Revolution Medicines(RVMD) - 2025 Q2 - Quarterly Results

Executive Summary Revolution Medicines reported strong Q2 2025 results, advancing pivotal trials, securing BTDs, and obtaining $2 billion in funding. Recent Achievements and Strategic Priorities Revolution Medicines reported strong Q2 2025 results, highlighting pivotal trial execution for daraxonrasib, FDA Breakthrough Therapy Designations, and a $2 billion funding agreement. - Strong execution of two ongoing Phase 3 trials of daraxonrasib; RASolute 302 enrollment winding down in U.S., expected to complete this year[4] - FDA Breakthrough Therapy Designations granted for daraxonrasib and elironrasib, two RAS(ON) inhibitors[4] - Company entered into a $2 billion flexible funding agreement with Royalty Pharma to support global development and commercialization[4] - Daraxonrasib received Breakthrough Therapy Designation from the U.S. FDA for previously treated metastatic PDAC in patients with KRAS G12 mutations[3] Corporate Progress and Pipeline Update Revolution Medicines is advancing its clinical pipeline, including daraxonrasib, mutant-selective inhibitors, and earlier-stage programs. Daraxonrasib Clinical Development Revolution Medicines is advancing daraxonrasib through late-stage clinical development, with ongoing Phase 3 and planned earlier line registrational trials. Pivotal Trials (RASolute 302, RASolve 301) Revolution Medicines is actively enrolling patients in global Phase 3 trials for daraxonrasib in PDAC and NSCLC. - RASolute 302, a global Phase 3 trial for daraxonrasib in previously treated PDAC, continues strong enrollment, with completion expected this year for a 2026 data readout[2] - RASolve 301, a global Phase 3 trial for daraxonrasib in previously treated NSCLC, continues U.S. enrollment and is activating sites in Europe and Japan[5] Earlier Line Registrational Trials The company plans to initiate registrational trials for daraxonrasib in first-line metastatic PDAC, adjuvant PDAC, and first-line RAS mutant NSCLC. - The company is on track to initiate a registrational trial this year for daraxonrasib as first-line treatment for metastatic PDAC, planned as a three-arm trial[6] - The company is also on track to initiate a registrational trial this year for daraxonrasib as adjuvant treatment for resectable PDAC[7] - Based on new clinical data, a Phase 3 registrational trial for daraxonrasib combined with pembrolizumab in first-line RAS mutant NSCLC is expected in 2026[8] Mutant-Selective Inhibitors (Elironrasib, Zoldonrasib) Revolution Medicines advances mutant-selective inhibitors elironrasib (BTD) and zoldonrasib, with pivotal combination trials anticipated in 2026. - Elironrasib monotherapy in previously treated KRAS G12C NSCLC demonstrated a highly competitive profile with differentiated safety and compelling efficacy[10] - Elironrasib received FDA Breakthrough Therapy Designation for KRAS G12C-mutated locally advanced or metastatic NSCLC in previously treated patients[11] - Zoldonrasib clinical data showed acceptable tolerability and encouraging antitumor activity in previously treated KRAS G12D NSCLC and PDAC[12] - The company expects to initiate one or more pivotal combination trials in 2026 incorporating zoldonrasib or elironrasib[12] Earlier Stage Pipeline and Discovery The company's earlier stage pipeline includes RMC-5127 (Phase 1 in 2026) and AI-driven discovery collaborations. - Clinical development of RMC-5127, a RAS(ON) G12V-selective inhibitor, is on track for Phase 1 initiation in 2026[13] - The company invests in discovery collaborations, including with Iambic Therapeutics, leveraging AI for lead discovery and optimization[14] Commercialization and Funding Revolution Medicines is expanding global commercialization and operational capabilities, supported by a $2 billion flexible funding agreement with Royalty Pharma. - A partnership with Royalty Pharma provides $2 billion in committed capital upon milestone achievement through flexible synthetic royalty and debt instruments[15] - The company continues to grow commercial and operational capabilities in support of a potential launch[16] Strategic Collaborations Revolution Medicines entered a clinical collaboration with Summit Therapeutics to evaluate RAS(ON) inhibitors combined with ivonescimab (PD-1 / VEGF bispecific antibody) in solid tumors. - The company entered a clinical collaboration with Summit Therapeutics to evaluate RAS(ON) inhibitors combined with ivonescimab (PD-1 / VEGF bispecific antibody) in solid tumors[18] Financial Results and Outlook Revolution Medicines reported Q2 2025 financial results, showing increased expenses and net loss, and provided full-year 2025 GAAP net loss guidance. Second Quarter 2025 Financial Highlights For Q2 2025, Revolution Medicines reported $2.1 billion in cash, increased R&D and G&A expenses, and a net loss of $247.8 million. | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :-------------------------------- | :--------------------- | :--------------------- | :----------- | | Cash, cash equivalents and marketable securities (as of June 30) | $2,137,171 | N/A | N/A | | R&D Expenses | $224,134 | $134,932 | +66.1% | | G&A Expenses | $40,580 | $21,711 | +86.9% | | Net Loss | $(247,787) | $(133,233) | +86.0% | | Net Loss per Share (basic & diluted) | $(1.31) | $(0.81) | +61.7% | | Weighted-average common shares | 188,583,288 | 165,141,936 | +14.2% | - Cash, cash equivalents, and marketable securities totaled $2.1 billion as of June 30, 2025, including $250 million from Royalty Pharma[19] - R&D expenses increased primarily due to higher clinical trial and manufacturing expenses for daraxonrasib, zoldonrasib, and elironrasib, plus personnel costs[20] - G&A expenses increased mainly due to higher personnel-related expenses, stock-based compensation, and commercial preparation activities[21] Financial Guidance Revolution Medicines projects full-year 2025 GAAP net loss guidance of $1.03 billion to $1.09 billion, including estimated non-cash stock-based compensation. - Revolution Medicines projects full-year 2025 GAAP net loss guidance between $1.03 billion and $1.09 billion[23] - The guidance includes estimated non-cash stock-based compensation expense of $115 million to $130 million[23] Company Overview Revolution Medicines is a late-stage clinical oncology company developing targeted therapies for RAS-addicted cancers. About Revolution Medicines Revolution Medicines is a late-stage clinical oncology company developing targeted therapies for RAS-addicted cancers, with a pipeline of RAS(ON) inhibitors. - Revolution Medicines is a late-stage clinical oncology company developing targeted therapies for RAS-addicted cancers[24] - The company's R&D pipeline includes RAS(ON) inhibitors designed to suppress diverse oncogenic RAS variants[24] - Key clinical-stage RAS(ON) inhibitors include daraxonrasib, elironrasib (G12C-selective), and zoldonrasib (G12D-selective)[24] - RMC-5127, a RAS(ON) G12V-selective inhibitor, is anticipated to be the next to enter clinical development[24] Additional Information This section provides important disclaimers regarding forward-looking statements and contact information. Forward-Looking Statements This section contains forward-looking statements regarding financial projections, development plans, and clinical timelines, subject to inherent risks and uncertainties. - This press release contains forward-looking statements regarding financial projections, development plans, clinical timelines, and capital sources[25][26] - Forward-looking statements are subject to substantial risks and uncertainties inherent in drug development, regulatory approval, intellectual property, and competitive changes[27] Contact Information Provides contact details for media and investor inquiries. - Media Contact: media@revmed.com[28] - Investor Contact: investors@revmed.com[28] Financial Statements This section presents the unaudited condensed consolidated statements of operations and balance sheets. Condensed Consolidated Statements of Operations Presents unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2025 and 2024, detailing operating expenses and net loss. | Operating Expenses (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $224,134 | $134,932 | $429,883 | $252,953 | | General and administrative | $40,580 | $21,711 | $75,591 | $44,549 | | Total operating expenses | $264,714 | $156,643 | $505,474 | $297,502 | | Loss from operations | $(264,714) | $(156,643) | $(505,474) | $(297,502) | | Net loss | $(247,787) | $(133,233) | $(461,203) | $(249,236) | | Net loss per share, basic and diluted | $(1.31) | $(0.81) | $(2.45) | $(1.51) | Selected Condensed Consolidated Balance Sheets Provides selected unaudited condensed consolidated balance sheet data as of June 30, 2025, and December 31, 2024, including cash, working capital, and total assets. | Balance Sheet Item (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Cash, cash equivalents and marketable securities | $2,137,171 | $2,289,299 | | Working capital (1) | $1,991,905 | $2,163,718 | | Total assets | $2,429,568 | $2,558,301 | | Total liabilities | $564,199 | $293,097 | | Total stockholders' equity | $1,865,369 | $2,265,204 |