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:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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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 February 27, 2023, Revolution Medicines, Inc. (the “Company”) announced its financial results for the quarter and year ended December 31, 2022. 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.
(d) 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: |
February 27, 2023 |
By: |
/s/Mark A. Goldsmith |
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Mark A. Goldsmith, M.D., Ph. D. |
Exhibit 99.1
Revolution Medicines Reports Fourth Quarter and Full Year 2022 Financial Results and Update on Corporate Progress
Early clinical data on RMC-6236 provided in support of RAS(ON) Inhibitor platform validation
Additional data releases for RMC-6236 (RASMULTI) and RMC-6291 (KRASG12C) expected in 2023
RMC-9805 (KRASG12D) expected to begin clinical development in mid-2023
Growing pipeline of development-stage assets, including RMC-0708 (KRASQ61H), that target every major RAS cancer mutation hotspot
Webcast today at 4:30 p.m. Eastern Time
REDWOOD CITY, Calif., February 27, 2023 – Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, today announced its financial results for the quarter and year ended December 31, 2022, and provided an update on corporate progress.
“2022 saw the entry of our first two RAS(ON) Inhibitor candidates, RMC-6236 (RASMULTI) and RMC-6291 (KRASG12C), into clinical development,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “For RMC-6236, initial pharmacokinetics, molecular, radiographic and tolerability/safety data provide encouraging evidence that we are dosing patients at clinically active and tolerated doses. Consistent with its preclinical profile, RMC-6236 has shown promising preliminary antitumor activity against multiple tumor types and genotypes. Combined with initial evidence of clinical activity for RMC-6291, we are encouraged that these data should have positive readthrough to our broad portfolio of RAS(ON) Inhibitors.
“In addition, IND-enabling development of RMC-9805, a mutant-selective RAS(ON) Inhibitor drug candidate designed to target cancers driven by the KRASG12D mutation, is progressing toward first-in-human dosing mid-year. And we recently announced the advancement of RMC-0708, a mutant-selective inhibitor of the KRASQ61H cancer variant, into IND-enabling development.
“As a result of the exceptional work of our entire organization, Revolution Medicines’ portfolio now includes clinical and development-stage assets that may be applicable to the majority of RAS-addicted cancers, including compounds targeting every major RAS cancer mutation hotspot — G12, G13 and Q61. Early results from our first wave of RAS(ON) Inhibitors support continued investment in advancing our development pipeline of clinical and preclinical RAS(ON) Inhibitors and clinical RAS Companion Inhibitors. Building on this ongoing portfolio progress and encouraging signs, part of management’s bandwidth is now directed toward defining the paths and steps we need to take now and over the next several years to ensure that we can maximize the value of these product candidates.”
Clinical and Development Highlights
RAS(ON) Inhibitors
RMC-6236 (RASMULTI)
RMC-6236 is an oral RAS(ON) Inhibitor designed to treat patients with cancers driven by a variety of RAS mutations, including KRASG12D, KRASG12V and KRASG12R. Initially being evaluated as monotherapy, it may also be deployed as a RAS Companion Inhibitor in combination with mutant-selective RAS(ON) Inhibitors.
RMC-6291 (KRASG12C)
RMC-6291, an oral, selective, covalent inhibitor of KRASG12C(ON) designed to treat patients with cancers driven by the KRASG12C mutant, is the first of the company’s mutant-selective RAS(ON) Inhibitors to enter clinical development and the first publicly reported inhibitor of KRASG12C that exhibits a highly differentiated mechanism of action.
RMC-9805 (KRASG12D)
RMC-9805 is an oral, selective, covalent inhibitor of KRASG12D(ON), the most common driver of RAS-addicted human cancers, predominantly among patients with pancreatic cancer, NSCLC or colorectal cancer (CRC). The company believes RMC-9805 is the first oral and covalent inhibitor of KRASG12D.
RAS Innovation Engine
Beyond this first wave of RAS(ON) Inhibitors, the company continues expanding its pipeline of RAS(ON) Inhibitor candidates.
RAS Companion Inhibitors
RMC-4630 (SHP2)
RMC-4630 is a clinical-stage, oral inhibitor of SHP2, which contributes to tumor survival and growth in many RAS-addicted cancers.
RMC-4630 and KRASG12C Inhibitor Lumakras™ (sotorasib)
Sanofi, Revolution Medicines’ partner for the development of RMC-4630, provided notice of termination of their global SHP2 development and commercialization collaboration, effective as of June 2023. The companies are collaborating for the transition of all Sanofi’s rights and obligations related to RMC-4630 back to Revolution Medicines over the first half of 2023. Following termination, Revolution Medicines will regain all global rights to RMC-4630.
RMC-5552 (mTORC1/4EPB1)
RMC-5552 is a first-in-class, bi-steric mTORC1-selective inhibitor designed to suppress phosphorylation and inactivation of 4EBP1 in cancers with hyperactive mTORC1 signaling, including certain RAS-addicted cancers. The company aims to combine RMC-5552 with RAS(ON) Inhibitors in patients with cancers harboring RAS/mTOR pathway co-mutations.
Fourth Quarter and Full Year 2022 Financial Highlights
Cash Position: Cash, cash equivalents and marketable securities were $644.9 million as of December 31, 2022, compared to $577.1 million as of December 31, 2021. The increase was primarily attributable to the company’s public equity offering in July 2022.
Revenue: Total revenue was $15.3 million for the quarter ended December 31, 2022, compared to $9.5 million for the quarter ended December 31, 2021 and consisted of revenue from the company’s collaboration agreement on SHP2 inhibitors with Sanofi. During the quarter ended December 31, 2022, the company recorded a non-cash GAAP accounting adjustment that increased collaboration revenue by $7.6 million. This non-cash revenue adjustment was due to the termination of the Sanofi collaboration agreement which resulted in changes to the company’s estimates of the accounting transaction price and estimated percentage of completion of work performed to date and resulted in a cumulative catch-up adjustment to collaboration revenue in the quarter.
Total revenue was $35.4 million for the year ended December 31, 2022, compared to $29.4 million for the year ended December 31, 2021. The increase in revenue was primarily due to the non-cash revenue adjustment.
R&D Expenses: Research and development expenses were $66.1 million for the quarter ended December 31, 2022, compared to $53.7 million for the quarter ended December 31, 2021. Research
and development expenses were $253.1 million for the year ended December 31, 2022, compared to $186.9 million for the year ended December 31, 2021. The increases were primarily due to an increase in RMC-6236 and RMC-6291 expenses as a result of commencing clinical trials in 2022, an increase in personnel-related expenses related to additional headcount, an increase in research expenses associated with the company’s pre-clinical research portfolio, and an increase in stock-based compensation.
G&A Expenses: General and administrative expenses were $10.9 million for the quarter ended December 31, 2022, compared to $8.7 million for the quarter ended December 31, 2021. General and administrative expenses were $40.6 million for the year ended December 31, 2022, compared to $30.5 million for the year ended December 31, 2021. The increases were primarily due to an increase in stock-based compensation and an increase in personnel-related expenses related to additional headcount.
Net Loss: Net loss was $56.5 million for the quarter ended December 31, 2022, compared to net loss of $52.7 million for the quarter ended December 31, 2021. Net loss was $248.7 million for the year ended December 31, 2022, compared to net loss of $187.1 million for the year ended December 31, 2021.
Financial Guidance
Revolution Medicines expects full year 2023 GAAP net loss to be between $335 and $365 million, which includes estimated non-cash stock-based compensation expense of $40 million and $50 million.
Based on the company’s current operating plan, the company projects current cash, cash equivalents and investments can fund planned operations through 2024.
Webcast
Revolution Medicines will host a webcast this afternoon, February 27, 2023, 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, and RAS Companion Inhibitors for use in combination treatment strategies. The company’s RAS(ON) Inhibitors RMC-6236 (RASMULTI) and RMC-6291(KRASG12C) are currently in clinical development. Additional RAS(ON) Inhibitors in the company’s pipeline include RMC-9805 (KRASG12D) and RMC-0708 (KRASQ61H), both of which are currently in IND-enabling development, RMC-8839 (KRASG13C), and additional compounds targeting other RAS variants. RAS Companion Inhibitors in clinical development include RMC-4630 (SHP2) and RMC-5552 (mTORC1/4EBP1).
Lumakras™ (sotorasib) is a trademark of Amgen 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; 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 and potential efficacy of the company’s candidates being studied; the potential advantages and effectiveness of the company’s clinical and preclinical candidates, including its RAS(ON) Inhibitors; the ability of the company’s product candidates to meet unmet medical needs and to be applicable to the majority of RAS-addicted cancers; whether data available from RMC-6236 and RMC-6291 will have positive readthrough to the company’s portfolio of RAS(ON) Inhibitors; the company’s ability to maximize the value of its product candidates; the potential of RMC-6236 to be first-in-class; the potential of RMC-6291 to show superior activity; the transition of rights and obligations related to RMC-4630 from Sanofi to the company; the potential of RMC-5552 to be first-in-class; the company’s plans to study RMC-5552 in combination with RAS inhibitors and the company’s aim to combine RMC-5552 with RAS(ON) Inhibitors in patients with cancers harboring RAS/mTOR pathway co-mutations. 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 and the effects on the company’s business of the COVID-19 pandemic and other global events. 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 on February 27, 2023, and its future periodic reports to be filed with the Securities and Exchange Commission. 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.
Contacts:
For Investors:
Vida Strategic Partners
Stephanie Diaz
415-675-7401
sdiaz@vidasp.com
For Media:
Vida Strategic Partners
Tim Brons
415-675-7402
tbrons@vidasp.com
REVOLUTION MEDICINES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended December 31, |
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Year Ended December 31, |
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2022 |
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2021 |
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2022 |
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2021 |
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Revenue: |
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Collaboration revenue |
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$ |
15,330 |
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$ |
9,460 |
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$ |
35,380 |
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$ |
29,390 |
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Total revenue |
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15,330 |
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9,460 |
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35,380 |
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29,390 |
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Operating expenses: |
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Research and development |
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66,127 |
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53,681 |
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253,073 |
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186,948 |
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General and administrative |
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10,910 |
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8,692 |
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40,586 |
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30,450 |
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Total operating expenses |
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77,037 |
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62,373 |
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293,659 |
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217,398 |
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Loss from operations |
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(61,707 |
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(52,913 |
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(258,279 |
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(188,008 |
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Other income, net: |
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Interest income |
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5,077 |
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237 |
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9,154 |
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929 |
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Interest and other expense |
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— |
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— |
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— |
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(12 |
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Total other income, net |
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5,077 |
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237 |
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9,154 |
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917 |
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Loss before income taxes |
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(56,630 |
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(52,676 |
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(249,125 |
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(187,091 |
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Benefit from income taxes |
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123 |
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— |
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420 |
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— |
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Net loss |
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$ |
(56,507 |
) |
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$ |
(52,676 |
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$ |
(248,705 |
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$ |
(187,091 |
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Net loss per share attributable to common stockholders - basic and diluted |
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$ |
(0.63 |
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$ |
(0.71 |
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$ |
(3.08 |
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$ |
(2.57 |
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Weighted-average common shares used to compute net loss per share, basic and diluted |
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89,158,785 |
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73,831,121 |
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80,626,525 |
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72,806,079 |
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REVOLUTION MEDICINES, INC.
SELECTED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, unaudited)
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December 31, |
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December 31, |
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2022 |
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2021 |
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Cash, cash equivalents and marketable securities |
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$ |
644,943 |
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$ |
577,054 |
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Working capital (1) |
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598,201 |
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529,423 |
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Total assets |
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811,930 |
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737,988 |
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Deferred revenue |
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4,459 |
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18,931 |
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Total liabilities |
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126,742 |
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135,420 |
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Total stockholders' equity |
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685,188 |
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602,568 |
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