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Centessa Pharmaceuticals plc (CNTA)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 featured strong clinical updates from the OX2R agonist franchise; ORX750 delivered statistically significant, clinically meaningful improvements in NT1, NT2, and IH, with management guiding to initiate registrational studies in Q1 2026 and maintaining cash runway into mid-2027 .
  • Financially, the company reported net loss of $54.9M and diluted EPS of -$0.41; license and other revenue was $0, and cash, cash equivalents and investments were $349.0M as of September 30, 2025 .
  • Versus S&P Global consensus, Q3 EPS of -$0.41 missed the -$0.388 mean by ~$0.02, and revenue of $0 missed the $1.27M mean; clinical progress and accelerated timelines are the likely investor focus despite the headline miss *.
  • In prior quarters, the company highlighted sequential execution and upcoming datasets; Q2 net loss was $50.3M and cash was $404.1M, while Q1 included a $15.0M license revenue and net loss of $26.1M, underpinning the cash runway guidance .

What Went Well and What Went Wrong

What Went Well

  • ORX750 achieved >20-minute change from baseline in mean sleep latency on MWT at 1.5 mg in NT1 (p=0.0026) and an 87% relative reduction in Weekly Cataplexy Rate; ESS moved into normative range (mean 5.1 on drug vs 18.7 placebo at Week 2) .
  • In NT2, ORX750 achieved >10-minute change on MWT at 4.0 mg (p=0.0193) and improved ESS to a mean of 8.1 vs 15.9 on placebo at Week 2, with dose escalation ongoing .
  • Management expects to initiate the ORX750 registrational program in Q1 2026; ORX142 Phase 1 showed rapid onset, differentiated PK, and statistically significant MWT improvements, with patient studies planned for Q1 2026 .

What Went Wrong

  • Q3 delivered no license or other revenue, and diluted EPS of -$0.41 missed consensus by ~$0.02; net loss widened year over year to $54.9M * .
  • R&D expense increased to $41.6M (vs $33.9M in Q3 2024), reflecting pipeline advancement, while cash and investments fell sequentially to $349.0M (from $404.1M in Q2 2025) .
  • Safety profile was generally favorable but TEAEs ≥10% included pollakiuria (51%), insomnia (22%), dizziness (13%), and headache (11%); one NT2 participant discontinued due to urinary urgency .

Financial Results

Quarterly Financials (oldest → newest)

MetricQ1 2025Q2 2025Q3 2025
License and other revenue ($USD Millions)$15.0 $0.0 $0.0
Net Loss ($USD Millions)$26.1 $50.3 $54.9
Diluted EPS ($USD)-$0.20 -$0.38 -$0.41
R&D Expense ($USD Millions)$33.4 $42.7 $41.6
G&A Expense ($USD Millions)$12.3 $11.9 $12.2
Cash, Cash Equivalents & Investments ($USD Millions)$424.9 $404.1 $349.0

YoY Comparison (Q3 2025 vs Q3 2024)

MetricQ3 2024Q3 2025YoY Change
R&D Expense ($USD Millions)$33.9 $41.6 +$7.7
G&A Expense ($USD Millions)$12.5 $12.2 -$0.3
Net Loss ($USD Millions)$42.6 $54.9 +$12.3
Diluted EPS ($USD)-$0.37 -$0.41 -$0.04

Q3 2025 vs S&P Global Consensus

MetricConsensus MeanActualBeat/Miss
EPS ($USD)-$0.388*-$0.41 Miss (~$0.02)
Revenue ($USD)$1.273M*$0.0 Miss

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayThrough mid-2027Into mid-2027 (Q2 guide) Into mid-2027 (reiterated) Maintained
ORX750 registrational program startQ1 2026Registrational planning underway (Q2) Initiate registrational program in Q1 2026 Refined timing/affirmed
ORX142 patient studies startQ1 2026Phase 1 ongoing; patient studies expected this year/next Initiate patient studies in Q1 2026 Refined timing
ORX489 clinical start (subject to IND)Q1 2026IND-enabling; clinical initiation planned Expect clinical studies in Q1 2026 (subject to IND) Maintained

Earnings Call Themes & Trends

TopicQ1 2025 (Previous Mentions)Q2 2025 (Previous Mentions)Q3 2025 (Current Period)Trend
OX2R pipeline strategyEmphasis on best-in-class OX2R across NT1/NT2/IH; ORX750 Phase 2a on track Continued confidence; Phase 2a adaptive design; posters and upcoming data Robust Phase 2a data in NT1/NT2/IH; registrational start Q1 2026 Accelerating toward registration
ORX142 profilePlanned first-in-human with rapid onset thesis Phase 1 initiated; data expected in 2025 Phase 1 showed rapid onset, differentiated PK; patient studies in Q1 2026 Advancing to patient studies
Cash runwayRunway into mid-2027 Runway into mid-2027 Runway into mid-2027 Stable runway guidance
Safety/tolerabilityPhase 1 supports favorable profile Phase 1/2a design built for dose optimization Generally favorable safety; TEAEs listed; no meaningful cardiac/visual/liver/renal changes Consistent favorable profile
Clinical endpoints and measuresMWT/ESS presented in Phase 1 poster Additional MWT/KSS time-course at AAN; sustained >30 min MWT at 5mg Significant MWT/ESS/WCR improvements across indications Strengthening efficacy signals
Regulatory/milestonesIND progress and planning IND-clearance for ORX142; World Sleep poster Registrational program timeline set for Q1 2026 Timeline firmed

Management Commentary

  • “Based on today’s update, ORX750 continues to stand out as a potential best-in-class OX2R agonist for the treatment of NT1, NT2 and IH… Given enrollment momentum across these cohorts, we expect to initiate the registrational program for ORX750 in Q1 2026.” — Saurabh Saha, M.D., Ph.D., CEO .
  • “ORX750 also achieved clinically meaningful wake promotion in NT2… And, for IH, ORX750 is the first OX2R agonist to demonstrate statistically significant and clinically meaningful improvements on multiple efficacy measures including on the MWT.” — Mario Alberto-Accardi, Ph.D., President, Centessa Orexin Program .

Q&A Highlights

  • No Q3 2025 earnings call transcript was identified in filings; analysis relies on the 8-K press release and the corporate presentation furnished as exhibits .

Estimates Context

  • Q3 EPS of -$0.41 missed the consensus mean (-$0.388) by ~$0.02, while revenue of $0 missed the ~$1.27M consensus; given the absence of quarterly revenue and the step-up in R&D to progress registrational readiness, near-term estimates may adjust to reflect spend and clinical timelines * .
    Values retrieved from S&P Global.*

Financial/Clinical KPIs (Q3 2025 highlights)

KPIQ3 2025 Detail
NT1 MWT change>20-minute change vs placebo at 1.5 mg, Week 2 (p=0.0026); half achieved >30 minutes
NT1 WCR87% relative reduction vs placebo at 1.5 mg (incidence rate ratio 0.13; p=0.0025)
NT1 ESSMean ESS 5.1 on ORX750 vs 18.7 placebo at Week 2; baseline 19.6
NT2 MWT change>10-minute change vs placebo at 4.0 mg, Week 2 (p=0.0193)
NT2 ESSMean ESS 8.1 on ORX750 vs 15.9 placebo at Week 2; baseline 17.3
IH MWTStatistically significant improvement at 2.0 mg (p=0.0213); dose escalation progressing
Cash runwayInto mid-2027

Key Takeaways for Investors

  • Clinical momentum: ORX750’s efficacy across NT1/NT2/IH with favorable tolerability positions the asset for near-term registrational initiation in Q1 2026, a key potential stock catalyst .
  • Near-term spend vs. value inflection: Elevated R&D spend supports pivotal readiness; continued runway into mid-2027 provides funding clarity through major milestones .
  • NT2/IH first-in-class opportunity: The demonstrated NT2/IH efficacy may expand the commercial opportunity beyond NT1, reinforcing the franchise’s potential .
  • ORX142 progression: Rapid onset and differentiated PK with a move to patient studies in Q1 2026 diversify the pipeline’s clinical shots on goal .
  • Safety profile: Generally favorable safety with manageable TEAEs and no meaningful organ function changes reduces program risk as dosing escalates .
  • Estimates reset risk: With no quarterly revenue and higher R&D, expect near-term EPS/revenue estimate recalibration; investor focus likely on clinical timelines and data flow rather than quarterly P&L .
    Values retrieved from S&P Global.