Revolution Medicines, Inc. (RVMD) Earnings Call Transcript & Summary

Good day, and thank you for standing by. Welcome to the Revolution Medicines Q2 2026 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Ryan Asay, Senior Vice President, Corporate Affairs. Please go ahead.

Thank you, and welcome, everyone, to the second quarter 2026 earnings call. Joining me on today's call are Dr. Mark Goldsmith, Revolution Medicine's 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 Medicine's 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, and then 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 continue 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. Second, 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 health care providers across the United States. 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, health care providers, patient advocacy organizations and regulators to make this possible, and 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 project based on its potential to address a high unmet medical need and that it has started a phase 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 authorization 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. Third, 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 on-path 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 the 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. I'd also like to note that RMC-5127, our RAS(ON) G12V-selective inhibitor continues in the ongoing first-in-human study. To date, RMC-5127 has been well tolerated at all dose levels evaluated with no dose-limiting toxicities reported so far. Encouraging early signs of antitumor activity have been seen across multiple tumor types, including objective responses starting at the first dose level. Overall, we are increasingly confident in our ability to help redefine the standard of care for patients with pancreatic cancer across the continuum of disease from early-stage settings to advanced metastatic disease and across RAS tumor genotypes. With these opportunities comes a profound responsibility for revolution medicines that we take very seriously. Recognizing that every patient's disease and treatment journey is unique and treatment optionality may best serve the collective unmet needs, we remain committed to developing a broad portfolio of potential treatment options as quickly as possible. I'll now turn the call over to Alan to discuss our progress and expanding efforts in non-small cell lung cancer, along with other pipeline updates. Alan?

Thank you, Mark. While pancreatic cancer remains an important and immediate opportunity for Revolution Medicines, non-small cell lung cancer represents another major malignancy where despite meaningful advances in treatment, significant unmet needs remain. There is growing evidence that our RAS(ON) inhibitor portfolio has the potential to significantly improve outcomes for patients with RAS-driven non-small cell lung cancer. We believe daraxonrasib has the potential to become an important treatment option for patients with non-small cell lung cancer. Based on encouraging previously reported non-small cell lung cancer results in patients with tumors carrying diverse RAS mutations other than RAS G12C the U.S. FDA granted breakthrough therapy designation to daraxonrasib for previously treated metastatic non-small cell lung cancer with KRAS mutations other than G12C who have received prior platinum-based chemotherapy and anti-PD-(L)1 or PD-1 antibody therapy. Building on these encouraging Phase I/II results, RASolve 301, our ongoing global Phase III registrational study in patients with previously treated RAS-mutant non-small cell lung cancer continues to see high demand and is enrolling well. We also believe that combining targeted RAS(ON) inhibition with innovative bispecific antibodies targeting both the PD-1, PD-L1 and VEGF accesses has the potential to improve outcomes for patients with previously untreated metastatic non-small cell lung cancer. In particular, through our ongoing clinical collaboration with Summit Therapeutics, we are evaluating daraxonrasib in combination with ivonescimab, Summit's PD-1 VEGF bispecific antibody and platinum doublet therapy in first-line non-small cell lung cancer. With impactful targeted therapies available now for patients with non-small cell lung cancer with tumors harboring EGFR, ALK, ROS1, RET, KRAS G12C or other genetic alterations, we recognize that practitioners increasingly view treatment of lung cancer through a biomarker-directed lens. In the context of RAS-driven disease, significant unmet needs remain across patients with non-small cell lung cancer carrying diverse RAS mutations for which no approved targeted therapies have been approved. Revolution Medicines is uniquely positioned to address these needs through our broad and differentiated pipeline of targeted inhibitors. Approximately 30% of patients with non-small cell lung cancer have tumors harboring a RAS mutation and our RAS(ON) mutant selective inhibitors, elironrasib, zoldonrasib and RMC-5127 targeting RAS G12C, G12D and G12V, respectively, have the potential to address over 70% of RAS-driven mutations in this disease. In the first-line setting, we're actively evaluating elironrasib and zoldonrasib in combination with the current standard of care regimen of pembrolizumab plus platinum doublet chemotherapy. We previously reported Phase I data for zoldonrasib and elironrasib monotherapy in previously treated RAS G12D or G12C non-small cell lung cancer, respectively, each exhibiting highly encouraging monotherapy efficacy and safety profiles. Today, I'm pleased to share new observations for each of these compounds in combination with pembrolizumab and chemotherapy in patients with previously untreated non-small cell lung cancer, data which we believe demonstrate the differentiated and compelling potential of our RAS(ON) mutant selective inhibitors in this treatment context. I'll begin with zoldonrasib, our RAS(ON) G12D selective inhibitor. The baseline characteristics of patients enrolled in this cohort are representative of the KEYNOTE-189 study population, which evaluated pembrolizumab plus platinum doublet chemotherapy. The principal difference is a somewhat lower proportion of patients with high PD-L1 expression, while other key demographic and disease characteristics are broadly consistent with expectations for patients with previously untreated metastatic non-small cell lung cancer. Taken together, these baseline characteristics provide an appropriate context for interpreting the safety and efficacy observations I'll discuss next. The safety profile of zoldonrasib was highly encouraging. Treatment-related adverse events were again broadly consistent with the established profile of pembrolizumab plus chemotherapy with no new or unexpected safety signals observed. With the data cutoff of May 11, 2026, the majority of adverse events were grade 1 or grade 2. No grade 5 treatment-related adverse events were reported, and there was a low incidence of liver enzyme elevations, which were manageable with standard dose modifications. The combination of zoldonrasib with pembrolizumab and platinum-based chemotherapy demonstrated encouraging antitumor activity in patients with previously untreated KRAS G12D non-small cell lung cancer. With the data cutoff of May 11, 2026, and median follow-up of 3.4 months, the objective response rate was 82%, with disease control achieved in all evaluable patients. Importantly, responses were observed across PD-L1 expression subgroups, including patients with low PD-L1 expression, supporting the broad activity of this combination. And although follow-up remains early, these findings provide encouraging evidence supporting this differentiated treatment strategy. Overall, these findings support the continued development of zoldonrasib in combination with standard of care. Turning now to elironrasib, our RAS(ON) G12C selective inhibitor. As with the zoldonrasib cohort, the baseline characteristics of patients enrolled in this study are generally representative of the population treated in pembrolizumab plus platinum doublet chemotherapy. The primary difference being a somewhat lower proportion of patients with PD-L1 negative subgroup and a higher proportion of patients with PD-L1 expression in the 1% to 49% subgroup. Overall, these baseline characteristics establish an appropriate context for interpreting the efficacy and safety observations I'll review next. Elironrasib continues to demonstrate a manageable safety and tolerability profile in combination with pembrolizumab and chemotherapy. Treatment-related adverse events were consistent with the established safety profile of pembrolizumab-based chemotherapy with minimal evidence of additive toxicity attributable to elironrasib. We were particularly encouraged by the favorable liver safety profile with relatively few grade 3 or higher transaminase elevations and no unexpected safety findings. Turning now to efficacy of elironrasib in combination with pembrolizumab and chemotherapy. Similar to what we observed with zoldonrasib, we have observed highly encouraging antitumor activity with elironrasib in combination with pembrolizumab and platinum-based chemotherapy in patients with previously untreated RAS G12C non-small cell lung cancer. Across the treated population with the data cutoff of May 11, 2026, and 8.7 months of median follow-up, the confirmed objective response rate was 85% with a disease control rate of 97%. Responses were observed across PD-L1 expression subgroups and like zoldonrasib, the elironrasib combination regimen appears to be highly competitive with the current standard of care of KEYNOTE-189 regimen. The early observations of durability were also encouraging with a progression-free survival rate at six months of 95%. We believe these early findings suggest that the responses observed are not only frequent, but also have the potential to be durable. We believe these results reinforce the significant potential for targeted RAS(ON) inhibition to further improve outcomes when combined with current standard of care. Taken together, we believe these observations support continued development of elironrasib in combination with standard of care pembrolizumab and platinum-based chemotherapy. As a whole, and consistent with the impact seen in pancreatic cancer, these emerging data showing a well-tolerated and highly encouraging antitumor profile provide evidence that our RAS(ON) mutant-selective inhibitors have the potential to become important first-line treatment options for patients with metastatic non-small cell lung cancer. We are observing that practitioners increasingly view treatment of lung cancer through a biomarker-directed lens and recognize the significant unmet needs that remain across patients with RAS mutant non-small cell lung cancer. With our broad and differentiated portfolio of RAS(ON) mutant selective inhibitors, we believe we are uniquely positioned to address these needs. Accordingly, in the next stage of our approach in non-small cell lung cancer, we are advancing both zoldonrasib and elironrasib into registrational development in combination with standard of care in first-line non-small cell lung cancer with the goal of addressing the majority of patients with RAS-mutant disease. We recently initiated RASolve 308, a randomized placebo-controlled trial evaluating zoldonrasib with pembrolizumab plus doublet platinum chemotherapy in patients with RAS G12D non-small cell lung cancer. And we expect to initiate RASolve 307, a randomized placebo-controlled trial evaluating elironrasib with pembrolizumab plus doublet platinum chemotherapy in patients with RAS G12C non-small cell lung cancer. Further, with the encouraging initial observations mentioned earlier for RMC-5127 in patients with tumors harboring a G12V mutation, we anticipate studying RMC-5127 in the first-line non-small cell lung cancer setting as well. While we conduct registrational studies for mutant selective inhibitors, we are also evaluating a broader set of first-line treatment strategies, including our multi-selective inhibitor daraxonrasib as well as our mutant selective inhibitors in combinations with emerging bispecific antibodies and chemotherapy. The additional information and insights we gain over time will inform decisions about potential future registrational plans. This layered portfolio strategy reflects our deep commitment to developing multiple targeted treatments across the spectrum of RAS mutant non-small cell lung cancer. As we have done in pancreatic cancer, we are advancing multiple potential solutions on behalf of patients with the goal of providing multiple first-line treatment options for patients with RAS mutant non-small cell lung cancer. I'll now hand the call over to Jack.

Thanks, Alan. Our financial position remains exceptionally strong and continues to provide the flexibility needed to support the rapid advancement of our portfolio and our commercial preparations. We ended the second quarter of 2026 with $3.9 billion in cash and investments. This balance includes the proceeds from our concurrent public offerings of common stock and convertible notes in April of this year, resulting in $2.2 billion in gross proceeds before deducting underwriting discounts, commissions and offering expenses. The ending second quarter balance also includes the receipt of the second royalty tranche of $250 million from our funding arrangement with Royalty Pharma. There remains up to an additional $1.5 billion in committed flexible capital under this funding arrangement, subject to the achievement of specific milestones. Moving to expenses. R&D expenses for the second quarter of 2026 were $395 million compared to $224 million for the second quarter of 2025. The increase in 2026 was primarily due to increased clinical trial and manufacturing expenses for daraxonrasib and zoldonrasib, increased personnel-related costs due to additional headcount and higher stock-based compensation expense related to increased headcount and changes in retirement provisions in 2026 previously described on our Q1 2026 earnings call. G&A expenses for the second quarter of 2026 were $110 million compared to $41 million for the second quarter of 2025. The increase in G&A expenses in 2026 was primarily due to higher personnel-related costs associated with higher -- with additional headcount, higher stock-based compensation expense related to increased headcount and changes in retirement provisions in 2026, increased commercialization preparation activities, and higher administrative costs. Net loss for the second quarter of 2026 was $644 million compared to $248 million for the second quarter of 2025. Net loss for the quarter ended June 30, 2026, included a noncash charge of $151 million related to a change in the fair value of warrants we assumed as part of the company's acquisition of EQRx. This change in the fair value of warrants is due to the increase in our stock price. The additional increase in net loss in 2026 was due to higher operating expenses. Turning to financial guidance. The company is updating its projected 2026 GAAP operating expense expectations and now expects full year 2026 GAAP operating expenses to be between $2.1 billion and $2.2 billion. This includes expected noncash stock-based compensation expense of between $270 million and $290 million. Today's updated guidance reflects our growing confidence in the breadth of our clinical pipeline and the magnitude of the opportunities ahead. As a result, we plan to increase our investment and spend in 2026, driven largely by three main factors: First, we are accelerating and increasing manufacturing for both commercial and clinical supply of daraxonrasib and zoldonrasib to ensure we have sufficient supply to meet a range of potential demand scenarios. Second, we anticipate higher clinical development expenses as we continue to execute on our aggressive development strategy across multiple programs within our portfolio with increased confidence. And third, we are accelerating and increasing investments in our commercial readiness efforts to support our preparedness for potential U.S. launches while also expanding our international infrastructure to support potential future launches outside the U.S. These additional investments in 2026 position us to execute on our bold ambitions for our portfolio. That concludes the financial update. I'll now turn the call back over to Mark.

Thank you, Jack. Before we open the call for questions, I'd like to briefly highlight our key upcoming priorities. Overall, we've begun the second half of 2026 with strong momentum and a compelling set of priorities. In pancreatic cancer, following the unprecedented results from RASolute 302, the U.S. FDA has accepted our full NDA submission for review. The EMA has initiated its phase review of daraxonrasib, and we are well prepared to execute a successful launch, subject to regulatory approvals. In addition, the global RASolute 303, 304 and 305 studies are actively enrolling, and we have initiated RASolute 309. In lung cancer, we expect to complete enrollment in RASolve 301 this year, supporting an initial readout in 2027. We also continue following patients in the zoldonrasib monotherapy expansion cohort in previously treated RAS G12D non-small cell lung cancer and have initiated RASolve 308, evaluating zoldonrasib in combination with standard of care in first-line RAS G12D non-small cell lung cancer. We are also preparing to initiate RASolve 307, evaluating elironrasib in combination with standard of care in first-line RAS G12C non-small cell lung cancer in the fourth quarter of 2026. In colorectal cancer, we look forward to providing a data update and visibility into our development plans during the fourth quarter of this year. With our earlier-stage pipeline, we expect to identify the recommended Phase II dose for RMC-5127 in the second half of this year and share initial clinical data in 2027. We also remain on track to initiate the first-in-human study of RM-055, our first inhibitor from our innovative new class of mutant targeted catalytic RAS(ON) inhibitors in the fourth quarter. Taken together, these milestones reflect the breadth, pace and ambition of Revolution Medicines today. We are preparing for a potential first commercial launch, conducting multiple registration programs and leading with further RAS innovation, all with intensity and continued excellence in execution. The progress we've made is the result of years of growing scientific conviction, disciplined investment and relentless effort by our team and collaborators. We believe we are now in a strong position to redefine what is possible for patients with RAS-driven cancers, beginning with pancreatic cancer and lung cancer and colorectal cancer coming soon as well. With our differentiated know-how, organizational depth and financial strength, we intend to continue operating against our aggressive plan with the urgency patients deserve. I'd like to thank patients and their families, our investigators and health care partners, our employees and our shareholders for their continued support and confidence. The ongoing support of all of our partners and constituencies is needed to deliver revolutionary advances on behalf of patients. With that, I'll turn the call over to the operator for the Q&A portion of the call.

Thank you. At this time we'll conduct the question-and-answer session. [Operator Instructions] Please limit to one question and one follow up question. [Operator Instructions] Our first question comes from the line of Marc Frahm from with TD Cowen.

Congrats on the progress you've made so far. Maybe on CRC, we're going to be getting that. Just what's your latest thoughts on kind of what proof-of-concept looks like in that indication, particularly after we've seen adagrasib's confirmatory trial in the second-line setting kind of failed to demonstrate PFS or OS benefit despite what appeared to be pretty exciting response rate data? And then just on the lung cancer side, can you maybe just walk through the confidence that on the G12C, not just that you can beat current standard of care, but there's also second-line trials or second-gen G12C trials running right now in the first line. Why do you think you're going to be better than those that will presumably have data faster than your trials?

Marc, thanks for your questions. On the CRC question, I think that's best addressed when we are able to frame our plans and provide some data. So I'm just going to ask that we defer that to a later time when I can be more concrete. On the non-small cell lung cancer question with regard to elironrasib, maybe Alan Sandler can make a comment on that.

Sure. Thanks, and thanks for the question. So an important question. We believe that elironrasib has a very good profile, both safety and efficacy. And we're always data-driven in terms of our decision-making. And we felt that it was important to have a robust data set available in order to make this important decision. Given that and given the data that we've shown you today, we believe that elironrasib has a highly competitive profile, both again, in monotherapy, potentially in subsequent lines of therapy and also in that first-line line of therapy in combination with pembrolizumab and doublet chemotherapy. And in addition, what I would add is with our suite of mutant selective agents, we have a very compelling position in that setting as we will be able to target over 70% of the patients with RAS mutant non-small cell lung cancer.

Our next question comes from the line of Charles Zhu with LifeSci Capital.

Congrats on all the broad progress across the board. Maybe one for me regarding frontline non-small cell lung cancer. So great to see either current or ongoing plans with various mutant selective inhibitors in combination with standard of care. I think you had also mentioned evaluating further opportunities not only with novel bispecifics, which makes sense, but also with the multi-selective RAS inhibitors. Curious as to your thoughts around given the multiple mutant selective you have covering a lot of those patients, how might you position a RAS multi-selective in that frontline setting? And would -- did that terminology refer to daraxonrasib or possibly RM-055 as well?

Yes. Thank you, Charles. Appreciate the question. I think all possibilities are still on the table. We've intentionally pursued both the multi-selective as well as the mutant selective inhibitors to create the most optionality for us and then ultimately for patients. And I think all of this will play out over time. We still think it's premature to make any exclusive commitments down to any particular treatment regimen. And as long as there remains the possibility that more than one regimen might be complementary and provide options for various patients, we'll pursue them. So this will continue to play out. You're now seeing are moving pretty aggressively with two mutant selective inhibitors and the third to come behind it. But by no means are we deprioritizing either daraxonrasib or RM-055 that's coming up or things that might come behind that as well.

Our next question comes from the line of Michael Schmidt with Guggenheim.

Congrats on all the progress and news today. I had a question on daraxonrasib. And I'm just curious if you have any early feedback from the EAP program and how the products perhaps are performing relative to the clinical trial experience? And secondly, what could the regulatory time lines in Europe look like based on this Phase I review process that's underway there?

Thank you, Michael. The EAP is quite robust now. We're serving a lot of patients. We don't have a mechanism to get explicit or quantitative feedback from those who are prescribing it since that -- this is a clinical access program. It's not a clinical trial. So we really don't have quantitative information. And I'm not sure that we ultimately ever will. Sort of on a qualitative basis, we certainly have feedback from some institutions that they're very enthusiastic. Some of the larger institutions have enrolled quite large numbers of patients, and they're continuing to enroll new patients. So that suggests that their experience so far is encouraging. We also do get anecdotal information from patients or their families, but that doesn't add up to a fair and broad-based representation. But from that anecdotal evidence, patients and their families are quite encouraged by having received access. So that's pretty much what we know from the EAP now, and I'm sure will continue to grow. With regard to the regulatory time lines in Europe, there's really not much we can provide on that. The EMA made it clear that the phase review is intended to be an expedited review process. What that actually ends up meaning really is a question for the EMA, and we'll just support it as well as we can.

Our next question comes from the line of Cory Kasimov with Evercore ISI.

So I want to ask about your Phase III frontline PDAC studies. For patients that end up in the control arm, how do you plan to assess those that drop out potentially even after receiving just a single dose of chemo and then eventually go on to receive commercial daraxonrasib upon approval? How much of a risk might this dynamic pose to your frontline studies in terms of measuring OS and potentially even PFS? And then a follow-up, just a clarification question. With the EAP, did those patients convert to commercial patients upon approval of daraxonrasib?

Thank you, Cory. I appreciate your questions. The first question is about first-line PDAC in the Phase III trial, I think you're really raising the question of crossover, some form of crossover risk for patients moving on to daraxonrasib. Maybe Wei Lin, our Chief Medical Officer, can comment on that, and then I'll come back to the EAP.

Yes. Thanks, Mark. Thanks for the question. Yes. It is certainly a very important question that we have given a lot of thought and planning to because we want to ensure the success of the 303 trial in frontline PDAC while we're trying to making sure patients globally have access to daraxonrasib in [indiscernible]. I think the -- currently, the Phase III trial has a co-primary endpoint of PFS and overall survival. And then it's -- the dropout in control would not affect the PFS obviously, but it could potentially affect the overall survival analysis. And so right now, we're trying to be very thoughtful in geographically the sites that we're activating 303 trial in, knowing that the global approval as well as access will be graduated starting with the U.S. and the rest of the world in a gradual fashion. So that's certainly, I think, one area. And the other is really working with investigators to making sure that the patients really understand their options before they come on trials and then probably be conducted in a rigorous fashion so then the integrity of the center experiments.

So that's with regard to the frontline PDAC and crossover risk on the expanded access program, it's an important program, important pathway for eligible patients before potential approval. Once an approval occurs, our patient support services team will work very closely with treating physicians and health care providers. And the intention here, of course, is to help minimize treatment interruptions, provide seamless transition of care over to commercial supply. That is a top priority for us. These patients will have access to our comprehensive patient support services, as we mentioned, the on-path support that will include coverage navigation, financial assistance and adherence support. We expect most patients would transition within a few month period.

Our next question comes from the line of Brian Cheng with JPMorgan.

Just first, on the EAP, can you talk about whether these patients are being recruited in the sites that have had prior daraxonrasib experience? And you noted that more than 90% of the requests have been accepted. What is the common reason for patients to get rejected? And then just one quick one on the 307 and 308 trial for frontline non-small cell trials. Are these studies setting any minimum or maximum threshold for the proportion of PD-L1 expression, depending on whether it's low or high that you're recruiting? Just curious if you can give us a sense of the trial design there would be great.

Nicely done. I think you squeezed in three questions into two questions. Well done. Maybe Alan can comment first on the 307, 308 PD-L1 expression topic.

Right. So yes, the -- we are not putting guidelines in terms of requirements of the numbers that have -- will let that play out in a large study such as Phase III study, there should be a natural -- a natural number of patients that appear on well representation of all three. What we will do, we generally want to stratify to make sure that there is equal representation on both arms. And I think that's the most important aspect of that.