Structure Therapeutics (GPCR) risk factors, FY2025 10-K

Risks Related to Our Limited Operating History, Financial Position and Capital Requirements

1. 01We have a limited operating history, have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future
2. 02We will require substantial additional capital to finance our operations, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate certain of our product development programs, commercialization efforts or other operations68% rewritten
3. 03operating plans, we may seek additional capital if market conditions are favorable or if we have specific strategic considerationsNew
4. 04Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our technologies or product candidates44% rewritten

Risks Related to the Discovery, Development and Regulatory Approval of Product Candidates

1. 05Our approach to the discovery of product candidates based on our technology platform is unproven, and we do not know whether we will be able to develop any products of commercial value
2. 06If any of these events occur, our ability to successfully discover, develop and commercialize any product candidates may be impaired and the value of our company could decline significantly94% rewritten
3. 07We are in the early stages of our development efforts and have five product candidates, aleniglipron, ACCG-2671, ANPA-0073, LTSE-2578 and ACCG-3535, in early clinical developmentNew
4. 08Clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes. The results of prior clinical studies and preclinical studies are not necessarily predictive of future results, and may not be favorable, or receive regulatory approval on a timely basis, if at all
5. 09Any difficulties or delays in the commencement or completion, or termination or suspension, of our ongoing and planned clinical studies could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects
6. 10Enrollment and retention of patients in clinical studies is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control, which could adversely affect our business, operating results and prospects
7. 11As an organization, we have never conducted later-stage clinical studies or submitted an NDA, and may be unable to do so for any of our product candidates
8. 12The marketing approval processes of the FDA and applicable foreign authorities are lengthy, time consuming, expensive and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our product candidates, our business will be substantially harmed
9. 13We may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success
10. 14We may not be able to obtain or maintain orphan drug designations or exclusivity for our product candidates, which could limit the potential profitability of our product candidates
11. 15Preliminary, topline and interim data from our clinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
12. 16Obtaining and maintaining marketing approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining marketing approval of our product candidates in other jurisdictions52% rewritten
13. 17International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospectsNew
14. 18employee terminations or resignations at the SEC could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operationsNew

Risks Related to Our Reliance on Third Parties

1. 19Our current and anticipated future dependence upon others for the manufacture of our product candidates or drugs may adversely affect our future profit margins and our ability to commercialize any product candidates that receive marketing approval on a timely and competitive basis
2. 20Our existing discovery collaborations with Schrödinger, LLC (together with its affiliates, “Schrödinger”) are important to our business. If we are unable to maintain these collaborations, or if these collaborations are not successful, our business could be adversely affected20% rewritten
3. 21Reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed
4. 22Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of trade secrets and other proprietary information
5. 23The adoption and deployment of AI in our, and any third-party collaborators’ operations, and in particular our and any third-party collaborators’ R&D efforts to explore new targets and develop effective products, may not be effective and may expose us to risk

Risks Related to Commercialization of Our Product Candidates

1. 24Even if our current or future 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
2. 25Coverage and adequate reimbursement may not be available for our current or any future product candidates, which could make it difficult for us to sell profitably, if approved23% rewritten
3. 26We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than us
4. 27If the market opportunities for any of our product candidates are smaller than we estimate, even assuming approval of a product candidate, our revenue may be adversely affected, and our business may suffer68% rewritten
5. 28treatment with our products or new patients may become increasingly difficult to identify or gain access to, all of which would adversely affect our results of operations and our businessNew
6. 29Our future growth may depend, in part, on our ability to commercialize products in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties

Risks Related to Our Business Operations and Industry

1. 30Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide
2. 31We are highly dependent on the services of our senior management team and if we are not able to retain these members of our management team and recruit and retain additional management, clinical and scientific personnel, our business will be harmed83% rewritten
3. 32additional management, clinical and scientific personnel. If we are not able to retain our management and to attract, on terms acceptable to us, additional qualified personnel necessary for the continued development of our business, we may not be able to sustain our operations or growNew
4. 33We will need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations
5. 34Healthcare legislative reform measures may have a negative impact on our business and results of operations74% rewritten
6. 35If we or our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages
7. 36Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop
8. 37coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claimsNew
9. 38Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading
10. 39Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any
11. 40There is tax risk associated with the reporting of cross-border arrangements and activities between us and our subsidiaries
12. 41Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits
13. 42Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition, or results of operations64% rewritten

Risks Related to Doing Business in China and Our International Operations

1. 43Changes in the political and economic policies or in relations between China and the United States may affect our business, financial condition, results of operations and the market price of our ADSs
2. 44Changes in U.S. and Chinese regulations may impact our business, our operating results, our ability to raise capital and the market price of our ADSs
3. 45Chinese domestic companies or assets in exchange for the shares of the offshore special purpose vehicles shall obtain CSRC approval prior to publicly listing their securities on an overseas stock exchangeNew
4. 46As a company with operations and business relationships outside of the United States, our business is subject to economic, political, regulatory and other risks associated with international operations
5. 47If we fail to comply with Chinese environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business
6. 48Development in the Chinese legal system could materially and adversely affect us73% rewritten
7. 49Regulatory Requirements on currency exchange may limit our ability to receive and use effectively financing in foreign currencies72% rewritten
8. 50If we are classified as a China resident enterprise for China income tax purposes, such classification could result in unfavorable tax consequences to us and our non-Chinese shareholders or ADS holders
9. 51We and our shareholders face uncertainties in China with respect to indirect transfers of equity interests in China resident enterprises
10. 52Any failure to comply with Chinese regulations regarding the registration requirements for our employee equity incentive plans may subject us to fines and other legal or administrative sanctions, which could adversely affect our business, financial condition and results of operations

Risks Related to Our Intellectual Property

1. 53We cannot ensure that patent rights relating to inventions described and claimed in our pending patent applications will issue or that patents based on our patent applications will not be challenged and rendered invalid and/or unenforceable
2. 54We rely on trade secret and proprietary know-how which can be difficult to trace and enforce and, if we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed47% rewritten
3. 55able to establish or maintain a competitive advantage in our market, and this scenario could materially adversely affect our business, financial condition and results of operationsNew
4. 56Our intellectual property licensed from third parties may be subject to retained rights
5. 57Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
6. 58Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time77% rewritten
7. 59approved. Even if patents covering our product candidates are obtained, once the patent life has expired for a product candidate, we may be open to competitionNew
8. 60Intellectual property rights do not necessarily address all potential threats to our business
9. 61Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a negative impact on the success of our business81% rewritten
10. 62We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful
11. 63other proceedings may result in a decision adverse to our interests and, even if we are successful, may result in substantial costs and distract our management and other employeesNew
12. 64Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties
13. 65Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our current and any future product candidates
14. 66We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business
15. 67We may be subject to claims that our employees, consultants, or advisors have wrongfully used or disclosed trade secrets or other confidential information of their current or former employers or claims asserting inventorship or ownership of what we regard as our own intellectual property
16. 68We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products
17. 69If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our business may be adversely affected

Risks Related to Our ADSs

1. 70The price of our ADSs may be volatile, and you could lose all or part of your investment
2. 71This material weakness did not result in any material misstatements to the consolidated financial statements. The material weakness was fully remediated as of June 30, 2024New
3. 72Our principal shareholders and management own a significant percentage of our voting securities and will be able to exert significant control over matters subject to shareholder approval45% rewritten
4. 73In the future we may issue ADSs or other securities if we need to raise additional capital and, in the event a large number of ADSs are sold in the public market, such sales could reduce the trading price of our ADSsNew
5. 74Holders of our ADSs have fewer rights than our shareholders and must act through the depositary to exercise their rights
6. 75ADS holders may not be entitled to a jury trial with respect to claims arising under the deposit agreement, which could result in less favorable outcomes to the plaintiff(s) in any such action
7. 76You may not receive distributions on our ordinary shares represented by the ADSs or any value for them if it is illegal or impractical to make them available to holders of ADSs
8. 77Your right to participate in any future rights offerings may be limited, which may cause dilution to your holdings
9. 78Because we do not anticipate paying any cash dividends on our ADSs in the foreseeable future, capital appreciation, if any, will be your sole source of gains and you may never receive a return on your investment
10. 79We are subject to tax in the Cayman Islands and the United States
11. 80Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited
12. 81We incur significantly increased costs as a result of operating as a company whose ADSs are publicly traded in the United States, and our management will be required to devote substantial time to new compliance initiatives39% rewritten
13. 82Since shareholder rights under Cayman Islands law differ from those under U.S. law, you may have difficulty protecting your shareholder rights
14. 83Provisions in our amended and restated memorandum and articles of association may prevent or frustrate attempts by our shareholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our ADSs may be lower as a result
15. 84You may be subject to limitations on transfers of your ADSs
16. 85Failure to build our finance infrastructure and improve our accounting systems and controls could impair our ability to comply with the financial reporting and internal controls requirements for publicly traded companies
17. 86If we are unable to maintain effective internal controls, our business, financial position and results of operations could be adversely affected
18. 87Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
19. 88Future changes in financial accounting standards or practices may cause adverse and unexpected revenue fluctuations and adversely affect our reported results of operations
20. 89If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, the price and trading volume of our ADSs could decline
21. 90We could be subject to securities class action litigation or material legal proceedings which could have a negative impact on our reputation or business
22. 91We or the third parties upon whom we depend may be adversely affected by earthquakes, fires or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
23. 92If 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 have a material adverse effect on the success of our business
24. 93Our failure to meet Nasdaq’s continued listing requirements could result in a delisting of our ADSs