UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 6, 2024, Revolution Medicines, Inc. (the “Company”) announced its financial results for the quarter ended September 30, 2024. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K and the attached Exhibit 99.1 is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
Exhibit No. |
Description |
99.1 |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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REVOLUTION MEDICINES, INC. |
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Date: |
November 6, 2024 |
By: |
/s/ Mark A. Goldsmith |
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Mark A. Goldsmith, M.D., Ph.D. |
Exhibit 99.1
Revolution Medicines Reports Third Quarter 2024 Financial Results and Update on Corporate Progress
Phase 3 pivotal trial underway evaluating RMC-6236 in patients with metastatic pancreatic ductal adenocarcinoma (PDAC), supported by compelling clinical profile
First clinical results for RMC-9805, a RAS(ON) G12D-selective inhibitor, demonstrate encouraging safety, tolerability and antitumor activity in patients with PDAC harboring a KRAS G12D mutation
Company on track to provide update on lung cancer programs in the fourth quarter of 2024
Revolution Medicines to hold webcast today at 4:30 p.m. Eastern Time
REDWOOD CITY, Calif., November 6, 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 September 30, 2024, and provided an update on corporate progress.
The company is committed to revolutionizing treatment for patients with RAS-addicted cancers through the discovery, development and delivery of innovative, targeted medicines across lines of therapy and tumor types.
“We’ve made enormous progress on behalf of patients against this year’s strategic priorities, having now demonstrated encouraging clinical results for our three pioneering clinical-stage RAS(ON) inhibitors. Recently updated data for RMC-6236 continued to elaborate its compelling clinical profile, including highly encouraging progression-free survival and overall survival in patients with previously treated pancreatic cancer, and a Phase 3 pivotal study is now underway. A first report on RMC-9805 showcased its encouraging initial clinical profile in patients with KRAS G12D pancreatic cancer, marking the first oral, covalent, mutant-selective investigational drug to show initial promise in patients with tumors harboring this common mutation,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “We believe these are major milestones on our path toward serving patients with RAS-addicted cancers, and we expect to provide additional updates before year-end that should help set the stage for continued pipeline progress in our multilayered approach in 2025.”
Recent Clinical Highlights & Upcoming Milestones
Pancreatic Cancer
The company currently has two RAS(ON) inhibitors being developed for patients with advanced or metastatic PDAC, RMC-6236, a RAS(ON) multi-selective inhibitor, and RMC-9805, a RAS(ON) G12D-selective inhibitor. The company is currently evaluating both compounds as monotherapy and in combination regimens.
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RMC-6236 Clinical Updates
RMC-9805 Clinical Updates
Beyond Pancreatic Cancer:
The company is currently evaluating its clinical-stage RAS(ON) inhibitors as monotherapy and/or combinations in patients with additional solid tumors carrying RAS mutations.
Upcoming Milestones
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Financial Highlights
Third Quarter Results
Cash Position: Cash, cash equivalents and marketable securities were $1.55 billion as of September 30, 2024.
R&D Expenses: Research and development expenses were $151.8 million for the quarter ended September 30, 2024, compared to $107.7 million for the quarter ended September 30, 2023. The increase in expense was primarily due to increases in clinical trial expenses for RMC-6236, RMC-6291 and RMC-9805, personnel-related expenses related to additional headcount and stock-based compensation expense.
G&A Expenses: General and administrative expenses were $24.0 million for the quarter ended September 30, 2024, compared to $15.5 million for the quarter ended September 30, 2023. The increase was primarily due to increases in personnel-related expenses associated with additional headcount, commercial preparation activities and stock-based compensation expense.
Net Loss: Net loss was $156.3 million for the quarter ended September 30, 2024, compared to net loss of $108.4 million for the quarter ended September 30, 2023.
Financial Guidance
Revolution Medicines is reiterating projected full year 2024 GAAP net loss guidance of between $560 million and $600 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
Revolution Medicines will host a webcast this afternoon, November 6, 2024, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: 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.
Revolution Medicines is a clinical-stage oncology company developing novel targeted therapies for RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors RMC-6236,
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a RAS(ON) multi-selective inhibitor, RMC-6291, a RAS(ON) G12C-selective inhibitor, and RMC-9805, a RAS(ON) G12D-selective inhibitor, are currently in clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-5127 (G12V), RMC-0708 (Q61H) and RMC-8839 (G13C), in addition to RAS companion inhibitors RMC-4630 and RMC-5552.
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 and expectations related to the company’s capital resources; the company’s development plans and timelines and its ability to advance its portfolio and R&D pipeline; the potential advantages and effectiveness of the company’s clinical and preclinical candidates, including its RAS(ON) inhibitors; progression of clinical studies and findings from these studies, including the safety, tolerability, potential efficacy and durability of the company’s candidates being studied; the company’s expectations regarding timing of data disclosures, regulatory alignment and clinical study initiation; the company’s plans to revolutionize treatment for patients with RAS-addicted cancers; readout of the company’s clinical trials; and the company’s commercial plans. 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’ current stage of development, the process of designing and conducting preclinical and clinical trials, risks that the results of prior clinical trials may not be predictive of future clinical trials, clinical efficacy, or other future results, 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, 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’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 6, 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.
Media & Investor Contacts
media@revmed.com
investors@revmed.com
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REVOLUTION MEDICINES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Revenue: |
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Collaboration revenue |
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$ |
— |
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$ |
— |
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$ |
— |
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$ |
10,838 |
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Total revenue |
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— |
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— |
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— |
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10,838 |
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Operating expenses: |
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Research and development |
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151,752 |
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107,735 |
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404,129 |
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274,663 |
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General and administrative |
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23,960 |
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15,513 |
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69,085 |
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43,377 |
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Total operating expenses |
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175,712 |
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123,248 |
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473,214 |
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318,040 |
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Loss from operations |
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(175,712 |
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(123,248 |
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(473,214 |
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(307,202 |
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Other income, net: |
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Interest income |
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20,411 |
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10,947 |
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65,658 |
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28,505 |
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Other income (expense), net |
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282 |
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— |
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(2,511 |
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— |
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Change in fair value of warrant liabilities and contingent earn-out shares |
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(1,269 |
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— |
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4,543 |
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— |
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Total other income, net |
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19,424 |
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10,947 |
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67,690 |
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28,505 |
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Loss before income taxes |
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(156,288 |
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(112,301 |
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(405,524 |
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(278,697 |
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Benefit from income taxes |
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— |
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3,867 |
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— |
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3,867 |
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Net loss |
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$ |
(156,288 |
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$ |
(108,434 |
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$ |
(405,524 |
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$ |
(274,830 |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.94 |
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$ |
(0.99 |
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(2.45 |
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$ |
(2.65 |
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Weighted-average common shares used to compute net loss per share, basic and diluted |
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166,843,984 |
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109,233,084 |
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165,576,333 |
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103,702,501 |
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REVOLUTION MEDICINES, INC.
SELECTED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, unaudited)
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September 30, 2024 |
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December 31, 2023 |
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Cash, cash equivalents and marketable securities |
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$ |
1,549,481 |
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$ |
1,852,955 |
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Working capital (1) |
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1,468,276 |
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1,735,430 |
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Total assets |
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1,762,999 |
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2,061,705 |
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Total liabilities |
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196,695 |
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235,511 |
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Total stockholders' equity |
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1,566,304 |
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1,826,194 |
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