Revolution Medicines(RVMD) - 2022 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - In Q2 2022, the company reported a net loss of $61.2 million, or $0.82 per share, compared to a loss of $X million in the prior year period [29] - Revenue from the collaboration agreement with Sanofi was $9.1 million in Q2 2022, up from $8.7 million in the prior year [28] - Total operating expenses for Q2 2022 were $71.2 million, an increase of 34% over the prior year [28] - The company updated its 2022 GAAP net loss guidance to between $260 million and $280 million, lowering the top end by $10 million [27] Business Line Data and Key Metrics Changes - The company advanced two drug candidates from its RAS(ON) Inhibitor portfolio into clinical development, with RMC-6236 now dosing patients and RMC-6291 preparing to begin dosing [22][12] - RMC-6236 is designed to inhibit a wide range of RAS proteins and is the first development candidate from the RAS(ON) Inhibitor portfolio to enter clinical development [9] - RMC-6291 is a selective covalent inhibitor targeting the KRASG12C variant, with extensive preclinical data supporting its antitumor profile [11] Market Data and Key Metrics Changes - The company is focusing on RAS-addicted cancers, which represent 30% of all human cancers, and aims to address the unmet needs of patients with these types of cancers [6] - The company is also evaluating RAS companion inhibitors, RMC-4630 and RMC-5552, which have shown clinical evidence of antitumor activity [13] Company Strategy and Development Direction - The company completed an equity financing raising gross proceeds of $265 million to strengthen its balance sheet and support ongoing development [16] - The focus for 2022 and 2023 will be on advancing the three most advanced RAS(ON) Inhibitors and two clinical-stage RAS companion inhibitors [17] - The company plans to nominate its next RAS(ON) Inhibitor development candidate in the second half of 2022 [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to fulfill its mission for cancer patients, emphasizing a science-driven approach to treating RAS-addicted cancers [32] - The company expects to deliver on important milestones in the coming period, including evidence of first-in-class activity for RMC-6236 and dosing of the first patient in studies for RMC-6291 and RMC-9805 [20][21] Other Important Information - The company maintains a strong commitment to research activities that provide critical scientific insights to support ongoing development [18] - The upcoming milestones for the RAS(ON) Inhibitor portfolio include providing evidence of single-agent activity for RMC-6236 in 2023 and dosing the first patient in monotherapy studies for RMC-6291 and RMC-9805 [20] Q&A Session Summary Question: How does the company weigh the pros and cons of using limited resources for expanding positive signals with combinations versus proof-of-concept for the platform? - Management indicated that the priority is to move additional RAS(ON) inhibitors into the clinic while also considering specialized inhibitors targeting specific mutants [36] Question: What are the gating factors for expanding into combinations with RMC-4630 and RMC-5552? - Management stated that they need sufficient information to believe they have an active drug and a good sense of the dosing schedule before starting combination programs [42] Question: Can the company provide details on the dose of RMC-4630 being taken forward in the context of the combination study? - Management confirmed that the plan is to dose escalate to 200 mg and continue expanding at that level until a clear RAS signal is observed [49] Question: How will the company prioritize which RAS(ON) inhibitors to advance? - Management explained that they will create a basket of additional development candidates and prioritize based on learnings from the initial three RAS(ON) inhibitors [56] Question: Can the company provide updates on the Phase 2 RMC-4630-03 study? - Management clarified that they will provide top-line data rather than interim updates, focusing on overall response rate and durability of response [63][66] Question: What are the enrollment criteria for the Phase 1 RMC-6291 study? - Management indicated that the eligibility criteria are similar to the CodeBreaK 101 study, allowing for both previously treated and KRAS inhibitor naive patients [72] Question: Is the observed tolerability profile of combining KRAS inhibitors and PD-1s a class effect or specific to individual molecules? - Management noted that while it is hard to tell, there may be a class effect due to shared chemical features among first-generation G12C inhibitors [80]