• Cash and Investments: $1.55 billion as of the end of Q3 2024.
• R&D Expenses: $151.8 million for Q3 2024, up from $107.7 million in Q3 2023.
• G&A Expenses: $24.0 million for Q3 2024, up from $15.5 million in Q3 2023.
• Net Loss: $156.3 million for Q3 2024, compared to $108.4 million in Q3 2023.
• Projected Full Year 2024 GAAP Net Loss: Expected to be between $560 million and $600 million.
• Non-Cash Stock-Based Compensation Expense: Estimated between $70 million and $80 million for 2024.

• Warning! GuruFocus has detected 6 Warning Signs with RVMD.

Release Date: November 06, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Revolution Medicines Inc (NASDAQ:RVMD) has made substantial progress in advancing its RAS inhibitor portfolio, particularly with RMC 6,236 and RMC 9,805, showing promising results in pancreatic ductal adenocarcinoma (PDAC).
• The company reported encouraging progression-free survival (PFS) and overall survival (OS) data for RMC 6,236 in metastatic PDAC, with a median PFS of 8.5 months and median OS of 14.5 months.
• RMC 9,805 demonstrated a 30% objective response rate and an 80% disease control rate in its phase one monotherapy study, indicating strong preliminary anti-tumor activity.
• Revolution Medicines Inc (NASDAQ:RVMD) is well-capitalized, with $1.55 billion in cash and investments, projected to fund operations into 2027.
• The company is actively exploring combination therapies, including RMC 6,236 with pembrolizumab and other RAS inhibitors, to enhance treatment efficacy across multiple cancer types.

Negative Points

• Research and development expenses increased significantly to $151.8 million in Q3 2024 from $107.7 million in Q3 2023, driven by clinical trial-related costs and personnel expenses.
• General and administrative expenses also rose to $24.0 million in Q3 2024 from $15.5 million in Q3 2023, primarily due to increased headcount and commercial preparation activities.
• The company reported a net loss of $156.3 million for Q3 2024, up from $108.4 million in Q3 2023, reflecting higher operating expenses.
• There is a delay in the initiation of the phase three registrational study for non-small cell lung cancer, now expected in Q1 2025, due to the need for regulatory alignment and holiday timing constraints.
• The company faces challenges in prioritizing and managing numerous requests for combination studies with RMC 6,236, which could strain resources and focus.

Q & A Highlights

Q: What should we look for in the upcoming combination data set with Pembro and the multi and G12C inhibitors? A: Mark Goldsmith, CEO, explained that the Pembro study is primarily focused on safety, particularly looking for any toxicity signals. For the RMC 6,236 and RMC 6,291 combination, the focus is on qualitative evidence of activity that distinguishes it from monotherapy agents.

Q: Can you provide details on the patient population for the RAS inhibitor doublet combination study? A: Mark Goldsmith, CEO, mentioned that the study includes patients with TSG12C variant tumors, comprising a mix of solid tumor types and prior treatment backgrounds. Specific details will be clearer upon data release.

Q: What is the clinical development strategy for the collaboration with Tango Therapeutics? A: Mark Goldsmith, CEO, stated that Revolution Medicines is providing clinical drug supply to Tango, who will sponsor the studies. The collaboration is based on preclinical work showing encouraging results when combining their agents.

Q: How are you approaching novel combinations with RMC 6,236? A: Mark Goldsmith, CEO, indicated that there is a long list of requests for collaborations. They prioritize studies combining RMC 6,236 with other RAS inhibitors, TLIS, and chemotherapy, but expect more combination studies to emerge over time.

Q: What are your thoughts on applying the RAS platform to liquid tumors like AML? A: Steve Kelsey, President of R&D, noted that while the focus has been on solid tumors, academic collaborators are exploring RAS mutations in AML. Revolution Medicines may consider clinical development in AML in the future.

Q: Can you provide color on the cash runway guidance and what's included? A: Jack Anders, CFO, explained that the guidance includes two phase three second-line studies. Beyond that, a probability-adjusted model is used for potential additional programs, but specifics are not disclosed.

Q: Are you considering a triplet combination of RMC 6,236, Pembro, and chemotherapy? A: Mark Goldsmith, CEO, confirmed that a combination study involving RMC 6,236, Pembro, and chemotherapy is planned, with sequential initiation after determining the appropriate dose for the doublet.

Q: What are the potential strategies for a phase three study in first-line pancreatic cancer? A: Mark Goldsmith, CEO, stated that they are planning for a phase three study with monotherapy and combinations with standard care regimens. The second-line data supports the concept of moving into first-line settings.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.