On November 6, 2024 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers, reported its financial results for the quarter ended September 30, 2024, and provided an update on corporate progress (Press release, Revolution Medicines, NOV 6, 2024, View Source [SID1234647829]).
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The company is committed to revolutionizing treatment for patients with RAS-addicted cancers through the discovery, development and delivery of innovative, targeted medicines across lines of therapy and tumor types.
"We’ve made enormous progress on behalf of patients against this year’s strategic priorities, having now demonstrated encouraging clinical results for our three pioneering clinical-stage RAS(ON) inhibitors. Recently updated data for RMC-6236 continued to elaborate its compelling clinical profile, including highly encouraging progression-free survival and overall survival in patients with previously treated pancreatic cancer, and a Phase 3 pivotal study is now underway. A first report on RMC-9805 showcased its encouraging initial clinical profile in patients with KRAS G12D pancreatic cancer, marking the first oral, covalent, mutant-selective investigational drug to show initial promise in patients with tumors harboring this common mutation," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "We believe these are major milestones on our path toward serving patients with RAS-addicted cancers, and we expect to provide additional updates before year-end that should help set the stage for continued pipeline progress in our multilayered approach in 2025."
Recent Clinical Highlights & Upcoming Milestones
Pancreatic Cancer
The company currently has two RAS(ON) inhibitors being developed for patients with advanced or metastatic PDAC, RMC-6236, a RAS(ON) multi-selective inhibitor, and RMC-9805, a RAS(ON) G12D-selective inhibitor. The company is currently evaluating both compounds as monotherapy and in combination regimens.
RMC-6236 Clinical Updates
On October 21, 2024, the company reported that the first patient was dosed in RASolute 302, a Phase 3 registrational study evaluating RMC-6236 compared with standard-of-care chemotherapy in patients with previously treated metastatic PDAC. Timing of RASolute 302 data readout will be event-driven after the study is fully enrolled.
On October 23, 2024, the company reported updated clinical safety/tolerability and efficacy data from its ongoing RMC-6236 monotherapy study at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (Triple meeting) in Barcelona. As of the July 23, 2024 data cutoff date, RMC-6236 demonstrated compelling antitumor activity, including encouraging progression-free survival (median 8.5 months) and overall survival (median 14.5 months) among second-line PDAC patients with tumors harboring a KRAS G12X mutation who received doses from 160 mg to 300 mg daily. The safety/tolerability findings were generally consistent with previously reported data, and no new safety signals were observed.
RMC-9805 Clinical Updates
On October 25, 2024, the company reported initial safety/tolerability and antitumor activity data from the RMC-9805 monotherapy dose-escalation study in patients with KRAS G12D tumors at the Triple meeting. As of the September 2, 2024 data cutoff date, RMC-9805 demonstrated an encouraging safety and tolerability profile among patients treated at all dose levels and across tumor types and showed encouraging initial antitumor activity in patients with PDAC treated at multiple dose levels and particularly among those who received 1200 mg once daily or 600 mg twice daily; 1200 mg once daily is a candidate recommended Phase 2 dose and schedule.
Evaluation of RMC-9805 in combination with RMC-6236 in a Phase 1 study is ongoing in patients with KRAS G12D solid tumors.
Beyond Pancreatic Cancer:
The company is currently evaluating its clinical-stage RAS(ON) inhibitors as monotherapy and/or combinations in patients with additional solid tumors carrying RAS mutations.
Upcoming Milestones
The company plans to provide updated data from its ongoing study of RMC-6236 monotherapy in patients with NSCLC in the fourth quarter of 2024. The company currently expects to reach regulatory alignment and initiate a Phase 3 registrational study evaluating RMC-6236 as monotherapy in patients with previously treated, advanced RAS-mutant NSCLC in the first quarter of 2025.
The company also plans to share initial clinical pharmacokinetics (PK), safety/tolerability and antitumor activity data from a combination study evaluating RMC-6236 with pembrolizumab in the fourth quarter of 2024.
Evaluation of the company’s RAS(ON) doublet combination of RMC-6291 with RMC-6236 is ongoing, and the company currently expects to disclose initial clinical PK, safety/tolerability and antitumor activity data from this combination study in the fourth quarter of 2024.
The company is evaluating the combination of RMC-6291 with pembrolizumab, with or without chemotherapy, in patients with advanced NSCLC, and currently expects to disclose initial clinical PK, safety/tolerability and antitumor activity data from this combination study in the first half of 2025.
Financial Highlights
Third Quarter Results
Cash Position: Cash, cash equivalents and marketable securities were $1.55 billion as of September 30, 2024.
R&D Expenses: Research and development expenses were $151.8 million for the quarter ended September 30, 2024, compared to $107.7 million for the quarter ended September 30, 2023. The increase in expense was primarily due to increases in clinical trial expenses for RMC-6236, RMC-6291 and RMC-9805, personnel-related expenses related to additional headcount and stock-based compensation expense.
G&A Expenses: General and administrative expenses were $24.0 million for the quarter ended September 30, 2024, compared to $15.5 million for the quarter ended September 30, 2023. The increase was primarily due to increases in personnel-related expenses associated with additional headcount, commercial preparation activities and stock-based compensation expense.
Net Loss: Net loss was $156.3 million for the quarter ended September 30, 2024, compared to net loss of $108.4 million for the quarter ended September 30, 2023.
Financial Guidance
Revolution Medicines is reiterating projected full year 2024 GAAP net loss guidance of between $560 million and $600 million, which includes estimated non-cash stock-based compensation expense of between $70 million and $80 million. Based on the company’s current operating plan, the company projects current cash, cash equivalents and marketable securities can fund planned operations into 2027.
Webcast
Revolution Medicines will host a webcast this afternoon, November 6, 2024, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.