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Revolution Medicines 8-K Report, Financial Results (Jan 9, 2024)

Reports
Earnings & Results·Regulation FD·Exhibits & Filings
Filing Date
Filed January 9, 2024
Period End
January 9, 2024
Securities
RVMDRVMDW
In the record · 2020–202610-K710-Q208-K72

RVMD filed 7 annual reports (10-K), 20 quarterly reports (10-Q) and 72 current reports (8-K) between 2020 and 2026.

  1. Leadership change8-K · Mar ’21Mar ’21
  2. Leadership change8-K · Sep ’22Sep ’22
  3. Material agreement8-K · Sep ’26Sep ’26

01—Abstract

Summary

Summary of the 8-K filed January 9, 2024. Cited figures are marked; the original filing is the authoritative source.

Revolution Medicines, Inc. (RVMD) filed this Form 8-K on January 9, 2024 to furnish a corporate presentation, posted that day to its investor website, under Item 2.02 (Results of Operations and Financial Condition) and Item 7.01 (Regulation FD Disclosure).

The information is furnished rather than filed, so it is not subject to Section 18 liabilities or incorporated by reference into other SEC filings. The presentation, Exhibit 99.1, is titled "On Target to Outsmart Cancer" and centers on the company's RAS(ON) inhibitor pipeline: RMC-6236 (a multi-selective inhibitor), RMC-6291 (a G12C-selective inhibitor) and RMC-9805 (a G12D-selective inhibitor), along with 2024 priorities to propel RMC-6236 into pivotal trials and advance mutant-selective inhibitors toward late-stage development. The presentation reports early Phase 1 data.

For RMC-6236 in KRAS G12X NSCLC (evaluable n=40), the objective response rate was 38%a (15 responses, 12 confirmed) and the disease control rate was 85%. In KRAS G12X PDAC (evaluable n=46), the objective response rate was 20% and the disease control rate was 87%. For RMC-6291 in previously treated or naive KRAS G12C NSCLC, the objective response rate was 50% in the G12C-inhibitor-naive group (n=10) and 43% in the prior-G12C-inhibitor group (n=7).

In CRC, the objective response rate was 40% (n=19 evaluable). The company stated that it projects its cash, cash equivalents and marketable securities, a preliminary estimate of $1.85 billionb as of December 31, 2023 (unaudited), can fund planned operations into 2027. It also guided to a 2023 net loss of $385 million to $415 million, excluding the impact of the EQRx acquisition, which the company said it could not quantify without unreasonable effort.

The presentation also outlines planned global randomized Phase 3 trials of RMC-6236 in previously treated RAS-mutant NSCLC (study initiation aimed for 2024) and in previously treated PDAC (potentially initiated in 2024). The filing notes that the presentation's forward-looking statements carry risk and that the company has not yet completed its year-end financial close.

02—Key points

Key Highlights

  1. Presentation posted January 9, 2024 and furnished under Item 2.02 and Item 7.01; information is not deemed filed under Section 18 of the Exchange Act.
  2. RMC-6236 (RAS(ON) multi-selective inhibitor): 38% objective response rate (15 of 40 evaluable) in KRAS G12X NSCLC and 20% objective response rate (9 of 46 evaluable) in KRAS G12X PDAC, per the presentation.
  3. RMC-6291 (RAS(ON) G12C-selective inhibitor): 50% objective response rate in G12C-inhibitor-naive NSCLC (n=10), 43% in prior-G12C-inhibitor NSCLC (n=7), and 40% in CRC (n=20 treated).
  4. Planned Phase 3 trials: global randomized trial of RMC-6236 in previously treated RAS-mutant NSCLC (N>400, study initiation aimed for 2024) and in previously treated PDAC (N>500, potentially in 2024).
  5. Preliminary unaudited cash, cash equivalents and marketable securities of $1.85 billion as of December 31, 2023, including balances acquired in the EQRx transaction; company projects funding planned operations into 2027.
  6. 2023 net loss guidance of $385 million to $415 million, excluding the EQRx acquisition impact, with non-cash stock-based compensation of approximately $45 million to $50 million.
  7. RMC-9805 (G12D-selective inhibitor) is in clinical stage with dose escalation begun in 3Q23; the company also cites a Phase 1b combination of RMC-6236 and RMC-6291 in KRAS G12C NSCLC, with first patient dosed in 4Q23.

03—Questions

Frequently Asked Questions

  1. What did Revolution Medicines disclose in this 8-K filing?

    The company furnished a corporate presentation, posted January 9, 2024 to its investor website, as Exhibit 99.1 under Item 2.02 and Item 7.01. The information is furnished, not filed, so it is not subject to Section 18 liability or incorporated by reference into other SEC filings.

  2. What were the early clinical response rates for RMC-6236 and RMC-6291?

    For RMC-6236, the presentation reports a 38% objective response rate (15 of 40 evaluable) in KRAS G12X NSCLC and 20% (9 of 46 evaluable) in KRAS G12X PDAC. For RMC-6291, it reports 50% in G12C-inhibitor-naive NSCLC (n=10), 43% in prior-G12C-inhibitor NSCLC (n=7), and 40% in CRC (n=20 treated).

  3. How much cash does the company have and how long will it fund operations?

    The company estimated cash, cash equivalents and marketable securities of $1.85 billion as of December 31, 2023, a preliminary unaudited figure that includes balances acquired in the EQRx transaction. It projects this can fund planned operations into 2027.

  4. What are the company's near-term development plans?

    The company aims to propel RMC-6236 into its first pivotal trials, with Phase 3 trials planned in previously treated RAS-mutant NSCLC (study initiation aimed for 2024) and PDAC (potentially in 2024). It also plans to advance mutant-selective inhibitors RMC-6291 and RMC-9805 toward late-stage development. Study designs are subject to regulatory feedback.

  5. What is the company's 2023 financial guidance?

    The company guided to a 2023 net loss of $385 million to $415 million, including non-cash stock-based compensation of approximately $45 million to $50 million. This guidance excludes the impact of the EQRx acquisition, which the company said it could not quantify without unreasonable effort.

04—Continue

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