Grace Therapeutics (GRCE) risk factors, FY2025 10-K

Other

1. 01We may not achieve our publicly announced milestones on time, or at all
2. 02We are heavily dependent on the success of our lead drug candidate, GTx-104
3. 03We may not be able to maximize value from our de-prioritized drug candidates, GTx-102 and GTx-101, through either development, out-licensing or sale
4. 04We may not be able to maintain our operations and advance our research and development and commercialization of our GTx-104 lead drug candidate without additional funding
5. 05We have no history of commercializing drugs, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability
6. 06Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel
7. 07We may need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations and our ability to compete
8. 08We face potential product liability, and if claims are brought against us, we may incur substantial liability
9. 09the inability to commercialize our product candidates
10. 10We rely on information technology and any failure, inadequacy, interruption, or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively
11. 11Unfavorable global economic conditions and geopolitical events, including as a result of trade tensions between the U.S. and China, could adversely affect our business, financial condition or results of operations, including conduct of our clinical trials and our manufacturing activities
12. 12Our ability to conduct our business is dependent on the data that we collect, process, and share in discovering, developing, and commercializing drug products. These data are often considered personal data and are therefore regulated by data privacy laws in the United States and abroad

Risks Related to Development, Testing and Commercialization of Our Products

1. 13Clinical development is a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results. Failure can occur at any stage of clinical development
2. 14delays by our CMOs to produce and deliver sufficient supply of clinical trial materials
3. 15The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our drug candidates, our business will be substantially harmed
4. 16the approval policies or regulations of the FDA or comparable foreign regulatory authorities may change significantly in a manner rendering our clinical data insufficient for approval
5. 17If a product candidate causes undesirable side effects, then we may be unable to receive regulatory approval or market acceptance for such product candidate
6. 18If the market opportunities for GTx-104 are smaller than we believe they are, our results of operations may be adversely affected, and our business may suffer
7. 19We are subject to uncertainty relating to healthcare reform measures and reimbursement policies which, if not favorable to our drug candidates, could hinder or prevent our drug candidates’ commercial success
8. 20Recent and future changes in healthcare legislation and regulations may increase the difficulty and cost to obtain marketing approval for a drug candidate, increase the costs to commercialize an approved product, and adversely affect the price set for such product
9. 21Our commercial success depends upon attaining significant market acceptance of our drug candidates and drug products, if approved, among physicians, nurses, pharmacists, patients and the medical community
10. 22the effectiveness of our sales and marketing efforts
11. 23If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our drug candidates, we may be unable to generate any revenue
12. 24Even if GTx-104 receives regulatory approval, we will still face regulatory difficulties
13. 25The occurrence of any event or penalty described above may inhibit or preclude our ability to commercialize GTx-104 and generate revenue
14. 26Even if our drug candidates receive regulatory approval in the United States, we may never obtain regulatory approval or successfully commercialize our products outside of the United States
15. 27If we obtain approval to commercialize any approved drug products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business
16. 28We are required to obtain regulatory approval for each of our drug candidates in each jurisdiction in which we intend to market such products, and the inability to obtain such approvals would limit our ability to realize their full market potential
17. 29We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively
18. 30We could incur substantial costs and disruption to our business and delays in the launch of our drug candidates if our competitors and/or collaborators bring legal actions against us, which could harm our business and operating results
19. 31We are subject to numerous complex regulatory requirements and failure to comply with these regulations, or the cost of compliance with these regulations, may harm our business
20. 32Our employees, independent contractors, principal investigators, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements

Risks Relating to Our Intellectual Property

1. 33If we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business
2. 34redesigning our drug candidates or processes so they do not infringe, which may not be possible or may require substantial funds and time
3. 35We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed alleged confidential information or trade secrets of their other clients or former employers to us
4. 36Our success depends in part upon our ability to protect our intellectual property for our branded products and drug candidates
5. 37we may not develop additional proprietary technologies that are patentable
6. 38If we fail to comply with our obligations in the agreements under which we license rights to technology from third parties, or if the license agreements are terminated for other reasons, we could lose license rights that are important to our business
7. 39We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
8. 40Intellectual property rights do not necessarily address all potential threats to our competitive advantage
9. 41We may not be able to protect our intellectual property rights throughout the world
10. 42If our estimates or judgments relating to our critical accounting policies for intangible assets prove to be incorrect, further impairment charges could result

Risks Related to Tax

1. 43We may not be able to use our net operating loss carry forwards to offset future taxable income for U.S. and Canadian federal income tax purposes
2. 44The IRS may not agree that we should be treated as a foreign corporation for U.S. federal tax purposes prior to the Domestication

Risks Relating to Our Common Stock

1. 45We do not expect to pay any cash dividends for the foreseeable future
2. 46The price of our common stock may be volatile
3. 47Raising additional capital may cause dilution to our existing stockholders, restrict our operations, or require us to relinquish rights to our technologies or drug candidates