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Mural Oncology plc (MURA)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 operating discipline drove lower YoY expenses and a narrower net loss versus Q4 2023; net loss was $34.3M and diluted EPS was $(2.01) as R&D fell to $28.7M and G&A to $7.2M .
  • Cash runway extended into Q1 2026 (from Q4 2025 prior guidance), a meaningful positive surprise that reduces near‑term financing risk .
  • Two potentially registrational catalysts in H1 2025: interim OS analysis for ARTISTRY‑7 in platinum‑resistant ovarian cancer (pembro+nema vs chemo), with BLA planned in 2025 if HR ≤0.727 at interim; and topline ARTISTRY‑6 cohort 2 mucosal melanoma monotherapy data in Q2 2025 (target ORR 25%) .
  • Pipeline expanded in Q4 with development candidate nominations for IL‑18 (MURA‑8518) and IL‑12 (MURA‑7012); IL‑18 IND/CTA timeline moved to 1H 2026 from prior Q4 2025 guidance (a delay to watch) .
  • Near‑term stock reaction catalysts: ARTISTRY‑7 interim OS decision (stop for success vs continue to final) and ARTISTRY‑6 mucosal melanoma ORR; guidance durability on cash runway supports tactical risk appetite into data readouts .

What Went Well and What Went Wrong

What Went Well

  • Operational efficiency: “By prioritizing operational efficiency and execution in 2024, we delivered on our milestones and positioned ourselves for a pivotal 2025,” said CEO Caroline Loew, Ph.D. .
  • Expense control: R&D decreased YoY to $28.7M (from $42.2M), G&A to $7.2M (from $16.3M); Q4 net loss narrowed to $34.3M (from $59.5M), aided by fewer separation-related charges versus 2023 .
  • Clinical execution: ARTISTRY‑7 reached 75% OS events for interim analysis; ARTISTRY‑6 cohort 2 and cohort 3 enrollments complete, sustaining H1 2025 catalyst visibility .

What Went Wrong

  • IL‑18 IND/CTA timing slipped from Q4 2025 to 1H 2026, extending the preclinical-to-clinic transition timeline for MURA‑8518 .
  • Cash declined sequentially to $144.4M from $175.5M, reflecting ongoing development spend ahead of pivotal data (though runway improved via efficiencies) .
  • No earnings call transcript available, limiting direct Q&A insights; reliance on press release and investor presentation for guidance specifics and narrative .

Financial Results

P&L and EPS (Sequential: Q2 → Q3 → Q4 2024)

MetricQ2 2024Q3 2024Q4 2024
R&D Expenses ($USD Millions)$27.544 $27.585 $28.669
G&A Expenses ($USD Millions)$6.733 $6.513 $7.185
Total Operating Expenses ($USD Millions)$34.277 $34.098 $35.854
Operating Loss ($USD Millions)$(34.277) $(34.098) $(35.854)
Other Income ($USD Millions)$2.713 $2.339 $1.580
Income Tax Provision ($USD Millions)$0.000 $(4.966) $0.000
Net Loss ($USD Millions)$(31.564) $(31.759) $(34.274)
Diluted EPS ($USD)$(1.86) $(1.87) $(2.01)
Weighted Avg Shares (Basic & Diluted)16,924,842 17,028,552 17,069,185

YoY (Q4 2024 vs Q4 2023)

MetricQ4 2023Q4 2024
R&D Expenses ($USD Millions)$42.243 $28.669
G&A Expenses ($USD Millions)$16.270 $7.185
Net Loss ($USD Millions)$(59.537) $(34.274)
Diluted EPS ($USD)$(3.57) $(2.01)

Balance Sheet Liquidity

MetricQ2 2024Q3 2024Q4 2024
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$204.7 $175.5 $144.4

KPIs and Clinical Execution

KPIQ2 2024Q3 2024Q4 2024
ARTISTRY‑7 Enrollment (PROC)Enrollment complete (targeted interim in 1Q’25) Completed: 456 patients Interim OS at ~75% events; HR bar 0.727 at IA
ARTISTRY‑6 Cohort 2 Enrollment (Mucosal Melanoma)Ongoing; topline H1’25 Completed: 92 patients Topline expected Q2 2025; target ORR 25%
ARTISTRY‑6 Cohort 3 (LFIV Monotherapy)RP2D informed by ARTISTRY‑3; prelim H1’25 Ongoing; prelim H1’25 Enrollment complete; prelim H1’25
ARTISTRY‑6 Cohort 4 (LFIV + Pembro)Ongoing; prelim 2H’25 Ongoing; prelim 2H’25 Ongoing; prelim 2H’25
Cash RunwayInto Q4 2025 Into Q4 2025 (reaffirmed) Into Q1 2026 (extended)
Pipeline MilestonesIL‑18/IL‑12 nominations expected 2024 Nominations expected Q4 2024 Nominations completed; IL‑18 IND/CTA in 1H 2026

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayOperating runwayInto Q4 2025 Into Q1 2026 Raised
IL‑18 IND/CTA (MURA‑8518)Submission timingQ4 2025 1H 2026 Lowered (delayed)
ARTISTRY‑7 Interim OSReadout timingLate Q1/Early Q2 2025 Late Q1/Early Q2 2025 Maintained
ARTISTRY‑6 Cohort 2 ToplineReadout timingQ2 2025 Q2 2025 Maintained
2025 OpEx vs 2024Operating expense trajectoryLower in 2025 vs 2024 Not restated in Q4 PR; prior guide stands Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
Clinical milestones & registrational pathARTISTRY‑7 interim in 1Q’25; ARTISTRY‑6 topline H1’25 Investor Day detailed stats, enrollment completion (456/92) Interim OS bar HR≤0.727 at IA; BLA in 2025 if met; final OS HR≤0.788 in 2026 if continued Increasing specificity and near‑term catalyst clarity
Cash & OpEx disciplineRunway into Q4 2025; lower 2025 OpEx Runway into Q4 2025 reaffirmed Runway extended into Q1 2026 via efficiencies Improving durability of liquidity
Pipeline expansion (IL‑18/IL‑12)Nominations expected 2024 Nominations expected by year‑end Candidates nominated; IL‑18 IND/CTA moved to 1H 2026 Progress with timing delay to clinic
Commercial readinessNew commercial division; SVP appointed Not highlighted in Q4 PR Building capabilities; limited Q4 update
Dosing optimization (LFIV)ARTISTRY‑3 data informed RP2D; LFIV cohorts launch Preliminary readouts expected H1/2H 2025 Preliminary timing maintained; cohort 3 enrollment complete Execution on schedule

Management Commentary

  • “By prioritizing operational efficiency and execution in 2024, we delivered on our milestones and positioned ourselves for a pivotal 2025, with several key inflection points anticipated for our nemvaleukin program.” — Caroline Loew, Ph.D., CEO .
  • “We are now focused on clinical execution, with major readouts of our two potentially registrational studies of nemvaleukin in the first half of next year, and commercial readiness.” — Caroline Loew, Ph.D. (Q3 press release) .
  • ARTISTRY‑7 IA/BLA pathway specifics: interim success if HR ≤0.727 (27.3% reduction in risk of death assuming 215 events); if not, continue to final with success threshold HR ≤0.788 (21.2% reduction assuming 286 events) .

Q&A Highlights

  • No Q4 earnings call transcript available; key clarifications provided via press release and investor presentation exhibits (Ex. 99.1 and Ex. 99.2) .
  • Trial design and statistical thresholds reiterated: ARTISTRY‑7 interim HR ≤0.727 for 2025 BLA; final HR ≤0.788 with 85% power at cumulative alpha for 2026 BLA if continued .
  • ARTISTRY‑6 cohort 2 target ORR is 25% with intent to discuss BLA/accelerated approval with FDA if durable responses achieved (20–25% deemed meaningful) .
  • Cash runway guidance clarified as into Q1 2026, supported by operational efficiencies .

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2024 EPS and revenue was unavailable at time of query due to provider limits; as such, we cannot assess beat/miss versus consensus for this quarter. We default to S&P Global for estimates when available, and note explicitly that consensus was unavailable.
  • Given Mural’s clinical‑stage status and lack of product revenue in reported statements, investor focus remains on operating expense trends, liquidity runway, and clinical/regulatory milestones rather than revenue/EPS beats .

Key Takeaways for Investors

  • Bolded catalysts loom: ARTISTRY‑7 interim OS decision in late Q1/early Q2 2025 and ARTISTRY‑6 mucosal melanoma topline in Q2 2025 could re‑rate the stock; HR ≤0.727 at interim would be a decisive positive and enable a 2025 BLA filing .
  • Liquidity risk mitigated: runway extended into Q1 2026, reducing near‑term financing overhang and giving management time to navigate data outcomes and regulatory steps .
  • Expense discipline continues: YoY reductions in R&D and G&A drive narrower net loss versus Q4 2023; monitor whether sequential 2025 OpEx trajectory aligns with prior guidance of lower OpEx vs 2024 .
  • Pipeline broadened with IL‑18/IL‑12 candidates, but IL‑18 IND/CTA timing was delayed to 1H 2026; valuation impact depends on nemvaleukin outcomes and the pace of next‑gen cytokine entry to clinic .
  • ARTISTRY‑6 cohort 2 target ORR (25%) sets a clear bar; durable ORR ≥20–25% in mucosal melanoma would support BLA discussions and potential accelerated approval pathway per company commentary .
  • Dosing optimization (LFIV) cohorts in cutaneous melanoma may enhance convenience and safety profile; preliminary data in H1/2H 2025 offers optionality beyond the two late‑stage indications .
  • Tactical stance: Position around interim OS event window with defined statistical thresholds; downside buffered by liquidity, upside asymmetric if ARTISTRY‑7 meets interim success criteria .

Appendix: Additional Data and Notes

  • Q4 2024 R&D decline drivers: lower employee‑related expenses and timing of ARTISTRY‑7 enrollment; wind‑down of ARTISTRY‑1 and ARTISTRY‑2 trials contributed to lower spend versus Q4 2023 .
  • Q4 2024 G&A decline drivers: lower employee‑related expenses versus prior Alkermes allocations and one‑time 2023 charges tied to separation and equity award modifications .
  • ARTISTRY‑7 enrollment and partners: 456 patients enrolled; trial conducted with GOG, ENGOT, APGOT; pembro supplied via MSD agreement .