The webcast will take place at 8:00 a.m. Eastern Time on Monday, July 15, 2024. To access the live webcast, please visit the "Events & Presentations" page of Revolution Medicines' website at https://ir.revmed.com/events-and-presentations. Additionally, a replay of the webcast will be available on the "Events & Presentations" page of the Revolution Medicines website for at least 14 days following the event. About Revolution Medicines, Inc. REDWOOD CITY, Calif., July 08, 2024 (GLOBE NEWSWIRE) -- Revolution Me ...

NEW YORK, July 8, 2024 /PRNewswire/ -- Purcell & Lefkowitz LLP announces that it is investigating Revolution Medicines, Inc. (NASDAQ: RVMD) on behalf of the company's shareholders. The investigation seeks to determine whether Revolution Medicines's directors breached their fiduciary duties in connection with recent corporate actions. If you are a shareholder of Revolution Medicines, Inc. and are interested in obtaining additional information regarding your rights and options, free of charge, please visit us ...

Financial Data and Key Metrics Changes - The company ended Q1 2024 with $1.7 billion in cash and investments, down from $1.85 billion at the end of 2023, primarily due to net loss and a decrease in accounts payable and accrued liabilities [15][34] - R&D expenses for Q1 2024 were $118.0 million, compared to $68.9 million in Q1 2023, driven by clinical trial expenses [34] - The net loss for Q1 2024 was $116.0 million, or $0.70 per share, with a projected full-year GAAP net loss expected to be between $480 million and $520 million [35] Business Line Data and Key Metrics Changes - The company is focused on advancing RMC-6236 into pivotal monotherapy trials for major cancers driven by oncogenic RAS variants, with updates expected in the second half of the year [23][24] - RMC-6236 is being evaluated in combination studies for pancreatic and colorectal cancers, which are crucial for establishing first-line registrational paths [9][10] Market Data and Key Metrics Changes - The company anticipates that the first registrational studies for RMC-6236 will launch in the second half of the year, targeting advanced pancreatic cancer and non-small cell lung cancer [14][24] - The competitive landscape includes other KRAS G12C inhibitors, but the company believes that RMC-6236 will provide a treatment option for patients without G12C mutations [42][44] Company Strategy and Development Direction - The company has outlined three strategic priorities for 2024: advancing RMC-6236 into pivotal trials, expanding its reach beyond G12X mutations, and qualifying its first two RAS(ON) mutant-selective inhibitors [4][25][28] - The company is exploring combination therapies to enhance treatment efficacy and is committed to moving RMC-6236 into earlier lines of therapy [27][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of RMC-6236, citing complete responses in some patients and the importance of targeting RAS addiction [26][32] - The company is well-capitalized and focused on delivering key data to advance its clinical programs, with a strong emphasis on safety and efficacy in combination therapies [36][37] Other Important Information - The company presented data at the AACR Annual Meeting, highlighting the potential of RMC-6236 across various RAS genotypes and tumor types [25][80] - Management emphasized the importance of establishing safety profiles for combination therapies before moving forward with clinical development [106][107] Q&A Session Summary Question: What questions are still being addressed for the pancreatic cancer study design? - The company needs to reach an agreement with the FDA on dosing and trial design, which are expected to be resolved in the first half of the year [37] Question: Will the first-line study wait for second-line trial results? - The company is evaluating both monotherapy and combination options for first-line treatment but has not made a definitive decision yet [39] Question: How might the KRYSTAL 12 trial results impact the company's studies? - The company believes that the impact will be minimal for pancreatic cancer, as G12C represents a small subpopulation [42] Question: What is the expected timeline for initial data from the RMC-6236 and pembrolizumab combination? - Initial safety data will likely not be from first-line patients, but the study is designed to enable a first-line strategy [46][51] Question: What is the company's approach to business development? - The company is committed to U.S. operations and plans to commercialize its compounds independently, while seeking partners for international markets [117][124]

Drug Development and Clinical Trials - The company is developing a pipeline of RAS(ON) inhibitors, including RMC-6236, RMC-6291, and RMC-9805, targeting various RAS mutations[106] - RMC-6236 demonstrated dose-dependent increases in exposure and reductions in circulating tumor DNA (ctDNA) variant allele frequency, indicating anti-tumor activity[108] - Preliminary evidence of clinical activity for RMC-6236 was observed in pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC) patients[109] - RMC-6291 showed preliminary clinical activity in KRAS G12C NSCLC and colorectal cancer (CRC) patients, with a correlation between ctDNA reduction and clinical response[119] - The company plans to initiate global randomized registrational trials for RMC-6236 in PDAC and NSCLC in the second half of 2024[114][115] - RMC-9805 demonstrated favorable tolerability with no dose-limiting toxicities reported, and initial clinical data is expected in the second half of 2024[124][125] - RMC-4630 is being evaluated in combination with Amgen's KRAS(OFF) G12C agent in a Phase 1b study, with additional studies being wound down[131] - RMC-5552 showed meaningful anti-tumor activity while avoiding toxicities associated with mTORC2 inhibition[134] - RMC-5845 is ready for Investigational New Drug (IND) application preparation based on preclinical development[137] Financial Performance and Expenses - Collaboration revenue decreased by $7.0 million, or 100%, in Q1 2024 compared to Q1 2023 due to the termination of the Sanofi Agreement[152] - Research and development expenses increased by $49.1 million, or 71%, in Q1 2024 compared to Q1 2023, primarily driven by increased costs in clinical trials and employee-related expenses[153][156] - General and administrative expenses rose by $9.6 million, or 73%, in Q1 2024 compared to Q1 2023, mainly due to higher personnel-related costs and pre-commercial development expenses[156] - Interest income increased by $16.7 million in Q1 2024 compared to Q1 2023, attributed to a larger balance of cash and marketable securities and higher interest rates[157] - The accumulated deficit as of March 31, 2024, was $1.3 billion, with ongoing expenses expected to increase due to continued product development[164] - Research and development expenses for RMC-6236 increased by $17.5 million in Q1 2024 compared to Q1 2023, reflecting higher clinical trial costs[153] - The company expects general and administrative expenses to rise due to anticipated increases in operating and commercial preparation activities[147] - Other expense increased by $2.8 million in Q1 2024 due to an impairment of a long-term asset acquired in the EQRx Acquisition[158] Cash Flow and Funding - Cash used in operating activities for Q1 2024 was $160.6 million, compared to $62.4 million in Q1 2023, reflecting a significant increase in net loss from $68.1 million to $116.0 million[167][169] - Cash used in investing activities in Q1 2024 amounted to $248.0 million, primarily due to purchases of marketable securities totaling $701.7 million, while cash provided in Q1 2023 was only $4.0 million[170][171] - Cash provided by financing activities in Q1 2024 was $0.8 million, a substantial decrease from $324.2 million in Q1 2023, which included proceeds from a public offering[172][173] - The company held cash, cash equivalents, and marketable securities of $1.7 billion as of March 31, 2024, down from $1.9 billion at the end of 2023[182] - A net change of $47.2 million in operating assets and liabilities contributed to the cash used in operating activities, primarily due to a $29.0 million decrease in accounts payable[167] - Non-cash charges in Q1 2024 included stock-based compensation expense of $16.2 million and a $2.8 million impairment related to the EQRx Acquisition[168] - The company anticipates needing substantial additional funding for ongoing clinical development and commercialization efforts, which may lead to dilution of existing stockholders' interests if raised through equity offerings[165] Acquisition and Portfolio Enhancement - The acquisition of EQRx, Inc. was completed on November 9, 2023, enhancing the company's portfolio[138] - EQRx Acquisition resulted in the issuance of 54.8 million shares and $1.1 billion in net cash, cash equivalents, and marketable securities after costs[140][162] Financial Structure and Risk Management - The company has not entered into any off-balance sheet arrangements, indicating a straightforward financial structure[176] - There have been no material changes to critical accounting estimates since the 2023 Form 10-K, ensuring consistency in financial reporting[179] - The company is exposed to interest rate risk but maintains a portfolio of high-quality, short-term securities to mitigate this risk[181]

Exhibit 99.1 Revolution Medicines Reports First Quarter 2024 Financial Results and Update on Corporate Progress Revolution Medicines to hold webcast today at 4:30 p.m. Eastern Time REDWOOD CITY, Calif., May 8, 2024 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced its financial results for the quarter ended March 31, 2024, and provided an update on corporate progress. The comp ...

Financial Data and Key Metrics Changes - The company ended 2023 with $1.85 billion in cash and investments, expected to fund operations into 2027 [18] - Collaboration revenue for Q4 2023 was $0.7 million, down from $15.3 million in the prior year quarter, and full-year revenue was $11.6 million compared to $35.4 million in the previous year [19] - Total operating expenses for Q4 2023 increased to $180.7 million, driven by R&D expenses totaling $148.5 million, while full-year operating expenses reached $498.8 million [26] - The net loss for Q4 2023 was $161.5 million, or $1.14 per share, and for the full year, the net loss was $436.4 million, or $3.86 per share [27][28] Business Line Data and Key Metrics Changes - The company reported favorable trends in aggregate objective response rates (ORR) for RMC-6236 in non-small cell lung cancer, reaching the low to mid-40s range, and in pancreatic ductal adenocarcinoma, trending into the mid-20s [12][13] - RMC-9805, an oral G12D selective inhibitor, has confirmed oral bioavailability in patients, with no dose-limiting toxicities reported [16][17] Market Data and Key Metrics Changes - The company is expanding the reach of RMC-6236 to include patients with tumors harboring RAS mutations beyond G12X, including G13X and Q61X mutations, and studying it in various tumor types beyond lung and pancreatic cancer [14] Company Strategy and Development Direction - The company has three strategic priorities for 2024: advancing RMC-6236 into pivotal trials, expanding its reach, and qualifying RMC-6291 and RMC-9805 for late-stage development [11][15] - The company aims to propel RMC-6236 into its first pivotal trial against standard-of-care chemotherapy for RAS-mutated non-small cell lung cancer and pancreatic ductal adenocarcinoma [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong balance sheet and pipeline, emphasizing the commitment to developing targeted therapies for patients with RAS-addicted cancers [24][29] - The company anticipates disclosing initial clinical data for RMC-6236 and its combinations in the second half of 2024, with a focus on safety and efficacy [15][40] Other Important Information - The company reported that the increase in expected GAAP net loss for 2024 is due to increased expenses associated with ongoing clinical development programs [28] - Management highlighted the importance of establishing a safety profile for combinations with checkpoint inhibitors before moving into first-line treatment settings [33] Q&A Session Summary Question: What data is needed to move combinations with pembrolizumab into pivotal development? - Management is primarily looking to validate safety, particularly concerning hepatotoxicity signals [33] Question: How much more data is needed to support initiation of Phase 3 trials for RMC-6236? - A mature progression-free survival (PFS) assessment is required, along with FDA input [39] Question: What are the gating steps for starting a frontline pancreatic combination study? - The company is exploring combinations with standard regimens like modified FOLFIRINOX and gem-ABRAXANE, focusing on response rates and survival benefits [54] Question: What is the primary endpoint for the Phase 3 trial in second-line pancreatic cancer? - The current thinking is to evaluate both PFS and overall survival (OS) as endpoints [64] Question: What indications should be expected for data updates from expansion cohorts? - Data will be provided for various RAS genotypes and tumor types, including colorectal cancer, in the second half of the year [72] Question: How does the company view partnering opportunities? - The company aims to build its own franchise in the U.S. but is open to partnerships outside the U.S. for commercialization [100][102]

RAS(ON) Inhibitors Development - The company is developing a pipeline of RAS(ON) inhibitors, including RMC-6236, RMC-6291, and RMC-9805, which are designed to target RAS-addicted cancers[24][40]. - RMC-6236 demonstrated dose-dependent increases in exposure and reductions in circulating tumor DNA (ctDNA) variant allele frequency, indicating anti-tumor activity[26]. - Preliminary evidence of clinical activity for RMC-6236 was observed in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) patients[27]. - The company expects to disclose updated clinical data for RMC-6236 in NSCLC and PDAC in the second half of 2024[29]. - RMC-6291 showed preliminary evidence of clinical activity in KRAS G12C NSCLC and colorectal cancer patients, with a correlation between ctDNA reduction and clinical response[36]. - The company plans to initiate a global randomized Phase 3 trial for RMC-6236 against docetaxel in RAS-mutated NSCLC patients in the second half of 2024[32]. - RMC-9805 demonstrated oral bioavailability and favorable tolerability results, with no dose-limiting toxicities reported[41]. - The company is pursuing pipeline expansion programs focused on additional RAS mutations, including G12R[43]. - RAS proteins drive 30% of human cancers, and the company's RAS(ON) inhibitors aim to address the unmet need in this area[49]. - The company believes its RAS(ON) inhibitors have the potential to deliver deeper anti-tumor activity and more durable clinical benefits compared to existing therapies[50]. - RAS mutant variants account for approximately 30% of all human cancers in the U.S., with an estimated 213,000 new RAS-mutant cancer diagnoses annually, indicating a significant market opportunity for RAS inhibitors[52]. Clinical Trials and Efficacy - The company is advancing RMC-6236 into Phase 3 pivotal studies, with plans for two monotherapy registration studies in second line NSCLC and PDAC, pending regulatory input[53]. - RMC-6236 is currently in a Phase 1/1b clinical study with 131 patients treated across nine dose cohorts (10 mg to 400 mg daily), showing it was generally well tolerated[60]. - The most common treatment-related adverse events (TRAEs) in the RMC-6236 study included rash (70%), nausea (42%), and diarrhea (32%), primarily Grade 1 or 2 in severity[63]. - As of the October 12, 2023 data cut-off, RMC-6236 demonstrated dose-dependent increases in exposure, with clinical exposures at doses of 80 mg and above comparable to those inducing tumor regressions in preclinical models[67]. - The company reported molecular responses in 27 patients with detectable baseline plasma KRAS G12X alleles, with reductions in KRAS variant allele frequency consistent with anti-tumor activity[67]. - RMC-6236 is designed as a potent, oral, RAS-selective tri-complex inhibitor targeting multiple RAS(ON) variants, including G12, G13, and Q61 mutations[58]. - The median duration of treatment for RMC-6236 was 2.1 months (range: 0.2–10.9) as of the latest data cut-off[70]. - RMC-6236 demonstrated an objective response rate (ORR) of 38% among efficacy-evaluable NSCLC patients, with a disease control rate (DCR) of 85%[79]. - Among efficacy-evaluable PDAC patients, the ORR was 20%, with a DCR of 87%[83]. - RMC-6291 showed a generally well-tolerated profile, with the most common TRAEs being diarrhea (29%) and nausea (27%) across 63 patients[89]. - In the RMC-6291 study, 50% of NSCLC patients previously treated with a KRAS(OFF) G12C inhibitor achieved a partial response[96]. - RMC-6291 demonstrated dose-dependent plasma pharmacokinetics and reduction in ctDNA of the KRAS G12C allele correlated with clinical response[92]. - As of the latest data cut-off, RMC-6291's ORR among efficacy-evaluable CRC patients naïve to KRAS(OFF) G12C inhibitors was 40%[102]. - RMC-6236 showed preliminary evidence of clinical activity in patients with KRAS mutations G12D, G12V, or G12R[74]. - The 300 mg daily dose of RMC-6236 appeared attractive for safety and antitumor activity in both NSCLC and PDAC settings[86]. - RMC-9805 showed deep tumor regressions and complete responses in preclinical studies across NSCLC, PDAC, and CRC models with KRAS G12D mutation[105]. Regulatory and Market Considerations - The company plans to retain significant development and commercialization rights for its product candidates and build necessary infrastructure over time[124]. - The FDA requires substantial time and financial resources for obtaining regulatory approvals, impacting the company's operational timeline[144]. - The NDA submission process includes a user fee, which is substantial unless a waiver applies[153]. - The FDA aims to review standard applications within 10 to 12 months and priority applications within 6 to 8 months[155]. - The FDA may require a risk evaluation and mitigation strategy (REMS) program as a condition of NDA approval[159]. - Post-approval testing and surveillance are required to monitor the drug's safety and efficacy, which may affect marketing[160]. - The company intends to pursue orphan drug designation for certain oncology indications, which could lead to orphan drug exclusivity if approved[167]. - The FDA may grant orphan designation to drugs intended for rare diseases affecting fewer than 200,000 individuals in the U.S.[168]. - Orphan drug exclusivity provides a seven-year market protection for the first FDA-approved drug for a specific disease, with certain exceptions[169]. - The company plans to seek fast track designation for product candidates aimed at serious diseases, allowing for more frequent interactions with the FDA during development[162]. - Breakthrough therapy designation may be pursued for products showing substantial improvement over existing therapies, enhancing FDA guidance and support[163]. - Priority review for NDAs can shorten the FDA's review time to six months if the product shows significant improvement over existing treatments[164]. - Accelerated approval may be granted based on early evidence of clinical benefit, but requires confirmatory studies post-approval[165]. - Pediatric exclusivity can extend existing exclusivity periods by six months if a pediatric study is completed as requested by the FDA[172]. - The company must comply with ongoing FDA regulations post-approval, including marketing only for approved indications and maintaining compliance with cGMP[173][174]. - International regulatory compliance is necessary for marketing products outside the U.S., with varying requirements across countries[178]. - In the EU, new products authorized for marketing receive eight years of data exclusivity and an additional two years of market exclusivity upon marketing authorization (MA)[188]. - The overall market exclusivity period can be extended to a maximum of 11 years if the MA holder obtains authorization for new therapeutic indications during the first eight years[189]. - Orphan medicinal products are entitled to ten years of market exclusivity upon MA, which can be extended by two years if an agreed pediatric investigation plan (PIP) is complied with[191]. - The orphan exclusivity period may be reduced to six years if the product no longer meets the criteria for orphan designation by the end of the fifth year[192]. - The UK regulatory framework for clinical trials is derived from existing EU legislation, with changes introduced by the MHRA to streamline approvals and enhance transparency[196]. - The MHRA has implemented a 150-day assessment and a rolling review procedure to prioritize access to new medicines in the UK[195]. Financial and Market Dynamics - The company faces competition from major pharmaceutical and biotechnology companies, as well as academic institutions and research organizations[127][128]. - The availability of coverage and reimbursement will significantly affect the pricing and competitiveness of the company's products[133]. - The company has increased the minimum level of Medicaid rebates from 15.1% to 23.1% under the ACA, impacting pricing strategies[211]. - The Inflation Reduction Act (IRA) requires price negotiations for certain drugs with Medicare starting in 2026, affecting future revenue[211]. - Coverage and reimbursement for pharmaceutical products depend on third-party payors, with significant uncertainty regarding the coverage status of newly approved products[205]. - Third-party payors are increasingly reducing reimbursements and implementing cost-containment programs, which could limit sales of pharmaceutical products[207]. - In international markets, reimbursement systems vary significantly, with many countries instituting price ceilings on specific products[208]. - The EU allows member states to control the prices of medicinal products and restrict the range of products covered by national health insurance systems[208]. Workforce and Corporate Strategy - As of December 31, 2023, the company had 378 full-time employees, with 308 engaged in research and development[214]. - The company completed the acquisition of EQRx, Inc. on November 9, 2023, as part of its growth strategy[219]. - As of December 31, 2023, 56% of the company's full-time employees were female, and 53% of self-identified employees were from underrepresented minorities[216]. - The company aims to enhance employee retention and development through competitive compensation and benefit programs[215]. - The company is committed to inclusiveness and fairness, fostering diverse perspectives within its workforce[216]. - The company anticipates further healthcare reform measures that could limit government payments for healthcare products, potentially reducing demand[213]. - The company regularly reviews its compensation practices to support employee needs, including health and wellness programs[215]. - The company is subject to increased scrutiny over pharmaceutical pricing, leading to legislative changes aimed at transparency and pricing reforms[212].

November 6, 2023 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 manage existing collaborations and establish new strategic collaborations, licensing or other arrangements, the scope, ...

Financial Data and Key Metrics Changes - The company ended Q3 2023 with $813.2 million in cash, cash equivalents, and investments, excluding anticipated proceeds from the acquisition of EQRx, which is expected to add approximately $1.1 billion in net cash [18] - GAAP net loss for Q3 2023 was $108.4 million, or $0.99 per share, with full-year 2023 GAAP net loss expected to be between $385 million and $415 million [58] Business Line Data and Key Metrics Changes - RMC-6236 has shown objective anti-tumor activity against three oncogenic RAS gene types, with a blended objective response rate in pancreatic ductal adenocarcinoma at 20%, which is higher than the 7% to 11% range for cytotoxic chemotherapy [5][8] - The objective response rate in non-small cell lung cancer is reported at 38%, with expectations to settle between 40% to 50% at the recommended Phase 2 dose [6][7] Market Data and Key Metrics Changes - The disease control rate for RMC-6236 was reported at 87%, significantly higher than most reports for salvage chemotherapy in pancreatic cancer [11] - The company is evaluating the potential for RMC-6291 in KRAS G12C cancers, with an objective response rate of 50% in lung cancer patients who had progressed on prior treatment with a G12C inhibitor [50] Company Strategy and Development Direction - The company plans to initiate a pivotal Phase 3 trial for RMC-6236 in pancreatic cancer and a Phase 3 trial for non-small cell lung cancer in 2024, focusing on achieving full regulatory approval [12][13] - The acquisition of EQRx is expected to enhance the company's ability to develop its pipeline and support late-stage development for RAS(ON) inhibitors [20][54] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of durability of clinical benefit as indicated by progression-free survival and overall survival, rather than solely relying on objective response rates [10] - The company is committed to evaluating several combination options for RMC-6236 and RMC-6291, with ongoing discussions with regulators and investigators [17][20] Other Important Information - Total operating expenses for Q3 2023 were $123.2 million, primarily due to clinical trial and manufacturing expenses for RMC-6236 and RMC-6291 [57] - The company reiterated its cash runway guidance into 2025 based on current plans, excluding the impact of the proposed EQRx transaction [58] Q&A Session Summary Question: Why pursue a monotherapy trial against docetaxel instead of a combination? - Management expressed a desire to eliminate chemotherapy from treatment options and aims to demonstrate superiority over docetaxel as a standalone treatment [64] Question: What is the strategy for prioritizing cohorts in the trials? - The company is expanding its protocol to include various histologies, including colorectal cancer, while focusing on dose selection for non-small cell lung cancer and pancreatic cancer [29] Question: What are the benchmarks for disease control and PFS in previously treated pancreatic ductal adenocarcinoma? - Management indicated that median progression-free survival for standard treatments is approximately three months, and they are working to establish benchmarks for RMC-6236 [49][73] Question: What is the anticipated expense ramp for supporting multiple studies? - The company plans to increase spending to support mid and late-stage studies while ensuring judicious use of capital, especially following the EQRx acquisition [100][101]

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 September 30, 2023 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) Delaware 47-2029180 (State or ...