Full-Year 2025 GAAP Net Loss

FY 2025

no prior guidance

Expected to be between $840 million and $900 million, with non-cash stock-based compensation expense of $115 million to $130 million "

no prior guidance

Regulatory uncertainty and trial delays

Q1 and Q3 detailed delays (e.g., lung cancer Phase III trial delay and dose/trial design discussions) and Q2 noted regulatory discussions for trial design " " "

Q4 mentioned the need to align with the FDA before initiating the global Phase III trial and cited forward‐looking risks without detailed delay explanations " "

Regulatory uncertainty remains, but Q4 provides less granular detail on delays than earlier periods.

Ambiguity in data disclosure timelines and transparency

Q1, Q2, and Q3 discussed unclear timing for combination and monotherapy data releases, with phrasing such as “stay tuned” and bundled updates " " "

Q4 acknowledged ambiguous timelines for updates on colorectal cancer, pembrolizumab combination, and zoldonrasib data with timeline shifts (e.g., moving a Q1 2025 update to Q4 2024) " " "

Consistent ambiguity persists, though Q4 shows slight adjustments in expected disclosure timelines.

Evolving combination therapy strategies

Q1 and Q2 emphasized safety and tolerability in combinations (e.g., RMC-6236 with pembrolizumab or chemotherapy) while Q3 detailed doublets and triplet regimens with safety as primary focus " " "

Q4 expanded discussion to include evaluation of daraxonrasib in combination with chemotherapy, RAS inhibitor doublets (e.g., elironrasib with daraxonrasib), and combinations with pembrolizumab, with continued focus on safety and tolerability " "

The focus on combination strategies remains steady but with broader exploration and a more mature approach in Q4.

Expansion into first-line, metastatic, and adjuvant treatment settings

Q1 and Q2 described plans for first-line and metastatic trials while Q3 focused on initiating first-line studies for pancreatic cancer without adjuvant details " "

Q4 discussed plans for a pivotal first-line metastatic PDAC trial and introduced designs for adjuvant treatment trials in resectable pancreatic cancer, as well as continuing focus on NSCLC "

There is an expanded outlook in Q4 with the addition of adjuvant strategies, building on first-line and metastatic expansions.

Pipeline evolution and candidate shifts

Q1, Q2, and Q3 centered on advancing RMC-6236 (and to a lesser extent RMC-9805) with no mention of products like daraxonrasib, elironrasib, or zoldonrasib " " "

Q4 introduced a richer pipeline including daraxonrasib, elironrasib, and zoldonrasib alongside RMC-9805, reflecting candidate shifts and broadening focus " " "

Q4 shows a clear diversification of the pipeline with new candidates, evolving from a narrow focus on RMC-6236.

Commercial and operational capability building

Q2 highlighted key leadership hires and Q3 mentioned initial steps toward commercial launch preparedness; Q1 did not address these capabilities " "

Q4 provided detailed plans on expanding commercial and medical teams, U.S. field expansion, and forming strategic partnerships (including advocacy organizations) to support future product launches " "

There is a growing emphasis in Q4 on building robust commercial and operational infrastructure compared to earlier periods.

Financial strength vs. rising operating expenses

Q1 through Q3 consistently reported strong cash balances (ranging from $1.55B to $1.85B) along with increasing R&D and G&A expenses and widening net losses " " "

Q4 reported an even higher cash balance ($2.3B) alongside further increased operating expenses and raised 2025 net loss guidance "

The company continues to showcase strong cash reserves, but rising operating expenses and net losses remain an ongoing concern.

Limited pipeline diversification beyond core RAS(ON) inhibitors

Q1 and Q2 repeatedly focused on the core Wave 1 RAS(ON) assets (RMC-6236 and RMC-9805) with explicit mention in Q2 regarding capital allocation to these assets " "

Q4 did not introduce new diversifications beyond the expansion of candidates within the RAS(ON) inhibitor space

The focus remains largely on RAS(ON) inhibitors, with no significant shift toward broader pipeline diversification.

Uncertainty in regulatory guidance and stakeholder collaborations impacting future progress

Q1 mentioned the need for FDA agreement on dosing and trial design along with an emphasis on collaborations with various stakeholders; Q3 referenced ongoing regulatory alignment and certain external collaborations " "

Q4 briefly noted the need for FDA alignment without much emphasis on stakeholder collaborations

Regulatory uncertainty continues, though Q4 places less emphasis on external collaborations compared to earlier calls.