Revolution Medicines, Inc. Common Stock 2026 Q2 Earnings Call

Please go ahead. Welcome everyone to the second quarter 2026 earnings call.

Joining me on today's call are Dr. Mark Goldsmith, Revolution Medicines Chairman and Chief Executive Officer, Dr. Alan Sandler, our Chief Development Officer, and Jack Anders, our Chief Financial Officer. Dr. Wei Lin, our Chief Medical Officer, and Anthony Mancini, our Chief Global Commercialization Officer, will join us for the Q&A portion of today's call. We would like to inform you that certain statements we make during this call will be forward-looking. Because such statements deal with future events and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 10-K and our quarterly reports on Form 10-Q that are filed with the U.S. Securities and Exchange Commission. This afternoon, we released financial results for the quarter ended June 30, 2026, and recent corporate updates.

The press release and updated corporate presentation are available on the investors section of our website at revmed.com. With that, I'll turn the call over to Dr. Mark Goldsmith, Revolution Medicines' Chairman and Chief Executive Officer.

Mark? Thank you, Ryan, and thanks to everyone for joining us this afternoon.

I'll begin today's call with initial remarks focused primarily on pancreatic cancer, Dr. Sandler will provide highlights of recent results and plans in non-small cell lung cancer. Jack Anders will then summarize our second quarter financial results before I share some closing comments and open the call to questions and answers. 2026 is proving to be a transformational year for Revolution Medicines, with substantial progress in many dimensions, supporting our mission to revolutionize treatment for patients with RAS-addicted cancers globally through the discovery, development, and delivery of innovative targeted medicines. We've continued to build on strong momentum in pancreatic cancer, reinforced by compelling results from RASolute 302, our recently completed global phase III study in patients with previously treated metastatic disease.

Catalyzed by the unprecedented clinical results, we quickly expanded availability to patients through our FDA-cleared expanded access program, advanced regulatory activities in support of potential approvals, strengthened our commercial readiness globally, and continued to expand our broad pioneering R&D pipeline targeting RAS-driven cancers. I'd like to spend a few more minutes reviewing some of these activities in more detail. First at the American Society of Clinical Oncology, or ASCO, Dr. Brian Wolpin presented the full results from RASolute 302, which were also published simultaneously in the New England Journal of Medicine. The data demonstrated paradigm-changing clinical outcomes with daraxonrasib monotherapy in patients with previously treated metastatic pancreatic cancer, including statistically significant and clinically meaningful improvements in overall survival, progression-free survival, and patient-reported quality-of-life indicators compared to chemotherapy, along with a manageable safety and tolerability profile.

Based on these and earlier results, we believe daraxonrasib represents a major advance for patients facing one of the most difficult to treat cancers, and we are moving with urgency to make this potential new treatment available to eligible patients as quickly as possible. In particular, since announcing our expanded access program shortly after disclosing top-line results from RASolute 302, we've made significant progress establishing access through healthcare providers across the U.S. It has been deeply gratifying to activate sites participating in the program in almost all 50 U.S. states and Puerto Rico, including both academic cancer centers and community oncology practices, with many additional sites still coming online to begin treating patients through the program. To date, our team has approved greater than 90% of reviewed requests and has provided daraxonrasib on behalf of more than 2,000 eligible patients.

Our teams continue working closely with investigators, healthcare providers, patient advocacy organizations, and regulators to make this possible. We're proud of the progress so far on behalf of patients. I'm also very pleased to note that our new drug application for daraxonrasib in pancreatic cancer has been accepted for review by the U.S. Food and Drug Administration. We continue to engage constructively with the FDA as they review this application. We're also making progress with additional regulatory authorities around the world. The European Medicines Agency, or EMA, recently announced that it had designated daraxonrasib as a high priority under EMA's Cancer Medicines Pathfinder based on its potential to address a high unmet medical need. That it has started a phased review of daraxonrasib with the goal of accelerating assessment by evaluating the data as they become available ahead of the submission of a full Marketing Authorisation Application.

We look forward to continuing collaborative interactions with the EMA and other health authorities around the world as we work to bring daraxonrasib to patients as quickly as possible. We continue preparing for a successful launch. In the U.S., our medical affairs organization has been in the field for over a year and continues to actively engage the oncology community through scientific exchange. We have also built the commercial infrastructure needed to support launch. Our sales organization is in place, our field access team is operational, and our OnPath patient services program, commercial supply, and distribution network are ready. We are well-positioned to serve patients with pancreatic cancer from day one. Internationally, we continue to build our launch capabilities at an accelerating pace, positioning us to support future commercialization across key markets.

Subject to regulatory approvals, we believe we are well-positioned to execute a strong launch and deliver daraxonrasib to patients quickly and broadly. Fourth, with our commitment to pancreatic cancer extending well beyond previously treated disease, we continue prosecuting a comprehensive development strategy involving multiple RAS(ON) inhibitors across lines of treatment. With daraxonrasib, enrollment continues in the RASolute 303 and 304 Phase III programs in the first-line metastatic and adjuvant settings respectively. With zoldonrasib, our RAS(ON) G12D selective covalent inhibitor, the RASolute 305 Phase III trial in first-line metastatic pancreatic cancer is also enrolling and treating patients. Further, we recently initiated RASolute 309, evaluating the novel RAS(ON) inhibitor doublet of daraxonrasib plus zoldonrasib in the first-line treatment setting.

These trials are supported by strong clinical data and continue to generate significant interest from investigators and patients around the world who recognize both the unmet needs and the underlying scientific rationale for these treatment strategies. At last month's European Society for Medical Oncology's Gastrointestinal Cancers Congress, or ESMO GI, we presented new pancreatic cancer data for zoldonrasib that reinforced its compelling profile and the breadth of our development strategy in pancreatic cancer specifically, including the differentiated first-line treatment approaches underlying the RASolute 305 and 309 trials. In one study reported at ESMO GI, zoldonrasib, combined with standard of care chemotherapy, showed compelling preliminary antitumor activity in first-line treatment of patients with RAS G12D pancreatic cancer, including objective response rates of 82% and 61%, and disease control rates of 96% and 90% in combination with modified FOLFIRINOX or gemcitabine plus nab-paclitaxel, respectively.

Longer follow-up will further establish the durability profiles for these regimens. These combinations also demonstrated favorable safety and tolerability profiles with treatment-related adverse events broadly consistent with the established profiles of each respective chemotherapy component. These encouraging findings strongly support the global pivotal Phase III RASolute 305 study of zoldonrasib plus chemotherapy in first-line treatment of patients with RAS G12D pancreatic cancer. In a second study reported at ESMO GI, the RAS(ON) inhibitor doublet of daraxonrasib plus zoldonrasib demonstrated compelling preliminary clinical activity in second and third line or later treatment of patients with RAS G12D pancreatic cancer, including objective response rates of 50% and 47%, and disease control rates of 97% and 90%, respectively, observations that are consistent with earlier preclinical studies.

Earlier indicators of durability for this combination are also compelling, showing median progression-free survival of 9.6 months and 7.6 months in patients in second and third line treatment or later, respectively. Median overall survival in the second line setting was not yet reached, while the median overall survival in the third line or later setting was 10.5 months. The combination also showed a favorable safety and tolerability profile. Treatment-related adverse events were broadly consistent with the established profile of daraxonrasib monotherapy. These encouraging preliminary results support the planned global pivotal Phase III RASolute 309 study evaluating the combination of daraxonrasib plus zoldonrasib as first-line treatment in patients with RAS G12D pancreatic cancer. Our RAS(ON) inhibitors are also being evaluated in combination with other investigational approaches, including with MTA-cooperative PRMT5 inhibitors through clinical collaborations with Tango Therapeutics and Bristol Myers Squibb.