Revolution Medicines(US:RVMD)2022-11-07 21:06Drug Development - The company is advancing three development-stage candidates as the first wave of RAS(ON) Inhibitors, including RMC-6236, RMC-6291, and RMC-9805, with expectations to provide evidence of first-in-class activity for these compounds in 2023[106][107][109] - RMC-6236 is designed to inhibit multiple RAS(ON) variants and is currently undergoing a monotherapy dose-escalation study[106] - RMC-6291 targets KRAS G12C(ON) with subnanomolar potency and has begun patient dosing in a monotherapy dose-escalation study, with preliminary evidence of superior activity expected in 2023[107] - RMC-9805 is designed to covalently inactivate KRAS G12D(ON) and is expected to announce dosing of the first patient in mid-2023[109] - The company is collaborating with Sanofi on RMC-4630, a SHP2 inhibitor, with multiple active clinical studies evaluating its combination with RAS inhibitors[111][113] - RMC-4630-03, a Phase 2 study of RMC-4630 in combination with sotorasib, is planned to release topline data in the second half of 2023[113] - The company is pursuing pipeline expansion programs targeting additional KRAS mutations, including KRAS G12R, G12V, G13D, and Q61X[110] - RMC-5552, another RAS Companion Inhibitor, is being evaluated as a monotherapy in a Phase 1 study, with additional evidence of single-agent activity expected in 2023[116][117] - RMC-5845, targeting SOS1, is ready for IND preparation and is under evaluation for advancement into clinical development[118] Financial Performance - Collaboration revenue for the three months ended September 30, 2022, was $3.356 million, a 205% increase from $1.101 million in the same period of 2021[138] - Total revenue for the nine months ended September 30, 2022, was $20.050 million, reflecting a $0.120 million increase from $19.930 million in the same period of 2021[138] - Research and development expenses increased by $23.0 million, or 49%, during the three months ended September 30, 2022, compared to the same period in 2021[142] - General and administrative expenses rose by $2.6 million, or 34%, during the three months ended September 30, 2022, compared to the same period in 2021[145] - Interest income increased by $2.7 million during the three months ended September 30, 2022, compared to the same period in 2021, due to a larger cash and marketable securities balance[147] - The net loss for the three months ended September 30, 2022, was $73.329 million, compared to a net loss of $52.940 million in the same period of 2021[138] - Research and development expenses for the nine months ended September 30, 2022, totaled $186.946 million, a $53.679 million increase from $133.267 million in the same period of 2021[143] - General and administrative expenses for the nine months ended September 30, 2022, were $29.676 million, reflecting a $7.918 million increase from $21.758 million in the same period of 2021[146] - The company expects research and development expenses to increase in the foreseeable future as it continues to invest in product candidates[134] - The company received an aggregate of $172.0 million from Sanofi through September 30, 2022, including the upfront payment and research and development expense reimbursements[128] - As of September 30, 2022, the company had $655.0 million in cash, cash equivalents, and marketable securities[154] - The accumulated deficit as of September 30, 2022, was $644.8 million, with cash used in operating activities amounting to $162.6 million for the nine months ended September 30, 2022[155][160] - Cash provided by financing activities for the nine months ended September 30, 2022, was $250.1 million, primarily from a follow-on offering[164] - The company expects to need substantial additional funding for research and development activities and ongoing operations[157] - Cash used in investing activities for the nine months ended September 30, 2022, was $17.0 million, with significant purchases of marketable securities[162] - The company anticipates that existing cash and marketable securities will fund planned operations for at least 12 months following the report date[156] - The net cash change for the nine months ended September 30, 2022, was an increase of $70.4 million[159] - The company incurred a net loss of $192.2 million during the nine months ended September 30, 2022[160] Contractual Obligations - The company has contractual obligations related to office and laboratory space leases in California and Massachusetts[166] - The company has not entered into any off-balance sheet arrangements as defined in Item 303 of Regulation S-K[168]