Revolution Medicines Reports Fourth Quarter and Full Year 2023 Financial Results and Update on Corporate Progress
Revolution Medicines, Inc. (RVMD) announced financial results for Q4 and full year 2023, focusing on RAS(ON) inhibitors development. The company aims to advance RMC-6236 into pivotal trials for NSCLC and PDAC, expand its reach into earlier therapy lines and qualify mutant-selective inhibitors. With a year-end cash balance of $1.85 billion after acquiring EQRx, Revolution Medicines is well-positioned for future developments.
Negative
Revenue decline due to termination of collaboration agreement with Sanofi in 2023
Significant increase in R&D and G&A expenses for Q4 and full year 2023
Net loss for Q4 and full year 2023 increased compared to the same periods in 2022
2024 financial guidance projects a GAAP net loss between $480 million and $520 million
The financial results disclosed by Revolution Medicines highlight a substantial increase in cash reserves, primarily due to the acquisition of EQRx. This acquisition has bolstered the company's balance sheet, providing a significant runway for operations and research activities. The financial guidance for 2024 indicates a projected GAAP net loss of $480 million to $520 million, a figure that investors should weigh against the potential future revenues from the company's pipeline. The projected cash runway into 2027 suggests that the company has ample time to advance its clinical trials without the immediate need for additional capital raises, which may reassure investors about the company's financial stability in the medium term.
The clinical development of RAS(ON) inhibitors is a critical focus for Revolution Medicines, with RMC-6236 showing promise in NSCLC and PDAC. The reported aggregate overall response rates and disease control rates are encouraging, suggesting potential efficacy of the drug. However, the true value of these findings will be determined by the outcomes of the pivotal trials set for the second half of 2024. The expansion of RMC-6236 into other RAS cancer genotypes and tumor types could significantly broaden the drug's market potential. Additionally, the progress on RMC-6291 and RMC-9805 is noteworthy, as these mutant-selective inhibitors could cater to a subset of patients with specific KRAS mutations, which are common drivers in various cancers.
Revolution Medicines operates within the oncology sector , a highly competitive area of the pharmaceutical industry. The company's focus on RAS-addicted cancers, a challenging target historically, positions it within a niche market with high unmet medical needs. The specificity of their inhibitors to particular RAS mutations could potentially lead to a strong market positioning if clinical efficacy and safety are demonstrated in pivotal trials. The company's strategic priorities and pipeline progress, including the development of RAS(ON) inhibitor candidates like RMC-5127, RMC-0708 and RMC-8839, suggest a long-term commitment to innovation in this space. The industry will closely monitor the clinical and regulatory milestones that could impact the company's valuation and market share.
02/26/2024 - 04:05 PM
Revolution Medicines to hold webcast today at 4:30 p.m. Eastern Time
REDWOOD CITY, Calif., Feb. 26, 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 and full year ended December 31, 2023, and provided an update on corporate progress.
The company’s strategic priorities for 2024 are focused on its pioneering RAS(ON) inhibitors:
Advancing its RAS(ON) multi-selective inhibitor RMC-6236 into monotherapy pivotal trials. Studies in second line (2L) non-small cell lung cancer (NSCLC) and in 2L pancreatic ductal carcinoma (PDAC) are expected to begin in the second half of 2024. Expanding the reach of RMC-6236 monotherapy and/or combination regimens into earlier lines of therapy, RAS cancer genotypes beyond RAS G12X, and tumor types beyond NSCLC and PDAC. Patient dosing is underway in studies evaluating the combination of RMC-6236 + RMC-6291 and the combination of RMC-6236 + pembrolizumab. Qualifying its mutant-selective inhibitors, RMC-6291 (G12C-selective inhibitor) and RMC-9805 (G12D-selective inhibitor), for late-stage development. Patient dosing is underway in the combination study evaluating RMC-6291 + pembrolizumab. “2023 was a transformative year for Revolution Medicines and our pioneering RAS(ON) inhibitors. We showed that both RMC-6236 and RMC-6291 as single agents can deliver clinically meaningful antitumor responses at doses that are generally safe and well tolerated, results we believe provide broad clinical validation of our RAS(ON) inhibitor portfolio,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “With a year-end cash and investments balance of $1.85 billion after acquiring EQRx, we are well capitalized to execute exciting plans this year and beyond to advance our compelling development-stage pipeline, aiming to change the treatment landscape for patients living with RAS-addicted cancers.”
Clinical Development Highlights
Studies to Support Advancing RMC-6236 into Pivotal Trial(s)
RMC-6236-001 (NCT05379985 ) is a clinical study of RMC-6236 monotherapy in patients with advanced solid tumors harboring diverse RAS mutations.
Following the preliminary safety and antitumor activity data in patients with NSCLC and PDAC presented at the Triple Meeting and ESMO Congress in October 2023, the company shared an update across the 80 to 400 mg daily dose range at the J.P. Morgan Healthcare Conference on January 9, 2024, that supports initiating pivotal trials in the second half of 2024. With two months of additional follow-up, the safety profile remained relatively consistent. The company also shared favorable trends for the aggregate overall response rate (ORR) for patients with NSCLC in the low- to mid-40 percent range, and aggregate ORR for patients with PDAC in the mid-20 percent range. In the 300 mg dose cohort, patients with NSCLC and PDAC response rates trended higher than the aggregate ORR, with a disease control rate in the high-80 percent range. While a maximum tolerated dose was not identified, dose escalation is now complete. Dose optimization is now focused on dose levels at or below 300 mg daily to support finalizing a recommended Phase 2 dose in NSCLC and PDAC. The company is developing a more mature data package to support regulatory engagement for final dose selection and the expected launch of pivotal trials with RMC-6236. The company expects to disclose updated clinical safety, tolerability, and antitumor activity data in the second half of 2024 supporting initiation of a Phase 3 study of 2L treatment of patients with NSCLC and a Phase 3 study of 2L treatment of patients with PDAC. The company plans to initiate both of these studies in the second half of 2024. Studies to Support Expanding the Reach of RMC-6236 into Earlier Lines of Therapy, RAS Cancer Genotypes Beyond RAS G12X, and Tumor Types Beyond NSCLC and PDAC RMC-LUNG-101 (NCT06162221 ) is a clinical study of RMC-6236 or RMC-6291 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS-mutated NSCLC or KRAS G12C-mutated NSCLC, respectively.
Patient dosing is underway in both the RMC-6236 and RMC-6291 cohorts, and the company expects to disclose initial clinical PK, safety, tolerability, and antitumor activity data from both cohorts in the second half of 2024. RMC-6236-001 (NCT05379985 ) is a clinical study of RMC-6236 monotherapy, and expansion cohorts were opened to evaluate patients with tumors harboring other RAS mutations beyond G12X, including G13X and Q61X mutations, and/or other tumor types, including colorectal cancer, melanoma, and gynecological malignancies.
Patient dosing is underway, and the company expects to disclose initial clinical PK, safety, tolerability, and activity data from the cohort expansions in the second or third quarter of 2024. Studies to Qualify Mutant-Selective Inhibitors RMC-6291-001 (NCT05462717 ) is a clinical study of RMC-6291 monotherapy in patients with advanced solid tumors harboring KRAS G12C mutations.
Following the preliminary safety and antitumor activity data presented at the Triple Meeting in October 2023, the company continues dosing patients at 200 mg twice daily. RMC-6291-101 (NCT06128551 ) is a clinical study of RMC-6291 in combination with RMC-6236 in patients with advanced KRAS G12C-mutated solid tumors.
Patient dosing is underway, and the company expects to disclose initial clinical PK, safety, tolerability, and activity data in the second half of 2024. RMC-9805-001 (NCT06040541 ) is a clinical study of RMC-9805 monotherapy in patients with advanced KRAS G12D-mutated solid tumors.
At the J.P. Morgan Healthcare Conference, the company indicated that early study results confirmed RMC-9805 is orally bioavailable in patients, consistent with preclinical projections, including dose-dependent increases in exposure with once daily dosing. RMC-9805 cleared several dose levels with acceptable safety and tolerability, and no dose limiting toxicities had been reported. The company expects to disclose initial clinical PK, safety, tolerability, and activity data in the second half of 2024. RAS Innovation Engine
Corporate and Financial Highlights
EQRx Acquisition $1.1 billion in net cash proceeds to its balance sheet after estimated post-closing EQRx wind-down and transition costs. At the closing, Dr. Sandra Horning joined the company’s board of directors. Wind-down of EQRx operations and activities is nearing completion.
Fourth Quarter Results
Cash Position : Cash, cash equivalents and marketable securities were $1.85 billion as of December 31, 2023, compared to $644.9 million as of December 31, 2022. The increase was primarily attributable to the acquisition of EQRx in November 2023 and the company’s public equity offering in March 2023.
Revenue : Total revenue was $0.7 million for the quarter ended December 31, 2023, compared to $15.3 million for the quarter ended December 31, 2022. The decrease in revenue was due to the termination of the company’s collaboration agreement with Sanofi in 2023.
R&D Expenses : Research and development expenses were $148.5 million for the quarter ended December 31, 2023, compared to $66.1 million for the quarter ended December 31, 2022. The increase was primarily due to an increase in clinical supply manufacturing and clinical trial expenses for RMC-6236, RMC-6291, and RMC-9805, an increase in personnel-related expenses related to additional headcount, and an increase in stock-based compensation. Research and development expenses for the quarter ended December 31, 2023, included $13.1 million of expenses related to the wind-down of EQRx, which primarily consisted of non-recurring employee-related termination expenses and stock-based compensation expense related to the acceleration of EQRx equity awards in conjunction with the closing of the transaction.
G&A Expenses : General and administrative expenses were $32.2 million for the quarter ended December 31, 2023, compared to $10.9 million for the quarter ended December 31, 2022. The increase was primarily due to an increase in stock-based compensation and an increase in personnel-related expenses related to additional headcount. General and administrative expenses for the quarter ended December 31, 2023, included $13.8 million of expenses related to the wind-down of EQRx, which primarily consisted of non-recurring employee-related termination expenses and stock-based compensation expense related to the acceleration of EQRx equity awards in conjunction with the closing of the EQRx transaction.
Net Loss : Net loss was $161.5 million for the quarter ended December 31, 2023, compared to net loss of $56.5 million for the quarter ended December 31, 2022. Net loss for the quarter ended December 31, 2023, included $26.9 million of operating expenses related to the wind-down of EQRx.
Full Year 2023 Financial Highlights
Revenue : Total revenue was $11.6 million for the year ended December 31, 2023, compared to $35.4 million for the year ended December 31, 2022. The decrease in revenue was due to the termination of the company’s collaboration agreement with Sanofi in 2023.
R&D Expenses : Research and development expenses were $423.1 million for the year ended December 31, 2022, compared to $253.1 million for the year ended December 31, 2022. The increase was primarily due to an increase in clinical supply manufacturing and clinical trial expenses for RMC-6236, RMC-6291, and RMC-9805, research expenses associated with the company’s pre-clinical portfolio, an increase in personnel-related expenses related to additional headcount, and an increase in stock-based compensation. Research and development expenses for the year ended December 31, 2023, included $13.1 million of expenses related to the wind-down of EQRx, which primarily consisted of non-recurring employee-related termination expenses and stock-based compensation expense related to the acceleration of EQRx equity awards in conjunction with the closing of the transaction.
G&A Expenses : General and administrative expenses were $75.6 million for the year ended December 31, 2023, compared to $40.6 million for the year ended December 31, 2022. The increase was primarily due to an increase in stock-based compensation and an increase in personnel-related expenses related to additional headcount. General and administrative expenses for the year ended December 31, 2023, included $13.8 million of expenses related to the wind-down of EQRx, which primarily consisted of non-recurring employee-related termination expenses and stock-based compensation expense related to the acceleration of EQRx equity awards in conjunction with the closing of the EQRx transaction.
Net Loss : Net loss was $436.4 million for the year ended December 31, 2023, compared to net loss of $248.7 million for the year ended December 31, 2022. Net loss for the year ended December 31, 2023, included $26.9 million of operating expenses related to the wind-down of EQRx.
2024 Financial Guidance $480 million and $520 million , which includes estimated non-cash stock-based compensation expense of between $70 million and $80 million . Based on the company’s current operating plan, the company projects current cash, cash equivalents and marketable securities can fund planned operations into 2027.
Webcast https://ir.revmed.com/events-and-presentations . Following the live webcast, a replay will be available on the company’s website for at least 14 days.
About Revolution Medicines, Inc.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered "forward-looking statements," including without limitation statements regarding the company’s financial projections; whether the company is well capitalized to execute plans this year and beyond to advance its compelling development-stage pipeline; the company’s development plans and timelines and its ability to advance its portfolio and R&D pipeline; progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company’s candidates being studied; the company’s expectations regarding timing of data disclosures; the company’s plans to expand the reach of RMC-6236 into earlier lines of therapy, additional RAS cancer genotypes, and additional tumor types; the company’s plans to qualify RMC-6291 and RMC-9805 for late-stage development; the potential advantages and effectiveness of the company’s clinical and preclinical candidates, including its RAS(ON) inhibitors; the company’s plans for regulatory engagement and initiation of Phase 3 clinical trials for RMC-6236; and the timing of completion of wind-down of EQRx operations and activities and related estimated costs . Forward-looking statements are typically, but not always, identified by the use of words such as "may," "will," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, the risk that the wind-down of EQRx may take longer than anticipated or result in unexpected costs, and the effects on the company’s business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 26, 2024, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances, or to reflect the occurrence of unanticipated events.
REVOLUTION MEDICINES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Revenue: Collaboration revenue $ 742 $ 15,330 $ 11,580 $ 35,380 Total revenue 742 15,330 11,580 35,380 Operating expenses: Research and development 148,481 66,127 423,144 253,073 General and administrative 32,244 10,910 75,621 40,586 Total operating expenses 180,725 77,037 498,765 293,659 Loss from operations (179,983 ) (61,707 ) (487,185 ) (258,279 ) Other income (expense), net: Interest income 18,977 5,077 47,482 9,154 Interest and other expense (303 ) - (303 ) - Change in fair value of warrant liability and contingent earn-out shares 115 - 115 - Total other income, net 18,789 5,077 47,294 9,154 Loss before income taxes (161,194 ) (56,630 ) (439,891 ) (249,125 ) Benefit (loss) from income taxes (343 ) 123 3,524 420 Net loss $ (161,537 ) $ (56,507 ) $ (436,367 ) $ (248,705 ) Net loss per share attributable to common stockholders - basic and diluted $ (1.14 ) $ (0.63 ) $ (3.86 ) $ (3.08 ) Weighted-average common shares used to compute net loss per share, basic and diluted 141,183,907 89,158,785 113,149,869 80,626,525
REVOLUTION MEDICINES, INC. SELECTED CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, unaudited) December 31, 2023 December 31, 2022 Cash, cash equivalents and marketable securities $ 1,852,955 $ 644,943 Working capital (1) 1,735,430 598,201 Total assets 2,061,705 811,930 Deferred revenue - 4,459 Total liabilities 235,511 126,742 Total stockholders' equity 1,826,194 685,188
(1) Working capital is defined as current assets less current liabilities.
What are Revolution Medicines' strategic priorities for 2024?
Revolution Medicines' strategic priorities for 2024 are focused on advancing RMC-6236 into pivotal trials, expanding its reach into earlier therapy lines, and qualifying mutant-selective inhibitors.
What is the company's year-end cash and investments balance after acquiring EQRx?
The company's year-end cash and investments balance after acquiring EQRx is $1.85 billion.
What are the key clinical development highlights mentioned in the press release?
Key clinical development highlights include advancing RMC-6236 into pivotal trials, expanding its reach into earlier therapy lines, and qualifying mutant-selective inhibitors.
What was the impact of the termination of the collaboration agreement with Sanofi on Revolution Medicines' revenue?
The termination of the collaboration agreement with Sanofi in 2023 led to a decrease in revenue for Revolution Medicines.
What is the 2024 financial guidance provided by Revolution Medicines?
Revolution Medicines expects a full year 2024 GAAP net loss between $480 million and $520 million, including estimated non-cash stock-based compensation expense of between $70 million and $80 million.
