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Structure Therapeutics Inc.

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Business Summary

Structure Therapeutics Inc. is a clinical-stage global biopharmaceutical company focused on developing novel oral small molecule therapeutics for chronic diseases with unmet medical needs . The company's core business model leverages a differentiated technology platform that combines structure-based drug discovery with computational chemistry expertise to develop small molecule therapeutics against G-protein coupled receptors (GPCRs) . This approach aims to overcome the limitations of existing biologic and peptide therapies, offering potentially more accessible, scalable, and cost-effective medicines [9, 10]. The company generates revenue primarily through its drug development programs and potential future commercialization of its product candidates, as well as through strategic partnerships and licensing agreements [58, 34].

The company's most advanced product candidate is aleniglipron (GSBR-1290), an oral small molecule selective glucagon-like-peptide-1 receptor (GLP-1R) agonist, currently in five ongoing clinical studies for the treatment of obesity, overweight, and related conditions . Aleniglipron was designed using the company's internal structure-based drug discovery platform and is intended to be a biased GPCR agonist, activating only the G-protein pathway without β-arrestin signaling at therapeutic doses to avoid receptor internalization and desensitization . The company has a current manufacturing capacity of 6,000 tons/year of aleniglipron, sufficient to supply over 120 million patients per year .

Structure Therapeutics is also advancing its oral small molecule amylin program with lead candidate ACCG-2671, which initiated Phase 1 clinical development in December 2025, and a second development candidate, ACCG-3535 . Both ACCG-2671 and ACCG-3535 are designed as oral small molecule Dual Amylin and Calcitonin Receptor Agonists (DACRA) and have shown sub-nanomolar in vitro functional activity and in vivo reductions in food intake and weight loss in preclinical studies [18, 20, 21]. These amylin receptor agonists are being developed for obesity, with potential for monotherapy or fixed-dose combination with GLP-1R agonists [11, 19].

Beyond GLP-1R and amylin receptor programs, the company is developing next-generation oral incretins for potential combination therapy, including small molecule candidates targeting Glucose-dependent Insulinotropic Polypeptide Receptor (GIPR) and Glucagon Receptor (GCGR) . The GIPR program has identified GIPR agonist, dual GLP-1R/GIPR agonist, and GIPR antagonist hits, while the GCGR program has identified GCGR agonist and dual GLP-1R/GCGR agonist hits [22, 23]. These programs aim to address diseases beyond obesity, such as type 2 diabetes mellitus (T2DM), heart failure, and metabolic dysfunction-associated steatotic liver disease (MASH) .

Other product candidates include ANPA-0073, an oral small molecule APJ receptor agonist, which was previously in Phase 1 clinical development for pulmonary arterial hypertension and idiopathic pulmonary fibrosis, but the company decided in 2025 that it was not suitable for selective weight loss and has prioritized other discovery-stage APJ receptor agonists . LTSE-2578, an oral small molecule LPA1R antagonist for idiopathic pulmonary fibrosis (IPF), completed a Phase 1 clinical study in July 2025, demonstrating no dose-dependent adverse events, and the company is now considering strategic alternatives for this Phase 2 ready program .

For the fiscal year ended December 31, 2025, Structure Therapeutics reported net losses of $141.2 million . This compares to net losses of $122.5 million for the year ended December 31, 2024, and $89.6 million for the year ended December 31, 2023 . As of December 31, 2025, the company had an accumulated deficit of $470.3 million . The company's market value of ordinary shares held by non-affiliates as of June 30, 2025, was approximately $834.9 million, based on a closing price of $20.74 per ADS . The number of outstanding ordinary shares as of February 15, 2026, was 212,525,437, with 207,451,347 ordinary shares held in the form of ADSs .

In terms of year-over-year comparisons, the net loss increased from $122.5 million in 2024 to $141.2 million in 2025, indicating a continued increase in operating expenses, primarily driven by research and development activities . The company's financial position reflects its early-stage development, with significant investments in preclinical and clinical studies.

Significant operational developments during the period include the completion of enrollment in the ACCESS and ACCESS II studies for aleniglipron in February 2025 . In December 2025, the company reported topline data from the ACCESS clinical program, including 36-week data from the core Phase 2b ACCESS study, 36-week interim data from the exploratory ACCESS II study, interim data from the Phase 2 body composition study, and the Phase 2b ACCESS open-label extension (OLE) study . The Phase 2b ACCESS study showed a placebo-adjusted mean weight loss of 11.3% with the 120 mg dose at 36 weeks, while the ACCESS II study demonstrated a placebo-adjusted mean weight loss of 15.3% at 240 mg at 36 weeks . The company also initiated a Phase 1 clinical study of ACCG-2671 in December 2025 and declared ACCG-3535 as a second amylin development candidate in November 2025 [18, 21]. In December 2025, Gasherbrum, a wholly-owned subsidiary, entered into a license agreement with Genentech, Inc. and F. Hoffmann-La Roche Ltd, receiving a one-time, non-refundable payment of $100 million for a non-exclusive, sublicensable, royalty-bearing license to certain patents covering a class of oral GLP-1 receptor agonists different from aleniglipron . Two milestones of $9.0 million were achieved under the Aconcagua-Schrödinger Agreement as of December 31, 2025, with $3.0 million paid and the remaining $6.0 million paid in January 2026 .

Business Outlook

Structure Therapeutics anticipates initiating its Phase 3 registrational program for aleniglipron in the second half of 2026, following an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to align on a program with a starting titration dose of 2.5 mg and the intent to evaluate multiple maintenance doses [11, 17]. The company expects to report topline results from its maintenance switching study, evaluating the transition from an approved injectable GLP-1RA to aleniglipron for weight loss maintenance, and its Phase 2 randomized placebo-controlled study assessing aleniglipron at doses of up to 240 mg in patients with obesity or overweight and type 2 diabetes mellitus, in the second half of 2026 .

A major growth area for the company is the advancement of its metabolic franchise, including next-generation GLP-1R and amylin receptor agonists, designed with customized properties for maximum benefit . The company believes its lead oral small molecule amylin development candidate, ACCG-2671, has the potential to be the first-in-class oral small molecule amylin treatment option for obesity, and it has declared ACCG-3535 as a second amylin development candidate . Initial Phase 1 study results for ACCG-2671 are expected in the second half of 2026, and a Phase 1 study for ACCG-3535 is also expected to be initiated in the second half of 2026 . The company's program also focuses on developing orally-available small molecules in combination with GLP-1R and/or amylin, including glucose-dependent insulinotropic polypeptide receptor (GIPR) and glucagon receptor (GCGR) modulators .

Another key growth vector involves investing in and leveraging its next-generation structure-based drug discovery platform to drive innovations in GPCR-targeted therapies and beyond . The company aims to continually grow its leadership in structure-based drug discovery and development by incorporating platform innovations that can expand the therapeutic opportunity of this field . This includes integrating advancements in computational chemistry, molecular imaging technologies, structural biology techniques, and machine learning, while deepening its understanding of GPCR signaling pathways and pharmacology . The company intends to expand into other emerging areas where its platform can develop orally-available molecules against targets historically limited to peptides or biologics .

The company's operational outlook includes a focus on improving tolerability for aleniglipron by utilizing a lower starting titration dose of 2.5 mg, as demonstrated by interim data from the body composition study and ACCESS OLE study, which showed no AE-related treatment discontinuations at the initial 2.5 mg dose or the subsequent 5 mg dose . Topline data from both the body composition study and the ACCESS OLE study are expected in the second half of 2026 . The company also continues to work on multiple generations of oral small molecule amylin positions and expects to declare additional development candidates in the future .

Regarding planned capital allocation, the company believes its cash, cash equivalents, and short-term investments as of December 31, 2025, will be sufficient to fund projected operations and key clinical milestones through the end of 2028 . This funding estimate includes costs related to the ongoing aleniglipron ACCESS OLE, ACCESS II extension study, supplementary studies, and the Phase 3 registrational program in chronic weight management, but excludes additional costs related to pre-commercialization activities, such as commercial manufacturing . The company has also engaged in various financing transactions, including issuing and selling an aggregate of 21,617,295 ordinary shares and 2,401,920 newly designated non-voting ordinary shares in October 2023, and 10,427,017 ADSs in June 2024 . In August 2025, the company entered into an ATM Sales Agreement to offer and sell ADSs up to an aggregate offering price of $250.0 million, under which 3,040,000 ADSs were sold during the three months ended September 30, 2025, with approximately $191.5 million remaining available for sale as of December 31, 2025 . In December 2025, the company issued and sold an aggregate of 9,961,538 ADSs and pre-funded warrants to purchase ordinary shares represented by 1,538,462 ADSs .

The company explicitly flags several structural headwinds and execution risks to its growth plan. These include the inherent uncertainty and high failure rate of clinical drug development, with results from prior studies not necessarily predictive of future outcomes . Delays in clinical studies due to factors like regulatory consensus, patient enrollment, third-party performance, or adverse events could increase costs and delay revenue generation [63, 65]. The company also highlights the risk of serious adverse events or undesirable side effects of product candidates, which could lead to discontinuation of development or limitations on use . As an organization, the company has no experience in conducting later-stage clinical studies or submitting New Drug Applications (NDAs), which could lead to difficulties and delays in regulatory approval .

Geographic, regulatory, and macro factors identified as constraints include the potential for the FDA and other foreign equivalents not to accept data from clinical studies conducted outside the United States, which could delay development plans . International trade policies, including tariffs, sanctions, and trade barriers, may adversely affect the business, particularly given reliance on third-party suppliers in several countries outside the United States, including China, for APIs and drug product . Disruptions to the operations of the FDA, SEC, or comparable foreign regulatory authorities due to funding shortages, leadership changes, or staffing cuts could materially and adversely affect the business . Furthermore, the company faces substantial competition from major pharmaceutical and biotechnology companies, many of whom have significantly greater financial resources and expertise .

Risk Factors

Structure Therapeutics faces material risks including its limited operating history and significant accumulated deficit of $470.3 million as of December 31, 2025, with expected continued losses for the foreseeable future . The company will require substantial additional capital to finance operations, and failure to obtain this funding on acceptable terms could force delays or termination of product development programs . The company's structure-based drug discovery platform is unproven, and there is no guarantee of developing commercially valuable products . Clinical and preclinical drug development is lengthy, expensive, and uncertain, with prior results not necessarily predictive of future outcomes, and serious adverse events or unexpected properties of product candidates could lead to discontinuation or refusal of regulatory approval [62, 67]. The company has no experience conducting later-stage clinical studies or submitting NDAs, which could hinder regulatory approval . Reliance on third parties for manufacturing and clinical studies increases risks of insufficient quantities, unacceptable costs, delays, or non-compliance with regulations like cGMP, potentially disrupting the supply chain [75, 76, 77]. International trade policies, including tariffs and sanctions, particularly impacting suppliers in China, could increase research and development expenses and disrupt the supply chain . Disruptions to the operations of regulatory agencies like the FDA and SEC due to funding shortages or staffing issues could delay regulatory reviews . The company faces substantial competition from companies with greater financial resources and expertise . Cybersecurity breaches or disruptions to information technology systems could lead to financial, legal, regulatory, business, and reputational harm . Compliance with evolving U.S. and foreign data privacy and security laws, including the EU GDPR, UK GDPR, and China's PIPL, could lead to significant fines, such as up to €20 million or 4% of annual global revenues under EU GDPR, or RMB 50 million or 5% of prior year's total annual revenue under PIPL, and operational disruptions [97, 98, 103]. Changes in political and economic policies or relations between China and the United States, including increased scrutiny on China-based companies and potential capital controls, could adversely affect the business and market price of ADSs .

Management Priorities

Management's message to shareholders emphasizes the company's mission to discover and develop broadly accessible oral therapeutics for chronic diseases by leveraging advancements in structure-based drug discovery and computational chemistry . They highlight the potential of oral small molecules to overcome limitations of biologics and peptide therapies, improving patient access and scalability [9, 10]. The three strategic priorities for the period ahead include advancing aleniglipron into late-stage development, with an anticipated initiation of the Phase 3 program in the second half of 2026, following an End-of-Phase 2 meeting with the FDA to align on a registrational program with a starting titration dose of 2.5 mg . The second priority is to advance the metabolic franchise, including GLP-1R and amylin backbone therapies, establishing a foundation for additional opportunities such as next-generation GLP-1R and amylin receptor agonists, and combination therapies with GIPR and GCGR modulators . The third priority involves investing in and leveraging their next-generation structure-based drug discovery platform to drive innovations in GPCR-targeted therapies and beyond, continually expanding therapeutic opportunities and integrating advancements in computational chemistry, molecular imaging, structural biology, and machine learning [11, 12]. Management also plans to maximize the potential of their platform and portfolio through strategic partnerships, building on existing collaborations with Schrödinger and exploring additional third-party collaborations . The company believes its cash, cash equivalents, and short-term investments as of December 31, 2025, will be sufficient to fund projected operations and key clinical milestones through the end of 2028, covering costs related to the ongoing aleniglipron ACCESS OLE, ACCESS II extension study, supplementary studies, and Phase 3 registrational program in chronic weight management, but excluding pre-commercialization activities .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Overview
  2. [2] Item 1, Business — Metabolic Franchise Strategy: Fixed-Dose Combinations and Potential Indication Expansion
  3. [3] Item 1, Business — Oral Small Molecules: A Solution for Long-Term Maintenance Therapy
  4. [4] Form 10-K Cover Page
  5. [5] Item 1, Business — Our Technology Platform and Approach
  6. [6] Item 1, Business — Overview
  7. [7] Item 1, Business — Metabolic Franchise Strategy: Fixed-Dose Combinations and Potential Indication Expansion
  8. [8] Item 1, Business — Oral Small Molecules: A Solution for Long-Term Maintenance Therapy
  9. [9] Item 1, Business — Benefits of Oral Small Molecules Versus Oral Peptides
  10. [10] Item 1, Business — Our Technology Platform and Approach
  11. [11] Item 1, Business — Our Strategy
  12. [12] Item 1, Business — Our Strategy
  13. [13] Item 1, Business — Aleniglipron (GSBR-1290) – Oral Small Molecule Selective GLP-1R Agonist for Obesity
  14. [14] Item 1, Business — Aleniglipron Design and Discovery
  15. [15] Item 1, Business — Aleniglipron Non-clinical Safety Pharmacology and Toxicology Studies
  16. [16] Item 1, Business — Aleniglipron Phase 2a Study in Obesity and Diabetes
  17. [17] Item 1, Business — Aleniglipron Safety
  18. [18] Item 1, Business — ACCG-2671 and ACCG-3535 – Oral Small Molecule Amylin Receptor Agonist for Obesity
  19. [19] Item 1, Business — Amylin Tool Compound Showed Add-on Effects When Used with Semaglutide
  20. [20] Item 1, Business — ACCG-2671 Demonstrated Sub-nanomolar Potency of DACRA Activity
  21. [21] Item 1, Business — ACCG-2671 Achieved Cagrilintide-like Efficacy in Preclinical DIO Rat Model
  22. [22] Item 1, Business — GIP and GCG Receptor Oral Small Molecule Obesity Programs Overview
  23. [23] Item 1, Business — GIPR Agonist/dual Agonist/antagonist Hits Identified for Potential GLP-1R Combinations
  24. [24] Item 1, Business — ANPA-0073- Oral Small Molecule APJ Receptor Agonist
  25. [25] Item 1, Business — LTSE-2578 – Oral Small Molecule LPA1R Antagonist for IPF
  26. [26] Item 1, Business — GPCRs as a Therapeutic Target Family
  27. [27] Item 1, Business — Challenges of GPCR Therapeutic Discovery and Development
  28. [28] Item 1, Business — Our Structure-Based Drug Discovery Technology Platform
  29. [29] Item 1, Business — Visualization of GPCR Structure and Binding Site Interactions
  30. [30] Item 1, Business — Non-biased vs Biased GPCR Agonists
  31. [31] Item 1, Business — Robust and Integrated Medicinal Chemistry to Generate and Optimize Hits on GPCR Targets
  32. [32] Item 1, Business — Partnership with Schrödinger Leveraging its Cutting-Edge Computational Chemistry Capability
  33. [33] Item 1, Business — Structure Therapeutics Integrated Platform
  34. [34] Item 1, Business — Gasherbrum License Agreement with Genentech and Roche
  35. [35] Item 1, Business — Manufacturing
  36. [36] Item 1, Business — Competition
  37. [37] Item 1, Business — Data Privacy and Security Laws
  38. [38] Item 1, Business — Government Regulation of Pharmaceutical Product Development and Approval
  39. [39] Item 1, Business — Preclinical Studies and Clinical Studies
  40. [40] Item 1, Business — NDA Submission and FDA Review Process
  41. [41] Item 1, Business — Pediatric Studies
  42. [42] Item 1, Business — Orphan Drug Designation and Exclusivity
  43. [43] Item 1, Business — Post-Marketing Requirements
  44. [44] Item 1, Business — Marketing Exclusivity
  45. [45] Item 1, Business — Other U.S. Regulatory Matters
  46. [46] Item 1, Business — Chinese Regulation of Pharmaceutical Product Development and Approval
  47. [47] Item 1, Business — Rest of the World Regulation of Pharmaceutical Product Development and Approval
  48. [48] Item 1, Business — Other Healthcare Laws
  49. [49] Item 1, Business — Coverage and Reimbursement
  50. [50] Item 1, Business — U.S. Health Care Reform
  51. [51] Item 1, Business — Other Significant Chinese Regulation Affecting Our Business Activities in China
  52. [52] Item 1, Business — Chinese Regulation of Foreign Investment
  53. [53] Item 1, Business — Chinese Regulation of Commercial Bribery
  54. [54] Item 1, Business — Chinese Regulation of Product Liability
  55. [55] Item 1, Business — Chinese Tort Law
  56. [56] Item 1, Business — Chinese Regulation of Intellectual Property Rights
  57. [57] Item 1, Business — Patents
  58. [58] Item 1, Business — Patent Enforcement
  59. [59] Item 1A, Risk Factors — Risks Related to Our Limited Operating History, Financial Position and Capital Requirements
  60. [60] Item 1A, Risk Factors — Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  61. [61] Item 1A, Risk Factors — Our 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.
  62. [62] Item 1A, Risk Factors — Clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes.
  63. [63] Item 1A, Risk Factors — Any 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.
  64. [64] Item 1A, Risk Factors — Enrollment 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.
  65. [65] Item 1A, Risk Factors — Serious adverse events, undesirable side effects or other unexpected properties of our product candidates may be identified during development or after approval, which could lead to the discontinuation of our clinical development programs, refusal by regulatory authorities to approve our product candidates or, if discovered following marketing approval, revocation of marketing authorizations or limitations on the use of our product candidates, any of which would limit the commercial potential of such product candidate.
  66. [66] Item 1A, Risk Factors — As 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.
  67. [67] Item 1A, Risk Factors — The 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.
  68. [68] Item 1A, Risk Factors — International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
  69. [69] Item 1A, Risk Factors — Disruptions to the operations of the FDA, the SEC, other U.S. governmental agencies or comparable foreign regulatory authorities caused by funding shortages, leadership changes, staffing cuts or other staffing shortages, along with uncertainty regarding the potential for new initiatives, laws, regulations, policies and guidance affecting our product candidates or other aspects of our business, could materially and adversely affect our business.
  70. [70] Item 1A, Risk Factors — We rely on third parties for the manufacture of our product candidates for preclinical and clinical development and expect to continue to do so for the foreseeable future.
  71. [71] Item 1A, Risk Factors — Our 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.
  72. [72] Item 1A, Risk Factors — We rely on third parties to conduct, supervise and monitor our discovery research, preclinical studies and clinical studies.
  73. [73] Item 1A, Risk Factors — Our existing discovery collaborations with Schrödinger, LLC (together with its affiliates, “Schrödinger”) are important to our business.
  74. [74] Item 1A, Risk Factors — Reliance 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.
  75. [75] Item 1A, Risk Factors — Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of trade secrets and other proprietary information.
  76. [76] Item 1A, Risk Factors — The 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.
  77. [77] Item 1A, Risk Factors — Even if we receive regulatory approval for any product candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense.
  78. [78] Item 1A, Risk Factors — Even 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.
  79. [79] Item 1A, Risk Factors — Coverage 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 approved.
  80. [80] Item 1A, Risk Factors — We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than us.
  81. [81] Item 1A, Risk Factors — If 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 suffer.
  82. [82] Item 1A, Risk Factors — We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may invest significant resources to develop these capabilities.
  83. [83] Item 1A, Risk Factors — Our 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.
  84. [84] Item 1A, Risk Factors — Our 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.
  85. [85] Item 1A, Risk Factors — We 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 harmed.
  86. [86] Item 1A, Risk Factors — We will need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
  87. [87] Item 1A, Risk Factors — Our relationships with customers, physicians and other healthcare providers, and third-party payors may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, other healthcare laws and regulations and health data privacy and security laws and regulations, contractual obligations and self-regulatory schemes.
  88. [88] Item 1A, Risk Factors — Healthcare legislative reform measures may have a negative impact on our business and results of operations.
  89. [89] Item 1A, Risk Factors — If 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.
  90. [90] Item 1A, Risk Factors — Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop.
  91. [91] Item 1A, Risk Factors — If our information technology systems or data, or those of third parties upon which we rely, are or were compromised or experienced significant disruptions of our information technology systems or data security incidents, we could experience adverse consequences including but not limited to significant financial, legal, regulatory, business and reputational harm; litigation; fines and penalties; disruptions of our business operations; loss of revenue or profits; loss of customers or sales; or other adverse consequences.
  92. [92] Item 1A, Risk Factors — We conduct certain research and development operations through our Australian wholly-owned subsidiaries.
  93. [93] Item 1A, Risk Factors — Our 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.
  94. [94] Item 1A, Risk Factors — Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
  95. [95] Item 1A, Risk Factors — We and the third parties with whom we work are subject to stringent and evolving U.S. and foreign laws, regulations, rules, industry standards, contractual obligations, policies and other obligations related to data security and privacy.
  96. [96] Item 1A, Risk Factors — There is tax risk associated with the reporting of cross-border arrangements and activities between us and our subsidiaries.
  97. [97] Item 1A, Risk Factors — Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits.
  98. [98] Item 1A, Risk Factors — Changes 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 operations.
  99. [99] Item 1A, Risk Factors — Changes 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.
  100. [100] Item 1A, Risk Factors — Changes 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.
  101. [101] Item 1A, Risk Factors — Compliance with China’s current Data Security Law, Cyber Security Law, Cybersecurity Review Measures, Personal Information Protection Law, regulations and guidelines relating to the multi-level protection scheme on cyber security and any other future laws and regulations may entail significant expenses and could affect our business.
  102. [102] Item 1A, Risk Factors — The approval of, filing or other procedures with the CSRC or other Chinese regulatory authorities may be required in connection with issuing securities to foreign investors under Chinese law, and, if required, we cannot predict whether we will be able, or how long it will take us, to obtain such approval or complete such filing or other procedures.
  103. [103] Item 1A, Risk Factors — Pharmaceutical companies operating in China are required to comply with extensive regulations and hold a number of permits and licenses to carry on their business.
  104. [104] Item 1A, Risk Factors — As 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.
  105. [105] Item 1A, Risk Factors — If 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.
  106. [106] Item 1A, Risk Factors — Development in the Chinese legal system could materially and adversely affect us.
  107. [107] Item 1A, Risk Factors — We may be exposed to liabilities under the U.S. Foreign Corrupt Practices Act (the “FCPA”), U.S. domestic bribery laws, and similar anti-corruption and anti-bribery laws of China and other countries in which we operate, as well as U.S. and certain foreign export controls, trade sanctions and import laws and regulations.
  108. [108] Item 1A, Risk Factors — Regulatory Requirements on currency exchange may limit our ability to receive and use effectively financing in foreign currencies.
  109. [109] Item 1A, Risk Factors — Chinese regulations relating to the establishment of offshore special purpose companies by residents in China may subject our China resident beneficial owners or our wholly foreign-owned subsidiaries in China to liability or penalties, limit our ability to inject capital into these subsidiaries, limit these subsidiaries’ ability to increase their registered capital or distribute profits to us, or may otherwise adversely affect us.
  110. [110] Item 1A, Risk Factors — If 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.
  111. [111] Item 1A, Risk Factors — We and our shareholders face uncertainties in China with respect to indirect transfers of equity interests in China resident enterprises.
  112. [112] Item 1A, Risk Factors — Any 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.
  113. [113] Item 1A, Risk Factors — If we are unable to obtain and maintain sufficient intellectual property protection for our platform technologies and product candidates, or if the scope of the intellectual property protection is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be adversely affected.
  114. [114] Item 1A, Risk Factors — We 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 harmed.
  115. [115] Item 1A, Risk Factors — We may rely on one or more in-licenses from third parties.

Analysis on 5/21/2026