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Revolution Medicines 8-K Report, Regulation FD Disclosure (Jul 15, 2024)

Reports
Regulation FD·Other Events·Exhibits & Filings
Filing Date
Filed July 15, 2024
Period End
July 15, 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 · Jul ’22Jul ’22
  3. Deal closed8-K · Nov ’23Nov ’23
  4. Material agreement8-K · Sep ’26Sep ’26

01—Abstract

Summary

Summary of the 8-K filed July 15, 2024. Cited figures are marked; the original filing is the authoritative source.

On July 15, 2024, Revolution Medicines, Inc. disclosed under Item 7.01 that it expects its net loss for the year ended December 31, 2024 to be between $560 milliona and $600 million, including estimated non-cash stock-based compensation expense of approximately $70 million to $80 million.

The Company confirmed it continues to project that its current cash, cash equivalents and marketable securities can fund planned operations into 2027. Under Item 8.01, the Company reported updated data for RMC-6236, its RAS(ON) multi-selective inhibitor, from the monotherapy first-in-human RMC-6236-001 study as of a May 11, 2024 data cutoff in previously treated pancreatic ductal adenocarcinoma (PDAC). Across 127 patients treated at 160 mg to 300 mg daily, 96%b had any treatment-related adverse event, with 22% at Grade 3 or higher; the most common were rash (87%) and gastrointestinal toxicities such as diarrhea (46%) and nausea (43%).

Median progression-free survival (PFS) in the second-line setting was 8.1 months for patients with KRAS G12X mutations and 7.6 months for G12X, G13X and Q61X PDAC, compared with the Company's estimated 2.0 to 3.5 months for certain second-line chemotherapy trials. The objective response rate was 20%c to 27% for KRAS G12X patients depending on time since first dose, versus an estimated mean of 9% in the chemotherapy trials.

The Company said these preliminary results support planned initiation of RASolute 302, a global randomized Phase 3 trial of RMC-6236 at 300 mg daily versus investigator's choice chemotherapy in second-line metastatic PDAC, which it expects to start in the second half of 2024. The trial design and dose remain subject to final protocol submission and FDA review.

02—Key points

Key Highlights

  1. Net loss guidance for fiscal 2024 of $560 million to $600 million, including $70 million to $80 million of non-cash stock-based compensation expense.
  2. Cash, cash equivalents and marketable securities expected to fund planned operations into 2027.
  3. RMC-6236 monotherapy study (127 PDAC patients, 160-300 mg daily): 96% any-grade treatment-related adverse events; 22% Grade 3 or higher; no dosing discontinuations due to TRAEs.
  4. Median PFS in second-line PDAC of 8.1 months (KRAS G12X) and 7.6 months (G12X, G13X, Q61X), versus an estimated 2.0 to 3.5 months for second-line chemotherapy trials.
  5. Objective response rate of 20% to 27% in KRAS G12X patients depending on time since first dose, versus an estimated mean of 9% in second-line chemotherapy trials.
  6. Planned global Phase 3 RASolute 302 trial (1:1 randomization, RMC-6236 300 mg daily vs. investigator's choice chemotherapy), expected to begin in the second half of 2024, with feedback from the FDA on design and dose.

03—Questions

Frequently Asked Questions

  1. What is the company's expected net loss for 2024?

    Revolution Medicines expects a net loss between $560 million and $600 million for the year ended December 31, 2024, including estimated non-cash stock-based compensation of approximately $70 million to $80 million.

  2. How long will current cash fund operations?

    The Company continues to project that its current cash, cash equivalents and marketable securities can fund planned operations into 2027.

  3. What were the key safety findings for RMC-6236?

    Among 127 PDAC patients treated at 160 mg to 300 mg daily, 96% experienced a treatment-related adverse event and 22% experienced Grade 3 or higher events. The most common were rash (87%), diarrhea (46%) and nausea (43%). Dose interruptions occurred in 27% of patients and dose reductions in 11%, with no discontinuations for TRAEs.

  4. How does the efficacy data compare with chemotherapy?

    Median PFS in second-line PDAC was 8.1 months for KRAS G12X patients and 7.6 months for G12X, G13X and Q61X patients, compared with the Company's estimate of 2.0 to 3.5 months for certain chemotherapy trials. The Company notes these trials were not head-to-head and cross-trial comparisons should be interpreted with caution.

  5. What is the next step for RMC-6236 in pancreatic cancer?

    The Company plans to initiate RASolute 302, a global randomized Phase 3 trial comparing RMC-6236 at 300 mg daily with investigator's choice chemotherapy in patients with metastatic PDAC who have had one prior line of therapy. The Company expects to start the study in the second half of 2024, subject to final protocol submission and FDA review.

04—Continue

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