Revolution Medicines(RVMD)

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Revolution Medicines(RVMD) - 2022 Q3 - Quarterly Report
2022-11-07 21:06
Drug 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]
Revolution Medicines(RVMD) - 2022 Q2 - Earnings Call Transcript
2022-08-10 01:01
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]
Revolution Medicines(RVMD) - 2022 Q2 - Earnings Call Presentation
2022-08-09 22:27
A u g u s t 9 , 2022 On Target to Outsmart Cancer TM © 2022 Revolution Medicines Legal Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective products, availability of funding, ability to maintain existing collaborations, incl ...
Revolution Medicines(RVMD) - 2022 Q2 - Quarterly Report
2022-08-09 20:12
RAS Inhibitors 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 [103]. - The RAS(ON) inhibitors portfolio includes four compounds: RMC-6236, RMC-6291, RMC-9805, and RMC-8839, with RMC-6236 expected to show first-in-class single agent activity in 2023 [106][110]. - RMC-6291 is designed to be a potent, selective inhibitor of KRAS G12C(ON) with subnanomolar potency, with first patient dosing expected in the second half of 2022 [107]. - RMC-9805 targets KRAS G12D(ON) and is planned for first patient dosing in mid-2023, while RMC-8839's dosing timeline is yet to be determined [109][110]. - 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 topline data expected in 2023 [111][113]. - The company plans to focus development resources on RAS(ON) inhibitors and RAS companion inhibitors through 2023 [110]. - The company is pursuing pipeline expansion programs targeting additional KRAS variants and other relevant pathways [110]. - RMC-5552 is being evaluated as a monotherapy in a Phase 1 study, with additional evidence of single agent activity expected in 2023 [115][116]. Financial Performance - Collaboration revenue for Q2 2022 was $9.1 million, a 5% increase from $8.7 million in Q2 2021, but a decrease of $2.1 million, or 11%, for the first half of 2022 compared to the same period in 2021 [138]. - Research and development expenses increased by $15.1 million, or 33%, in Q2 2022 compared to Q2 2021, primarily due to higher third-party costs and increased employee-related expenses [139]. - Total operating expenses for Q2 2022 were $71.2 million, an increase of $17.9 million, or 34%, from $53.2 million in Q2 2021 [137]. - The net loss for Q2 2022 was $61.2 million, compared to a net loss of $44.3 million in Q2 2021, reflecting an increase of $16.9 million [137]. - As of June 30, 2022, the company had $461.4 million in cash, cash equivalents, and marketable securities [150]. - The accumulated deficit as of June 30, 2022, was $571.5 million, with ongoing expenses expected to increase due to continued product development [151]. - The company received a total of $166.4 million from Sanofi through upfront payments and research and development reimbursements as of June 30, 2022 [127]. - General and administrative expenses increased by $2.9 million, or 40%, in Q2 2022 compared to Q2 2021, driven by higher stock-based compensation and legal fees [141]. - Interest income increased by $0.6 million in Q2 2022 compared to Q2 2021, attributed to higher interest rates [143]. - The company expects research and development expenses to continue to rise as it advances product candidates into later stages of development [133]. - Cash used in operating activities for the six months ended June 30, 2022, was $110.9 million, compared to $71.3 million for the same period in 2021, reflecting a net loss of $118.9 million [156]. - Cash provided by investing activities for the six months ended June 30, 2022, was $106.4 million, primarily from maturities of marketable securities totaling $350.3 million [159]. - Cash provided by financing activities for the six months ended June 30, 2022, was $1.7 million, significantly lower than $283.1 million in the same period of 2021 [161]. - The company expects to require substantial additional funding for research and development activities and ongoing operations, with potential dilution of existing stockholders' interests if additional capital is raised through equity offerings [154]. - As of June 30, 2022, the company held cash, cash equivalents, and marketable securities totaling $461.4 million, down from $577.1 million as of December 31, 2021 [172]. - The company incurred non-cash charges of $20.0 million during the six months ended June 30, 2022, primarily due to stock-based compensation expenses of $14.7 million [156]. Risk Factors - The company is subject to interest rate risk, but historical fluctuations in interest income have not been significant, with an immediate one percent change in interest rates not materially affecting the fair value of cash equivalents and marketable securities [172]. - The company has contractual obligations related to office and laboratory space leases in Redwood City, California, and Cambridge, Massachusetts [163]. - The company has not entered into any off-balance sheet arrangements as defined in Item 303 of Regulation S-K [165]. - The company is exposed to foreign currency risk due to limited contracts with vendors for research and development services denominated in foreign currencies, but such risks have not been material to financial results [173]. Collaboration with Sanofi - The company has a collaboration agreement with Sanofi, which includes an upfront payment of $50 million and potential milestone payments up to $520 million [124]. - Sanofi is responsible for the commercialization of SHP2 inhibitors globally, with the company retaining co-promotion rights in the U.S. [122].
Revolution Medicines(RVMD) - 2022 Q1 - Earnings Call Transcript
2022-05-10 08:00
Revolution Medicines, Inc. (NASDAQ:RVMD) Q1 2022 Earnings Conference Call May 9, 2022 4:30 PM ET Company Participants David Errington - Senior Vice President of Investor Relations & Corporate Affairs Mark Goldsmith - Chairman & Chief Executive Officer Jack Anders - Senior Vice President of Finance Conference Call Participants Marc Frahm - Cowen & Company Michael Smith - Guggenheim Christopher Zap - Goldman Sachs Jonathan Chang - SVB Leerink Operator Good day. My name is Katherine, and I'll be your conferenc ...
Revolution Medicines(RVMD) - 2022 Q1 - Quarterly Report
2022-05-09 20:13
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___ to ___ Commission File Number: 001-39219 Revolution Medicines, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of i ...
Revolution Medicines(RVMD) - 2021 Q4 - Earnings Call Transcript
2022-03-01 00:52
Financial Data and Key Metrics Changes - The company ended 2021 with $577 million in cash and investments, with revenue from collaboration agreements totaling $9.5 million for Q4 2021 and $29.4 million for the full year [42] - Total operating expenses for Q4 2021 increased to $62 million, primarily driven by R&D expenses of $54 million, while total operating expenses for the full year rose to $217 million, with R&D expenses increasing to $187 million [44] - The net loss for Q4 2021 was $53 million or $0.71 per share, and for the full year, the net loss was $187 million or $2.57 per share [45] - For 2022, the company expects a GAAP net loss between $260 million and $290 million, including estimated non-cash stock-based compensation of $35 million to $40 million [46] Business Line Data and Key Metrics Changes - The company is advancing its RAS (ON) inhibitor portfolio, which includes several drug candidates targeting RAS-addicted cancers, particularly focusing on KRAS mutations [5][10] - RMC-6236, the first RAS (ON) inhibitor, is in late stages of IND preparation, with plans to submit an IND in the coming months [11] - RMC-6291, a selective inhibitor for KRAS G12C, is also expected to submit an IND in the first half of 2022 [14] Market Data and Key Metrics Changes - The company targets over 130,000 new pancreatic, colorectal, and lung cancer patients in the US each year with tumors bearing various KRAS mutations [9] - RMC-6291 is aimed at approximately 29,000 new US patients per year, primarily with lung or colorectal cancers [13] Company Strategy and Development Direction - The company aims to combine RAS (ON) inhibitors with companion inhibitors to enhance clinical outcomes for patients with RAS-addicted cancers [21] - The strategy includes developing specific KRAS companion inhibitors to suppress cooperating targets and pathways that sustain RAS-addicted cancers [21] - The company is focused on expanding its pipeline with distinctive new assets derived from its RAS cancer innovation engine [40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to aggressively pursue its mission for cancer patients, supported by a strong balance sheet and a compelling strategy [48] - The management highlighted the importance of addressing resistance mechanisms in RAS-mutant cancers and the potential for combination therapies to improve patient outcomes [28][30] Other Important Information - The company has initiated a global Phase 2 study of RMC-4630 in combination with sotorasib for KRAS G12C lung cancer patients [25] - RMC-5552, an innovative mTORC1 inhibitor, is in the dose escalation phase of its initial clinical trial, showing promising anti-tumor activity [36] Q&A Session Summary Question: How many addressable second line non-small cell lung cancer KRAS G12C patients are there in the US? - The company acknowledged the complexity of the question and suggested discussing it offline [52] Question: How does targeting just mTORC1 compare to targeting both mTORC1 and mTORC2? - The company explained that RMC-5552 selectively inhibits mTORC1 without the toxicity associated with mTORC2, allowing for higher dosing and better therapeutic effects [56] Question: How different are the pharmacokinetics of the KRAS inhibitors? - The company noted that pharmacokinetics vary among their RAS (ON) inhibitors, influenced by factors such as affinity for cyclophilin A and whether the warhead is covalent or non-covalent [64] Question: What are the expectations for the preliminary data readout from RMC-4630? - The company plans to treat up to 46 patients in the RMC-4630-03 study, with a focus on overall response rate as the primary outcome measure [69] Question: Will there be an accelerated pathway for RMC-4630? - The company indicated that options for accelerated approval are being explored, particularly for RAS inhibitors outside of the G12C space, which may have more straightforward pathways due to the lack of existing therapies [91] Question: Can you discuss the bioavailability and dosing for RMC-9805? - The company reported good pharmacodynamic effects in preclinical models, with expectations for once-daily dosing in humans, though actual dosing will depend on clinical pharmacokinetics [97]
Revolution Medicines(RVMD) - 2021 Q4 - Annual Report
2022-02-28 21:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39219 Registrant's telephone number, including area code: (650) 481-6801 Securities registered pursuant to Section 12(b) of the Act: ...
Revolution Medicines (RVMD) Investor Presentation - Slideshow
2022-02-12 14:42
Pipeline and Clinical Development - Revolution Medicines is developing RAS(ON) inhibitors and RAS companion inhibitors to target RAS-addicted cancers [6, 12] - RMC-6236, a RASMULTI(ON) inhibitor, shows robust anti-tumor activity in preclinical models with various KRASG12X drivers, with objective response rates (ORR) of 38% (5/13) in NSCLC, 57% (8/14) in PDAC, and 62% (8/13) in CRC models [24] - RMC-6291, a KRASG12C inhibitor, demonstrates superior outcomes in mouse clinical trials with KRASG12C NSCLC models, showing a 72% (18/25) ORR compared to 52% (13/25) for Adagrasib [47, 48] - RMC-9805, a KRASG12D inhibitor, exhibits tumor regressions in preclinical models of KRASG12D cancers [70, 71] - RMC-8839, a KRASG13C inhibitor, shows tumor regressions in preclinical models of KRASG13C cancers [82, 83] Market and Financial Position - RAS proteins drive 30% of human cancers, representing a high unmet need [6, 8, 108] - The company estimates 137,000 new KRASG12X patients per year in the U S [20] - The company estimates 29,000 new KRASG12C patients per year in the U S [43] - The company estimates 55,000 new KRASG12D patients per year in the U S [62] - The company estimates 3,000 new KRASG13C patients per year in the U S [74] - As of September 30, 2021, Revolution Medicines had $608 7 million in cash, cash equivalents, and marketable securities, expected to fund operations to the end of 2023 [106]
Revolution Medicines(RVMD) - 2021 Q3 - Earnings Call Presentation
2021-11-16 16:22
RMC-6291 (KRASG12C Inhibitor) - RMC-6291 is a potent and selective inhibitor of KRASG12C, with a median EC50 of 0.1 nM in KRASG12C cells and a selectivity of 12,700-fold over non-KRASG12C cells[23] - In a mouse clinical trial with KRASG12C NSCLC xenografts, RMC-6291 achieved a 68% overall response rate (ORR) (13/19)[29] - RMC-6291 is active against all reported second-site KRASG12C(OFF) inhibitor resistance mutations[40] - The IND submission for RMC-6291 is projected for 1H2022[44] RMC-6236 (RASMULTI Inhibitor) - RMC-6236 is a potent, oral, RAS-selective tri-complex RASMULTI(ON) inhibitor, with IC50 values ranging from 0.4-3 nM for pERK and 1-27 nM for CTG in RAS-dependent cells[48] - In preclinical studies, RMC-6236 demonstrated a 62% ORR (8/13) and 100% disease control rate (DCR) (13/13) in diverse RAS pathway mutant tumors[53] - RMC-6236 drove regressions in KRASG12X PDAC tumor models in vivo, with a 57% ORR (8/14) and 86% DCR (12/14)[57] - RMC-6236 also drove regressions in KRASG12X CRC tumor models in vivo, with a 38% ORR (5/13) and 54% DCR (7/13)[61] - The IND submission for RMC-6236 is projected for 1H2022[70] Financial Status - As of September 30, 2021, Revolution Medicines had $608.7 million in cash, cash equivalents, and marketable securities[114] - The company projects a 2021 GAAP net loss of $170 million to $190 million, including approximately $20 million in non-cash stock-based compensation[114]