Revolution Medicines, a clinical-stage oncology company specializing in therapies for RAS-addicted cancers, released its financial results for the quarter ending June 30, 2024. The company also shared updates on its ongoing projects and corporate developments.
Progress in 2024 Development Priorities
Advancement of RMC-6236: Revolution Medicines is progressing its RAS(ON) multi-selective inhibitor, RMC-6236, into pivotal monotherapy trials. For pancreatic ductal adenocarcinoma (PDAC), recent data highlight the clinical safety and antitumor efficacy of RMC-6236. Preliminary results show encouraging progression-free survival (PFS) and overall survival (OS) rates, setting the stage for a Phase 3 randomized, controlled study for metastatic PDAC this year. In non-small cell lung cancer (NSCLC), the company is on track to start pivotal trials for previously-treated RAS-mutated NSCLC patients later this year.
Expanding RMC-6236: Based on promising preliminary data in second-line PDAC, Revolution Medicines plans to explore RMC-6236 in earlier treatment stages for pancreatic cancer. The company is also evaluating RMC-6236 in combination with chemotherapy for PDAC.
Qualification of RMC-6291 and RMC-9805: The RAS(ON) mutant-selective inhibitors, RMC-6291 (G12C-selective) and RMC-9805 (G12D-selective), are being positioned for late-stage development. RMC-6291 is under evaluation in combination with RMC-6236 and pembrolizumab for NSCLC. In parallel, RMC-9805 is being tested as a monotherapy for solid tumors with KRAS G12D mutations.
Corporate Enhancements
New Board Appointment: Frank Clyburn, former executive vice president and president of human health at Merck, has joined the board of directors. Clyburn's experience in leading Merck's global Keytruda® franchise is expected to be invaluable as Revolution Medicines advances its RAS(ON) inhibitor programs.
Executive Team Expansion: The company has bolstered its leadership team with key hires, including Mary Pinder-Schenck, M.D., as senior vice president and head of medical affairs; Ryan Asay as senior vice president of corporate affairs; Mason Shih, M.D., as senior vice president and head of drug safety; and Jing Yi, Ph.D., as senior vice president and head of program leadership.
Clinical Development Highlights
RMC-6236 Monotherapy Trials: Updated data on the safety, tolerability, and antitumor activity of RMC-6236 in metastatic PDAC patients were reported. Out of 127 patients evaluated, 22% experienced Grade 3 or higher treatment-related adverse events (TRAEs), predominantly rash and gastrointestinal issues. No patients discontinued due to TRAEs. Preliminary PFS for KRAS G12X mutation patients was 8.1 months, and OS data were not estimable for both KRAS G12X and RAS mutation groups. A Phase 3 trial named RASolute 302 for second-line PDAC treatment is set to begin this year.
Lung Cancer Developments: The company plans to release updated NSCLC data in the fourth quarter of 2024 and initiate a registrational study for RMC-6236 in advanced NSCLC patients within the same time frame.
Early-Line Therapy Evaluations: RMC-6236 is under examination in combination with standard chemotherapy for first-line PDAC and with pembrolizumab, with or without chemotherapy, for advanced RAS-mutated NSCLC. Initial data on these combinations are expected in late 2024.
Combination Therapy Evaluations: RMC-6291 in combination with both RMC-6236 and pembrolizumab is being evaluated. Initial data for the RMC-6291 and RMC-6236 combination are anticipated in late 2024, with pembrolizumab combination data expected in the first half of 2025.
New Drug Developments: Beyond the first wave of RAS(ON) inhibitors, Revolution Medicines is developing additional RAS(ON) mutant-selective inhibitors, including RMC-5127, RMC-0708, and RMC-8839, as well as RAS companion inhibitors RMC-4630 and RMC-5552.
Financial Performance
Cash Reserves: As of June 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $1.59 billion.
Revenue and Expenses: The company reported no revenue for the quarter, a decrease from $3.8 million in the same period last year due to the termination of a collaboration with Sanofi. Research and development expenses rose to $134.9 million, driven by increased clinical trial activity and personnel-related costs. General and administrative expenses increased to $21.7 million, reflecting additional headcount and commercial preparation activities. The net loss for the quarter was $133.2 million.
Future Financial Guidance: Revolution Medicines projects a full-year 2024 net loss between $560 million and $600 million. Current cash reserves are expected to fund operations into 2027.
Overall, Revolution Medicines remains focused on advancing its clinical programs and expanding its therapeutic potential to address significant unmet needs in oncology.
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