Structure Therapeutics(GPCR) - 2025 Q2 - Quarterly Results

Executive Summary & Business Update Q2 2025 Overview and Key Highlights 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][2] - Aleniglipron clinical development program expanded to optimize competitive positioning and Phase 3 program design[1][2] - Oral small molecule amylin receptor agonist (ACCG-2671) Phase 1 initiation anticipated by year-end 2025[1][2] 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][13] Recent and Upcoming Milestones Aleniglipron (GSBR-1290) Development 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 - The fully enrolled ACCESS and ACCESS II studies are on track for topline 36-week data readouts by year-end 2025[3] - ACCESS study enrolled approximately 220 adults, evaluating doses up to 120 mg with a slower four-week titration schedule[6] - ACCESS II study enrolled approximately 80 adults, evaluating higher doses (180 mg and 240 mg) with a slower four-week titration schedule[6] Expanded Data Collection from ACCESS and ACCESS II Studies - ACCESS Open Label Extension (OLE) allows patients to roll over for longer-term weight loss effects and expanded safety data[4] - 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] Additional Aleniglipron Studies - Three new aleniglipron clinical studies are being conducted to generate additional data for competitive positioning and Phase 3 program design[5] - 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] - 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] - 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] Other Pipeline Programs 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) - IND-enabling activities for ACCG-2671 are ongoing, with a first-in-human Phase 1 clinical study planned by year-end 2025[12] - 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] - Combination therapy of ACCG-2671 with semaglutide resulted in superior weight loss compared to monotherapy of either compound[12] Oral Small Molecule Metabolic Pipeline and Potential Combinations - Structure Therapeutics is developing GIPR selective agonists and antagonists, and GLP-1R/GIPR combinations to treat obesity and related diseases[12] - The company is also developing GCGR selective agonists and GLP-1R/GCGR combinations for obesity and related diseases[12] - 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] Oral Small Molecule LPA1R Program (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] - 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] Financial Performance Q2 2025 Financial Highlights 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] 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] 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] 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] Condensed Consolidated Statements of Operations 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 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 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] - Focuses on discovering and developing innovative oral small molecule treatments for chronic metabolic and cardiopulmonary conditions with significant unmet medical needs[17] - Utilizes a next-generation structure-based drug discovery platform to establish a robust GPCR-targeted pipeline[17] - Aims to surpass scalability limitations of traditional biologic and peptide therapies and make treatments accessible to more patients globally[17] Forward-Looking Statements Disclaimer and Risk Factors 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] - Statements concern future plans, prospects, expected timing of data readouts, study initiations, cash runway, and potential benefits/efficacy of therapeutic candidates[18] - 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] - 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] Contact Information Investor and Media Relations This section provides contact details for investor and media inquiries related to Structure Therapeutics - Investors can contact Danielle Keatley at ir@structuretx.com[23] - Media inquiries can be directed to Dan Budwick of 1AB at Dan@1abmedia.com[23]