Item 2.02 Results of Operations and Financial Condition.
On
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
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
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
Item 8.01 Other Events.
The Company's corporate presentation on
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.
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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
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 99.1 Company presentation datedJanuary 11, 2022 . 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
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