Item 2.02 Results of Operations and Financial Condition.
On January 11, 2022, Revolution Medicines, Inc. (the “Company”) confirmed to
investors that it continues to expect that its net loss for the year ended
December 31, 2021 to be between $170 million and $190 million, which includes
estimated non-cash stock-based compensation expense of approximately
This information furnished under this Item 2.02 shall not be considered “filed”
under the Securities Act of 1934, as amended (the “Exchange Act”), nor shall it
be incorporated by reference into any future filings under the Securities Act of
1933, as amended (the “Securities Act”), or under the Exchange Act unless the
Company expressly sets forth in such future filing that such information is to
be considered “filed” or incorporated by reference therein.
Item 7.01 Regulation FD Disclosure.
On January 11, 2022, the Company provided a corporate presentation relating to
its research and development programs by posting an additional corporate
presentation to the investor section of the Company’s website
at: https://ir.revmed.com/events-and-presentations. The Company’s additional
corporate presentation is attached hereto as Exhibit 99.1.
The furnishing of the attached presentation is not an admission as to the
materiality of any information therein. The information contained in the slides
is summary information that is intended to be considered in the context of more
complete information included in the Company’s filings with the U.S. Securities
and Exchange Commission (the “SEC”) and other public announcements that the
Company has made and may make from time to time by press release or otherwise.
The Company undertakes no duty or obligation to update or revise the information
contained in this report, although it may do so from time to time as its
management believes is appropriate. Any such updating may be made through the
filing of other reports or documents with the SEC, through press releases or
through other public disclosures. For important information about forward
looking statements, see the slide titled “Legal Disclaimer” in Exhibit 99.1
The information in this Item 7.01 of this Current Report on Form 8-K and Exhibit
99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of
the Exchange Act or otherwise subject to the liabilities of that section or
Sections 11 and 12(a)(2) of the Securities Act. The information contained in
this Item 7.01 and in the presentation attached as Exhibit 99.1 to this Current
Report shall not be incorporated by reference into any filing with the SEC made
by the Company, whether made before or after the date hereof, regardless of any
general incorporation language in such filing.
Item 8.01 Other Events.
The Company’s corporate presentation on January 11, 2022 included the following
The Company remains on track to file an investigational new drug (“IND”)
application in the first half of 2022 for its RAS(ON) Inhibitor, RMC-6236
(RASMULTI), and expects to provide evidence of first-in-class single agent
activity for this compound in 2023. The Company also remains on track to file an
IND application in the first half of 2022 for its RAS(ON) Inhibitor RMC-6291
(KRASG12C) and expects to provide preliminary evidence of superior activity for
this compound in 2023.
The Company announced that it has advanced two new RAS(ON) Inhibitors into
IND-enabling development: RMC-9805, an oral, mutant-selective, covalent
inhibitor of KRASG12D and RMC-8839, an oral, mutant-selective, covalent
inhibitor of KRASG13C. The Company expects to file an IND application for
RMC-9805 in the first half of 2023 and an IND application for RMC-8839 in the
second half of 2023.
The Company also announced that the first patient has been dosed in RMC-4630-03,
its global, multicenter, open-label Phase 2 study evaluating the efficacy,
safety, tolerability, and pharmacokinetics of RMC-4630 in combination with
Lumakras™ (sotorasib), Amgen’s KRASG12C inhibitor, in subjects with advanced
non-small cell lung cancer. The Company is sponsoring the RMC-4630-03 study
under its global partnership with Sanofi and conducting the trial in
collaboration with Amgen, which is supplying sotorasib to study sites globally.
The Company expects to complete enrollment in RMC-4630-03 in the second half of
2022, to provide preliminary evidence of the clinical benefit of RMC-4630 as a
RAS Companion Inhibitor from the RMC-4630-03 study in the second half of 2022
and to provide additional evidence of the clinical benefit of this compound from
this study in 2023.
The Company also reported initial findings from the ongoing dose escalation
portion of its Phase 1/1b clinical trial of RMC-5552, the Company’s mTORC1
inhibitor, including preliminary evidence of clinical activity against advanced
tumors with mutations associated with hyperactive mTORC1 signaling. To date, all
four efficacy evaluable patients treated with 6 mg per week have experienced
disease control, including one patient with a confirmed partial response with a
63% reduction from baseline and the other three with stable disease. The Company
expects to provide additional evidence of single agent activity for this
compound in 2023.
The Company’s SOS1 inhibitor, RMC-5845, is ready for preparation of an IND
application based on the Company’s preclinical development.
Forward Looking Statements
This report contains forward-looking statements within the meaning of the U.S.
Private Securities Litigation Reform Act of 1995. Any statements in this report
that are not historical facts may be considered “forward-looking statements”,
including, without limitation, statements regarding the Company’s expected net
loss and stock-based compensation expense; the Company’s development plans and
timelines and its ability to advance its portfolio and R&D pipeline; dosing and
enrollment in the Company’s clinical trials and the tolerability and potential
efficacy of the Company’s candidates being studied; planned IND applications for
RMC-6236, RMC-6291, RMC-9805 and RMC-8839; completion of enrollment in the
RMC-4630-03 study and evidence of clinical benefit for RMC-4630; and the
Company’s expectation of providing additional evidence of single agent activity
for RMC-5552. 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 worldwide COVID-19 pandemic. 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 the Company in general, see the Company’s Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission on November 10,
2021, and its future periodic reports to be filed with the Securities and
Exchange Commission. Except as required by law, the Company undertakes no
obligation to update any forward-looking statements to reflect new information,
events or circumstances, or to reflect the occurrence of unanticipated events.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 99.1 Company presentation dated January 11, 2022. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
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