer substantial dilution or an unrealized loss of seniority in preferences and privileges if we need to seek additional funding in the future34% rewritten
9. 55We 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
10. 56We may expand through acquisitions of, or investments in, other companies or through business relationships, all of which may result in additional dilution to our stockholders and consumption of resources that are necessary to sustain our business26% rewritten
11. 57If 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 us95% rewritten