Revolution Medicines(US:RVMD)2021-11-10 21:11Drug Development - The company is focused on developing RAS(ON) inhibitors and RAS Companion Inhibitors to target RAS-addicted cancers, leveraging proprietary technologies and a deep understanding of cancer biology [116]. - RMC-6291 and RMC-6236, the company's RAS(ON) inhibitors, are in IND-enabling preclinical development, with plans to submit INDs in the first half of 2022 [118]. - RMC-4630, a RAS Companion Inhibitor, is being evaluated in multiple clinical studies, including a Phase 1b study in combination with Amgen's sotorasib, with a target dose of 200 mg [120][121]. - The company expects preliminary findings from the RMC-4630-03 study, which targets non-small cell lung cancer patients with KRASG12C mutations, by the end of 2022 [123]. - RMC-5552, another RAS Companion Inhibitor, is in a Phase 1 study, with initial data expected in 2022 [128]. - RMC-5845, targeting SOS1, is in the IND-enabling stage and expected to be IND-ready in the second half of 2021 [130]. - The company plans to nominate a third RAS(ON) Inhibitor as a development candidate in the second half of 2021 [118]. - The company has deprioritized the RMC-4630-02 study, which included combinations with MEK and EGFR inhibitors, and will not enroll additional patients [127]. Financial Performance - Collaboration revenue decreased by $11.6 million, or 91%, during the three months ended September 30, 2021, compared to the same period in 2020, and decreased by $14.3 million, or 42%, during the nine months ended September 30, 2021 [156]. - Research and development expenses increased by $11.6 million, or 33%, during the three months ended September 30, 2021, primarily due to a $7.1 million increase in third-party costs and a $2.6 million increase in salaries [157]. - General and administrative expenses increased by $2.4 million, or 46%, during the three months ended September 30, 2021, primarily due to an increase in stock-based compensation and salaries [159]. - As of September 30, 2021, the company had $608.7 million in cash, cash equivalents, and marketable securities [171]. - The accumulated deficit as of September 30, 2021, was $400 million, with primary cash usage for operating expenses related to research and development [172]. - The company expects research and development expenses to increase as it continues to invest in product candidates and advance them into later stages of development [148]. - Interest income decreased by $0.1 million and $1.3 million during the three and nine months ended September 30, 2021, respectively, due to lower interest rates [162]. - The company received an aggregate of $147.2 million from Sanofi, including upfront payments and research and development expense reimbursements [170]. - Cash used in operating activities for the nine months ended September 30, 2021, was $107.9 million, compared to $75.0 million for the same period in 2020, reflecting a net loss of $134.1 million in 2021 [177][178]. - Cash used in investing activities for the nine months ended September 30, 2021, was $150.7 million, primarily due to purchases of marketable securities totaling $560.5 million [179]. - Cash provided by financing activities for the nine months ended September 30, 2021, was $283.5 million, mainly from net proceeds of $281.1 million from a public offering [181]. - The company held cash, cash equivalents, and marketable securities of $608.7 million as of September 30, 2021, up from $440.7 million at the end of 2020 [197]. - Total contractual obligations as of September 30, 2021, amounted to $43.4 million, with $5.1 million due within one year [183]. - The company has a lease agreement for additional office and laboratory space, with an annual base rent of approximately $2.7 million, increasing by 3.5% each subsequent year [185]. - Non-cash charges in operating activities for the nine months ended September 30, 2021, included stock-based compensation of $14.5 million and depreciation of $2.3 million [177]. - The company experienced a net change of $4.2 million in operating assets and liabilities during the nine months ended September 30, 2021 [177]. - The company has not entered into any off-balance sheet arrangements as defined in Item 303 of Regulation S-K [188]. - Foreign currency transaction gains and losses have not been material to the company's consolidated financial statements, with no formal hedging program in place [198]. Collaboration and Agreements - The Sanofi Agreement includes an upfront payment of $50 million and potential milestone payments up to $520 million, with profit-sharing on commercialization in the U.S. [137]. - The company is responsible for early clinical development of RMC-4630, while Sanofi handles regulatory activities and commercialization [132][135]. - The company entered into a sales agreement to sell shares of common stock with aggregate gross sales proceeds of up to $250.0 million [169]. - The company believes that existing cash, cash equivalents, and marketable securities will fund planned operations for at least 12 months following the report date [173].