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CI

CURIS INC (CRIS)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 results beat on both revenue and EPS: revenue $3.18M vs $2.86M consensus and GAAP EPS -$0.49 vs -$0.60 consensus; YoY revenue +8% and losses narrowed as operating expenses declined. Drivers were cost discipline (R&D and G&A lower YoY) and stable Erivedge royalty revenue in the quarter . Consensus sourced from S&P Global estimates (see table for details).*
  • Strategic pivot: On Nov 6, Curis sold the Erivedge royalty business to Oberland for $2.5M cash and extinguishment of the royalty liability; going forward Curis will no longer receive Erivedge royalties (a structural shift for revenue) and expects to recognize a gain in Q4 2025 and remove the royalty liability from the balance sheet .
  • Pipeline momentum: 50% MRD conversion in initial AML triplet cohorts; CLL Phase 2 protocol filed with first patient expected late Q4 or early Q1; PCNSL enrollment continues with multiple November SNO presentations and ASH triplet data in December serving as near-term catalysts .
  • Liquidity/runway: Cash was $9.1M at 9/30; company reiterated runway into Q1’26 in the press release; CFO on the call said “into 2026” and flagged plans to raise additional capital near year-end, highlighting financing risk as a stock driver .

What Went Well and What Went Wrong

What Went Well

  • Beat on revenue and EPS with operating leverage: revenue $3.18M (+8% YoY), GAAP EPS -$0.49 vs -$0.60 consensus; R&D down to $6.4M (from $9.7M YoY) and G&A slightly lower YoY, narrowing losses .*
  • Clinical progress and data flow: AML triplet (ema+ven+aza) showed 50% MRD conversion (4/8 evaluable) with no disease progression among those remaining MRD+; DLTs resolved; SNO (PCNSL/SCNSL) and ASH (AML triplet) presentations set for Nov/Dec .
  • Clarifying CLL plan: Protocol filed; ~40-patient Phase 2 with goal to achieve deeper responses; management said “anything north of 20% [CR] would be very exciting,” underscoring a clear proof-of-concept bar .

What Went Wrong

  • Liquidity tight and financing needed: Cash fell to $9.1M at 9/30; CFO reiterated intent to raise additional capital by year-end; runway commentary varied between “into Q1’26” (PR) and “into 2026” (call) .
  • Loss of steady royalty revenue: Sale of the Erivedge royalty stream eliminates future royalty revenues, creating a step-down in reported revenue starting Q4 despite balance sheet simplification (gain and liability extinguishment) .
  • Other income turned to expense: Q3 other expense was -$0.8M vs +$0.5M YoY due to higher expense related to sale of future royalties and lower interest income, a headwind to bottom line quality .

Financial Results

Headline metrics vs prior periods and consensus

MetricQ3 2024Q2 2025Q3 2025 Consensus*Q3 2025 Actual
Revenue ($USD Millions)$2.931 $2.749 $2.860*$3.176
GAAP EPS-$1.70 -$0.68 -$0.60*-$0.49

Notes: Asterisks indicate values retrieved from S&P Global.*

Income statement detail

Metric ($USD Millions except per-share)Q3 2024Q1 2025Q2 2025Q3 2025
Revenue$2.931 $2.380 $2.749 $3.176
R&D Expense$9.723 $8.539 $7.458 $6.432
G&A Expense$3.753 $3.984 $3.526 $3.653
Loss from Operations$(10.567) $(10.157) $(8.251) $(6.924)
Other Income (Expense)$0.475 $(0.459) $(0.342) $(0.805)
Net Loss$(10.092) $(10.616) $(8.593) $(7.729)
GAAP EPS (basic/diluted)-$1.70 -$1.25 -$0.68 -$0.49
Weighted Avg Shares5.941M 8.494M 12.628M 15.680M

Margins (calculated from reported GAAP)

MarginQ1 2025Q2 2025Q3 2025
Operating Loss Margin %-426.7% (=(10.157/2.380)) -300.1% (=(8.251/2.749)) -218.1% (=(6.924/3.176))
Net Loss Margin %-445.9% (=(10.616/2.380)) -312.6% (=(8.593/2.749)) -243.4% (=(7.729/3.176))

Methodology: percentages computed using GAAP revenue, operating loss, and net loss from company press releases.

Liquidity & other KPIs

KPIQ1 2025Q2 2025Q3 2025
Cash & Cash Equivalents ($M)$20.282 $10.138 $9.051
Shares Outstanding (approx., end of period)~10.5M ~10.7M ~12.7M
AML Triplet MRD Conversion (%)——50% (4/8 evaluable)

Revenue composition: until Nov 6, revenue consisted of Erivedge royalties; subsequent to the Oberland transaction, Curis will no longer receive Erivedge royalties .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough 2026“Into Q1 2026” (Q2 PR) “Into Q1 2026” (Q3 PR); CFO: “into 2026” (call) Maintained (minor wording variance)
CLL Phase 2 InitiationLate 2025 / Early 2026Start “later this year” for 20–30 pts (proof-of-concept) Protocol filed; first patient late Q4 or early Q1; ~40 pts planned Timing narrowed; cohort size clarified/higher
AML Triplet DataDec 2025Data at ASH December 2025 Initial clinical data at ASH Dec 6–9, 2025 Maintained
PCNSL Registration Path12–18 months enrollmentAccelerated approval path agreed with FDA/EMA; enroll 30–40 more pts Continued enrollment; three SNO presentations in Nov Maintained
Royalty Revenue OutlookOngoing royaltiesErivedge royalties from Roche/Genentech Sold Erivedge business; no future royalties; expect Q4 gain; royalty liability extinguished Lower (structural change)
Nasdaq Listing2025 complianceMVLS deficiency disclosed earlier in 2025 [34 not read here]Panel exception until Nov 14, 2025; believes equity >$2.5M but outcome uncertain Mixed; time-limited extension

Earnings Call Themes & Trends

TopicQ1 2025 (Prev-2)Q2 2025 (Prev-1)Q3 2025 (Current)Trend
PCNSL accelerated approvalFDA/EMA alignment; 27-pt update; plan to enroll 30–40 add’l pts Expect 30–40 add’l pts; 37 sites; steady enrollment Continued enrollment; SNO presentations in Nov Steady execution
CLL expansionConcept framed; broader NHL strategy with BTKi combos Plan for 20–30 pt POC; start by YE25 Protocol filed; ~40 pts; CR target “north of 20%” exciting; first patient late Q4/early Q1 Accelerating
AML triplet (frontline)7-day cohort completed; 14-day ongoing Present 7- & 14-day cohorts at ASH 50% MRD conversion across first two cohorts; present at ASH Positive signals emerging
Funding/runwayCash $20.3M; runway to 4Q25 Cash $10.1M; +$7M July raise; runway into Q1’26 Cash $9.1M; runway into 2026; planning near-term capital raise Persistent financing need
Regulatory/macrosFDA climate uncertainty flagged broadly Continued alignment; cautious on FDA environment Maintained stance; SNO/ASH de-risking updates ahead Unchanged caution

Management Commentary

  • “We made good progress advancing our clinical studies in PCNSL, CLL, and AML this quarter... we expect to enroll our first [CLL] patient in late Q4 or early Q1, with data expected at the ASH annual meeting in December 2026.” — James Dentzer, CEO .
  • “MRD conversion... was observed in 4 of 8 patients (50%)... No patients who remained MRD+ progressed... Two dose-limiting toxicities... were observed in the 14-day cohort and both resolved.” — Q3 business update (AML triplet) .
  • “We are anticipating a study design... that anticipates 40 patients [in CLL]... anything north of 20% [CR] would be very exciting.” — CEO/CMO, Q3 call .
  • “We will be looking to bring in additional capital prior to the end of the year.” — CFO, Q3 call .

Q&A Highlights

  • CLL study design and expectations: ~40 patients; dual-pathway blockade (BCR + TLR) aimed at deeper responses; CR “north of 20%” seen as compelling; small dose escalation then expansion at 200 mg .
  • Safety with BTKi combos: Prior experience with ~25 patients on ibrutinib showed no additive toxicities or DDI signals; expect clean profile with other BTKis; PK/DDI monitoring planned .
  • Resource prioritization and financing: Priority on PCNSL enrollment and launching CLL study; management explicitly plans to raise capital by year-end to fund programs .
  • Near-term catalysts: SNO (three PCNSL/SCNSL presentations) and ASH (AML triplet) updates; management avoided front-running but expressed optimism .

Estimates Context

  • Q3 2025 vs S&P Global consensus: Revenue $3.176M vs $2.860M consensus (+$0.316M, +11%); GAAP EPS -$0.49 vs -$0.60 consensus (+$0.11) with 5 and 4 covering estimates respectively. Implication: magnitude of beat driven by lower OpEx and steady royalties in-quarter; forward consensus likely to reduce revenue trajectory post-Erivedge sale and contemplate a Q4 non-operating gain and liability extinguishment .*
MetricQ3 2025 Consensus*Q3 2025 ActualSurprise
Revenue ($USD Millions)$2.860*$3.176 +$0.316
GAAP EPS-$0.60*-$0.49 +$0.11
# of EstimatesRev: 5*; EPS: 4*——

Notes: Asterisks indicate values retrieved from S&P Global.*

Where estimates may adjust:

  • Elimination of future Erivedge royalties post-transaction likely lowers out-quarter revenue models; Q4 should reflect a gain on sale and removal of royalty liability (non-operating), affecting EPS mix .
  • OpEx trajectory trended lower through 2025 (R&D/G&A reductions), potentially supporting improved loss per share run-rate assumptions if sustained .

Key Takeaways for Investors

  • Clean beat on revenue and EPS with clear cost control; however, the structural removal of royalty revenue resets the topline base starting Q4 despite balance sheet simplification from extinguishing the royalty liability .
  • Near-term catalysts are stacked (SNO Nov 19–23, ASH Dec 6–9): updated PCNSL/SCNSL data and initial AML triplet data; positive read-throughs could be stock-moving given small-cap biotech sensitivity to clinical updates .
  • CLL Phase 2 design (~40 pts) targets a tangible bar (>20% CR would be “very exciting”); first patient late Q4/early Q1 sets up 2026 data, expanding TAM beyond PCNSL .
  • Financing overhang: $9.1M cash at quarter-end; management indicated intent to raise capital near term; runway language varied (PR: into Q1’26; call: into 2026) — monitor deal timing/terms and potential dilution .
  • Nasdaq listing risk management: extension to Nov 14 to regain compliance; company believes stockholders’ equity now above $2.5M post-Erivedge transaction, but panel outcome uncertain .
  • For trading: watch for press releases around SNO/ASH and any financing 8-Ks; for the medium-term thesis: de-risking in PCNSL plus proof in CLL/AML could broaden the emavusertib story, but sustained funding is essential to execute .

Footnote: Consensus estimates marked with an asterisk are values retrieved from S&P Global.*