Structure Therapeutics(GPCR)
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Structure Therapeutics (GPCR) 2025 Conference Transcript
2025-09-03 20:55
Summary of Structure Therapeutics Conference Call Company Overview - Structure Therapeutics focuses on accessibility in obesity treatment, emphasizing the importance of providing patients with options in their healthcare journey [4][6][8] Key Priorities and Developments - The company is excited about the potential of oral small molecules in the obesity market, which are expected to become first-line treatments for patients transitioning from primary care physicians [5][4] - Lead molecules include aleniglapron, with two significant data readouts (Access and Access 2) expected by the end of the year [6][7] - The company is also developing an oral amylin small molecule, amylin 2671, which is set to enter clinical trials later this year [8] Clinical Trials and Data - Access and Access 2 studies are 36-week trials, with Access allowing doses up to 120 mg and Access 2 allowing doses up to 240 mg [6][7] - The company is implementing an open-label extension to trials to address high discontinuation rates in placebo groups, allowing participants to experience the drug after initial trial phases [17][18] - Recent FDA guidelines have eased requirements for chronic weight management studies, increasing confidence in the clinical trial process [25][26] Market Opportunity - The company believes that the primary care physician market will drive growth, with an estimated 70% of the market coming from this segment [39] - Oral small molecules are expected to expand the market, providing flexibility and ease of use compared to injectables [39][36] Competitive Landscape - Structure Therapeutics positions itself as having the second most advanced oral GLP-1 small molecule, aleniglapron, and is focused on a multigenerational approach to drug development [40][41] - The company is actively monitoring competitive developments, particularly in markets like China, and is committed to maintaining a strong intellectual property portfolio [65][66] Formulation and Combinability - The company has invested in advanced formulation technologies, including extended-release and gastric retention technologies, to enhance the efficacy and tolerability of its drugs [45][46] - Aleniglapron is designed for combinability with other treatments, allowing for flexible dosing ratios to optimize efficacy and tolerability [64][49] Long-term Strategy and Partnerships - Structure Therapeutics aims to partner for commercialization to expand its reach and capabilities in conducting multiple phase three studies [67][69] - The company emphasizes the importance of making medicines accessible to all, aligning its mission with the growing need for effective obesity treatments [67][66] Conclusion - Structure Therapeutics is positioned to capitalize on the growing demand for obesity treatments through innovative oral small molecules, strategic clinical trial designs, and a focus on accessibility and flexibility in treatment options [4][39][67]
Structure Therapeutics to Participate in Two Upcoming Healthcare Investor Conferences
Globenewswire· 2025-09-02 12:30
Company Overview - Structure Therapeutics Inc. is a clinical-stage global biopharmaceutical company focused on developing novel oral small molecule therapeutics for metabolic diseases, particularly obesity [1][3] - The company utilizes a next-generation structure-based drug discovery platform to create a robust GPCR-targeted pipeline, featuring multiple proprietary clinical-stage oral small molecule compounds [3] Upcoming Events - Management will participate in the Cantor Global Healthcare Conference on September 3 at 3:55 p.m. ET in New York, NY, featuring a fireside chat and 1x1 meetings [2] - The company will also attend the Morgan Stanley 23rd Annual Global Healthcare Conference on September 10 at 10:45 a.m. ET, also in New York, NY, with a similar format [2] - Live and archived webcasts of these events will be available on the company's website for 90 days [2]
临床节点密集来袭,高盛看好生物科技股2025重估机会
Zhi Tong Cai Jing· 2025-08-12 08:31
Group 1: Core Insights - Goldman Sachs' latest report focuses on "2Q25 EPS updates," analyzing biotech companies such as Amylyx (AMLX.US), CG Oncology (CGON.US), GPCR (GPCR.US), and Ideaya Biosciences (IDYA.US), concluding that operational data largely meets expectations with minor adjustments to target prices due to cash flow or clinical milestones [1] Group 2: Amylyx (AMLX.US) - In Q2, Amylyx reported operating expenses of approximately $43 million, slightly above market consensus of $41 million and Goldman Sachs' estimate of $40 million, primarily due to higher R&D costs of $27 million compared to the expected range of $22 million to $25 million [2] - The management reiterated the timeline for the Phase III clinical trial for post-bariatric hypoglycemia (PBH), aiming for enrollment completion in 2025, data readout in the first half of 2026, and potential market entry in 2027, with an estimated patient population of around 160,000 [2] - Goldman Sachs maintains a "Buy" rating with a target price of $10 [2] Group 3: CG Oncology (CGON.US) - CG Oncology's BOND-003 Phase III trial data showed a complete response rate of 75.5% for its bladder cancer gene therapy, with 12-month and 24-month sustained response rates of 50.7% and 42.3%, respectively [3] - The company has $661 million in cash, sufficient to support operations until mid-2028, and Goldman Sachs maintains a "Buy" rating with minor model adjustments [3] Group 4: GPCR (GPCR.US) - GPCR's Q2 R&D expenses were approximately $54 million, significantly higher than market expectations of $36 million and Goldman Sachs' estimate of $44 million, attributed to workforce expansion and increased trial costs [4] - The company has $787 million in cash, expected to last until 2027, and plans to read out Phase 2b ACCESS data in 2025 [4] Group 5: Ideaya Biosciences (IDYA.US) - Ideaya reported Q2 R&D expenses of about $74 million, slightly above market expectations of $71 million and Goldman Sachs' estimate of $68 million, with cash reserves of $992 million projected to last until 2029 [5] - The core pipeline includes darovasertib in combination with crizotinib for HLA-A2 negative metastatic uveal melanoma, with Phase 2/3 results expected by year-end [5] Group 6: Terns Pharmaceuticals (TERN.US) and RNA (RNA.US) - Terns Pharmaceuticals plans to release preliminary data for its leukemia drug TERN-701 and obesity drug TERN-601 in Q4 2025, with cash reserves of $315 million sufficient until 2028 [6] - RNA has signed a manufacturing agreement with Lonza to ensure product supply stability from 2026 to 2028, with BLA submissions expected for its treatments by the end of 2025 and mid-2026 [6] Group 7: AI in Biotech - Goldman Sachs emphasizes the core role of biotechnology R&D, highlighting collaborations with institutions like OpenAI to drive innovation, while also focusing on the pricing potential of rare disease drugs and opportunities for indication expansion [7] Group 8: Overall Industry Outlook - The biotech sector is expected to see over 15 key clinical data readouts from late 2025 to early 2026, with a focus on companies like AMLX, CGON, and RNA for their potential breakthroughs [8] - Despite some companies facing increased short-term losses due to R&D spending, pipeline progress remains in line with expectations, and cash flow is generally secure [8]
Structure Therapeutics(GPCR) - 2025 Q2 - Quarterly Report
2025-08-06 20:28
[PART I. FINANCIAL INFORMATION](index=10&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section provides the unaudited condensed consolidated financial statements and management's discussion and analysis of the company's financial condition and results of operations [Item 1. Financial Statements (Unaudited)](index=10&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations and comprehensive loss, statements of shareholders' equity, and statements of cash flows, along with detailed notes explaining the company's financial position, performance, and significant accounting policies for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=10&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This statement presents the company's financial position, including assets, liabilities, and equity, at specific reporting dates Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | | Cash and cash equivalents | $147,024 | $169,510 | | Short-term investments | $639,472 | $714,008 | | Total current assets | $799,298 | $891,211 | | Total assets | $816,443 | $903,330 | | Total current liabilities | $39,033 | $36,021 | | Total liabilities | $44,362 | $38,487 | | Total shareholders' equity | $772,081 | $864,843 | - Total assets decreased from **$903.3 million** at December 31, 2024, to **$816.4 million** at June 30, 2025, primarily due to a reduction in cash, cash equivalents, and short-term investments[16](index=16&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This statement details the company's revenues, expenses, and net loss over specific reporting periods, reflecting operational performance Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :------------------------------------------ | :------------------------------------------ | | Research and development | $54,710 | $22,050 | $97,577 | $42,729 | | General and administrative | $15,741 | $11,266 | $29,185 | $22,602 | | Total operating expenses | $70,451 | $33,316 | $126,762 | $65,331 | | Loss from operations | $(70,451) | $(33,316) | $(126,762) | $(65,331) | | Interest and other income, net | $8,929 | $7,335 | $18,505 | $13,343 | | Net loss attributable to ordinary shareholders | $(61,661) | $(26,034) | $(108,494) | $(52,070) | | Net loss per share, basic and diluted | $(0.36) | $(0.18) | $(0.63) | $(0.36) | - Net loss attributable to ordinary shareholders significantly increased for both the three and six months ended June 30, 2025, compared to the same periods in 2024, primarily driven by a substantial rise in research and development expenses[19](index=19&type=chunk) [Condensed Consolidated Statements of Shareholders' Equity](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders%27%20Equity) This statement outlines changes in the company's equity accounts, including net losses, share-based compensation, and share issuances Condensed Consolidated Statements of Shareholders' Equity (in thousands) | Metric | December 31, 2024 (in thousands) | March 31, 2025 (in thousands) | June 30, 2025 (in thousands) | | :-------------------------------- | :------------------------------- | :---------------------------- | :--------------------------- | | Total Shareholders' Equity | $864,843 | $824,638 | $772,081 | | Accumulated Deficit | $(329,098) | $(375,931) | $(437,592) | - Total shareholders' equity decreased from **$864.8 million** at December 31, 2024, to **$772.1 million** at June 30, 2025, primarily due to net losses and unrealized losses on investments, partially offset by share-based compensation and proceeds from share issuances[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=13&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement summarizes the cash inflows and outflows from operating, investing, and financing activities over specific periods Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(106,787) | $(60,473) | | Net cash provided by (used in) investing activities | $82,975 | $(203,097) | | Net cash provided by financing activities | $1,326 | $515,405 | | Net change in cash and cash equivalents | $(22,486) | $251,835 | | Cash and cash equivalents, end of period | $147,024 | $381,627 | - For the six months ended June 30, 2025, net cash used in operating activities increased to **$106.8 million**, while investing activities provided **$83.0 million**, primarily from net maturities of short-term investments. Financing activities provided **$1.3 million**, resulting in a net decrease in cash and cash equivalents of **$22.5 million**[23](index=23&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=14&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and supplementary information for the figures presented in the unaudited financial statements - The company is a clinical-stage global biopharmaceutical company incorporated in the Cayman Islands with operating subsidiaries in the United States and China, focused on developing novel oral therapeutics for chronic diseases[24](index=24&type=chunk) Summary of Financing Events | Financing Event | Net Proceeds (approx.) | | :---------------- | :--------------------- | | Initial Public Offering (Feb 2023) | $166.7 million | | Private Placement (Oct 2023) | $281.5 million | | Follow-On Offering (June 2024) | $512.7 million | - As of June 30, 2025, the company had **$786.5 million** in cash, cash equivalents, and short-term investments, which it believes will be sufficient to fund projected operations for at least 12 months[31](index=31&type=chunk) Research and Development and General and Administrative Expenses (in thousands) | R&D Expense Category | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Discovery research and development | $48,031 | $20,392 | | Clinical research and development | $40,306 | $17,696 | | Other research and development expenses | $9,240 | $4,641 | | General and administrative | $29,185 | $22,602 | | Total operating expenses | $126,762 | $65,331 | - A **$3.0 million** milestone payment was achieved and paid under the Aconcagua-Schrödinger Agreement as of June 30, 2025. Additionally, Basecamp Bio Inc. entered into an Asset Purchase Agreement with Exelixis, Inc. on August 5, 2025, for early-stage assets, with potential initial payments of **$10.0 million** and up to **$90.0 million** in contingent milestones[80](index=80&type=chunk)[81](index=81&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of the company's clinical-stage biopharmaceutical business, its pipeline of oral small molecule therapeutics targeting GPCRs for chronic diseases, and a detailed analysis of its financial performance, liquidity, and capital resources. The company reported increased net losses driven by higher R&D expenses, particularly for aleniglipron, and discussed its funding strategy and future capital needs [Overview](index=32&type=section&id=Overview) This section introduces the company's clinical-stage biopharmaceutical business, its drug discovery platform, and its pipeline of oral small molecule therapeutics - The company is a clinical stage global biopharmaceutical company focused on developing novel oral small molecule therapeutics for chronic diseases, utilizing a differentiated technology platform that leverages structure-based drug discovery and computational chemistry against G-protein coupled receptors (GPCRs)[84](index=84&type=chunk) - Aleniglipron (GSBR-1290), an oral GLP-1R agonist, is the most advanced product candidate, currently in two Phase 2 clinical studies (ACCESS and ACCESS II) for obesity and overweight. Positive topline Phase 2a data showed a **6.2% placebo-adjusted mean weight decrease** at 12 weeks. Enrollment for ACCESS and ACCESS II was completed in February 2025, with topline data expected in Q4 2025[85](index=85&type=chunk)[86](index=86&type=chunk)[89](index=89&type=chunk) - The pipeline also includes ACCG-2671 (oral amylin receptor agonist, IND-enabling studies ongoing, Phase 1 expected by year-end 2025), ANPA-0073 (oral APJ receptor agonist, Phase 2 ready), and LTSE-2578 (oral LPA1R antagonist for IPF, completed Phase 1 in July 2025)[85](index=85&type=chunk)[92](index=92&type=chunk)[95](index=95&type=chunk) - The company relies on third parties for manufacturing product candidates and is diversifying suppliers outside of China. It has incurred significant net operating losses (**$108.5 million** for six months ended June 30, 2025) and had an accumulated deficit of **$437.6 million** as of June 30, 2025[97](index=97&type=chunk)[98](index=98&type=chunk)[100](index=100&type=chunk) - Existing cash, cash equivalents, and short-term investments (**$786.5 million** as of June 30, 2025) are expected to fund operations through at least 2027, including Phase 3 readiness for aleniglipron (excluding registrational studies). Substantial additional capital will be needed for Phase 3 and future growth[101](index=101&type=chunk)[102](index=102&type=chunk) [Impact of Geopolitical and Macroeconomic Factors](index=38&type=section&id=Impact%20of%20Geopolitical%20and%20Macroeconomic%20Factors) This section assesses the potential effects of global geopolitical and macroeconomic developments on the company's operations and financial outlook - While no significant financial impact was observed for the six months ended June 30, 2025, the company acknowledges potential future impacts from geopolitical and macroeconomic developments, including disruptions in access to bank deposits, tariffs, global pandemics, and US-China tensions[103](index=103&type=chunk)[105](index=105&type=chunk) - The One Big Beautiful Bill Act (OBBBA), signed on July 4, 2025, repeals the requirement to capitalize domestic R&D expenditures for federal income tax purposes for taxable years beginning after December 31, 2024, and allows **100% bonus depreciation**. The company preliminarily does not anticipate a material change to its effective income tax rate due to a full valuation allowance[106](index=106&type=chunk) [Components of Our Results of Operations](index=40&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section outlines the primary categories of expenses and income that constitute the company's financial performance - Research and development expenses primarily consist of costs for discovery, engineering, preclinical and clinical studies, including personnel, consulting, clinical trial expenses, and regulatory costs. These expenses are expected to increase substantially as product candidates advance[107](index=107&type=chunk)[109](index=109&type=chunk) - General and administrative expenses include personnel costs for executive, legal, finance, and administrative functions, professional fees, and other operating expenses. These are expected to increase due to headcount expansion and public company operating costs[110](index=110&type=chunk)[111](index=111&type=chunk) - Interest and other income, net, primarily comprises interest earned on cash, cash equivalents, and short-term investments, including amortization/accretion of premiums/discounts, and foreign currency exchange gains/losses[114](index=114&type=chunk) [Results of Operations](index=42&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, highlighting key changes in revenues, expenses, and net loss over the reporting periods Results of Operations - Three Months Ended June 30 (in thousands) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Change ($) | Change (%) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :--------- | :--------- | | Research and development | $54,710 | $22,050 | $32,660 | 148% | | General and administrative | $15,741 | $11,266 | $4,475 | 40% | | Interest and other income, net | $8,929 | $7,335 | $1,594 | 22% | | Net loss | $(61,661) | $(26,034) | $(35,627) | 137% | Results of Operations - Six Months Ended June 30 (in thousands) | Metric | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | Change ($) | Change (%) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :--------- | :--------- | | Research and development | $97,577 | $42,729 | $54,848 | 128% | | General and administrative | $29,185 | $22,602 | $6,583 | 29% | | Interest and other income, net | $18,505 | $13,343 | $5,162 | 39% | | Net loss | $(108,494) | $(52,070) | $(56,424) | 108% | - The increase in R&D expenses was primarily due to preclinical research, clinical trial costs, employee expenses (personnel increase), and a **$3.0 million** milestone payment under the Aconcagua-Schrödinger Agreement[116](index=116&type=chunk)[121](index=121&type=chunk) Product Candidate R&D Expenses - Three Months Ended June 30 (in thousands) | Product Candidate R&D Expenses | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Aleniglipron (GSBR-1290) | $28,365 | $9,943 | | ACCG-2671 | $9,649 | $2,429 | | ANPA-0073 | $1,048 | $1,635 | | LTSE-2578 | $1,493 | $2,181 | | Other | $14,155 | $5,862 | | Total R&D Expenses | $54,710 | $22,050 | Product Candidate R&D Expenses - Six Months Ended June 30 (in thousands) | Product Candidate R&D Expenses | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Aleniglipron (GSBR-1290) | $53,350 | $19,478 | | ACCG-2671 | $15,259 | $4,412 | | ANPA-0073 | $2,154 | $2,749 | | LTSE-2578 | $2,919 | $4,343 | | Other | $23,895 | $11,747 | | Total R&D Expenses | $97,577 | $42,729 | [Liquidity and Capital Resources](index=44&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's ability to generate and manage cash, its funding sources, and future capital requirements - The company has funded operations through equity financings, including an IPO (**$166.7 million** net proceeds in Feb 2023), a Private Placement (**$281.5 million** net proceeds in Oct 2023), and a Follow-On Offering (**$512.7 million** net proceeds in June 2024)[125](index=125&type=chunk) - As of June 30, 2025, cash, cash equivalents, and short-term investments totaled **$786.5 million**, with an accumulated deficit of **$437.6 million**. The company believes existing capital is sufficient for at least 12 months, covering projected operations and key clinical milestones through 2027 (excluding Phase 3 registrational studies)[125](index=125&type=chunk)[126](index=126&type=chunk)[127](index=127&type=chunk) - Substantial additional capital will be needed for Phase 3 clinical studies of aleniglipron and future operations, with funding expected from equity sales, debt, grants, or collaborations[102](index=102&type=chunk)[129](index=129&type=chunk)[131](index=131&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(106,787) | $(60,473) | | Net cash provided by (used in) investing activities | $82,975 | $(203,097) | | Net cash provided by financing activities | $1,326 | $515,405 | | Net (decrease) increase in cash and cash equivalents | $(22,486) | $251,835 | - Contractual obligations as of June 30, 2025, include **$8.6 million** in facilities lease payments, with **$3.1 million** due within the next 12 months[141](index=141&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=51&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there were no material changes to the company's quantitative and qualitative disclosures about market risk during the six months ended June 30, 2025, compared to those reported in its Annual Report - No material changes to quantitative and qualitative disclosures about market risk were reported during the six months ended June 30, 2025[145](index=145&type=chunk) [Item 4. Controls and Procedures](index=51&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the Chief Executive Officer and Chief Financial Officer, concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025. No changes in internal control over financial reporting were identified that materially affected, or are reasonably likely to materially affect, internal control during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[147](index=147&type=chunk) - No changes in internal control over financial reporting were identified during the quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[148](index=148&type=chunk) [PART II. OTHER INFORMATION](index=53&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional disclosures beyond financial statements, including legal proceedings, risk factors, and other required information [Item 1. Legal Proceedings](index=53&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material governmental investigations, private lawsuits, or other legal proceedings that would have a material adverse effect on its financial position, results of operations, or cash flows - The company is not currently the subject of any material governmental investigation, private lawsuit, or other legal proceeding[151](index=151&type=chunk) [Item 1A. Risk Factors](index=53&type=section&id=Item%201A.%20Risk%20Factors) The company faces numerous risks, including its limited operating history, significant ongoing losses, and substantial capital requirements for product development. Key risks also involve the uncertain and lengthy drug development and regulatory approval processes, reliance on third parties for manufacturing and clinical studies, intense competition, and challenges in achieving market acceptance and reimbursement. Furthermore, the company's international operations, particularly in China, expose it to geopolitical, regulatory, and intellectual property risks, while its public company status adds compliance costs and potential stock price volatility [Risks Related to Our Limited Operating History, Financial Position and Capital Requirements](index=53&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History%2C%20Financial%20Position%20and%20Capital%20Requirements) This section highlights financial risks stemming from the company's early operational stage, consistent losses, and significant future capital needs - The company has a limited operating history, has incurred significant operating losses since its inception, and expects to incur significant losses for the foreseeable future, with an accumulated deficit of **$437.6 million** as of June 30, 2025[153](index=153&type=chunk)[154](index=154&type=chunk) - Substantial additional capital will be required to finance operations, particularly for Phase 3 clinical studies of aleniglipron, and this capital may not be available on acceptable terms or at all, potentially forcing delays or termination of product development programs[156](index=156&type=chunk)[157](index=157&type=chunk)[159](index=159&type=chunk) - Raising additional capital may dilute shareholder ownership, restrict operations through debt covenants, or require relinquishing rights to technologies or product candidates through collaborations[161](index=161&type=chunk) [Risks Related to the Discovery, Development and Regulatory Approval of Product Candidates](index=57&type=section&id=Risks%20Related%20to%20the%20Discovery%2C%20Development%20and%20Regulatory%20Approval%20of%20Product%20Candidates) This section details the inherent uncertainties, high costs, and lengthy processes involved in drug discovery, clinical development, and obtaining regulatory approvals - The company's structure-based drug discovery platform is unproven, and there is no guarantee of developing commercially valuable products. Failure of one program could negatively impact perception of others[162](index=162&type=chunk) - The company is in early development stages with only four product candidates (aleniglipron, ACCG-2671, ANPA-0073, LTSE-2578) in early clinical development, and all other programs are preclinical or discovery stage. Successful advancement, regulatory approval, and commercialization are uncertain and subject to significant delays[165](index=165&type=chunk)[168](index=168&type=chunk)[169](index=169&type=chunk) - Clinical and preclinical drug development is a lengthy, expensive, and uncertain process. Prior results are not necessarily predictive of future outcomes, and product candidates can fail at any stage[170](index=170&type=chunk)[174](index=174&type=chunk) - Difficulties or delays in clinical studies, such as data collection omissions, patient enrollment challenges, or regulatory hurdles, could increase costs, delay revenue generation, and adversely affect commercial prospects[175](index=175&type=chunk)[177](index=177&type=chunk)[179](index=179&type=chunk)[189](index=189&type=chunk) - Serious adverse events or unexpected properties of product candidates identified during development or after approval could lead to discontinuation of programs, refusal of regulatory approval, or revocation of marketing authorizations[191](index=191&type=chunk)[192](index=192&type=chunk)[193](index=193&type=chunk) - The company lacks experience in conducting later-stage clinical studies or submitting New Drug Applications (NDAs), which are lengthy, time-consuming, expensive, and inherently unpredictable processes[196](index=196&type=chunk)[198](index=198&type=chunk) - There is a risk of expending limited resources on product candidates or indications that may be less profitable or have a lower likelihood of success, potentially missing greater commercial opportunities[202](index=202&type=chunk) - The company may not be able to obtain or maintain orphan drug designations or exclusivity for its product candidates, which could limit their potential profitability[203](index=203&type=chunk)[206](index=206&type=chunk) - Clinical studies conducted outside the United States (e.g., Australia, China) may not be accepted by the FDA or other foreign equivalents, leading to delays and increased costs[207](index=207&type=chunk)[208](index=208&type=chunk) - Preliminary, topline, and interim data from clinical studies are subject to change and audit, and may differ materially from final data, potentially harming business prospects[209](index=209&type=chunk)[210](index=210&type=chunk) [Risks Related to Commercialization of Our Product Candidates](index=98&type=section&id=Risks%20Related%20to%20Commercialization%20of%20Our%20Product%20Candidates) This section addresses challenges in bringing approved product candidates to market, including regulatory compliance, market acceptance, reimbursement, and competitive pressures - Even if product candidates receive marketing approval, they will be subject to ongoing regulatory obligations and review, potentially leading to significant additional expenses, labeling restrictions, or market withdrawal[255](index=255&type=chunk)[256](index=256&type=chunk)[259](index=259&type=chunk)[260](index=260&type=chunk)[261](index=261&type=chunk) - Market acceptance by physicians, patients, and third-party payors is crucial for commercial success, and failure to achieve adequate acceptance could prevent significant product revenue[263](index=263&type=chunk)[264](index=264&type=chunk) - Coverage and adequate reimbursement may not be available for approved product candidates, making profitable sales difficult and impacting demand and pricing[265](index=265&type=chunk)[267](index=267&type=chunk)[268](index=268&type=chunk) - The company faces substantial competition from major pharmaceutical and biotechnology companies, including those utilizing AI for drug discovery, which may result in others commercializing products more successfully[269](index=269&type=chunk)[270](index=270&type=chunk)[271](index=271&type=chunk)[273](index=273&type=chunk)[274](index=274&type=chunk)[276](index=276&type=chunk) - If market opportunities for product candidates are smaller than estimated, revenue may be adversely affected[277](index=277&type=chunk) - The company currently lacks a marketing and sales organization and experience in commercializing products, requiring significant investment or reliance on third parties, which may not generate sufficient product revenue[279](index=279&type=chunk) - Commercializing products in foreign markets exposes the company to additional regulatory burdens, economic, political, and other risks[280](index=280&type=chunk) [Risks Related to Our Business Operations and Industry](index=110&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations%20and%20Industry) This section covers operational challenges, regulatory compliance, personnel dependency, and external factors affecting the company's business and the broader industry - Operating results may fluctuate significantly due to various factors, making future predictions difficult and potentially causing results to fall below expectations[281](index=281&type=chunk)[282](index=282&type=chunk) - High dependence on senior management and the ability to attract and retain qualified personnel. Failure to do so could harm business operations and growth[283](index=283&type=chunk)[286](index=286&type=chunk)[287](index=287&type=chunk) - The need to expand the organization and manage growth could disrupt operations and divert management attention[289](index=289&type=chunk)[290](index=290&type=chunk) - Operations in Australia, conducted through wholly-owned subsidiaries, are subject to risks including the potential loss or refund of research and development tax credits[292](index=292&type=chunk)[294](index=294&type=chunk) - Relationships with healthcare providers and third-party payors are subject to federal and state healthcare fraud and abuse laws, false claims laws, and health data privacy and security laws. Non-compliance could lead to substantial penalties[295](index=295&type=chunk)[296](index=296&type=chunk)[297](index=297&type=chunk)[298](index=298&type=chunk)[299](index=299&type=chunk)[300](index=300&type=chunk) - Healthcare legislative reform measures, such as the ACA, IRA, and OBBBA, may negatively impact the business and results of operations, particularly regarding drug pricing and reimbursement[301](index=301&type=chunk)[302](index=302&type=chunk)[303](index=303&type=chunk)[304](index=304&type=chunk)[305](index=305&type=chunk)[306](index=306&type=chunk)[307](index=307&type=chunk)[310](index=310&type=chunk) - The use of hazardous and biological materials by third-party manufacturers could lead to liability for damages, fines, or operational interruptions[311](index=311&type=chunk) - Product liability lawsuits related to clinical testing or commercialized products could result in substantial liabilities, decreased demand, and harm to reputation[312](index=312&type=chunk)[315](index=315&type=chunk) - Compromises or disruptions to information technology systems or data, including those of third parties, could lead to significant financial, legal, regulatory, business, and reputational harm[316](index=316&type=chunk)[317](index=317&type=chunk)[318](index=318&type=chunk)[320](index=320&type=chunk)[321](index=321&type=chunk)[322](index=322&type=chunk) - Misconduct by employees, principal investigators, consultants, or commercial partners, including non-compliance with regulatory standards or insider trading, could lead to regulatory sanctions and reputational damage[323](index=323&type=chunk) - Governments outside the United States may impose strict price controls on prescription pharmaceuticals, adversely affecting potential revenues[324](index=324&type=chunk) - The company is subject to stringent and evolving U.S. and foreign data security and privacy laws (e.g., GDPR, CCPA, PIPL), with non-compliance potentially leading to government enforcement actions, litigation, fines, and business disruptions[325](index=325&type=chunk)[327](index=327&type=chunk)[328](index=328&type=chunk)[329](index=329&type=chunk)[330](index=330&type=chunk)[331](index=331&type=chunk)[332](index=332&type=chunk)[335](index=335&type=chunk)[336](index=336&type=chunk)[337](index=337&type=chunk)[338](index=338&type=chunk)[339](index=339&type=chunk)[342](index=342&type=chunk) - Tax risks are associated with cross-border arrangements and activities between the company and its subsidiaries, with potential challenges to transfer pricing and increased tax liabilities[343](index=343&type=chunk)[344](index=344&type=chunk)[345](index=345&type=chunk)[346](index=346&type=chunk) - Changes in tax laws or regulations, such as the One Big Beautiful Bill Act, could adversely affect the business, cash flow, financial condition, or results of operations[348](index=348&type=chunk) [Risks Related to Doing Business in China and Our International Operations](index=132&type=section&id=Risks%20Related%20to%20Doing%20Business%20in%20China%20and%20Our%20International%20Operations) This section outlines the specific political, economic, regulatory, and legal risks associated with the company's operations and business relationships in China and other international markets - Changes in political and economic policies or relations between China and the United States may affect the company's business, financial condition, results of operations, and the market price of its ADSs[349](index=349&type=chunk)[351](index=351&type=chunk) - Compliance with China's Data Security Law, Cyber Security Law, Cybersecurity Review Measures, and Personal Information Protection Law (PIPL) may entail significant expenses and affect business operations, with uncertainties in interpretation and implementation[352](index=352&type=chunk)[353](index=353&type=chunk)[354](index=354&type=chunk)[355](index=355&type=chunk)[356](index=356&type=chunk)[357](index=357&type=chunk)[358](index=358&type=chunk)[359](index=359&type=chunk) - Approval, filing, or other procedures with the CSRC or other Chinese regulatory authorities may be required for issuing securities to foreign investors, and the ability to obtain such approvals or complete procedures is uncertain[360](index=360&type=chunk)[362](index=362&type=chunk)[363](index=363&type=chunk) - Pharmaceutical companies operating in China are subject to extensive regulations and permit requirements, and the ability to obtain and maintain these approvals is uncertain, with future government regulation potentially placing additional burdens[364](index=364&type=chunk)[366](index=366&type=chunk) - As a company with operations and business relationships outside the United States, the business is subject to economic, political, regulatory, and other risks associated with international operations[367](index=367&type=chunk)[369](index=369&type=chunk) - Failure to comply with Chinese environmental, health, and safety laws and regulations could lead to fines, penalties, or costs that materially adversely affect the business[370](index=370&type=chunk)[371](index=371&type=chunk) - Developments in the Chinese legal system, which is a civil law system with evolving laws and regulations, could materially and adversely affect the company[372](index=372&type=chunk) - Exposure to the U.S. Foreign Corrupt Practices Act (FCPA), U.S. domestic bribery laws, and similar anti-corruption and anti-bribery laws in China and other countries, as well as export controls and trade sanctions, could limit competitiveness and harm reputation[373](index=373&type=chunk)[375](index=375&type=chunk)[376](index=376&type=chunk) - Chinese regulatory requirements on currency exchange may limit the ability to receive and effectively use financing in foreign currencies for Chinese subsidiaries[377](index=377&type=chunk)[378](index=378&type=chunk) - Chinese regulations relating to the establishment of offshore special purpose companies by residents in China may subject beneficial owners or subsidiaries to liability or penalties, and limit capital injection or profit distribution[379](index=379&type=chunk)[380](index=380&type=chunk)[381](index=381&type=chunk) - Classification as a China resident enterprise for China income tax purposes could result in unfavorable tax consequences, including a **25% EIT** on global income and withholding taxes on dividends and gains for non-Chinese shareholders[382](index=382&type=chunk)[384](index=384&type=chunk)[385](index=385&type=chunk) - Uncertainties exist in China regarding indirect transfers of equity interests in China resident enterprises, potentially subjecting such transfers to income tax[386](index=386&type=chunk)[388](index=388&type=chunk) - Failure to comply with Chinese regulations regarding registration requirements for employee equity incentive plans may lead to fines and sanctions[389](index=389&type=chunk) [Risks Related to Our Intellectual Property](index=151&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section addresses the critical risks associated with obtaining, maintaining, and enforcing intellectual property rights, including patents, trade secrets, and trademarks - Inability to obtain and maintain sufficient or broad intellectual property protection for platform technologies and product candidates could allow competitors to develop similar products, adversely affecting commercialization[390](index=390&type=chunk)[392](index=392&type=chunk)[393](index=393&type=chunk)[394](index=394&type=chunk)[395](index=395&type=chunk) - Patent rights relating to pending applications may not issue, or issued patents may be challenged, invalidated, or rendered unenforceable, leading to loss of exclusivity or narrowed protection[396](index=396&type=chunk)[398](index=398&type=chunk)[399](index=399&type=chunk)[401](index=401&type=chunk) - Reliance on trade secrets and proprietary know-how is vulnerable to disclosure or misappropriation, which can be difficult to trace and enforce, harming the business and competitive position[402](index=402&type=chunk)[403](index=403&type=chunk) - Reliance on in-licenses from third parties means losing these rights or disputes with licensors could materially adversely affect the business and ability to develop/commercialize products[404](index=404&type=chunk)[405](index=405&type=chunk)[406](index=406&type=chunk)[407](index=407&type=chunk)[409](index=409&type=chunk)[410](index=410&type=chunk)[411](index=411&type=chunk) - Intellectual property licensed from third parties may be subject to retained rights by licensors or government agencies (e.g., Bayh-Dole Act), potentially limiting the company's ability to exploit or enforce patents[412](index=412&type=chunk)[414](index=414&type=chunk) - Obtaining and maintaining patent protection requires compliance with various procedural, document submission, and fee payment requirements; non-compliance could lead to loss of patent rights[415](index=415&type=chunk)[416](index=416&type=chunk) - Patent terms may be inadequate to protect competitive position for a sufficient amount of time, especially given the lengthy development and regulatory review process[417](index=417&type=chunk)[419](index=419&type=chunk)[420](index=420&type=chunk) - Intellectual property rights have limitations and may not adequately protect the business from various threats, such as competitors developing similar compounds not covered by claims or independent development[421](index=421&type=chunk)[424](index=424&type=chunk) - Third parties may initiate legal proceedings alleging infringement, misappropriation, or other violations of their intellectual property rights, leading to uncertain outcomes, substantial litigation expenses, and potential limitations on commercialization[422](index=422&type=chunk)[425](index=425&type=chunk)[426](index=426&type=chunk)[427](index=427&type=chunk)[428](index=428&type=chunk)[429](index=429&type=chunk) - Lawsuits to protect or enforce patents or other intellectual property could be expensive, time-consuming, and unsuccessful, potentially resulting in loss of patent protection or an inability to stop infringers[430](index=430&type=chunk)[431](index=431&type=chunk)[432](index=432&type=chunk)[434](index=434&type=chunk)[435](index=435&type=chunk)[436](index=436&type=chunk) - Changes in U.S. patent law (e.g., Leahy-Smith Act) or foreign patent law could diminish the value of patents, increasing uncertainties and costs for protecting inventions[437](index=437&type=chunk)[438](index=438&type=chunk)[439](index=439&type=chunk)[440](index=440&type=chunk)[441](index=441&type=chunk) - Inability to protect intellectual property rights throughout the world, particularly in countries with weaker enforcement, could negatively impact the business and competitive advantage[442](index=442&type=chunk)[443](index=443&type=chunk)[444](index=444&type=chunk) - Claims that employees, consultants, or advisors have wrongfully used or disclosed trade secrets of former employers, or claims asserting inventorship or ownership of the company's intellectual property, could lead to litigation and loss of valuable rights[445](index=445&type=chunk)[446](index=446&type=chunk)[447](index=447&type=chunk)[448](index=448&type=chunk) - Failure to identify relevant third-party patents or incorrect interpretation of their relevance, scope, or expiration could adversely affect the ability to develop and market products[449](index=449&type=chunk)[450](index=450&type=chunk) - Inadequate protection of trademarks and trade names could prevent building name recognition and adversely affect the business[451](index=451&type=chunk)[452](index=452&type=chunk) [Risks Related to Our ADSs](index=179&type=section&id=Risks%20Related%20to%20Our%20ADSs) This section addresses risks specific to the company's American Depositary Shares (ADSs), including market volatility, delisting potential, and shareholder rights - The trading price of the company's ADSs is likely to be highly volatile and subject to wide fluctuations due to various factors, including clinical study results, regulatory decisions, competition, and general market conditions, potentially leading to a loss of investment[453](index=453&type=chunk)[455](index=455&type=chunk) - There is a risk of delisting under the Holding Foreign Companies Accountable Act (HFCA Act) or Accelerating Holding Foreign Companies Accountable Act (AHFCA Act) if the SEC identifies that the company's audit work is performed by an auditor not subject to PCAOB inspection, although currently, the company's auditor is PCAOB-inspected[456](index=456&type=chunk)[457](index=457&type=chunk)[458](index=458&type=chunk)[460](index=460&type=chunk)[461](index=461&type=chunk)[462](index=462&type=chunk) - The company previously identified and remediated material weaknesses in internal control over financial reporting as of June 30, 2024. Future material weaknesses could lead to material misstatements in financial statements or failure to meet reporting obligations[463](index=463&type=chunk)[464](index=464&type=chunk)[465](index=465&type=chunk)[466](index=466&type=chunk) - Principal shareholders and management own approximately **45%** of the voting power, allowing them to exert significant control over matters requiring shareholder approval, potentially conflicting with other shareholders' interests[467](index=467&type=chunk) - Substantial future sales of ADSs by existing shareholders or through equity offerings could cause the market price to drop significantly[468](index=468&type=chunk)[469](index=469&type=chunk) - Holders of ADSs have fewer rights than ordinary shareholders and must act through the depositary to exercise voting rights, potentially limiting their ability to vote or receive distributions[470](index=470&type=chunk)[471](index=471&type=chunk)[473](index=473&type=chunk) - ADS holders may not be entitled to a jury trial for claims arising under the deposit agreement, which could result in less favorable outcomes for plaintiffs[472](index=472&type=chunk) - The right to participate in future rights offerings may be limited, potentially causing dilution to holdings[474](index=474&type=chunk) - The company does not anticipate paying cash dividends in the foreseeable future, making capital appreciation the sole source of gains for investors[475](index=475&type=chunk) - The company is subject to tax in both the Cayman Islands and the United States, potentially leading to a material adverse effect on financial condition and results of operations[476](index=476&type=chunk)[477](index=477&type=chunk)[478](index=478&type=chunk) - The ability to use net operating loss carryforwards and certain other tax attributes may be limited by ownership changes (Sections 382 and 383 of the Code) or state tax laws, potentially increasing future tax liability[479](index=479&type=chunk)[480](index=480&type=chunk) [General Risk Factors](index=195&type=section&id=General%20Risk%20Factors) This section covers broad risks impacting the company's overall operations, including financial infrastructure, internal controls, legal proceedings, and external disasters - Failure to build adequate finance infrastructure and improve accounting systems and controls could impair compliance with financial reporting and internal controls requirements for publicly-traded companies, leading to significant costs and potential misstatements[492](index=492&type=chunk)[495](index=495&type=chunk)[496](index=496&type=chunk)[497](index=497&type=chunk)[499](index=499&type=chunk) - Disclosure controls and procedures, or internal controls, may not prevent or detect all errors or acts of fraud due to inherent limitations[500](index=500&type=chunk)[501](index=501&type=chunk) - Future changes in financial accounting standards or practices may cause adverse and unexpected revenue fluctuations and affect reported results of operations[502](index=502&type=chunk) - Lack of or unfavorable equity research analyst coverage could negatively impact the price and trading volume of the company's ADSs[503](index=503&type=chunk) - The company could be subject to securities class action litigation or material legal proceedings, which could have a negative impact on its reputation or business[504](index=504&type=chunk)[506](index=506&type=chunk) - The company or third parties it depends on may be adversely affected by earthquakes, fires, or other natural disasters, and business continuity plans may not adequately protect against serious disasters[507](index=507&type=chunk) - Failure to comply with environmental, health, and safety laws and regulations could lead to fines, penalties, or costs that materially adversely affect the business[508](index=508&type=chunk)[510](index=510&type=chunk) - Failure to meet Nasdaq's continued listing requirements could result in a delisting of the company's ADSs, negatively affecting their price and liquidity[511](index=511&type=chunk)[512](index=512&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=203&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the three months ended June 30, 2025 - No unregistered sales of equity securities occurred during the three months ended June 30, 2025[513](index=513&type=chunk) [Item 3. Defaults Upon Senior Securities](index=203&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - No defaults upon senior securities were reported[514](index=514&type=chunk) [Item 4. Mine Safety Disclosures](index=203&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reported no mine safety disclosures - No mine safety disclosures were reported[515](index=515&type=chunk) [Item 5. Other Information](index=203&type=section&id=Item%205.%20Other%20Information) The company reported no other information - No other information was reported[515](index=515&type=chunk) [Item 6. Exhibits](index=204&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including organizational documents, specimen certificates, the deposit agreement, certifications of principal officers, and XBRL interactive data files - The exhibits include the Amended and Restated Memorandum and Articles of Association, Registrant's Specimen Certificate for Ordinary Shares, Form of Deposit Agreement, and certifications of the Principal Executive Officer and Principal Financial Officer[517](index=517&type=chunk) [Signatures](index=205&type=section&id=Signatures) The report was duly signed on August 6, 2025, by Raymond Stevens, Ph.D., Chief Executive Officer, and Jun Yoon, Chief Financial Officer, on behalf of Structure Therapeutics Inc - The report was signed by Raymond Stevens, Ph.D., Chief Executive Officer, and Jun Yoon, Chief Financial Officer, on August 6, 2025[520](index=520&type=chunk)
Structure Therapeutics(GPCR) - 2025 Q2 - Quarterly Results
2025-08-06 20:06
Executive Summary & Business Update [Q2 2025 Overview and Key Highlights](index=1&type=section&id=1.1%20Q2%202025%20Overview%20and%20Key%20Highlights) Structure Therapeutics reported strong Q2 2025 results, advancing aleniglipron and ACCG-2671, backed by $786.5 million cash for operations through 2027 - Topline data from oral small molecule GLP-1 receptor agonist aleniglipron ACCESS and ACCESS II studies are on track for **year-end 2025** readouts[1](index=1&type=chunk)[2](index=2&type=chunk) - Aleniglipron clinical development program expanded to optimize competitive positioning and Phase 3 program design[1](index=1&type=chunk)[2](index=2&type=chunk) - Oral small molecule amylin receptor agonist (ACCG-2671) Phase 1 initiation anticipated by **year-end 2025**[1](index=1&type=chunk)[2](index=2&type=chunk) Cash Position as of June 30, 2025 | Metric | Amount (Millions) | | :------------------------------------ | :---------------- | | Cash, cash equivalents and short-term investments | $786.5 | - The strong financial position is expected to fund projected operations and key clinical milestones through at least **2027**[1](index=1&type=chunk)[13](index=13&type=chunk) Recent and Upcoming Milestones [Aleniglipron (GSBR-1290) Development](index=2&type=section&id=2.1%20Aleniglipron%20(GSBR-1290)%20Development) Structure Therapeutics updated on aleniglipron, with ACCESS/ACCESS II data due year-end 2025 and new studies initiated for competitive positioning [Ongoing ACCESS and ACCESS II Studies](index=2&type=section&id=2.1.1%20Ongoing%20ACCESS%20and%20ACCESS%20II%20Studies) - The fully enrolled ACCESS and ACCESS II studies are on track for topline **36-week** data readouts by **year-end 2025**[3](index=3&type=chunk) - ACCESS study enrolled approximately **220 adults**, evaluating doses up to **120 mg** with a slower four-week titration schedule[6](index=6&type=chunk) - ACCESS II study enrolled approximately **80 adults**, evaluating higher doses (**180 mg** and **240 mg**) with a slower four-week titration schedule[6](index=6&type=chunk) [Expanded Data Collection from ACCESS and ACCESS II Studies](index=2&type=section&id=2.1.2%20Expanded%20Data%20Collection%20from%20ACCESS%20and%20ACCESS%20II%20Studies) - ACCESS Open Label Extension (OLE) allows patients to roll over for longer-term weight loss effects and expanded safety data[4](index=4&type=chunk) - ACCESS II Extension continues patients on assigned doses to **44 weeks**, providing an additional **eight weeks** of double-blinded safety, tolerability, and efficacy data, particularly for higher dose arms (**180 mg** and **240 mg**)[4](index=4&type=chunk) [Additional Aleniglipron Studies](index=2&type=section&id=2.1.3%20Additional%20Aleniglipron%20Studies) - Three new aleniglipron clinical studies are being conducted to generate additional data for competitive positioning and Phase 3 program design[5](index=5&type=chunk) - A Phase 2 study to assess a maintenance switching strategy from an approved injectable GLP-1 receptor agonist to oral aleniglipron is expected to start in **Q3 2025**[7](index=7&type=chunk) - A Phase 2 body composition study to assess the effect of aleniglipron on body fat loss over **40 weeks** is expected to start in **Q3 2025**[7](index=7&type=chunk) - A Phase 2 study in patients with type 2 diabetes mellitus (T2DM) is anticipated to start in **Q4 2025**, with data potentially supporting a T2DM cohort in the Phase 3 obesity program[8](index=8&type=chunk) [Other Pipeline Programs](index=3&type=section&id=2.2%20Other%20Pipeline%20Programs) Structure Therapeutics updated its diverse pipeline, advancing ACCG-2671 to Phase 1 and completing other early-stage studies [Oral Small Molecule Amylin Receptor Agonists (ACCG-2671)](index=3&type=section&id=2.2.1%20Oral%20Small%20Molecule%20Amylin%20Receptor%20Agonists%20(ACCG-2671)) - IND-enabling activities for ACCG-2671 are ongoing, with a first-in-human Phase 1 clinical study planned by **year-end 2025**[12](index=12&type=chunk) - New preclinical data for ACCG-2671 demonstrated high binding affinity, balanced potency, and significant, dose-dependent body weight reductions in diet-induced obese rats[12](index=12&type=chunk) - Combination therapy of ACCG-2671 with semaglutide resulted in superior weight loss compared to monotherapy of either compound[12](index=12&type=chunk) [Oral Small Molecule Metabolic Pipeline and Potential Combinations](index=3&type=section&id=2.2.2%20Oral%20Small%20Molecule%20Metabolic%20Pipeline%20and%20Potential%20Combinations) - Structure Therapeutics is developing GIPR selective agonists and antagonists, and GLP-1R/GIPR combinations to treat obesity and related diseases[12](index=12&type=chunk) - The company is also developing GCGR selective agonists and GLP-1R/GCGR combinations for obesity and related diseases[12](index=12&type=chunk) - ANPA-0073, a Phase 2 ready biased APJR agonist for selective or muscle-sparing weight loss, completed a Phase 1 study with good tolerability. Long-term toxicology studies are underway, expected by **year-end 2025**[12](index=12&type=chunk) [Oral Small Molecule LPA1R Program (LTSE-2578)](index=3&type=section&id=2.2.3%20Oral%20Small%20Molecule%20LPA1R%20Program%20(LTSE-2578)) - Structure Therapeutics successfully finished a Phase 1 single and multiple ascending dose clinical study of LTSE-2578, an oral small molecule antagonist for Idiopathic Pulmonary Fibrosis (IPF)[11](index=11&type=chunk) - The study showed no evidence of dose-dependent LTSE-2578-related adverse events, including clinical, laboratory, and electrocardiogram recordings, and no SAEs were observed[11](index=11&type=chunk) Financial Performance [Q2 2025 Financial Highlights](index=4&type=section&id=3.1%20Q2%202025%20Financial%20Highlights) Structure Therapeutics reported a strong $786.5 million cash position, but increased expenses led to a higher Q2 2025 net loss Cash Position | Metric | June 30, 2025 | | :------------------------------------ | :------------ | | Cash, cash equivalents and short-term investments | $786.5 million | - Current cash, cash equivalents and short-term investments are expected to fund projected operations and key clinical milestones through at least **2027**[13](index=13&type=chunk) Research and Development (R&D) Expenses (YoY Change) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :------------------- | :----------------- | :----------------- | :----------- | | R&D Expenses | $54.7 | $22.1 | +$32.6 million | - The increase in R&D expenses was primarily due to increases related to pre-clinical research and development, clinical trial costs, and personnel-related expenses to support the GLP-1R franchise[14](index=14&type=chunk) General and Administrative (G&A) Expenses (YoY Change) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :------------------- | :----------------- | :----------------- | :----------- | | G&A Expenses | $15.7 | $11.3 | +$4.4 million | - The increase in G&A expenses was primarily due to increases in employee expenses as infrastructure expanded to support growth as a publicly-traded company[15](index=15&type=chunk) Net Loss (YoY Change) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :------- | :----------------- | :----------------- | :----------- | | Net Loss | $61.7 | $26.0 | +$35.7 million | - Non-cash share-based compensation expense increased to **$7.5 million** in Q2 2025 from **$4.2 million** in Q2 2024[16](index=16&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=3.2%20Condensed%20Consolidated%20Statements%20of%20Operations) The condensed consolidated statements of operations show a significant increase in operating expenses, particularly in research and development, leading to a higher net loss for both the three and six months ended June 30, 2025, compared to the prior year periods Condensed Consolidated Statements of Operations (Unaudited, In thousands) | | THREE MONTHS ENDED | | | | SIX MONTHS ENDED | | | | | :-------------------------- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | | JUNE 30, | | | JUNE 30, | | | | | | 2025 | | 2024 | 2025 | | 2024 | | Operating expenses: | | | | | | | | | | Research and development | $ 54,710 | | $ 22,050 | $ 97,577 | | $ 42,729 | | General and administrative | 15,741 | | 11,266 | 29,185 | | 22,602 | | Total operating expenses | 70,451 | | 33,316 | 126,762 | | 65,331 | | Loss from operations | (70,451) | | (33,316) | (126,762) | | (65,331) | | Interest and other income, net | 8,929 | | 7,335 | 18,505 | | 13,343 | | Loss before provision for income taxes | (61,522) | | (25,981) | (108,257) | | (51,988) | | Provision for income taxes | 139 | | 53 | 237 | | 82 | | Net loss | $ (61,661) | | $ (26,034) | $ (108,494) | | $ (52,070) | [Condensed Consolidated Balance Sheet Data](index=6&type=section&id=3.3%20Condensed%20Consolidated%20Balance%20Sheet%20Data) Total assets decreased from $903.3 million to $816.4 million due to reduced cash, with liabilities increasing and equity decreasing Condensed Consolidated Balance Sheet Data (Unaudited, In thousands) | | JUNE 30, | | DECEMBER 31, | | :---------------------------------- | :--- | :--- | :--- | :--- | | | 2025 | | 2024 | | Assets | | | | | | Current assets: | | | | | | Cash, cash equivalents and short-term investments | $ 786,496 | | $ 883,518 | | Prepaid expenses and other current assets | 12,802 | | 7,693 | | Total current assets | 799,298 | | 891,211 | | Property and equipment, net | 3,459 | | 3,478 | | Operating right-of-use assets | 7,484 | | 3,535 | | Other non-current assets | 6,202 | | 5,106 | | Total assets | $ 816,443 | | $ 903,330 | | Liabilities and shareholders' equity | | | | | | Current liabilities: | | | | | | Accounts payable | $ 8,990 | | $ 8,024 | | Accrued expenses and other current liabilities | 27,379 | | 26,299 | | Operating lease liabilities, current portion | 2,664 | | 1,698 | | Total current liabilities | 39,033 | | 36,021 | | Operating lease liabilities, net of current portion | 5,012 | | 2,164 | | Other non-current liabilities | 317 | | 302 | | Total liabilities | 44,362 | | 38,487 | | Total shareholders' equity | 772,081 | | 864,843 | | Total liabilities and shareholders' equity | $ 816,443 | | $ 903,330 | About Structure Therapeutics [Company Overview](index=4&type=section&id=4.1%20Company%20Overview) Structure Therapeutics is a clinical-stage biopharmaceutical company developing oral small molecule treatments for chronic metabolic and cardiopulmonary conditions - Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company[17](index=17&type=chunk) - Focuses on discovering and developing innovative oral small molecule treatments for chronic metabolic and cardiopulmonary conditions with significant unmet medical needs[17](index=17&type=chunk) - Utilizes a next-generation structure-based drug discovery platform to establish a robust GPCR-targeted pipeline[17](index=17&type=chunk) - Aims to surpass scalability limitations of traditional biologic and peptide therapies and make treatments accessible to more patients globally[17](index=17&type=chunk) Forward-Looking Statements [Disclaimer and Risk Factors](index=5&type=section&id=5.1%20Disclaimer%20and%20Risk%20Factors) This section cautions that forward-looking statements are subject to risks and uncertainties, with no obligation to update - The press release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995[18](index=18&type=chunk) - Statements concern future plans, prospects, expected timing of data readouts, study initiations, cash runway, and potential benefits/efficacy of therapeutic candidates[18](index=18&type=chunk) - Readers are cautioned that actual results, levels of activity, safety, performance, or events could differ materially due to various risks and uncertainties, including those described in SEC filings[18](index=18&type=chunk) - The Company undertakes no obligation to update such statements to reflect events or circumstances that exist after the date on which they were made, except as required by law[18](index=18&type=chunk) Contact Information [Investor and Media Relations](index=6&type=section&id=6.1%20Investor%20and%20Media%20Relations) This section provides contact details for investor and media inquiries related to Structure Therapeutics - Investors can contact Danielle Keatley at ir@structuretx.com[23](index=23&type=chunk) - Media inquiries can be directed to Dan Budwick of 1AB at Dan@1abmedia.com[23](index=23&type=chunk)
Structure Therapeutics Reports Second Quarter 2025 Financial Results and Recent Highlights
GlobeNewswire News Room· 2025-08-06 20:01
Core Insights - Structure Therapeutics is advancing its clinical development programs for aleniglipron, an oral small molecule GLP-1 receptor agonist, with topline data readouts expected by the end of 2025 [1][2] - The company is also initiating a Phase 1 study for ACCG-2671, an oral small molecule amylin receptor agonist, anticipated by year-end 2025 [1][2] - As of June 30, 2025, the company reported a strong financial position with cash, cash equivalents, and short-term investments totaling $786.5 million, expected to fund operations through at least 2027 [1][9] Clinical Development - The ACCESS and ACCESS II studies for aleniglipron are fully enrolled, with approximately 220 and 80 adults participating, respectively, and are designed to evaluate various doses and long-term effects [3][4] - Additional studies for aleniglipron include an open-label extension and an extension of ACCESS II to gather more long-term data on safety and efficacy [4][5] - The company is also developing a pipeline of oral small molecule therapeutics targeting obesity and related metabolic diseases, focusing on combinability and long-term weight loss maintenance [2][10] Financial Performance - Research and Development (R&D) expenses for Q2 2025 were $54.7 million, a significant increase from $22.1 million in Q2 2024, driven by clinical trial costs and pre-clinical research [10][11] - General and Administrative (G&A) expenses rose to $15.7 million in Q2 2025 from $11.3 million in Q2 2024, reflecting increased personnel-related expenses [11] - The net loss for Q2 2025 was $61.7 million, compared to a net loss of $26.0 million in Q2 2024, with non-cash share-based compensation contributing to the loss [12][16] Pipeline and Future Studies - Structure Therapeutics is planning to initiate several new studies, including a Phase 2 body composition study and a Phase 2 study in patients with type 2 diabetes mellitus (T2DM), both expected to start in late 2025 [10][12] - The company is also advancing its oral small molecule programs targeting various receptors, including GIPR and GCGR, to treat obesity and related diseases [10][12] - ACCG-2671 has shown promising preclinical results, demonstrating significant body weight reductions in diet-induced obese rats and potential for combination therapy with semaglutide [10][12]
Structure Therapeutics Announces Two Late-Breaking Poster Presentations at the American Diabetes Association 85th Scientific Sessions Including New Preclinical Data for Oral Small Molecule Amylin Agonist, ACCG-2671
Globenewswire· 2025-06-20 23:30
Core Insights - Structure Therapeutics Inc. is presenting two late-breaking posters at the American Diabetes Association 85 Scientific Sessions, focusing on their oral small molecule therapeutics for metabolic diseases [1][2] Group 1: Product Development - ACCG-2671 is positioned as a frontrunner oral small molecule targeting obesity, expected to enter clinical development by the end of 2025, with promising preclinical data showing significant weight-loss effects [2][3] - The combination therapy of ACCG-2671 with semaglutide resulted in superior weight loss compared to monotherapy in diet-induced obese rats [3] - GSBR-5595, another small molecule GLP-1 receptor agonist, demonstrated significant improvements in motor coordination and an increase in dopaminergic neurons in a Parkinson's disease mouse model [4][7] Group 2: Company Overview - Structure Therapeutics is focused on developing innovative oral small molecule treatments for chronic metabolic and cardiopulmonary conditions, utilizing a structure-based drug discovery platform [5] - The company has established a robust pipeline targeting GPCRs, aiming to create scalable and cost-effective treatments that are accessible to a broader patient population [5]
Structure Therapeutics (GPCR) FY Conference Transcript
2025-06-11 15:40
Summary of Structure Therapeutics (GPCR) FY Conference Call Company Overview - Structure Therapeutics focuses on accessibility in the obesity treatment space, addressing healthcare inequality [3][4] - The company specializes in oral small molecules, particularly in converting biologic peptide drugs into oral forms [4] Key Products and Pipeline - **Aleniglipperon**: The most advanced oral small molecule GLP-1, currently in two Phase 2b studies (ACCESS and ACCESS 2) [4][5] - The company has a broad small molecule portfolio, including amylin, GIP, GCG, and apelin small molecules [5] - Emphasis on fixed-dose combinations to provide patients with more treatment options [5][14] Market Insights - The obesity market is evolving, with increasing recognition of obesity as a disease and a pandemic [8] - There is a growing demand for both oral and injectable treatments, with many patients preferring oral options for convenience [6][7] - The obesity epidemic is linked to various chronic conditions, expanding the market opportunities [8] Clinical Development - **Phase 2b Studies**: - ACCESS study: 36-week study with 220 participants, testing a maximum dose of 120 mg [31] - ACCESS 2 study: Higher doses of 180 mg and 240 mg, focusing on tolerability and efficacy directionality [34][36] - The company aims to demonstrate equivalence in efficacy and tolerability compared to competitors like orfagliptin [40][41] Regulatory Environment - Recent FDA guidance acknowledges chronic weight management as a pandemic, with no cardiovascular outcome studies required for obesity treatments [49][50] - The FDA emphasized the importance of maintenance therapy to prevent weight regain [51] Strategic Partnerships - Structure Therapeutics is exploring strategic partnerships for commercialization to enhance accessibility of their drugs [56][58] - The company is open to partnerships for various indications beyond chronic weight management, including type 2 diabetes and chronic kidney disease [54][56] Financial Position - As of Q1, the company reported a cash runway of $837 million, sufficient to fund operations until the end of 2027 [97][98] Future Directions - The company is focused on executing its clinical trials and exploring additional small molecule candidates, including GIP and GCG [88][93] - There is a strong emphasis on the potential of amylin small molecules and their role in combination therapies for obesity treatment [86][90] Conclusion - Structure Therapeutics is positioned to capitalize on the growing obesity treatment market with its innovative oral small molecules and strategic focus on accessibility and partnerships [56][66]
Structure Therapeutics(GPCR) - 2025 Q1 - Quarterly Report
2025-05-08 20:30
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)](index=9&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) 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](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders%27%20Equity) 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](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=13&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) 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](index=30&type=chunk) - The company operates as **one reportable segment**: the research and development of medicines for chronic diseases with unmet medical needs[34](index=34&type=chunk) - 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](index=74&type=chunk)[78](index=78&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=29&type=section&id=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](index=83&type=chunk)[87](index=87&type=chunk) - 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](index=88&type=chunk)[89](index=89&type=chunk) - 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](index=91&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) 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](index=108&type=chunk) 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](index=111&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=113&type=chunk)[114](index=114&type=chunk) - 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](index=94&type=chunk)[144](index=144&type=chunk) - 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](index=95&type=chunk)[117](index=117&type=chunk) [Cash Flows](index=41&type=section&id=Summary%20Statements%20of%20Cash%20Flows) 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](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=132&type=chunk) [Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=134&type=chunk) - **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](index=135&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=138&type=chunk) [Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) 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](index=46&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History%2C%20Financial%20Position%20and%20Capital%20Requirements) 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](index=140&type=chunk) - **Substantial additional capital is required** to finance operations, and failure to obtain it may force **delays, limitations, or termination** of product development programs[143](index=143&type=chunk) - Existing cash is estimated to be **sufficient through at least 2027**, but this **excludes Phase 3 registrational studies for aleniglipron**[144](index=144&type=chunk) [Risks Related to the Discovery, Development and Regulatory Approval of Product Candidates](index=50&type=section&id=Risks%20Related%20to%20the%20Discovery%2C%20Development%20and%20Regulatory%20Approval%20of%20Product%20Candidates) 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](index=150&type=chunk) - 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](index=163&type=chunk) - 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](index=189&type=chunk) [Risks Related to Our Reliance on Third Parties](index=73&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) 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](index=205&type=chunk) - 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](index=213&type=chunk)[215](index=215&type=chunk) - 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](index=227&type=chunk)[228](index=228&type=chunk) [Risks Related to Commercialization of Our Product Candidates](index=85&type=section&id=Risks%20Related%20to%20Commercialization%20of%20Our%20Product%20Candidates) 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](index=253&type=chunk)[254](index=254&type=chunk) - 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](index=259&type=chunk) - 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](index=249&type=chunk) [Risks Related to Our Business Operations and Industry](index=95&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations%20and%20Industry) 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](index=265&type=chunk)[266](index=266&type=chunk) - 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](index=271&type=chunk)[272](index=272&type=chunk) - **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](index=281&type=chunk)[283](index=283&type=chunk) [Risks Related to Doing Business in China and Our International Operations](index=115&type=section&id=Risks%20Related%20to%20Doing%20Business%20in%20China%20and%20Our%20International%20Operations) 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](index=318&type=chunk) - 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](index=321&type=chunk)[327](index=327&type=chunk) - 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](index=331&type=chunk)[332](index=332&type=chunk) [Risks Related to Our Intellectual Property](index=132&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) 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](index=353&type=chunk) - 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](index=383&type=chunk) - **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](index=397&type=chunk) [Risks Related to Our ADSs](index=153&type=section&id=Risks%20Related%20to%20Our%20ADSs) 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](index=413&type=chunk) - 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](index=416&type=chunk)[419](index=419&type=chunk) - The company **previously identified and has since remediated a material weakness** in its internal control over financial reporting as of June 30, 2024[422](index=422&type=chunk)[424](index=424&type=chunk)[425](index=425&type=chunk) [General Risk Factors](index=168&type=section&id=General%20Risk%20Factors) 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](index=452&type=chunk)[454](index=454&type=chunk) - 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](index=463&type=chunk) - **Failure to comply with Nasdaq's continued listing requirements** could result in the **delisting** of the company's ADSs[467](index=467&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=171&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) 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](index=468&type=chunk) [Defaults Upon Senior Securities](index=171&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - **None**[468](index=468&type=chunk) [Mine Safety Disclosures](index=171&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - **None**[468](index=468&type=chunk) [Other Information](index=171&type=section&id=Item%205.%20Other%20Information) The company reported no other information required to be disclosed under this item - **None**[468](index=468&type=chunk) [Exhibits](index=172&type=section&id=Item%206.%20Exhibits) 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](index=470&type=chunk) [Signatures](index=173&type=section&id=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](index=473&type=chunk)
Structure Therapeutics(GPCR) - 2025 Q1 - Quarterly Results
2025-05-08 20:21
Exhibit 99.1 Structure Therapeutics Reports First Quarter 2025 Financial Results and Recent Highlights Topline data from oral small molecule aleniglipron (GSBR-1290) Phase 2b ACCESS and ACCESS II studies anticipated by year-end 2025 Oral small molecule amylin receptor agonist (ACCG-2671) Phase 1 initiation anticipated by year-end 2025; New preclinical data to be presented at American Diabetes Association (ADA) 85 Scientific Sessions in June 2025 Strong financial position with cash, cash equivalents and shor ...