01—Abstract
Summary
Summary of the 8-K filed August 5, 2026. Cited figures are marked; the original filing is the authoritative source.
Revolution Medicines, Inc. (Nasdaq: RVMD) reported financial results for the quarter ended June 30, 2026 in a press release furnished as Exhibit 99.1 to this Form 8-K, dated August 5, 2026.
The company highlighted that the U.S. FDA accepted its New Drug Application for daraxonrasib for previously treated metastatic pancreatic cancer following Phase 3 RASolute 302 results, that it opened an FDA-cleared Expanded Access Program in May 2026 with distribution to physicians on behalf of more than 2,000 patients, and that it achieved U.S. commercial launch readiness and began submissions to the European Medicines Agency under a phased review process. Financially, net loss was $644.4 milliona for the quarter, compared with $247.8 million a year earlier, including a non-cash $151.0 million charge tied to a change in the fair value of warrants assumed in the acquisition of EQRx, Inc. Research and development expenses rose to $394.9 million from $224.1 million, and general and administrative expenses rose to $110.2 million from $40.6 million. Cash, cash equivalents and marketable securities were $3.9 billion at June 30, 2026, reflecting April 2026 offerings with total gross proceeds of $2,225.0 million and a $250.0 million Royalty Pharma payment received in May 2026.
Up to an additional $1.5 billionb in committed capital remains under the Royalty Pharma arrangements, subject to milestones. The company updated its full-year 2026 GAAP operating expense guidance to $2.1 to $2.2 billion.
On clinical programs, the company reported initial first-line NSCLC data for zoldonrasib and elironrasib in combination with standard of care, and noted FDA Breakthrough Therapy Designation for daraxonrasib in previously treated non-G12C KRAS-mutant NSCLC. The company expects enrollment completion in the Phase 3 RASolve 301 trial this year, with an initial readout anticipated in 2027.
02—Key points
Key Highlights
- FDA accepted the New Drug Application for daraxonrasib for previously treated metastatic pancreatic cancer following Phase 3 RASolute 302 results.
- Expanded Access Program opened in May 2026; daraxonrasib has been distributed on behalf of more than 2,000 patients across nearly all 50 U.S. states and Puerto Rico.
- Net loss of $644.4 million for Q2 2026, versus $247.8 million in Q2 2025, including a non-cash $151.0 million warrant fair value charge related to the EQRx acquisition.
- R&D expenses of $394.9 million and G&A expenses of $110.2 million for the quarter, up from $224.1 million and $40.6 million a year earlier.
- Cash, cash equivalents and marketable securities of $3.9 billion at June 30, 2026, including April 2026 offering gross proceeds of $2,225.0 million and a $250.0 million Royalty Pharma payment in May 2026.
- Up to an additional $1.5 billion in committed capital available under Royalty Pharma funding arrangements, subject to milestones.
- Full-year 2026 GAAP operating expense guidance updated to $2.1 to $2.2 billion, including estimated non-cash stock-based compensation of $270 to $290 million.
03—Questions
Frequently Asked Questions
What regulatory milestones did the company report for daraxonrasib?
The FDA accepted the NDA for daraxonrasib for previously treated metastatic pancreatic cancer, and the company achieved U.S. commercial launch readiness. The EMA initiated a phased review under its Cancer Medicines Pathfinder project, and Swissmedic granted Orphan Drug Status for pancreatic cancer. Daraxonrasib was also selected for the FDA Commissioner's National Priority Voucher pilot program.
Why was the net loss so much larger than in the prior-year quarter?
The filing attributes higher R&D spending to clinical trial and manufacturing costs for daraxonrasib and zoldonrasib, along with personnel costs and stock-based compensation. G&A rose on stock-based compensation, headcount, and commercial preparation. Net loss also included a non-cash $151.0 million charge from a change in the fair value of warrants assumed in the EQRx acquisition, and interest expense rose to $23.8 million from $0.9 million.
How is the company funding its operations?
Cash, cash equivalents and marketable securities were $3.9 billion at June 30, 2026. This includes gross proceeds of $2,225.0 million from April 2026 concurrent offerings of common stock and 0.50% convertible senior notes due 2033, and a $250.0 million Royalty Pharma payment received in May 2026. Up to an additional $1.5 billion remains available under the Royalty Pharma arrangements, subject to milestones.
What are the next expected clinical catalysts?
The company expects to initiate the Phase 3 RASolve 307 trial of elironrasib in first-line RAS G12C NSCLC in the fourth quarter of 2026, and to provide updated colorectal cancer data in the fourth quarter of 2026. It expects to identify a recommended Phase 2 dose for RMC-5127 in the second half of 2026 and to begin a first-in-human trial of RM-055 in the fourth quarter of 2026. Enrollment completion in RASolve 301 is expected this year, with an initial readout anticipated in 2027.
What did the company report on zoldonrasib and elironrasib in first-line NSCLC?
In a combination with standard of care pembrolizumab and platinum doublet chemotherapy, zoldonrasib showed an overall response rate of 82% (confirmed and pending confirmation) and a disease control rate of 100% in 28 efficacy-evaluable patients, with a median follow-up of 3.4 months. Elironrasib in combination with standard of care showed a confirmed ORR of 85% and a DCR of 97% in 39 patients, with a median follow-up of 8.7 months, and 95% of patients progression-free at 6 months. The company described both combinations as having manageable safety profiles.
04—Continue