Revolution Medicines, Inc. Q1 FY2025 earnings call

• Mark Goldsmith highlighted progress on strategic priorities, including executing daraxonrasib registrational studies in pancreatic and non-small cell lung cancers. RASolute 302 in pancreatic cancer is enrolling globally with expected data readout in 2026. • Steve Kelsey outlined the strategic framework for non-small cell lung cancer, noting segmentation of RAS mutant non-small cell lung cancer into G12C and non-G12C groups, and discussed development strategies for single agent and combination therapies. • Wei Lin provided updates on clinical programs, including monotherapy data for daraxonrasib, elironrasib, and zoldonrasib in non-small cell lung cancer, and highlighted combination clinical development efforts for first-line metastatic non-small cell lung cancer. • Jack Anders shared first quarter financial results, noting R&D and G&A expenses increased, with net loss at $213.4M, and reiterated 2025 financial guidance with net loss expected between $840M and $900M.

No detailed segment performance data on product segments in terms of absolute revenue and contribution % provided in the transcript.

• Reiterated 2025 financial guidance with projected full year 2025 GAAP net loss between $840 million and $900 million. • Confident in substantially completing enrollment in RASolute 302 in 2025 for expected data readout in 2026. • Planning to initiate registrational trials for daraxonrasib in first-line and adjuvant pancreatic cancer in the second half of 2025. • Activating study sites for RASolute 301, a Phase 3 trial in previously treated RAS mutant non-small cell lung cancer.

• Forward-looking statements are subject to many risks and uncertainties, with actual results possibly differing materially from forward-looking statements.需参考 annual report on Form 10-K and quarterly reports on Form 10-Q for full discussion of risks.

Q: Michael Schmidt asked about confidence and tolerability of the triplet combination in first-line non-small cell lung cancer.

A: Wei Lin responded that they are optimistic given the profile seen so far, with ongoing dose optimization and no new safety signaling emerging.

Q: Marc Frahm inquired about average follow-up in cohorts and what's needed for Phase 3 intent.

A: Steve Kelsey commented that for non-G12C program, it's more operational execution; for G12C program, dose optimization is needed, with response rate a reasonable correlate of PFS in lung cancer.

Q: Eric Joseph asked about datasets granting confidence in response rate predicting PFS and enrollment in frontline cohorts.

A: Mark Goldsmith and Wei Lin noted references in literature and ongoing dose optimization with enrollment continuing.

Q: Jonathan Chang asked about duration of clinical benefit of daraxonrasib vs mutant-selective inhibitors.

A: Mark Goldsmith and Steve Kelsey discussed that no direct head-to-head comparison exists, but combination of agents is expected to provide longer PFS due to different escape mechanisms.

Q: Kelly Shi asked about resource allocation and cadence of initiating pivotal combination trials.

A: Mark Goldsmith stated resource allocation considers clinical data, biological rationale, competitive landscape, with plans to begin rolling out combination trials in 2026.

Q: Ellie Merle asked about ex-U.S. commercial strategy and pivotal combination trial designs.

A: Mark Goldsmith mentioned ongoing consideration of ex-U.S. strategy with interest from global pharma, and no specific timeline provided for FDA discussions on trial designs.