Revolution Medicines(RVMD) - 2025 Q1 - Quarterly Results

Corporate Progress and Highlights 2025 Strategic Priorities & Execution Revolution Medicines progresses pivotal daraxonrasib trials, plans new studies, and builds commercial capabilities - The company is executing two ongoing Phase 3 trials of daraxonrasib: RASolute 302 trial in pancreatic cancer expected to be substantially completed in 2025 with a data readout anticipated in 2026, and RASolve 301 trial for NSCLC currently activating study sites[2][3][4] - Planning continues for new registrational trials for daraxonrasib in first-line metastatic PDAC and as an adjuvant treatment, both expected to begin in the second half of 2025[5] - The company plans to initiate one or more pivotal combination trials in 2026 featuring either the G12D-selective inhibitor zoldonrasib or the G12C-selective inhibitor elironrasib[6] - The pipeline is advancing with RMC-5127, a RAS(ON) G12V-selective inhibitor, on track to be clinic-ready later in 2025, enabling a potential Phase 1 start in 2026[9] - To support a potential launch, the company is building its commercial capabilities and has appointed Anthony Mancini as Chief Global Commercialization Officer[10][11] Clinical Data Highlights Zoldonrasib Monotherapy in G12D NSCLC Zoldonrasib monotherapy in G12D NSCLC showed encouraging antitumor activity with a 61% ORR and favorable safety Zoldonrasib Monotherapy Efficacy in G12D NSCLC | Metric | Result (%) | | :--- | :--- | | Objective Response Rate (ORR) | 61% | | Disease Control Rate (DCR) | 89% | - The safety profile was favorable, with treatment-related adverse events (TRAEs) being predominantly low-grade, and Grade 3 TRAEs reported in only 2% of patients, with no Grade 4 or 5 events[15] Elironrasib Monotherapy in G12C NSCLC Elironrasib monotherapy in G12C NSCLC demonstrated promising efficacy with a 56% ORR and 9.9 months PFS Elironrasib Monotherapy Efficacy in G12C NSCLC | Metric | Result | | :--- | :--- | | Objective Response Rate (ORR) | 56% | | Disease Control Rate (DCR) | 94% | | Median Progression-Free Survival (PFS) | 9.9 months (estimated) | - The treatment was generally well-tolerated, with predominantly low-grade TRAEs, and Grade 3 TRAEs reported in 19% of patients, with no Grade 4 or 5 events[18] Combination Therapies in NSCLC Combination therapies in RAS mutant NSCLC show encouraging antitumor activity and acceptable tolerability Daraxonrasib with Pembrolizumab (+/- Chemotherapy) Daraxonrasib with pembrolizumab (+/- chemo) showed encouraging 1L NSCLC activity and no new safety signals Daraxonrasib with Pembrolizumab (+/- Chemo) Efficacy in 1L NSCLC | Patient Group (1L NSCLC) | Treatment | ORR (%) | DCR (%) | | :--- | :--- | :--- | :--- | | TPS ≥ 50% | Daraxonrasib + Pembrolizumab | 86% | 100% | | TPS < 50% | Daraxonrasib + Pembrolizumab + Chemo | 60% | 90% | - The combination showed an acceptable safety profile, with no new safety signals, no evidence of significant hepatotoxicity (no Grade 3+ AST/ALT elevations), or increased immune-related adverse events like colitis or pneumonitis[22][23] Elironrasib with Pembrolizumab Elironrasib with pembrolizumab achieved 100% ORR in 1L KRAS G12C NSCLC (TPS ≥50%) with acceptable tolerability - Among five efficacy-evaluable patients with 1L NSCLC and TPS ≥50%, the ORR and DCR were both 100%[28] - The combination showed acceptable tolerability, with Grade 3 or higher TRAEs reported in 25% of patients and no new safety signals observed[27] RAS(ON) Inhibitor Doublet (Elironrasib + Daraxonrasib) RAS(ON) inhibitor doublet showed encouraging activity in NSCLC with 62% ORR, supporting a triplet regimen RAS(ON) Inhibitor Doublet Efficacy in NSCLC | Metric | Result (%) | | :--- | :--- | | Objective Response Rate (ORR) | 62% | | Disease Control Rate (DCR) | 92% | - The combination was acceptably tolerated, with 46% Grade 3 TRAEs and no Grade 4 or 5 events, and hepatotoxicity was not observed as a safety signal[30] - These preliminary results support the company's goal of developing a chemotherapy-sparing triplet combination including elironrasib, daraxonrasib, and pembrolizumab for first-line metastatic RAS G12C NSCLC[31] Financial Performance First Quarter 2025 Financial Results Q1 2025 net loss increased due to higher R&D expenses, maintaining a strong cash position First Quarter 2025 Financial Summary | Financial Metric (in millions USD) | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | R&D Expenses | $205.7 | $118.0 | | G&A Expenses | $35.0 | $22.8 | | Net Loss | $213.4 | $116.0 | - The company's cash, cash equivalents, and marketable securities totaled $2.1 billion as of March 31, 2025[32] - The increase in R&D expenses was mainly due to higher clinical trial and manufacturing costs for daraxonrasib, zoldonrasib, and elironrasib, as well as increased personnel-related expenses, while G&A expenses rose due to headcount growth and commercial preparation activities[33][34] 2025 Financial Guidance Revolution Medicines reiterates 2025 GAAP net loss guidance, with cash funding operations into the second half of 2027 - The company reiterated its full-year 2025 GAAP net loss guidance of $840 million to $900 million, which includes an estimated $115 million to $130 million in non-cash stock-based compensation expense[36] - Based on the current operating plan, the company projects its cash, cash equivalents, and marketable securities can fund operations into the second half of 2027[36] Appendix: Financial Statements Condensed Consolidated Statements of Operations This section details the unaudited income statement for Q1 2025, showing a net loss of $213.4 million Condensed Consolidated Statements of Operations | (in thousands USD, except per share data) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Operating expenses: | | | | Research and development | 205,749 | 118,021 | | General and administrative | 35,011 | 22,838 | | Total operating expenses | 240,760 | 140,859 | | Loss from operations | (240,760) | (140,859) | | Interest income | 24,915 | 23,760 | | Other income (expense), net | 2,429 | 1,096 | | Net loss | $ (213,416) | $ (116,003) | | Net loss per share - basic and diluted | $ (1.13) | $ (0.70) | Selected Condensed Consolidated Balance Sheets This section presents the condensed balance sheet as of March 31, 2025, highlighting cash and equivalents Selected Condensed Consolidated Balance Sheets | (in thousands USD) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $ 2,102,675 | $ 2,289,299 | | Working capital | 1,975,983 | 2,163,718 | | Total assets | 2,365,353 | 2,558,301 | | Total liabilities | 287,203 | 293,097 | | Total stockholders' equity | 2,078,150 | 2,265,204 |