CURIS INC (CRIS)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 delivered a modest EPS beat and a revenue miss versus consensus: Diluted EPS was -$1.25 vs -$1.26 consensus (beat by ~$0.01), while revenue was $2.38M vs $2.60M consensus (miss by ~$0.22M), driven by Erivedge royalties and lower operating costs year over year . EPS consensus/actual values from S&P Global.*
• Management emphasized continued progress on the accelerated approval path for emavusertib in relapsed/refractory PCNSL, with EMA/FDA alignment in place and Q1 operational momentum adding 37 clinical sites and advancing enrollment .
• Cash runway remains guided into Q4 2025 following recent financings, but filings reiterate the need for substantial additional capital and near-term funding risks in forward-looking statements .
• Near-term catalysts: additional TakeAim Lymphoma data at ASH later this year, further site additions/enrollment progress, and AML program updates (triplet cohort and FLT3 monotherapy signals) .

What Went Well and What Went Wrong

What Went Well

• Accelerated approval pathway clarity: “We have made exciting progress with both the FDA and EMA on the potential for accelerated approval of emavusertib in R/R PCNSL… We expect to provide additional data… at ASH later this year” — CEO James Dentzer ; Q4 call confirmed EMA/FDA support and the study as registrational .
• Clinical efficacy signals sustained: In PCNSL, 9/13 BTK-experienced showed tumor burden reduction (6 ORR; 4 CR, 2 PR) and 5/6 BTK-naïve showed responses (1 CR, 4 PR) at the Jan 2, 2025 cut-off; several CRs >6 months . AML FLT3 cohort showed a 38% composite CR rate in salvage-line patients where >80% had prior FLT3i exposure .
• Operating discipline: R&D ($8.5M) and G&A ($4.0M) decreased y/y, helping deliver an EPS outcome slightly better than consensus despite a small revenue miss .

What Went Wrong

• Revenue miss vs consensus: Erivedge royalty revenue ($2.38M) fell short of $2.60M consensus; royalty variability continues to drive short-term revenue unpredictability . Consensus from S&P Global.*
• Other expense swung negative ($0.5M) vs prior-year other income ($0.6M), tied to increased expense related to sale of future royalties and lower interest income, pressuring net results .
• Funding overhang: Disclosures caution insufficient cash to support operations for the next 12 months absent additional financing, despite stated runway into Q4 2025, highlighting near-term capital risk .

Financial Results

Segment breakdown: Not applicable; revenue consists of Erivedge royalty income .

KPIs

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We have made exciting progress with both the FDA and EMA on the potential for accelerated approval of emavusertib in R/R PCNSL… We expect to provide additional data… at ASH later this year.” — James Dentzer, President & CEO .
• “We continue to make steady progress in our TakeAim lymphoma study… we expect the study to support accelerated submissions in both the U.S. and Europe.” — James Dentzer .
• “Curis reported a net loss of $10.6 million or $1.25 per share… R&D expenses were $8.5 million… G&A expenses were $4.0 million… cash and cash equivalents totaled $20.3 million… [and] enable planned operations into the fourth quarter of 2025.” — CFO Diantha Duvall .
• “I’m excited to join… at this very critical time to advance emavusertib towards regulatory filings in primary CNS lymphoma… expand… into NHL, AML and solid tumors.” — Dr. Ahmed Hamdy (new CMO) .

Q&A Highlights

• Prioritization and resource allocation: Management is pursuing both PCNSL (higher resourcing) and AML (lighter spend; safety-focused triplet cohorts) concurrently; PCNSL enrollment target remains 30–40 patients needed for NDA submission .
• FDA environment: Company believes prior collaborative discussions with FDA occurred “before this current turmoil,” limiting risk to Curis’s agreed path; supportive stance reiterated .
• Site expansion and timelines: 37 sites open across US/EU/Israel; engagement efforts ongoing; timeline to complete enrollment remains 12–18 months .
• AML and mutations: Benefits attributed to dual IRAK4/TLR and BCR pathway downregulation rather than specific mutations; development plans to follow completion of triplet safety study with potential R/R and frontline paths .

Estimates Context

Note: Consensus values retrieved from S&P Global.*

Interpretation: EPS beat was aided by lower R&D and G&A y/y; revenue miss reflects royalty variability tied to Erivedge sales .

Key Takeaways for Investors

• EPS slightly beat consensus as OpEx declines y/y offset a small revenue shortfall; watch for continued expense discipline to sustain EPS trajectory . Consensus from S&P Global.*
• Regulatory momentum and registrational clarity in PCNSL are intact; ASH data updates and ongoing enrollment progress are pivotal near-term catalysts .
• PCNSL site expansion to 37 and focus on achieving 6–8 additional responses in the next data set increase confidence in the accelerated filing plan over 12–18 months .
• AML programs show compelling signals: 38% composite CR in FLT3 salvage-line and active triplet safety cohorts; future readouts could broaden the thesis beyond PCNSL .
• Funding remains the central overhang: while runway is guided into Q4 2025, filings reiterate near-term capital needs; expect potential financing or partnerships as milestones approach .
• Trading implications: stock likely to be sensitive to ASH data, further site/enrollment updates, and any FDA/EMA communications; financing headlines could be a countervailing risk.
• Medium-term thesis: If accelerated approval is achieved in PCNSL, expansion across NHL indications where BTK inhibitors are used presents a meaningful opportunity; AML could provide additional upside contingent on pivotal design and safety/efficacy outcomes .

Non-GAAP note: Company reports GAAP results; no non-GAAP adjustments disclosed in the Q1 2025 materials **[1108205_20250506NE80426:3]** **[1108205_0001108205-25-000045_a1q25earningspressrelease.htm:1]**.