Structure Therapeutics(GPCR) - 2025 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION For the three months ended March 31, 2025, the company reported a net loss of $46.8 million, an increase from a $26.0 million net loss in the same period of 2024, driven by higher research and development expenses. The balance sheet shows total assets of $866.5 million and total shareholders' equity of $824.6 million as of March 31, 2025. The company used $52.2 million in cash for operating activities during the quarter Financial Statements (Unaudited) For the three months ended March 31, 2025, the company reported a net loss of $46.8 million, an increase from a $26.0 million net loss in the same period of 2024, driven by higher research and development expenses. The balance sheet shows total assets of $866.5 million and total shareholders' equity of $824.6 million as of March 31, 2025. The company used $52.2 million in cash for operating activities during the quarter Condensed Consolidated Balance Sheets As of March 31, 2025, the company had total assets of $866.5 million, a decrease from $903.3 million at the end of 2024. This was primarily composed of $152.1 million in cash and cash equivalents and $684.8 million in short-term investments. Total liabilities increased slightly to $41.9 million, while total shareholders' equity decreased to $824.6 million from $864.8 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $152,123 | $169,510 | | Short-term investments | $684,759 | $714,008 | | Total Assets | $866,549 | $903,330 | | Total current liabilities | $36,487 | $36,021 | | Total Liabilities | $41,911 | $38,487 | | Total Shareholders' Equity | $824,638 | $864,843 | Condensed Consolidated Statements of Operations and Comprehensive Loss For the first quarter of 2025, the company reported a net loss of $46.8 million, or ($0.27) per share, compared to a net loss of $26.0 million, or ($0.19) per share, for the same period in 2024. The increased loss was primarily driven by a significant rise in research and development expenses, which grew to $42.9 million from $20.7 million year-over-year Q1 2025 vs Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $42,867 | $20,679 | | General and administrative | $13,444 | $11,336 | | Total operating expenses | $56,311 | $32,015 | | Loss from operations | ($56,311) | ($32,015) | | Interest and other income, net | $9,576 | $6,008 | | Net loss | ($46,833) | ($26,036) | | Net loss per share, basic and diluted | ($0.27) | ($0.19) | Condensed Consolidated Statements of Shareholders' Equity Total shareholders' equity decreased from $864.8 million at December 31, 2024, to $824.6 million at March 31, 2025. The decrease was primarily due to the net loss of $46.8 million for the quarter, partially offset by $5.9 million in share-based compensation expense and $1.0 million from the exercise of share options - Shareholders' equity decreased by $40.2 million during Q1 2025, mainly driven by a net loss of $46.8 million[20] Condensed Consolidated Statements of Cash Flows For the three months ended March 31, 2025, net cash used in operating activities was $52.2 million, an increase from $34.1 million in the prior-year period, reflecting higher operating expenses. Net cash provided by investing activities was $34.0 million, primarily from net maturities of short-term investments. Net cash provided by financing activities was $0.8 million from the exercise of share options. Cash and cash equivalents decreased by $17.4 million to end the period at $152.1 million Q1 2025 vs Q1 2024 Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(52,229) | $(34,080) | | Net cash provided by investing activities | $34,033 | $1,418 | | Net cash provided by financing activities | $809 | $702 | | Net change in cash and cash equivalents | ($17,387) | ($31,960) | Notes to Unaudited Condensed Consolidated Financial Statements The notes detail the company's financial position and operations. Key points include the company's belief that its $836.9 million in cash, cash equivalents, and short-term investments are sufficient to fund operations for at least the next 12 months. The company operates as a single segment focused on R&D for chronic diseases. It has significant operating lease commitments totaling $8.6 million and collaboration agreements with Schrödinger that include potential future milestone and royalty payments - The company believes its cash, cash equivalents, and short-term investments of $836.9 million as of March 31, 2025, are sufficient to fund operations for at least the next 12 months[30] - The company operates as one reportable segment: the research and development of medicines for chronic diseases with unmet medical needs[34] - The company has collaboration agreements with Schrödinger involving potential future payments, including up to $17.0 million in milestones for the Lhotse agreement and up to $89.0 million for the Aconcagua agreement, plus low single-digit royalties[74][78] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's financial performance, highlighting a 107% increase in R&D expenses to $42.9 million in Q1 2025, driven by advancing its clinical programs, particularly aleniglipron. The company's cash, cash equivalents, and short-term investments totaled $836.9 million as of March 31, 2025, which is expected to fund operations and key clinical milestones through at least 2027, excluding Phase 3 registrational studies. The company continues to advance its pipeline, including initiating Phase 2b studies for aleniglipron and a Phase 1 study for LTSE-2578 Overview Structure Therapeutics is a clinical-stage biopharmaceutical company focused on oral small molecule therapies for chronic diseases, using a structure-based drug discovery platform targeting GPCRs. Its lead candidate, aleniglipron, is in Phase 2b studies for obesity. The pipeline also includes ACCG-2671 (amylin agonist), ANPA-0073 (APJ agonist), and LTSE-2578 (LPA1R antagonist). The company has incurred significant losses since inception and expects them to continue as it advances its pipeline - The company's most advanced candidate, aleniglipron (GLP-1R agonist), is in two Phase 2b studies (ACCESS and ACCESS II) for obesity, with topline data expected in Q4 2025[83][87] - Other key pipeline programs include ACCG-2671 (amylin agonist) for which a Phase 1 study is expected to start in Q4 2025, and LTSE-2578 (LPA1R antagonist) for IPF, which entered a Phase 1 study in June 2024 with initial data expected in 2025[88][89] - The company outsources all clinical drug manufacturing and has established a manufacturing plan in the U.S. to diversify its supply chain beyond China[91] Results of Operations For Q1 2025, R&D expenses increased by 107% to $42.9 million from $20.7 million in Q1 2024, mainly due to higher pre-clinical and clinical trial costs, particularly for aleniglipron. General and administrative expenses rose 19% to $13.4 million due to increased employee expenses to support growth as a public company. Interest income increased to $9.6 million from $6.0 million due to higher cash and investment balances - R&D expenses increased by $22.2 million (107%) in Q1 2025 compared to Q1 2024, driven by increased pre-clinical research, clinical trial costs, and personnel expenses[108] Research and Development Expenses by Program (in thousands) | Product candidate | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Aleniglipron (GSBR‑1290) | $24,985 | $9,535 | | ACCG-2671 | $5,610 | $1,983 | | LTSE‑2578 | $1,426 | $2,162 | | ANPA‑0073 | $1,106 | $1,114 | | Other | $9,740 | $5,885 | | Total R&D expenses | $42,867 | $20,679 | - G&A expenses increased by $2.1 million (19%) in Q1 2025 compared to Q1 2024, primarily from higher employee expenses related to company growth, partially offset by lower consulting fees[111] Liquidity and Capital Resources As of March 31, 2025, the company had $836.9 million in cash, cash equivalents, and short-term investments. This position was bolstered by a Follow-On Offering in June 2024 that raised $512.7 million in net proceeds. Management believes current capital is sufficient to fund operations and key clinical milestones through at least 2027, but this excludes the costs of Phase 3 registrational studies for aleniglipron, for which substantial additional capital will be required - As of March 31, 2025, the company had $836.9 million in cash, cash equivalents, and short-term investments and an accumulated deficit of $375.9 million[113][114] - The company estimates its existing cash will be sufficient to fund operations and key clinical milestones through at least 2027, but this excludes funding for Phase 3 registrational studies of aleniglipron[94][144] - The company will need substantial additional capital to fund future operations, particularly for Phase 3 clinical studies of aleniglipron, and may seek it through equity or debt financings, or collaborations[95][117] Cash Flows In Q1 2025, net cash used in operating activities was $52.2 million, driven by a net loss of $46.8 million and changes in operating assets. Net cash provided by investing activities was $34.0 million from net maturities of short-term investments. Net cash provided by financing activities was $0.8 million, mainly from the exercise of share options Summary of Cash Flows (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(52,229) | $(34,080) | | Net cash provided by investing activities | $34,033 | $1,418 | | Net cash provided by financing activities | $809 | $702 | Quantitative and Qualitative Disclosures About Market Risk The company states that there were no material changes to its quantitative and qualitative disclosures about market risk during the three months ended March 31, 2025, as compared to those described in its Annual Report on Form 10-K - There were no material changes to the company's quantitative and qualitative disclosures about market risk during the first quarter of 2025[132] Controls and Procedures Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2025. There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, these controls - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective at a reasonable assurance level[134] - No changes in internal control over financial reporting were identified during the quarter ended March 31, 2025, that have materially affected or are likely to materially affect internal controls[135] PART II. OTHER INFORMATION Legal Proceedings The company reports that it is not currently subject to any material legal proceedings. It acknowledges that it may be involved in ordinary course legal matters in the future - The company is not currently the subject of any material governmental investigation, private lawsuit, or other legal proceeding[138] Risk Factors This section details numerous risks that could materially harm the company's business. Key risks include its limited operating history and history of losses, the need for substantial additional capital, the unproven nature of its drug discovery platform, and reliance on third parties for manufacturing and clinical trials. It also highlights risks related to competition, regulatory approval, intellectual property protection, and operating in China. Specific concerns mentioned include the BIOSECURE Act's potential impact on its supplier WuXi AppTec and the inherent uncertainties of clinical development Risks Related to Our Limited Operating History, Financial Position and Capital Requirements The company has a limited operating history, has incurred significant losses since inception ($375.9 million accumulated deficit as of March 31, 2025), and expects losses to continue. It will require substantial additional capital to finance operations, especially for Phase 3 studies, which may not be available on acceptable terms. Failure to obtain capital could force delays or termination of development programs - The company has a limited operating history, has incurred significant operating losses since inception, and expects to incur significant losses for the foreseeable future[140] - Substantial additional capital is required to finance operations, and failure to obtain it may force delays, limitations, or termination of product development programs[143] - Existing cash is estimated to be sufficient through at least 2027, but this excludes Phase 3 registrational studies for aleniglipron[144] Risks Related to the Discovery, Development and Regulatory Approval of Product Candidates The company's drug discovery platform is unproven, and its product candidates are in early clinical development. Drug development is a lengthy, expensive, and uncertain process. Positive early-stage results are not predictive of future success. The company faces risks of clinical trial delays, such as the data collection omission experienced for aleniglipron, and potential rejection of foreign clinical data by the FDA. There is also a risk of serious adverse events emerging in later-stage trials - The company's drug discovery platform is unproven, and it is uncertain if it can develop any products of commercial value[150] - The company has experienced clinical trial delays, citing a data collection omission at a clinical site for its Phase 2a study of aleniglipron, which delayed data reporting[163] - The company conducts initial clinical studies outside the U.S. (e.g., in Australia), and there is a risk that the FDA or other authorities may not accept data from these studies, which would delay development[189] Risks Related to Our Reliance on Third Parties The company relies on third parties for manufacturing, preclinical studies, and clinical trials, which increases risks related to supply, cost, and quality. A key supplier, WuXi STA, is a subsidiary of WuXi AppTec, which has been named in the proposed BIOSECURE Act, potentially disrupting the supply chain. The company also depends on CROs for trial execution and has experienced delays due to their actions - The company relies on third-party manufacturers, including WuXi STA, a subsidiary of WuXi AppTec. Proposed legislation like the BIOSECURE Act could restrict the ability to work with such entities, potentially disrupting the supply of materials[205] - The company relies on CROs to conduct clinical studies and has experienced delays due to their actions, such as a data collection omission at a clinical site during the Phase 2a trial of aleniglipron[213][215] - The company's collaborations with Schrödinger are critical for its discovery capabilities. Termination of or failure by Schrödinger to perform under these agreements could materially harm the development of product candidates[227][228] Risks Related to Commercialization of Our Product Candidates Even if approved, the company's products face significant commercialization hurdles. These include ongoing regulatory obligations, potential failure to achieve market acceptance, and challenges in securing coverage and adequate reimbursement from payors. The company faces substantial competition from large pharmaceutical companies like Eli Lilly and Novo Nordisk in the obesity market. As a company with no commercialization experience, it would need to build a sales and marketing organization or rely on partners - The company faces substantial competition from major pharmaceutical and biotechnology companies, including Eli Lilly, Novo Nordisk, AstraZeneca, and Roche, who are developing or marketing products for the same indications[253][254] - The company has no marketing and sales organization or experience in commercializing products and would need to invest significant resources to build these capabilities or rely on third parties[259] - Market acceptance and sales will depend on securing coverage and adequate reimbursement from third-party payors, which is uncertain in the current cost-containment environment[249] Risks Related to Our Business Operations and Industry The company's success is highly dependent on its senior management team and its ability to attract and retain qualified personnel. It faces risks related to managing growth, potential loss of R&D tax credits from its Australian subsidiaries, and compliance with complex healthcare fraud and abuse laws. The business is also subject to risks from cybersecurity threats, potential product liability lawsuits, and the impact of healthcare reform like the Inflation Reduction Act (IRA) - The company is highly dependent on its senior management team and faces intense competition for qualified personnel[265][266] - The company's Australian subsidiaries may not be able to receive the R&D tax credit, or could be required to refund credits previously received, which would harm business results[271][272] - Healthcare legislative reforms, such as the Inflation Reduction Act (IRA) which includes Medicare drug price negotiation and inflation rebates, could negatively impact the business and ability to sell products profitably[281][283] Risks Related to Doing Business in China and Our International Operations The company's operations in China expose it to risks from changes in Chinese political, economic, and legal policies, as well as U.S.-China relations. It must comply with complex and evolving Chinese laws on data security (e.g., Cybersecurity Law, PIPL) and human genetic resources (HGR Regulation). Future securities offerings may require filing with the CSRC under new regulations. The company also faces risks related to currency exchange controls and potential classification as a China resident enterprise for tax purposes - Changes in political and economic policies between China and the United States may adversely affect the company's business, financial condition, and results of operations[318] - The company is subject to complex Chinese data security laws (e.g., Cybersecurity Law, Data Security Law, PIPL) and regulations on human genetic resources, which may entail significant compliance expenses and risks[321][327] - Under new CSRC regulations effective March 31, 2023, the company may be required to complete filings with the CSRC for future securities offerings, and failure to do so could result in penalties[331][332] Risks Related to Our Intellectual Property The company's success depends on its ability to obtain and maintain intellectual property protection for its platform and product candidates. There is a risk that patents may not be issued, or if issued, may not be broad enough or may be invalidated. The company also relies on trade secrets, which are difficult to protect. It faces the risk of third-party infringement claims, which could be costly and time-consuming to defend, and changes in patent law could diminish the value of its IP - The company's ability to successfully commercialize its products is dependent on obtaining and maintaining sufficient intellectual property protection, which is uncertain[353] - The company may become involved in lawsuits alleging infringement of third-party intellectual property rights, which could be expensive and have a negative impact on the business[383] - Changes in U.S. patent law, such as the Leahy-Smith Act, or the patent laws of other countries could diminish the value of patents and impair the ability to protect product candidates[397] Risks Related to Our ADSs The trading price of the company's ADSs is likely to be volatile. Although its auditor is currently subject to PCAOB inspection, future changes could subject it to the HFCA Act, potentially leading to delisting. The company has previously identified and remediated a material weakness in internal controls. Principal shareholders hold significant voting power, and future sales of ADSs could depress the market price. ADS holders have fewer rights than direct shareholders and waive the right to a jury trial for claims arising under the deposit agreement - The trading price of the company's ADSs may be highly volatile due to factors such as clinical trial results, regulatory decisions, and market conditions[413] - While the company's auditor is currently subject to PCAOB inspection, if this changes, the company could be subject to the HFCA Act, which could lead to delisting from Nasdaq[416][419] - The company previously identified and has since remediated a material weakness in its internal control over financial reporting as of June 30, 2024[422][424][425] General Risk Factors The company faces general risks including the significant costs and compliance burdens of being a public company, particularly after losing its 'emerging growth company' status. Failure to maintain effective internal controls could harm financial reporting reliability. The company is also exposed to risks from natural disasters like earthquakes and fires at its California headquarters, and potential liabilities from the use of hazardous materials in its R&D operations - As a public company, the company must maintain effective internal controls over financial reporting, a process that is costly and challenging. Failure to do so could harm investor confidence and the stock price[452][454] - The company's headquarters and main research facility are located in an area prone to earthquakes and fires, and it lacks a comprehensive disaster recovery plan and earthquake insurance[463] - Failure to comply with Nasdaq's continued listing requirements could result in the delisting of the company's ADSs[467] Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities during the three months ended March 31, 2025 - There were no unregistered sales of equity securities during the three months ended March 31, 2025[468] Defaults Upon Senior Securities The company reported no defaults upon senior securities - None[468] Mine Safety Disclosures This item is not applicable to the company - None[468] Other Information The company reported no other information required to be disclosed under this item - None[468] Exhibits This section lists the exhibits filed with the Form 10-Q, including the Amended and Restated Memorandum and Articles of Association, forms of deposit agreement and ADR, CEO and CFO certifications (Sections 302 and 906), and XBRL data files - The report includes standard exhibits such as organizational documents, CEO/CFO certifications under Sarbanes-Oxley Sections 302 and 906, and Inline XBRL filings[470] Signatures The report is duly signed by the company's Chief Executive Officer (Raymond Stevens, Ph.D.) and Chief Financial Officer (Jun Yoon) on May 8, 2025 - The report was signed on May 8, 2025, by Raymond Stevens, Ph.D., Chief Executive Officer, and Jun Yoon, Chief Financial Officer[473]