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8/6/2025
Good day and thank you for standing by. Welcome to the Revolution Medicine's Q2 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. 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 A.C., SVP of Corporate Affairs. Please go ahead.
Thank you, and welcome everyone to the second quarter 2025 earnings call. Joining me on today's call are Dr. Mark Goldsmith, Revolution Medicine's Chairman and Chief Executive Officer, and Jack Anders, our Chief Financial Officer. Dr. Steve Kelsey, our President of R&D, Anthony Mancini, our Chief Global Commercialization Officer, and Peg Horn, our Chief Operating Officer, will join us for the Q&A portion of today's call. I'd 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 10Q that are filed with the U.S. Securities and Exchange Commission. This afternoon, we released financial results for the quarter ended June 30th, 2025, and recent corporate updates. The press release is available on the investor section of our website at redmed.com. With that, I'll turn the call over to Dr. Mark Goldsmith, our Chairman and Chief Executive Officer. Mark?
Thanks, Ryan. It's good to be with you this afternoon. Today, I'll highlight the progress we've made this quarter with a look ahead to the strategic priorities and milestones on the horizon for RevMed. I'll then pass the call over to Jack, who will provide a financial summary before I share closing remarks and open the call for questions and answers. At RevMed, we remain steadfast in our commitment to revolutionizing treatment for patients with RAS-addicted cancers through the discovery, development, and global delivery of innovative targeted medicines. We have a compelling pipeline of three distinguished clinical stage Rasson inhibitors. Teraxon Rassib, a groundbreaking Rasson multi-selective inhibitor. Aliron Rassib, a differentiated G12C selective covalent inhibitor. And Zoldon Rassib, a groundbreaking G12D selective covalent inhibitor for which a full report was published recently in Science describing the innovative chemistry, mechanism of action, and biological impact of this unique racinone inhibitor in preclinical cancer models. We are executing well and making meaningful progress in advancing all of these programs, which we believe have the potential to transform treatment for patients living with RAS-driven cancers. Starting with our efforts in pancreatic cancer, Durexone RACIB is our most advanced clinical program. We were pleased to announce recently that Durexanracib received breakthrough therapy designation from the US Food and Drug Administration in previously treated metastatic pancreatic cancer with KRAS G12 mutations. This designation underscores the large unmet medical needs for patients living with pancreatic cancer and the urgency of advancing development of Durexanracib on behalf of patients. Toward this objective, we continue to make progress across our active and planned Draxon RACIB registrational studies in pancreatic cancer. First, RASLUTE302, our ongoing global phase three trial in patients with second-line metastatic pancreatic ductal adenocarcinoma, or PDAC, has been enrolling well, and we expect to complete enrollment this year to enable an expected data readout in 2026. Notably, With robust contributions by U.S. investigational sites to date, we are winding down enrollment in the U.S. while continuing to enroll patients outside the U.S. to ensure we have a reasonable geographic mix to support global registration. Second, we continue progressing toward initiating our first-line metastatic pancreatic cancer registrational trial, which we plan to conduct as a three-arm trial, comparing duraxone RACIB or Deraxon RACIB plus chemotherapy to chemotherapy. Later this year, we expect to share the trial design and clinical combination data that inform this plan and to initiate the trial. Third, we also continue progressing toward a registrational trial with Deraxon RACIB as adjuvant treatment for patients with resectable PDAC. And later this year, we expect to share the trial design and initiate this trial as well. For patients with pancreatic cancer specifically bearing a RAS G12D mutation, the clinical activity and tolerability profile we've reported for Zoldon RASib is quite encouraging and suggests it is a remarkable inhibitor of this common cancer driver. We continue to follow patients in the ongoing monotherapy trial and are currently studying several combination treatments, including as part of a RASon inhibitor doublet with Deraxon RASib, in combination with standard of care regimens and with other novel targeted agents. For example, for patients with pancreatic cancers carrying both a RAS mutation and deletion of MTAP, Tango Therapeutics announced that a first patient was dosed in a collaborative phase one trial evaluating their PRM T5 inhibitor TNG462 with either Durexone RACID or Zoldone RACID. Such novel combinations have the potential to provide differentiated options for patients with these cancer genotypes. Moving to non-small cell lung cancer, Rasolut 301, our phase three trial of Durexon Ravcib in previously treated patients with Ras mutant non-small cell lung cancer continues enrolling patients in the U.S., and we are now activating trial sites in Europe and Japan as planned. Evaluating Deraxanracib in earlier lines of therapy for patients with non-small cell lung cancer is also an area of strategic priority for RevMed. We recently showed clinical evidence that Deraxanracib can be combined productively and tolerably with pembrolizumab with or without platinum doublet chemotherapy. With these results in hand, we're working toward initiating a registrational trial in first-line non-small cell lung cancer in 2026, and expect to share the trial design in connection with the initiation. Clinical development efforts also continue across our RAS on mutant selective inhibitors, Eliron RASib and Zoldon RASib in patients with RAS G12C or G12D non-small cell lung cancer, respectively. First, we recently reported an updated clinical data set from patients with previously treated KRAS G12C non-small cell lung cancer treated with Aliron Rassib as monotherapy that showed a highly competitive profile, including differentiated safety and tolerability, along with a compelling objective response rate and progression-free survival. We recently announced that Aliron Rassib was granted breakthrough therapy designation by the FDA for locally advanced or metastatic KRAS G12C non-cell lung cancer following prior systemic therapy, including anti-PD-1 and chemotherapy. This designation is a recognition of the significant unmet medical need and Aliron RACIB's potential to serve these patients. Currently, there are no RAS-targeted inhibitors with full FDA approval for treating patients with KRAS G12C non-small cell lung cancer. Second, we also recently expanded the clinical evidence supporting the potential benefit of combining Aliron RACIB with other inhibitors. In particular, the RAS-on inhibitor doublet of Aliron RACIB and Deraxon RACIB was shown to exhibit significant antitumor activity in advanced non-small cell lung cancer patients who had progressed on treatment with a KRAS G12C off-inhibitor. This observation mirrored similar findings that we had previously reported in patients with KRAS G12C colorectal cancer. Third, we showed clinical evidence that aliron racib can be combined productively with pembrolizumab and first-line non-small-cell lung cancer patients with an acceptable safety and tolerability profile. These findings suggest that Aliron RASib in various treatment configurations warrants evaluation in patients with RAS G12C non-small-cell lung cancer, and we continue work to prioritize among the multiple options for advancing development of this differentiated RAS on G12C inhibitor. Fourth, we continue to advance Zoldon RASIB for patients with RAS G12D non-small cell lung cancer. We recently shared promising data for patients with previously treated RAS G12D non-small cell lung cancer. We are following these patients and enrolling an expansion cohort to generate a robust data set. We are also evaluating its potential in combination settings to inform potential registration opportunities. Fifth, We were pleased to announce recently a new clinical collaboration with Summit Therapeutics to evaluate combinations of Summit's Ivanesumab, an advanced PD-1 VEGF bispecific antibody, with each of Deraxon RASIB, Valeron RASIB, and Zoldon RASIB. This collaboration builds on promising initial clinical evidence we have reported indicating that Deraxon RASIB and Aliron RASB can deliver additive anti-tumor activity with an acceptable safety and tolerability profile when combined with a PD-1 antibody. The new cohorts will assess whether combinations with a next generation PD-1 VEGF bispecific inhibitor can unlock further therapeutic impact. Beyond our first three clinical stage RASB inhibitors that are progressing nicely, the next asset we are preparing to enter clinical development is RMC5127, a RAS-on G12V selective inhibitor. We expect this program to be clinic-ready later this year to support the planned initiation of a Phase I trial in 2026. And we continue investing to produce next-generation assets to build on our momentum and support our commitment to creating the leading global RAS-targeted franchise. Among these investments are collaborations that will enhance our discovery efforts. This includes our work with Athon announced last year to discover novel bispecific antibodies that can complement Rasson inhibitors. We also recently announced a significant drug discovery collaboration with iambic to use their cutting edge AI capabilities and generate customized models through training with our proprietary data. This work may be particularly impactful by enhancing our lead discovery and optimization processes directed against both current and new drug targets. This exciting collaboration brings together AI and our well-validated drug discovery capability to help ensure that we continue building a highly impactful and sustainable pipeline. The progress I've outlined today is enabled by a strong operational foundation and the capabilities talent, and financial wherewithal needed to scale the efforts to meet the ever-growing opportunities afforded by our pipeline. Our position of financial strength has been meaningfully bolstered by our recently announced partnership with Royalty Pharma. This partnership supplements our strong balance sheet by providing us with an additional $2 billion in committed capital through a highly flexible mix of synthetic royalty and debt instruments which are available to us upon achievement of agreed upon milestones. This capital access gives us the firepower, autonomy, and strategic agility we need to advance our ambitious clinical development and commercialization plans. Importantly, it also provides the financial muscle behind the commitment we announced for RevMed to direct and execute independently on a global development and commercialization strategy for our promising RAS-targeted portfolio. This financial strength, combined with our maturing pipeline and organizational capabilities, empower our intention to become a fully integrated global oncology company that discovers, develops, and delivers innovative targeted therapies on behalf of patients worldwide living with RAS-addicted cancers. I'd now like to turn the call over to Jack to provide more specifics on our Royalty Pharma partnership and summarize our second quarter results. Jack?
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