RVMD

Image source: The Motley Fool. Wednesday, Aug. 5, 2026 at 4:30 p.m. ET Senior Vice President, Corporate Affairs - Ryan Asay Chairman and Chief Executive Officer - Mark Goldsmith Chief Development Officer - Alan Sandler Chief Financial Officer - Jack Anders Chief Medical Officer - Wei Lin Chief Global Commercialization Officer - Anthony Mancini Operator: Good day, and thank you for standing by. Welcome to the Revolution Medicines Q2 2026 Earnings Conference Call. 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. Ryan Asay: 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? Mark Goldsmith: 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? Alan Bart Sandler: 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. Jack Anders: 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. Mark Goldsmith: 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. Operator: [Operator Instructions] Our first question comes from the line of Marc Frahm from with TD Cowen. Marc Frahm: 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? Mark Goldsmith: 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. Alan Bart Sandler: 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 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. Operator: Our next question comes from the line of Charles Zhu with LifeSci Capital. Yue-Wen Zhu: 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? Mark Goldsmith: 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. Operator: Our next question comes from the line of Michael Schmidt with Guggenheim. Michael Schmidt: 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? Mark Goldsmith: 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. Operator: Our next question comes from the line of Cory Kasimov with Evercore ISI. Cory Kasimov: 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? Mark Goldsmith: 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. Wei Lin: 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. Mark Goldsmith: 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. Operator: Our next question comes from the line of Brian Cheng with JPMorgan. Lut Ming Cheng: 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. Mark Goldsmith: 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. Alan Bart Sandler: 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. Mark Goldsmith: It's more about balance than anything else. Yes. Thanks, Alan. And then the -- on the EAP, there are participants in the program who have been investigators and have treated patients before, and there are participants who have not and significant numbers of both. I don't know that I can quantitate that for you, but I think we're experiencing both kinds. We've certainly put a lot of effort into providing education and support to all of the prescribers. So the experience that the more experienced providers have obtained, we've learned from -- we've all learned from, and we've developed protocols, approaches that we have invested heavily in developing and also conveying through education to anybody who might prescribe daraxonrasib. As to the greater than 90% rate, actually a very high rate as to who might be disapproved, it's really not subjective. It comes down to the eligibility criteria that are established in the FDA-cleared protocol. It's very well defined. There are very few edge cases where it requires some judgment. Most of it's really just making sure that somebody is actually eligible. And if they're eligible and the request comes through a U.S. licensed physician from a qualified institution that's met all the institutional requirements, then they will be approved. Operator: Our next question comes from the line of Faisal Khurshid with Jefferies. Faisal Khurshid: There's been a lot of investor excitement about PRMT5 combination data generated with your molecule from your partner, Tango. Just want to understand from your perspective, what's your latest thoughts on the potential of that combination? And do you feel like you need a PRMT5 within your own portfolio in order to kind of cover all of your bases? Mark Goldsmith: Thanks for your questions. Yes, our position on PRMT5 inhibitors remains what it's been, which is that biologically, it's intriguing -- pharmacologically, it's intriguing hypothesis that's supported by preclinical work. Tango has now put forth some initial data that show high response rates. We think that body of evidence should be grown. And we know that Tango is working to do that, growing both in terms of numbers of patients, exposure to different dose levels, so dose optimization and a longer follow-up, and that will help us really establish a level of conviction about whether and if so, how to go forward with it. So certainly a credible idea, and we'll just continue to learn more about it as we support Tango in their efforts. With regard to do we need a PRMT5 inhibitor in our portfolio, I don't think we need it. We have plenty to do that's high priority within RevMed as we've described now one looks at the pipeline, it's a pretty rich pipeline of work. And the other thing to point out, of course, is that there are many PRMT5 inhibitors, growing number out there, each with a slightly different profile. some with more or less propensity to drug-drug interactions that would have to be managed, different levels of potency and so on. So I think there's a lot of opportunity out there. I think at the end of the day, daraxonrasib should be the backbone of therapy for zoldonrasib in the context of the right settings, G12D selective setting. And we may add various things, whether it's PRMT5 inhibitors, immunologic agents, other RAS inhibitors, chemotherapy, et cetera, a wide variety of possibilities there. Operator: Our next question comes from the line of Michael Yee with UBS. Unknown Analyst: This is [ Madeline ] on for Michael. Just wanted to get your -- any updated commentary around -- obviously, there is some precedent in oncology to get accelerated approval in the first line based on similar data to what you have, along with the full approval that you're expecting for the second-line PDAC indication. So just wondering if you have any updated commentary around that now that your NDA has been accepted by the FDA. Mark Goldsmith: Not really much to add to that. We're certainly aware of the history here. The NDA is primarily driven by the 302 data set, which is randomized data in patients being treated for second line -- in second line for metastatic pancreatic cancer. But there are additional data outside of that study that, of course, many people have access to, including the FDA, have access to it. And so how they want to deal with that, I think we'll just have to learn over time. Operator: Our next question comes from the line of Alec Stranahan with Bank of America. Alec Stranahan: Two from us. First, on daraxonrasib in the metastatic RAS mutant lung cancer setting. Curious which data was shared with the FDA to support breakthrough therapy designation here? And if there's any read-through to be made to what we could see from RASolve 301. And I appreciate you probably aren't talking at all about pricing at this point. But from a qualitative perspective, assuming initial approvals with the 300 mg dose, how would you think about relative price in combos that are investigating a lower daraxonrasib dose like in the PRMT5 studies? If you have any thoughts here that you could share, that would be great. Mark Goldsmith: So the first question was what data did we share with the FDA? Well, it's kind of a general rule of thumb. You have to share pretty much everything with the FDA. So anything they want to look at, they look at. I don't think we can provide any more specificity around that, unfortunately. With regard to pricing, it's early for us to be talking about pricing. You're raising more of a kind of layered or nuanced question about pricing in combinations. And I guess I'd say the same thing. It's probably too early to be talking about that. We don't have a combination that's approaching commercialization today and nothing to address. I think you might have had another layer to it, but given that I didn't hit the first two layers, I'm not sure we'll make it to the third. Operator: Our next question comes from the line of Laura Prendergast with Stifel. Laura Prendergast: Congrats on all the progress. I was hoping you could clarify what you mean by visibility into CRC development strategy expected in the fourth quarter. I guess the real question here is should investors expect to leave this update having conviction that you have a registrational path in CRC? And then second question is, do you guys have any plans to make a registrational move outside the big three RAS indications, kind of maybe bringing back that tumor-agnostic approach question. Is that something that we could see down the road once you've read out pivotal data for your first two PDAC and lung indications? Mark Goldsmith: Yes. Laura, thanks for your questions. Visibility into our development strategy we'll show some data, and we'll tell you what we plan to do with it. As to what investors will leave -- what impression they'll leave with that, that's up to investors to decide. I don't think it serves us to get out in front of that. But that's our plan. And typically, in the past, when we've announced a development strategy, we've supported it by data that justify it. So I think that would be a reasonable expectation. Yes, regarding tumors outside of the big three, we're certainly interested in those. I mean our expectation is that daraxonrasib and other compounds as well, but daraxonrasib could serve a wide variety of tumors. Of course, there are smaller subsets of patients. And we have prioritized the big three as you put them, which makes sense to do. But we do have data across other tumor types. We've shown some of that data publicly. We have other data that hasn't yet made it out into the public domain. We have external research collaborations as ways to explore this. So, yes, I think you should expect that daraxonrasib will continue to make its way into other context. But the exact strategy by which we develop those may differ from indication to indication, context to context. Operator: Our next question comes from the line of Leonid Timashev with RBC. Leonid Timashev: Just wanted to ask on the commercial side. At least clinically, you guys have always been planning for success. I guess to what extent does that extend to the sales force sizing commercially? Are you planning a force that's commensurate with the second-line PDAC setting? Are you also going to size it for frontline and potentially non-small cell lung cancer right away? Or is this going to expand later? And then maybe just a quick follow-up as well. Just on the EAP, are those 2,000 patient adds starting from May when the 1-ish when the FDA first made that announcement? I'm just trying to better understand sort of the cadence of how quickly patients came on. Mark Goldsmith: Well, I'll comment on the second one, and then Anthony Mancini can comment on the commercial organization. The number that I gave was greater than 2,000. So it wasn't 2,000, greater than 2,000. And that is a cumulative number. As you might recall, I think that once we filed the EAP request, it was approved within a couple of days. And I think within three weeks, we were shipping the first drug on behalf of patients. And it started out more as a trickle and then expanded as you'd expect over time as sites became part of the program, completed their process for entering the program. So I don't know that you can quite get a rhythm out of it other than to say qualitatively, it's a very robust program. There's very, very high interest in it, and it continues to grow. With regard to the commercial question, maybe Anthony can comment. Anthony Mancini: Yes, Javier, thanks for the question. We've been preparing for some time and are ready for a successful PDAC launch in the U.S. And as we think about commercialization infrastructure, there are parts of that commercialization infrastructure that are broad and that can apply to our future indications. But as for our sales force, which, as Mark alluded to in his prepared remarks, are fully trained and in place, we have a team of around 60 individuals that will fill the need for PDAC. But it's also important to note that there are many different stakeholders in the U.S. market, and we're prepared for those as well. So we have a fully operational field access team field patient services team, MSL team and thought leader liaison team that are in place. We're excited and ready to go. All systems go. But yes, we're ready for PDAC, and we will be ready should other indications come. Operator: Our next question comes from the line of Kalpit Patel with Wolfe Research. Gugan Raghuraman: Gugan on for Kalpit. Just a quick one from us. Given Roche's head win against sotorasib and adagrasib in KRASCENDO-1, do you think you'd need to run a trial against divarasib? Mark Goldsmith: Thanks for your question. Do you want to comment? The question is whether if divarasib is approved, I think, is what he's asking then would we be required to run an elironrasib frontline study against that? Alan Bart Sandler: Yes. We'll be having all of our discussions with the FDA. We basically -- really the control arm is dictated by the current state of affairs at the time that the study is initiated, and that requires not necessarily a positive study, but that requires a full approval. And so since that's not the case at this time, we don't feel that, that would be necessary. Operator: Thank you. This concludes the question-and-answer session. I would now like to turn it back to Dr. Mark Goldsmith for closing remarks. Mark Goldsmith: Thank you, operator, and thank you to everyone for participating today and for your continued support of Revolution Medicines. Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Before you buy stock in Revolution Medicines, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Revolution Medicines wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Revolution Medicines (RVMD) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Interested in Revolution Medicines, Inc.? Here are five stocks we like better. Daraxonrasib moved closer to commercialization: The FDA accepted Revolution Medicines’ application for previously treated metastatic pancreatic cancer, while the company expanded patient access and prepared its U.S. sales, services, supply and distribution infrastructure. Pipeline development is accelerating: The company reported encouraging early response data for zoldonrasib and elironrasib combinations in pancreatic and lung cancer, advanced multiple Phase III studies and plans additional registrational trials in 2026. Spending and funding both increased: Revolution ended the quarter with $3.9 billion in cash and investments after raising $2.2 billion and receiving $250 million from Royalty Pharma, but its net loss widened to $644 million and 2026 operating expenses are now projected at $2.1 billion–$2.2 billion. Revolution Medicines (NASDAQ:RVMD) said its second-quarter 2026 results reflected continued investment in late-stage cancer programs, commercial launch preparations and manufacturing capacity as it advances daraxonrasib and other RAS-targeted therapies across pancreatic and lung cancer. The company ended the quarter with $3.9 billion in cash and investments, including proceeds from April offerings of common stock and convertible notes that generated $2.2 billion in gross proceeds, as well as a $250 million second royalty tranche from Royalty Pharma. Revolution Medicines said up to an additional $1.5 billion remains available under that funding arrangement if specified milestones are achieved. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control Net loss for the quarter ended June 30 widened to $644 million from $248 million a year earlier. The quarterly loss included a $151 million non-cash charge related to the increased fair value of warrants assumed in the EQRx acquisition, driven by an increase in Revolution Medicines’ stock price. Chairman and Chief Executive Officer Mark Goldsmith said the company’s new drug application for daraxonrasib in previously treated metastatic pancreatic cancer has been accepted for review by the U.S. Food and Drug Administration. The application is supported by the completed Phase III RASolute 302 study, whose results were presented at the American Society of Clinical Oncology meeting and published in the New England Journal of Medicine. → 3 Drone Stocks That Should Soar After the Summer Slump Goldsmith said RASolute 302 showed statistically significant and clinically meaningful improvements in overall survival, progression-free survival and patient-reported quality-of-life measures for daraxonrasib monotherapy compared with chemotherapy, with what the company described as a manageable safety and tolerability profile. Revolution Medicines has also established an FDA-cleared expanded access program for eligible U.S. patients. Goldsmith said the program has activated sites in nearly all 50 states and Puerto Rico, spanning academic cancer centers and community oncology practices. The company has approved more than 90% of reviewed requests and provided daraxonrasib on behalf of more than 2,000 eligible patients. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure In Europe, the European Medicines Agency has designated daraxonrasib as a high priority under its Cancer Medicines Pathfinder and started a phased review intended to accelerate assessment ahead of a full marketing authorization application. Goldsmith said the company is continuing discussions with the EMA and other regulatory authorities. The company said its U.S. commercial infrastructure is in place for a potential launch, including a sales organization, field access team, patient services program, commercial supply and distribution network. Anthony Mancini, chief global commercialization officer, said the sales organization includes about 60 individuals and is designed to support a pancreatic cancer launch while broader commercialization infrastructure could support future indications. Revolution Medicines continues to enroll patients in the Phase III RASolute 303 study in first-line metastatic pancreatic cancer and RASolute 304 study in the adjuvant setting, both involving daraxonrasib. The company is also enrolling patients in RASolute 305, a Phase III study of zoldonrasib plus chemotherapy in first-line metastatic pancreatic cancer with RAS G12D mutations. The company recently initiated RASolute 309, a Phase III study evaluating the combination of daraxonrasib and zoldonrasib in the first-line RAS G12D pancreatic cancer setting. At the European Society for Medical Oncology Gastrointestinal Cancers Congress, Revolution Medicines reported preliminary data for zoldonrasib combined with chemotherapy in first-line RAS G12D pancreatic cancer. The company reported objective response rates of 82% with modified FOLFIRINOX and 61% with gemcitabine plus nab-paclitaxel, with disease control rates of 96% and 90%, respectively. It said longer follow-up is needed to assess durability. In another study, the daraxonrasib-zoldonrasib doublet produced objective response rates of 50% in second-line patients and 47% in patients treated in the third line or later, according to the company. Median progression-free survival was 9.6 months in the second-line group and 7.6 months in the later-line group. Median overall survival had not been reached in the second-line setting, while it was 10.5 months in the third-line-or-later group. Chief Development Officer Alan Sandler said the company is advancing mutant-selective RAS(ON) inhibitors in first-line non-small cell lung cancer. The FDA has granted breakthrough therapy designation to daraxonrasib for previously treated metastatic non-small cell lung cancer with KRAS mutations other than G12C in patients who previously received platinum chemotherapy and PD-1 or PD-L1 therapy. Revolution Medicines expects to complete enrollment in its Phase III RASolve 301 study of daraxonrasib in previously treated RAS-mutant non-small cell lung cancer this year, supporting an initial readout in 2027. The company also disclosed early combination data for zoldonrasib and elironrasib with pembrolizumab and platinum-based chemotherapy in previously untreated non-small cell lung cancer. In KRAS G12D disease, zoldonrasib’s combination produced an 82% objective response rate and disease control in all evaluable patients after a median 3.4 months of follow-up as of May 11. For elironrasib in RAS G12C non-small cell lung cancer, the company reported an 85% confirmed objective response rate, a 97% disease control rate and a 95% progression-free survival rate at six months, based on median follow-up of 8.7 months. Sandler said safety findings for both regimens were broadly consistent with pembrolizumab-based chemotherapy, with no new or unexpected safety signals reported for zoldonrasib. Revolution Medicines has initiated RASolve 308, a randomized placebo-controlled study of zoldonrasib plus pembrolizumab and platinum-doublet chemotherapy in RAS G12D non-small cell lung cancer. It expects to begin RASolve 307, a similar study of elironrasib in RAS G12C disease, in the fourth quarter of 2026. Research and development expense increased to $395 million from $224 million a year earlier, primarily reflecting higher clinical trial and manufacturing costs for daraxonrasib and zoldonrasib, additional personnel and stock-based compensation. General and administrative expense rose to $110 million from $41 million, driven by headcount, commercialization preparations and administrative costs. The company increased its full-year 2026 GAAP operating expense forecast to between $2.1 billion and $2.2 billion, including expected non-cash stock-based compensation of $270 million to $290 million. Chief Financial Officer Jack Anders said the higher outlook reflects accelerated manufacturing for clinical and potential commercial supply, expanded clinical development activity and increased U.S. and international commercialization investments. Goldsmith said Revolution Medicines plans to provide a colorectal cancer data update and outline its development plans in the fourth quarter. The company also expects to identify a recommended Phase II dose for RMC-5127 in the second half of 2026 and initiate a first-in-human study of RM-055 in the fourth quarter. Revolution Medicines is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapies to treat RAS-dependent cancers and other diseases driven by the RAS/MAPK pathway. The company's research efforts target historically “undruggable” proteins, aiming to inhibit critical nodes in cell signaling that promote tumor growth and therapeutic resistance. The lead pipeline includes RMC-4630, a SHP2 inhibitor; RMC-6291, a selective KRAS G12C inhibitor; and RMC-6236, a pan-RAS inhibitor designed to address multiple RAS mutations. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Revolution Medicines Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

This article first appeared on GuruFocus. Cash and Investments: $3.9 billion at the end of Q2 2026, including $2.2 billion in gross proceeds from public offerings and a $250 million royalty tranche from Royalty Pharma. R&D Expenses: $395 million in Q2 2026, up from $224 million in Q2 2025, driven by increased clinical trial and manufacturing costs. G&A Expenses: $110 million in Q2 2026, up from $41 million in Q2 2025, due to higher personnel costs and commercialization activities. Net Loss: $644 million in Q2 2026, compared to $248 million in Q2 2025, including a $151 million noncash charge related to warrant fair value changes. 2026 GAAP Operating Expense Guidance: Updated to between $2.1 billion and $2.2 billion, including $270 million to $290 million in noncash stock-based compensation. Warning! GuruFocus has detected 4 Warning Sign with RVMD. Is RVMD fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Revolution Medicines Inc (NASDAQ:RVMD) reported paradigm-changing clinical results from the Phase 3 RASolute 302 study, showing statistically significant improvements in overall survival, progression-free survival, and quality of life for daraxonrasib in previously treated metastatic pancreatic cancer. The company's expanded access program (EAP) has been highly successful, providing daraxonrasib to over 2,000 eligible patients across nearly all US states, with more than 90% of requests approved. The FDA has accepted the New Drug Application (NDA) for daraxonrasib in pancreatic cancer, and the EMA has initiated a phase review under its Cancer Medicines Pathfinder project, potentially accelerating regulatory timelines. Early clinical data for zoldonrasib in first-line pancreatic cancer showed compelling antitumor activity, with objective response rates of 82% and 61% when combined with modified FOLFIRINOX or gemcitabine plus nab-paclitaxel, respectively. In non-small cell lung cancer, both zoldonrasib and elironrasib demonstrated highly encouraging antitumor activity in combination with pembrolizumab and chemotherapy, with objective response rates of 82% and 85%, respectively, supporting the initiation of registrational trials RASolve 308 and 307. The company ended Q2 2026 with a strong cash position of $3.9 billion, including proceeds from a $2.2 billion capital raise and a $250 million royalty tranche, providing ample financial flexibility. The company reported a significant increase in net loss for Q2 2026, reaching $644 million compared to $248 million in the same period last year, driven by higher operating expenses and a noncash charge related to warrant fair value changes. R&D and G&A expenses increased substantially year-over-year, with R&D expenses rising to $395 million from $224 million and G&A expenses rising to $110 million from $41 million, reflecting aggressive investment in pipeline and commercial readiness. The company updated its 2026 GAAP operating expense guidance upward to between $2.1 billion and $2.2 billion, indicating higher-than-expected spending on manufacturing, clinical development, and commercial infrastructure. There is a potential risk of crossover in the Phase 3 frontline pancreatic cancer trials (RASolute 303), as patients in the control arm may drop out to receive commercial daraxonrasib upon approval, potentially confounding overall survival analyses. The company acknowledged that it lacks quantitative feedback from the expanded access program, making it difficult to assess real-world performance of daraxonrasib outside of clinical trials. Management declined to provide specific details on the data shared with the FDA to support breakthrough therapy designation for daraxonrasib in non-small cell lung cancer, leaving some uncertainty about the strength of the evidence. Q: Regarding the frontline non-small cell lung cancer (NSCLC) trials (RASolve 307 and 308), 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? A: Alan Sandler (Chief Development Officer): We are not putting guidelines in terms of requirements of the numbers. In a large Phase 3 study, there should be a natural representation of all three PD-L1 subgroups. The most important aspect is to stratify to ensure equal representation on both arms to maintain balance. Q: For patients that end up in the control arm of your Phase 3 frontline PDAC studies, 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? A: Wei Lin (Chief Medical Officer): This is a very important question we have given a lot of thought to. The Phase 3 trial has a co-primary endpoint of PFS and overall survival. A dropout in the control would not affect PFS, but it could potentially affect the overall survival analysis. We are being very thoughtful in geographically activating the 303 trial sites, knowing that global approval and access will be graduated starting with the US. We are also working with investigators to ensure patients understand their options before coming on trial to maintain the integrity of the experiment. Q: There's been a lot of investor excitement about PRMT5 combination data generated with your molecule from your partner, Tango. What are your latest thoughts on the potential of that combination? And do you feel like you need a PRMT5 within your own portfolio in order to cover all of your bases? A: Mark Goldsmith (Chairman and CEO): Biologically and pharmacologically, it's an intriguing hypothesis supported by preclinical work. Tango has put forth initial data showing high response rates, but that body of evidence should be grown with more patients, dose optimization, and longer follow-up. We don't think we need a PRMT5 inhibitor in our portfolio as we have plenty of high-priority work. At the end of the day, daraxonrasib should be the backbone of therapy, and we may add various things, including PRMT5 inhibitors, immunologic agents, or other RAS inhibitors. Q: On the commercial side, are you planning a sales force that's commensurate with the second-line PDAC setting, or are you also going to size it for frontline and potentially non-small cell lung cancer right away? And on the EAP, are those 2,000 patient adds starting from May 1st-ish, when the FDA first made that announcement? A: Mark Goldsmith (Chairman and CEO): The number I gave was greater than 2,000, and that is a cumulative number. The EAP started out more as a trickle and then expanded as sites became part of the program. Qualitatively, it's a very robust program with very high interest that continues to grow. Anthony Mancini (Chief Global Commercialization Officer): We have a team of around 60 individuals that will fill the need for PDAC. We also have a fully operational field access team, field patient services team, MSL team, and thought leader liaison team in place. We are ready for PDAC and will be ready should other indications come. Q: Given Roche's head win against sotorasib and adagrasib in CRESCENDO-1, do you think you'd need to run a trial against divarasib? A: Alan Sandler (Chief Development Officer): We will be having all of our discussions with the FDA. The control arm is dictated by the current state of affairs at the time the study is initiated, which requires not necessarily a positive study, but a full approval. Since that is not the case at this time, we don't feel that would be necessary. Q: On CRC, what's your latest thoughts on what proof-of-concept looks like in that indication, particularly after we've seen adagrasib's confirmatory trial in the second-line setting fail to demonstrate PFS or OS benefit despite exciting response rate data? And on the lung cancer side, why do you think you're going to be better than the second-gen G12C trials running right now in the first line? A: Mark Goldsmith (Chairman and CEO): On the CRC question, that is best addressed when we are able to frame our plans and provide some data, so we will defer that to a later time. Alan Sandler (Chief Development Officer): On the NSCLC question, we believe elironrasib has a very good profile, both safety and efficacy. Given the data we've shown today, we believe elironrasib has a highly competitive profile in monotherapy and in the first-line setting in combination with pembrolizumab and doublet chemotherapy. With our suite of mutant selective agents, we have a very compelling position as we will be able to target over 70% of patients with RAS mutant non-small cell lung cancer. Q: I was hoping you could clarify what you mean by visibility into CRC development strategy expected in the fourth quarter. Should investors expect to leave this update having conviction that you have a registrational path in CRC? And do you have any plans to make a registrational move outside the big three RAS indications? A: Mark Goldsmith (Chairman and CEO): We will show some data and tell you what we plan to do with it. Typically, when we've announced a development strategy, we've supported it by data that justify it, so that would be a reasonable expectation. Regarding tumors outside of the big three, we are certainly interested in those. Daraxonrasib could serve a wide variety of tumors, and we have data across other tumor types. You should expect daraxonrasib to continue to make its way into other contexts, but the exact strategy may differ from indication to indication. Q: Just wanted to get any updated commentary around the precedent in oncology to get accelerated approval in the first line based on similar data to what you have, along with the full approval that you're expecting for the second-line PDAC indication, now that your NDA has been accepted by the FDA. A: Mark Goldsmith (Chairman and CEO): Not really much to add to that. The NDA is primarily driven by the 302 data set, which is randomized data in patients being treated in the second line for metastatic pancreatic cancer. There are additional data outside of that study that the FDA has access to. How they want to deal For the complete transcript of the earnings call, please refer to the full earnings call transcript.

U.S. FDA accepted daraxonrasib New Drug Application for review for previously treated metastatic pancreatic cancer following unprecedented Phase 3 RASolute 302 results Rapidly implemented U.S. Expanded Access Program for eligible patients with previously treated metastatic pancreatic cancer Achieved U.S. commercial launch readiness, and began submissions to the European Medicines Agency under a new phased review process designed to accelerate assessment FDA granted Breakthrough Therapy Designation to daraxonrasib for certain patients with previously treated metastatic RAS mutant non-small cell lung cancer Reporting encouraging new combination data in first-line non-small cell lung cancer supporting registrational studies of elironrasib and zoldonrasib Revolution Medicines to hold webcast today at 4:30 p.m. Eastern Time REDWOOD CITY, Calif., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced its financial results for the quarter ended June 30, 2026, and provided an update on corporate progress. “This has been a transformational period for Revolution Medicines, as we rapidly translated unprecedented Phase 3 results for daraxonrasib into an active Expanded Access Program and the filing of our first New Drug Application to the U.S. Food and Drug Administration on behalf of patients with previously treated metastatic pancreatic cancer,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “We achieved U.S. launch readiness, advanced regulatory activities globally, and expanded our pancreatic cancer development programs across multiple lines of therapy. Beyond our deep commitment to pancreatic cancer, we are building significant momentum in lung cancer with a differentiated portfolio of RAS(ON) mutant-selective and multi-selective inhibitors designed to provide a broad range of options for patients across multiple stages of disease.” Clinical Highlights Pancreatic Adenocarcinoma (PDAC) Daraxonrasib in PDAC Daraxonrasib, the company’s oral RAS(ON) multi-selective inhibitor, continues to demonstrate a differentiated clinical profile across lines of therapy and in both monotherapy and combination settings. At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, detailed results from global RASolute 302 were presented in a Plenary Session and published simultaneously in The New England Journal of Medicine. The study demonstrated statistically significant and clinically meaningful improvements in the dual primary endpoints of overall survival and progression-free survival (PFS) as well as in patient-reported quality of life compared with chemotherapy, with a manageable safety profile. Following the unprecedented Phase 3 results from RASolute 302, the company announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for daraxonrasib for the treatment of patients with previously treated metastatic PDAC. The company also announced that the European Medicines Agency (EMA) initiated a phased review of daraxonrasib in pancreatic cancer under its Cancer Medicines Pathfinder project to accelerate regulatory assessment by evaluating in phases as sections become available, ahead of submission of a full Marketing Authorization Application. In addition, daraxonrasib was granted Orphan Drug Status (ODS) by Swissmedic for the treatment of pancreatic cancer. As previously shared, daraxonrasib was also selected for the FDA Commissioner’s National Priority Voucher pilot program, which is designed to accelerate the review of medicines that address key national health priorities. The company opened an FDA-cleared Expanded Access Program (EAP) in May and within three weeks began distributing daraxonrasib to participating treating physicians on behalf of patients. Since opening the EAP, daraxonrasib has been distributed to physicians on behalf of more than 2,000 patients through participating academic cancer centers and community oncology practices across nearly all 50 U.S. states and Puerto Rico. The company also enhanced its commercial readiness during the quarter, putting in place the commercialization infrastructure needed to support a successful U.S. launch of daraxonrasib, if approved, while accelerating build out of global commercialization capabilities in preparation for potential international regulatory approvals. The company continues to advance daraxonrasib across earlier lines of treatment for PDAC through the ongoing global Phase 3 RASolute 303 and RASolute 304 studies evaluating daraxonrasib in the first-line metastatic and adjuvant settings, respectively. Zoldonrasib in PDAC At the European Society for Medical Oncology Gastrointestinal Cancers Congress, the company presented new Phase 1/2 clinical data supporting two complementary development strategies for zoldonrasib, the company’s oral RAS(ON) G12D-selective covalent inhibitor, in metastatic PDAC. Zoldonrasib in combination with chemotherapy demonstrated compelling preliminary antitumor activity and manageable safety and tolerability in patients with first-line RAS G12D PDAC. These findings support the ongoing global Phase 3 RASolute 305 trial. The novel RAS(ON) inhibitor doublet of zoldonrasib plus daraxonrasib in previously treated RAS G12D PDAC demonstrated compelling preliminary antitumor activity and a manageable safety and tolerability profile. These findings support the recently initiated global Phase 3 RASolute 309 trial. Non-Small Cell Lung Cancer (NSCLC) Revolution Medicines continues to advance a broad RAS-targeted portfolio in NSCLC, with both clinical-stage RAS(ON) multi-selective and mutant-selective inhibitors designed to address a broad spectrum of RAS-driven malignancies, including inhibitors targeting RAS G12C, G12D and G12V that together account for more than 70% of RAS mutant NSCLC. Daraxonrasib in NSCLC Development of daraxonrasib in previously treated RAS mutant NSCLC continues to advance. Based on previously reported Phase 1 data in patients with tumors harboring RAS mutations other than G12C, the FDA granted Breakthrough Therapy Designation to daraxonrasib for the treatment of patients with previously treated metastatic NSCLC harboring KRAS mutations other than G12C who have received prior platinum-based chemotherapy and anti-PD-(L)1 therapy. Enrollment in the global Phase 3 RASolve 301 trial evaluating daraxonrasib in patients with previously treated RAS mutant NSCLC is expected to be completed this year, supporting an anticipated initial readout in 2027. Zoldonrasib in NSCLC Zoldonrasib also continues to advance across multiple treatment settings in NSCLC. Today the company is reporting initial clinical data evaluating zoldonrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with first-line RAS G12D NSCLC. The analysis included 38 patients, with efficacy evaluable in 28 patients who had at least 8 weeks of follow-up. PD-L1 tumor proportion score (TPS) was <1% in 39% of patients, 1–49% in 39% of patients, ≥50% in 16% of patients, and TPS score missing in 5% of patients. As of a data cutoff of May 11, 2026, with a median follow-up of 3.4 months, the zoldonrasib plus standard of care combination demonstrated encouraging preliminary antitumor activity, including an overall response rate (ORR; confirmed and pending confirmation) of 82% and disease control rate (DCR) of 100%. Confirmed and pending ORRs ranged from 60% to 100% across PD-L1 TPS subgroups (<1% to ≥50%). The combination demonstrated a manageable safety profile, with treatment-related adverse events (TRAEs) generally consistent with the established safety profile of standard of care pembrolizumab and platinum doublet chemotherapy, with minimal added toxicity and a favorable liver safety profile. These findings support the recently initiated global Phase 3 RASolve 308 study evaluating zoldonrasib in combination with standard of care in patients with first-line metastatic RAS G12D NSCLC, while the company continues following patients in a Phase 2 monotherapy expansion cohort in previously treated disease. Elironrasib in NSCLC Elironrasib, the company's oral RAS(ON) G12C-selective covalent inhibitor, continues to demonstrate promising potential in NSCLC. Today the company is reporting clinical data evaluating elironrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with first-line RAS G12C NSCLC. As of a data cutoff of May 11, 2026, the analysis included 39 patients who had at least 14 weeks of follow-up. PD-L1 TPS was <1% in 10% of patients, 1–49% in 67% of patients, and ≥50% in 23% of patients. With a median follow-up of 8.7 months, the elironrasib plus standard of care combination demonstrated encouraging preliminary antitumor activity, including a confirmed ORR of 85% and DCR of 97%. Confirmed ORRs ranged from 50% to 100% across PD-L1 TPS subgroups (<1% to ≥50%). Early PFS findings suggest encouraging preliminary durability, with 95% of patients progression-free at 6 months. The combination demonstrated a manageable safety profile, with TRAEs generally consistent with the established safety profile of standard of care pembrolizumab and platinum doublet chemotherapy, with minimal added toxicity and a favorable liver safety profile. These findings support the planned global Phase 3 RASolve 307 study evaluating elironrasib in combination with standard of care for patients with first-line metastatic RAS G12C NSCLC, which the company expects to initiate in the fourth quarter of 2026. Colorectal Cancer (CRC) The company continues to evaluate multiple combination approaches in CRC, including RAS(ON) inhibitor doublets and combinations with standard of care and other investigational therapies. The company expects to provide updated clinical data and additional visibility into its CRC development strategy during the fourth quarter of 2026. Early-Stage Programs RMC-5127The company continues enrollment in an ongoing first-in-human trial studying RMC-5127, the company’s oral RAS(ON) G12V-selective inhibitor. RMC-5127 has been well tolerated at all dose levels evaluated to date, with no dose-limiting toxicities reported as of July 20, 2026. Encouraging early signs of antitumor activity have been seen across multiple tumor types, including objective responses starting at the first dose level. The company remains on track to identify a recommended Phase 2 dose during the second half of 2026 and expects to share initial clinical data in 2027. Innovative New Class of RAS(ON) InhibitorsThe company also remains on track to initiate a first-in-human clinical trial evaluating RM-055, a representative from a novel class, during the fourth quarter of 2026. Clinical CollaborationsThe company's development efforts continue to include clinical collaborations evaluating its RAS(ON) inhibitors in combination with other targeted therapies, including through ongoing collaborations with Summit Therapeutics, Tango Therapeutics and Bristol Myers Squibb. These collaborations are evaluating combinations across multiple RAS-driven solid tumors, including with PD-1/VEGF bispecific antibodies and MTA-cooperative PRMT5 inhibitors. Financings In April 2026, the company completed concurrent upsized public offerings of $1,725.0 million of common stock and $500.0 million aggregate principal amount of 0.50% convertible senior notes due 2033. Total gross proceeds from the offerings, before deducting underwriting discounts, commissions and other offering expenses, were $2,225.0 million. Royalty Pharma Funding Arrangement In May 2026, the company received a $250.0 million payment from Royalty Pharma in exchange for additional rights to royalty payments in connection with the second tranche under the royalty purchase agreement with Royalty Pharma. Financial Highlights Second Quarter Results Cash Position: Cash, cash equivalents and marketable securities were $3.9 billion as of June 30, 2026. This balance includes the proceeds from the company’s concurrent public offerings of common stock and convertible notes in April 2026 as well as receipt of the second royalty tranche in May 2026 from Royalty Pharma. There remains up to an additional $1.5 billion in committed, flexible capital under the Royalty Pharma funding arrangements, subject to the achievement of specific milestones. R&D Expenses: Research and development expenses were $394.9 million for the quarter ended June 30, 2026, compared to $224.1 million for the quarter ended June 30, 2025. The increase was primarily driven by higher 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 changes in retirement provisions for equity awards and increased headcount. G&A Expenses: General and administrative expenses were $110.2 million for the quarter ended June 30, 2026, compared to $40.6 million for the quarter ended June 30, 2025. The increase was primarily driven by higher stock-based compensation expense related to changes in retirement provisions for equity awards and increased headcount, higher personnel-related costs associated with additional headcount, increased commercial preparation activities, and higher administrative costs. Net Loss: Net loss was $644.4 million for the quarter ended June 30, 2026, compared to net loss of $247.8 million for the quarter ended June 30, 2025. Net loss for the quarter ended June 30, 2026 included a non-cash charge of $151.0 million related to a change in the fair value of warrants assumed as part of the company’s acquisition of EQRx, Inc. Financial GuidanceRevolution Medicines is updating its full year 2026 GAAP operating expense guidance to a range of $2.1 to $2.2 billion, which includes estimated non-cash stock-based compensation expense of between $270 and $290 million. WebcastRevolution Medicines will host a webcast this afternoon, August 5, 2026, 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: https://ir.revmed.com/events-and-presentations. Following the live webcast, a replay will be available on the company’s website for at least 14 days. About Revolution Medicines, Inc. Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. These product candidates are investigational and have not been approved for commercial use in any indication. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit www.revmed.com and follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding the company’s financial projections and guidance; the company’s commercialization plans and readiness, including its ability to establish commercial, sales, marketing, market access and distribution infrastructure, the timing and potential success of any commercial launch, and its development of global commercialization capabilities; the company’s regulatory filings, including the NDA for daraxonrasib and the EMA’s phased review of daraxonrasib; the timing, progress and outcome of regulatory reviews and the company’s ability to obtain regulatory approvals, including the timing, scope and conditions of any such approvals; the company’s development opportunities, plans and timelines and its ability to build or advance its portfolio and R&D pipeline; the progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company’s candidates being studied; the company’s expectations regarding timing of clinical trial strategies, milestones, initiation, enrollment and data readouts or disclosures and clinical trial designs including timing for enrollment completion in RASolve 301 and initiation of RASolve 307; the company’s ability to discover and develop approaches that improve outcomes for patients with RAS-addicted cancers; collaborations, including the aims and expected benefits of the company’s collaborations with Summit, Tango, and Bristol Myers Squibb; plans for developing any of the company’s product candidates as part of a combination treatment; and sources of capital. Forward-looking statements are typically, but not always, identified by the use of words such as “aims,” “anticipate,” "believe," "estimate," "expect," "plan," “potential,” “project,” “up to,” "will" and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ development stages, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, commercialization preparation and launch readiness, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company’s business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 5, 2026, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances, or to reflect the occurrence of unanticipated events. Revolution Medicines Media & Investor Contact:[email protected] [email protected] (1) Working capital is defined as current assets less current liabilities.

Interested in Summit Therapeutics PLC? Here are five stocks we like better. Updated HARMONi trial data showed a median follow-up improvement and an overall survival hazard ratio of 0.76 in both the total population and Western patients. Summit said it submitted the new results to the FDA, and the ivonescimab plus chemotherapy BLA remains under review with a Nov. 14 PDUFA date. Management outlined several late-stage trial milestones, including HARMONi-3, HARMONi-7, HARMONi-GI3 and other studies. The company expects key PFS and OS readouts to arrive from late 2026 through 2027, while additional collaboration programs with Revolution Medicines, GSK and Arcus are expanding the development pipeline. Summit ended Q2 with $690.7 million in cash and no debt, helped by ATM financing, but operating expenses rose as clinical trial spending increased. The company is also building commercial infrastructure ahead of a possible U.S. launch if ivonescimab is approved. Why Wall Street Is Backing These 3 Comeback Stocks Summit Therapeutics (NASDAQ:SMMT) executives used the company’s latest earnings call to emphasize updated survival data for ivonescimab, outline the timing of key late-stage trial readouts and detail the company’s cash position as it prepares for a potential U.S. regulatory decision later this year. Chairman and Co-Chief Executive Officer Bob Duggan said Summit remains focused on ivonescimab, its PD-1/VEGF bispecific antibody and lead investigational asset. Duggan said ivonescimab has produced positive data in four Phase III clinical studies to date, leading to two approvals in China, with one additional filing under review there. He said 15 Phase III trials are ongoing or have read out across multiple tumor types, and that Summit and partner Akeso have initiated 52 clinical trials evaluating the drug. → Could Truth API Become Trump Media’s First Meaningful Revenue Driver? MarketBeat Week in Review – 11/4 - 11/8 Duggan also said more than 4,000 patients have been dosed with ivonescimab in Summit- or Akeso-sponsored clinical trials globally, while more than 70,000 patients have received the drug commercially in China. President and Co-Chief Executive Officer Dr. Maky Zanganeh highlighted an updated overall survival analysis from the global Phase III HARMONi trial, which evaluated ivonescimab plus chemotherapy versus chemotherapy alone in patients with EGFR-mutated non-small cell lung cancer after TKI therapy. → 3 Photonics Companies Making Quantum Tech Possible Summit Therapeutics: Is Their Lung Cancer Drug a Game Changer? Zanganeh said the latest analysis, with a June 2026 data cutoff, showed Western patients had reached a median follow-up of more than 23 months, while Asian patients remained at a median follow-up of 33 months. The company reported an overall survival hazard ratio of 0.76 in both the total population and the Western regional data. “The hazard ratio for Western patients has improved with more follow-up time,” Zanganeh said, adding that the Western results are now consistent with the magnitude of overall survival benefit seen in Asian patients, who had longer follow-up at the primary analysis. → AeroVironment’s Stock Is Down, But Drone Demand Is Taking Off Summit said no new safety signals were observed in the latest data cut, and that the safety profile remained acceptable and manageable, consistent with previous Phase III results of ivonescimab plus chemotherapy. Zanganeh said Summit has made the updated results available to the U.S. Food and Drug Administration. The company’s biologics license application for ivonescimab plus chemotherapy in the EGFR-mutated non-small cell lung cancer post-TKI setting remains under FDA review, with a target PDUFA date of Nov. 14. Zanganeh noted that the FDA has previously said a statistically significant overall survival benefit is necessary to support marketing authorization in this setting. Summit also provided updates on several global Phase III studies. HARMONi-3 is evaluating ivonescimab plus chemotherapy against pembrolizumab plus chemotherapy in first-line metastatic non-small cell lung cancer in both squamous and non-squamous histologies, which will be analyzed separately. Zanganeh said enrollment has been completed in both cohorts. Summit expects to reach the number of events needed for a progression-free survival analysis in the squamous cohort in the second half of this year, along with an early interim look at overall survival. The company expects a separate overall survival interim analysis in the first half of 2027. For the non-squamous cohort, Summit expects to reach the number of events for a progression-free survival analysis in the first half of 2027. In the question-and-answer session, Chief Business and Strategy Officer Dave Gancarz said the HARMONi-3 squamous PFS timing is likely “towards the middle to back end of 2026,” rather than in the near term. He said the first-half 2027 overall survival analysis should have median follow-up generally consistent with the HARMONi-6 analysis and the updated Western patient data from HARMONi. Summit said HARMONi-7, which compares ivonescimab monotherapy against pembrolizumab monotherapy in first-line non-small cell lung cancer with high PD-L1 expression, continues to enroll. HARMONi-GI3 is evaluating ivonescimab plus chemotherapy versus bevacizumab plus chemotherapy as first-line therapy in unresectable colorectal cancer. Zanganeh also reviewed Summit’s collaborations with Revolution Medicines, GSK and Arcus Biosciences. The Revolution Medicines collaboration began enrolling in the first quarter and is evaluating ivonescimab with three novel RAS inhibitors across solid tumor settings including pancreatic, colorectal and non-small cell lung cancers. Summit expects its GSK collaboration, which will evaluate ivonescimab with GSK’s B7-H3 antibody-drug conjugate in multiple solid tumors, to enroll its first patient later this quarter. The company also announced a collaboration with Arcus to evaluate ivonescimab with Arcus’ HIF-2α inhibitor casdatifan in first-line metastatic clear cell renal cell carcinoma. Summit expects initial data from that collaboration by mid-next year. The company also pointed to ILLUMINE, a Phase III head and neck cancer study sponsored by European cooperative group GORTEC, which is enrolling in Europe and is expected to begin in China later this year. Chief Operating Officer and Chief Financial Officer Manmeet Soni said Summit ended the second quarter of 2026 with $690.7 million in cash, up from $598.7 million at the end of the first quarter. Soni attributed the $92 million increase primarily to $231 million raised through the company’s at-the-market facility, partially offset by approximately $140 million used in operating activities during the quarter. Soni said Summit filed a prospectus supplement for a new ATM facility of up to $380 million to provide additional financing flexibility. He also said the company currently has no debt on its balance sheet. Total GAAP operating expenses were $220.5 million in the second quarter, compared with $195.2 million in the first quarter. Non-GAAP operating expenses, which exclude stock-based compensation, were $151.8 million, compared with $122.4 million in the prior quarter. Soni said the increase was primarily driven by higher research and development expenses related to clinical trial costs for HARMONi-GI3, HARMONi-3 and HARMONi-7. In response to an analyst question, Soni said Summit is preparing for a possible U.S. commercial launch ahead of the Nov. 14 PDUFA date. He said the company has hired its commercial leadership team, market access staff and marketing personnel, while field force hiring would typically occur closer to the regulatory date. Gancarz added that the company has also ramped up medical science liaisons. Duggan closed the call by reiterating management’s confidence in ivonescimab. “We know that ivonescimab works,” he said. “The question I leave you with is, what if ivonescimab works really well?” Summit Therapeutics plc is a clinical‐stage biotechnology company dedicated to the discovery and development of precision medicines for serious and life‐threatening diseases. The company applies a targeted approach to drug design, focusing on novel mechanisms of action that differentiate its candidates from existing therapies. Summit's lead asset, ridinilazole (formerly SMT19969), is being developed to treat Clostridioides difficile infections and has received both Fast Track and Qualified Infectious Disease Product designations from the U.S. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Summit Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for July 2026.

Shares of Tango Therapeutics TNGX surged 53% on Monday after the company reported encouraging initial data from an ongoing phase I/II study evaluating combination treatments involving its investigational drug, vopimetostat. The study is assessing vopimetostat plus one of Revolution Medicines’ RVMD experimental RAS inhibitors — daraxonrasib or zoldonrasib — in previously treated patients with MTAP-deleted and RAS-mutant metastatic pancreatic ductal adenocarcinoma (PDAC). The strongest results were reported from the vopimetostat-daraxonrasib arm. Among 12 evaluable patients, the combination achieved an objective response rate (ORR) of 92%, with a disease control rate (DCR) of 100% and a six-month progression-free survival (PFS) rate of 90%. In contrast, the vopimetostat-zoldonrasib combination achieved a 52% ORR across 27 evaluable patients, a DCR of 96% and a six-month PFS rate of 74%. Both combinations were generally well tolerated. The data drew significant attention from investors and analysts, many of whom were particularly impressed by the vopimetostat-daraxonrasib results. Investors also welcomed the company's decision to advance this combination into late-stage development for first-line MTAP-deleted pancreatic cancer. Management believes the findings support the broader strategy of combining PRMT5 inhibition with RAS-targeted therapies and reinforce the potential for a chemotherapy-free treatment option in patients with MTAP-deleted pancreatic cancer. Year to date, the company’s shares have skyrocketed 249% against the industry’s 3% fall. Image Source: Zacks Investment Research The drug is a selective PRMT5 inhibitor designed to target cancers harboring MTAP deletions, a genetic alteration found across multiple tumor types, including pancreatic cancer. Apart from the above study, vopimetostat is also being tested as a monotherapy in a phase I/II study across MTAP-deleted solid tumors. Data from this study is expected later this year. In March, Tango Therapeutics entered into a clinical trial collaboration and supply agreement with Erasca ERAS. Under the agreement, the companies will evaluate vopimetostat in combination with ERAS' pan-RAS molecular glue, ERAS-0015, in patients with MTAP-deleted RAS-mutant cancers. Tango plans to initiate a phase I/II study before year-end, further expanding the development opportunities for vopimetostat. Tango Therapeutics, Inc. price | Tango Therapeutics, Inc. Quote Tango Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Revolution Medicines, Inc. (RVMD) : Free Stock Analysis Report Erasca, Inc. (ERAS) : Free Stock Analysis Report Tango Therapeutics, Inc. (TNGX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

A month has gone by since the last earnings report for Revolution Medicines, Inc. (RVMD). Shares have added about 9.3% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Revolution Medicines due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the latest earnings report in order to get a better handle on the important drivers. Revolution Medicines reported a first-quarter 2026 loss of $2.29 per share, wider than the Zacks Consensus Estimate of a loss of $1.83. The company had incurred a loss of $1.13 in the year-ago quarter. Currently, the company does not have any approved products in its portfolio. It has yet to generate revenues. Research and development expenses amounted to about $344 million, up 67% year over year. This significant increase was primarily driven by higher costs associated with clinical studies and manufacturing for the company’s drug candidates. General and administrative expenses surged 189% to $101.3 million, primarily driven by higher stock-based compensation expenses, headcount costs and administrative costs, as well as increased commercial preparation activities during the quarter. The company revised its guidance for operating expenses. It expects the figure to be between $1.7 billion and $1.8 billion (previously: $1.6-$1.7 billion), which includes non-cash stock-based compensation expense of $260-$280 million (previously: $180-$200 million). In the past month, investors have witnessed a downward trend in estimates review. The consensus estimate has shifted -8.19% due to these changes. At this time, Revolution Medicines has a poor Growth Score of F, a grade with the same score on the momentum front. Following the exact same course, the stock has a score of F on the value side, putting it in the bottom 20% quintile for this investment strategy. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Revolution Medicines has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Revolution Medicines is part of the Zacks Medical - Biomedical and Genetics industry. Over the past month, Alkermes (ALKS), a stock from the same industry, has gained 22.5%. The company reported its results for the quarter ended March 2026 more than a month ago. Alkermes reported revenues of $392.91 million in the last reported quarter, representing a year-over-year change of +28.2%. EPS of -$0.40 for the same period compares with $0.13 a year ago. For the current quarter, Alkermes is expected to post a loss of $0.04 per share, indicating a change of -107.7% from the year-ago quarter. The Zacks Consensus Estimate has changed +61.4% over the last 30 days. Alkermes has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of F. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Revolution Medicines, Inc. (RVMD) : Free Stock Analysis Report Alkermes plc (ALKS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Find your next quality investment with Simply Wall St's easy and powerful screener, trusted by over 7 million individual investors worldwide. Revolution Medicines (RVMD) is back in focus after presenting detailed Phase 3 results for its RASolute 302 trial at ASCO 2026, where oral RAS(ON) inhibitor daraxonrasib doubled median overall survival versus chemotherapy. See our latest analysis for Revolution Medicines. The latest daraxonrasib data has come alongside powerful momentum in the stock, with a 90 day share price return of 58.22% and a year to date share price return of 97.03%. The 1 year total shareholder return of 287.29% and very large 3 year total shareholder return suggest investors have been steadily repricing Revolution Medicines as clinical and regulatory milestones accumulate. If the RASolute 302 results have you thinking about where else breakthrough treatments could emerge next, it may be worth scanning for other oncology and biotech ideas through our 40 healthcare AI stocks With Revolution Medicines now worth about US$33.2b and the stock up very sharply over the past year, the key question is whether current prices still leave room for upside or if the market is already factoring in several years of future growth. At a last close of $155.69 versus a most followed fair value estimate of $133.70, the current price sits above what that narrative implies. Read the complete narrative. Curious what kind of revenue curve and margin profile that outlook assumes, and what sort of future earnings multiple ties it all together. Result: Fair Value of $133.70 (OVERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, heavy 2026 operating expenses of US$1.6b to US$1.7b and the company’s reliance on a concentrated RAS oncology pipeline could quickly test that optimistic setup. Wall Street's queuing for one rocket. While SpaceX counts down to its IPO, other companies tied to the new space race are already in orbit. → 20 Compelling Space Companies watchlist · Global Space Race Investing Ideas screener · Scan the sector by valuation on Rocket Lab's valuation page. While the most followed narrative pegs fair value at $133.70 and flags the stock as overvalued, our DCF model lands in a very different place, with an estimate of $611.60 per share that frames RVMD as deeply undervalued. When two approaches disagree this sharply, which one do you trust more and why? Look into how the SWS DCF model arrives at its fair value. Simply Wall St performs a discounted cash flow (DCF) on every stock in the world every day (check out Revolution Medicines for example). We show the entire calculation in full. You can track the result in your watchlist or portfolio and be alerted when this changes, or use our stock screener to discover 46 high quality undervalued stocks. If you save a screener we even alert you when new companies match - so you never miss a potential opportunity. If this mix of optimism and concern leaves you on the fence, take a closer look at the underlying data now and shape your own stance with 2 key rewards and 3 important warning signs If RVMD has sharpened your focus, do not stop here. Broaden your watchlist now with other stocks that could fit different roles in your portfolio. Target quality at a discount by scanning 46 high quality undervalued stocks that pair solid fundamentals with prices that may not fully reflect their underlying strength. Strengthen your foundation with solid balance sheet and fundamentals stocks screener (46 results) that emphasize robust finances and staying power when conditions get tougher. Spot future standouts early by using the screener containing 22 high quality undiscovered gems before these opportunities sit firmly on everyone else’s radar. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include RVMD. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]