Quoin Pharmaceuticals (QNRX) risk factors, FY2025 10-K

Risks Related to Our Financial Position and Capital Requirements

1. 01We have a limited operating history that you can use to evaluate us, and the likelihood of our success must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered by a small developing company
2. 02We must raise additional capital to fund our operations in order to continue as a going concernNew
3. 03We have incurred significant losses since our inception and have limited cash available for our operations44% rewritten
4. 04We have never generated any revenue from product sales or any other sources since inception, and may never be profitable
5. 05We expect that we will need to raise additional capital, which may not be available on acceptable terms, or at all
6. 06The terms of our October 2025 private placement may make it difficult for us to procure additional financingNew

Risks Related to the Discovery and Development of Product Candidates

1. 07Pre-clinical and clinical studies of our product candidates may not be successful. If we are unable to generate successful results from pre-clinical and clinical studies of our product candidates, or experience significant delays in doing so, our business may be materially harmed
2. 08We may not be successful in our efforts to identify or develop potential product candidates
3. 09Accordingly, we cannot be sure that we will submit INDs on our expected timelines and we cannot be certain the FDA or foreign regulatory agencies, such as the EMA, will allow us to progress into clinical trials based on the submission of any IND
4. 10Any of our product candidates may cause undesirable side effects or have other properties impacting safety that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance
5. 11Even if we complete the necessary pre - clinical studies and clinical trials, we cannot predict whether or when we will obtain regulatory approval to commercialize a product candidate and we cannot, therefore, predict the timing of any revenue from a future product
6. 12Even if we obtain regulatory approval for a product candidate, we will still face extensive regulatory requirements, and our products may face future development and regulatory challenges
7. 13We may not be able to maintain orphan drug designation or obtain orphan drug exclusivity for our product candidates32% rewritten
8. 14We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success
9. 15We expect competition in the marketplace for our product candidates, should any of them receive regulatory approval21% rewritten
10. 16We face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively
11. 17The commercial success of our product candidates will depend upon the acceptance of these product candidates by the medical community, including physicians, patients and healthcare payors
12. 18If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate any revenues
13. 19If we obtain approval to commercialize any approved products outside of the United States a variety of risks associated with international operations could materially adversely affect our business
14. 20Coverage and adequate reimbursement may not be available for our product candidates, if approved, which could make it difficult for us to sell products profitably46% rewritten

Risks Related to Our Reliance on Third Parties

1. 21We rely on third parties to conduct some aspects of our compound formulation, research and pre - clinical studies, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such formulation, research or testing
2. 22We do not expect to independently conduct all aspects of our drug development activities, compound formulation research or pre-clinical studies of product candidates. We currently rely and expect to continue to rely on third parties to conduct some or all aspects of our pre-clinical studies and formulation development
3. 23Reliance on third-party manufacturers entails risks, including risks that we would not be subject to if we manufactured the product candidates ourselves
4. 24We rely on limited sources of supply for the drug substance of product candidates and any disruption in the chain of supply may cause a delay in developing and commercializing these product candidates
5. 25Manufacturing issues may arise that could increase product and regulatory approval costs or delay commercialization
6. 26We rely on third parties to conduct, supervise and monitor our clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business90% rewritten
7. 27conducted in accordance with the applicable protocol, legal, regulatory and scientific standards and our reliance on the CROs will not relieve us of our regulatory responsibilitiesNew

Risks Related to Our Intellectual Property

1. 28If we are unable to obtain or protect intellectual property rights related to our future products and product candidates, we may not be able to compete effectively in our markets
2. 29Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts
3. 30We are a party to intellectual property license agreements that are important to our business and expect to enter into additional license agreements in the future. Our existing license agreements impose, and we expect that future license agreements will impose, various obligations on us
4. 31We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful
5. 32We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties
6. 33The pausing or termination of government grants by the United States government could have a major effect on the pharmaceutical industry, and as a result, our operations and prospectsNew
7. 34Our future success depends on our ability to attract and retain key executives and to attract, retain and motivate qualified personnel
8. 35We may need to expand our organization and may experience difficulties in managing our growth, which could disrupt our operations
9. 36Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading
10. 37operations in the EU, including potentially conducting pre - clinical and clinical trials. With such expansion, we would be subject to increased governmental regulation in the EU countries in which we might operate, including regulation due to the GDPRNew
11. 38Our operations and commercial success may be impacted from changes to current regulations and future legislation93% rewritten
12. 39We face potential product liability, and, if successful claims are brought against us, we may incur substantial liability and costs
13. 40Cyber security risks and the failure to maintain the confidentiality, integrity, and availability of our computer hardware, software, and Internet applications and related tools and functions could result in damage to our reputation and/or subject us to costs, fines or lawsuits
14. 41We have been, and may in the future be, adversely affected by health epidemics and pandemics which may significantly harm our business, prospects, financial condition and operating results
15. 42Business interruptions could delay us in the process of developing our future products

Risks Related to Being an Israeli Company

1. 43The rights and responsibilities of our shareholders are governed by Israeli law, which may differ in some respects from the rights and responsibilities of shareholders of U.S. corporations
2. 44Provisions of Israeli law may delay, prevent or otherwise impede a merger with, or an acquisition of, our company, which could prevent a change of control, even when the terms of such a transaction are favorable to us and our shareholders

Risks Related to Ownership of Our ADSs and Ordinary Shares

1. 45We do not know whether a market for our securities will be sustained and as a result it may be difficult for shareholders to sell our securities
2. 46We incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies, which may harm our businessNew
3. 47Our ADSs are listed on the Nasdaq Capital Market, which imposes, among other requirements, a minimum bid requirementNew
4. 48There can be no assurance that we will be able to maintain compliance with Nasdaq’s Minimum Bid Price Requirement for continued listing or other continued listing requirementsNew
5. 49The market price for our ADSs may be volatile
6. 50We may be at risk of securities class action litigation
7. 51Substantial future sales or perceived potential sales of our ADSs in the public market could cause the price of our ADSs to decline
8. 52Our shareholders may experience substantial dilution as a result of future issuances of our equity securities
9. 53We have not paid, and do not intend to pay, dividends on our ordinary shares and, therefore, unless our traded securities appreciate in value, our investors may not benefit from holding our securities87% rewritten
10. 54these securities unless their market price becomes greater than the price paid by such investors and they are able to sell such securities. We cannot assure you that shareholders will ever be able to resell our securities at a price in excess of the price paidNew
11. 55Holders of ADSs must act through the depositary to exercise their rights
12. 56Holders of ADSs may be subject to limitations on the transfer of their ADSs