Structure Therapeutics(GPCR) - 2024 Q4 - Annual Results

Overview and Business Update Structure Therapeutics made significant advancements in its oral small molecule obesity portfolio in 2024, strengthening its financial position and preparing for key clinical data readouts in 2025 Executive Summary Structure Therapeutics advanced its oral obesity portfolio in 2024, securing $547 million financing and preparing for key aleniglipron data in 2025 - Completed a $547 million financing in 2024, significantly strengthening the company's financial position[2] - The company is positioned as a leader with aleniglipron (GSBR-1290), the second most advanced oral GLP-1 small molecule, with 36-week data expected by year-end 2025[2] - The pipeline was expanded with the selection of an oral small molecule amylin receptor agonist, ACCG-2671, with Phase 1 development expected to begin by year-end 2025[1][2] Pipeline Development and Milestones The company advances its oral small molecule obesity pipeline, including aleniglipron, ACCG-2671, and other programs for combination therapies Aleniglipron (GSBR-1290) – Oral Small Molecule Selective GLP-1R Agonist Aleniglipron's ACCESS and ACCESS II studies completed enrollment, with 36-week data for doses up to 240 mg anticipated by year-end 2025 - The ACCESS and ACCESS II studies have completed enrollment on schedule, with a total of over 300 patients[8] - The studies are designed to evaluate doses up to 120 mg (ACCESS) and higher doses of 180 mg and 240 mg (ACCESS II)[8] - Topline 36-week data from both studies are expected by year-end 2025[1][8] ACCG-2671 – Oral Small Molecule Amylin Receptor Agonist ACCG-2671, the first oral amylin receptor agonist, began IND-enabling activities in December 2024, with Phase 1 trials planned by year-end 2025 - Selected as the first development candidate in December 2024, with IND-enabling activities commenced[8] - The preclinical profile supports once-daily oral dosing in humans[8] - The company plans to initiate a Phase 1 clinical study by year-end 2025[1][8] Other Oral Small Molecule Obesity Pipeline Programs The company develops other oral small molecule obesity programs, including GIPR and GCGR agonists for combination therapies, and a Phase 2 ready APJR agonist - GIPR Program: Developing a GIPR selective agonist and antagonist for combination therapies to treat obesity[8] - GCGR Program: Developing a GCGR selective agonist for combination therapies with GLP-1R[8] - APJR Program (ANPA-0073): A Phase 2 ready biased APJR agonist being evaluated for muscle-sparing weight loss, with long-term toxicology studies expected to be completed in 2025[8] Financial Performance The company significantly strengthened its financial position in 2024 with a substantial cash balance, despite increased operating expenses and a wider net loss Fourth Quarter and Full Year 2024 Financial Highlights The company ended 2024 with a strong $883.5 million cash position, extending its runway through 2027, despite increased R&D and G&A expenses and a wider net loss - Ended 2024 with $883.5 million in cash, cash equivalents, and short-term investments, providing a cash runway through at least 2027 for operations and key clinical milestones (excluding Phase 3 studies)[1][6] Operating Expenses and Net Loss | Expense/Loss (in millions) | Full Year 2024 | Full Year 2023 | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $108.8 | $70.1 | +55.2% | | G&A Expenses | $49.4 | $32.7 | +51.1% | | Net Loss | $122.5 | $89.6 | +36.7% | Condensed Consolidated Statements of Operations Operating expenses significantly increased in 2024, with R&D up 55% and G&A up 51%, resulting in a net loss of $122.5 million for the year Condensed Consolidated Statements of Operations (in thousands) | Metric (in thousands) | Q4 2024 | Q4 2023 | FY 2024 | FY 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $33,487 | $20,042 | $108,814 | $70,103 | | General and administrative | $13,574 | $10,952 | $49,414 | $32,672 | | Total operating expenses | $47,061 | $30,994 | $158,228 | $102,775 | | Loss from operations | $(47,061) | $(30,994) | $(158,228) | $(102,775) | | Interest and other income, net | $10,718 | $6,179 | $36,012 | $13,391 | | Net loss | $(36,479) | $(24,503) | $(122,526) | $(89,620) | Condensed Consolidated Balance Sheet Data The balance sheet strengthened significantly by December 31, 2024, with cash and equivalents increasing to $883.5 million, nearly doubling total assets to $903.3 million Condensed Consolidated Balance Sheet Data (in thousands) | Metric (in thousands) | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents and short-term investments | $883,518 | $467,323 | | Total assets | $903,330 | $482,017 | | Total liabilities | $38,487 | $29,051 | | Total shareholders' equity | $864,843 | $452,966 |