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CI

CURIS INC (CRIS)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 delivered a clean execution quarter with modest revenue growth and a materially narrower net loss year over year; revenue was $2.75M and diluted EPS was -$0.68, with opex down sharply YoY .
  • Results were above Wall Street: revenue beat consensus ($2.64M*) and EPS beat significantly (-$1.52*), reflecting disciplined cost control and lower R&D/G&A; both consist primarily of Erivedge royalties and reduced operating expenses .
  • Liquidity improved via a $7.0M July financing; cash runway guidance extended to Q1 2026 from Q4 2025 previously, though management disclosed ongoing near‑term capital needs and risks tied to royalty monetization obligations .
  • Strategic update: accelerated approval path in PCNSL continues with 30–40 additional patients targeted over the next 12–18 months; new CLL proof‑of‑concept BTKi combo study to start enrollment by year‑end; AML triplet data expected at ASH, and registrational design vs gilteritinib advancing—key stock catalysts near term .

What Went Well and What Went Wrong

What Went Well

  • Cost discipline: R&D fell to $7.5M (from $10.3M YoY) and G&A to $3.5M (from $4.8M YoY), narrowing net loss to $8.6M from $11.8M YoY .
  • Regulatory momentum: “We are … continuing to enroll PCNSL patients … to enable accelerated approval filings in the US and EU” (CEO Dentzer), with both FDA/EMA supportive feedback confirmed earlier in the year .
  • Pipeline expansion: New proof‑of‑concept study of emavusertib + BTKi in R/R CLL (20–30 patients) to potentially enable time‑limited treatment and deeper responses (MRD‑negativity), with first patient targeted by year‑end .

What Went Wrong

  • Liquidity remains constrained: cash was $10.1M at Q2 end; management reiterated the need for additional funding and disclosed risk factors (including obligations tied to sale of future royalties and Nasdaq listing risks) .
  • Other income swung to expense ($0.3M) vs other income of $0.7M last year, due to lower interest income and royalty‑sale expense, modestly pressuring the P&L .
  • Stockholders’ deficit widened to -$14.0M; liability for sale of future royalties remained elevated ($30.2M), underscoring balance sheet constraints .

Financial Results

P&L summary (USD)

MetricQ2 2024Q4 2024Q1 2025Q2 2025
Revenue ($USD Millions)$2.546 $3.345 $2.380 $2.749
Loss from Operations ($USD Millions)$(12.512) $(8.994) $(10.157) $(8.251)
Net Loss ($USD Millions)$(11.803) $(9.618) $(10.616) $(8.593)
Diluted EPS ($USD)$(2.03) $(1.25) $(1.25) $(0.68)

Operating expenses detail (USD)

MetricQ2 2024Q4 2024Q1 2025Q2 2025
Research & Development ($USD Millions)$10.254 $8.968 $8.539 $7.458
General & Administrative ($USD Millions)$4.792 $3.354 $3.984 $3.526
Total Operating Expenses ($USD Millions)$15.058 $12.339 $12.537 $11.000

Balance sheet & shares

MetricQ4 2024Q1 2025Q2 2025
Cash & Cash Equivalents ($USD Millions)$20.0 $20.282 $10.138
Weighted Avg Shares (Basic & Diluted) (Millions)7.671 8.494 12.628
Liability – Sale of Future Royalties ($USD Millions)$34.174 $31.712 $30.157
Stockholders’ Deficit ($USD Millions)$(5.998) $(6.607) $(13.986)

Estimates vs Actual (Q2 2025)

MetricConsensusActual
Revenue ($USD Millions)$2.639*$2.749
Primary EPS ($USD)$(1.515)*$(0.68)
# of Estimates (Revenue / EPS)5 / 4*

Values retrieved from S&P Global.*

Note: Revenue consists of royalty revenues from Genentech/Roche’s sales of Erivedge .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCurrentInto Q4 2025 Into Q1 2026 Raised (extended)
PCNSL Accelerated Approval Path (TakeAim Lymphoma)12–18 monthsFDA/EMA supportive; target 30–40 additional patients Enrollment ongoing; ~30+ sites; expectation ~1 patient/site/year; supports accelerated submissions Maintained with operational color
CLL BTKi Combination PoC2025 startNot disclosed prior~20–30 R/R CLL patients; first patient in by year‑end 2025 New program (initiated)
AML Triplet (ema‑ven‑aza)2025First cohort completed; escalation ongoing 7‑ and 14‑day regimens completed; plan to present safety/efficacy at ASH Maintained with near‑term data milestone
AML Registrational (vs gilteritinib)PlanningPost‑ASH data; design discussions ongoing Advancing to head‑to‑head registrational design Advanced design
Financing2025$8.8M net (Q1) $7.0M gross (July registered direct + private placement) Additional capital raised

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’24 & Q1’25)Current Period (Q2’25)Trend
PCNSL accelerated approvalFDA/EMA supportive; target 30–40 patients; ODD in US/EU Enrollment steady in ultra‑rare PCNSL; ~30+ sites; ~1 pt/site/year expectation; supports accelerated filings Steady execution
CLL BTKi combo expansionLimited prior disclosureNew PoC study (20–30 pts) targeting deeper responses/MRD‑negativity; first patient by YE’25 New initiative
AML registrational path (vs gilteritinib)Strong ASH FLT3 data; 38% composite CR context Plan registrational study vs gilteritinib in R/R AML; mechanism blocks IRAK4 & FLT3 Advancing
AML triplet (frontline)First cohort completed; escalation ongoing 7/14‑day regimens completed; aim to present ASH efficacy/safety Data catalyst near
Capital & runwayRunway into Q4’25; $8.8M financing Runway into Q1’26; $7.0M financing; exploring dilutive/non‑dilutive options Slight improvement, cautious
Competitive BTK landscapePositioning to add to BTKi including degraders; goal to deepen responses/time‑limited treatment Strategically proactive
FDA environmentNoted uncertainty at FDA broadly; PCNSL lack of standard care seen as favorable context Cautiously optimistic
IST solid tumorsCorporate deck mentions5 ISTs ongoing; timing not controlled, hope for data this year Ongoing/low cost

Management Commentary

  • “We are pleased with our progress in the TakeAim Lymphoma study … to enable accelerated approval filings in the US and EU … We are also excited to add a clinical study … in Chronic Lymphocytic Leukemia … to enable time‑limited treatment.” — James Dentzer, CEO .
  • “We have completed the design for [CLL PoC] … targeting first patient in by year end, and initial data in mid‑2026.” — CEO .
  • “Curis reported a net loss of $8.6M or $0.68 per share … R&D $7.5M … G&A $3.5M … cash and cash equivalents $10.1M … runway into the first quarter of 2026.” — CFO .
  • “We’re looking to improve current standard of care by adding emavusertib to a BTK inhibitor, enabling patients to achieve deeper responses and potentially come off treatment.” — CEO .
  • “Our plans will be to present … efficacy and safety data … from the seven and fourteen day cohort [triplet] at the ASH meeting.” — CDO Zung .

Q&A Highlights

  • CLL study bar and competitive fit: Management emphasized aiming for MRD‑negativity/CR to enable time‑limited treatment; degraders or inhibitors are complementary—emavusertib targets TLR/IRAK4 pathway, potentially deepening BTKi responses .
  • AML triplet expectations: Company plans ASH presentation of 7/14‑day cohorts; cautious on details pre‑acceptance but optimistic on combining well with SOC ven‑aza .
  • PCNSL enrollment pace: Ultra‑rare indication; ~30+ sites; guide ~1 patient per site per year; steady progress toward submission packages .
  • Regulatory environment and finance: FDA uncertainty noted, but PCNSL lack of approved therapies supportive; runway into 2026 with ongoing pursuit of dilutive/non‑dilutive financing .
  • BTKi competitor (tirabrutinib): Management expects approval and plans to establish emavusertib as an add‑on across BTKi modalities over time .

Estimates Context

  • Q2 2025 results beat consensus on both revenue and EPS: revenue $2.749M vs $2.639M*, EPS -$0.68 vs -$1.515*; # of estimates: revenue 5*, EPS 4* .
  • Cost reductions suggest potential estimate revisions to opex/earnings trajectory; near‑term catalysts (ASH data, PCNSL updates, CLL first‑patient) could influence probability‑weighted timelines across indications .

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Results were above Street on both top line and EPS, driven by disciplined opex cuts; this de‑risks near‑term funding pace and supports focus on clinical catalysts .
  • Runway extended to Q1 2026 with July financing, but management continues to evaluate capital options amid disclosed royalty encumbrance and listing risks—funding remains a central consideration .
  • PCNSL accelerated approval path remains intact; steady enrollment across ~30+ sites underpins potential filings; additional data later this year is a stock driver .
  • CLL BTKi combo initiation by year‑end introduces a broader NHL/CLL expansion story focused on deeper responses and time‑limited therapy—watch for study start and initial mid‑2026 read .
  • AML program has two catalysts: ASH triplet efficacy/safety and advancing registrational design vs gilteritinib in R/R AML; strong FLT3 data context supports differentiation .
  • Operating leverage via lower R&D/G&A improved loss trajectory; continued expense discipline is key to sustaining beats vs EPS expectations .
  • Near‑term trading: stock likely sensitive to ASH abstract acceptance/timing, PCNSL data cadence, and any financing updates; medium‑term thesis hinges on clinical validation enabling accelerated paths and broader combo utility .