Executive Summary

Q4 2024 delivered a clear clinical/regulatory inflection: FDA and EMA provided supportive feedback that the ongoing single‑arm TakeAim Lymphoma study could support Accelerated Approval (US) / Conditional Marketing Authorization (EU) in PCNSL; Curis plans to enroll 30–40 additional patients over 12–18 months to file .
Results beat Wall Street revenue consensus and were essentially in line on EPS: revenue $3.35m vs $2.04m consensus (beat); GAAP EPS −$1.25 vs −$1.24 consensus (−$0.01 miss). Consensus from S&P Global estimates; see Estimates Context section for details and disclaimer .
Operating discipline continued: R&D and G&A declined y/y; net loss improved y/y/q/q; cash and equivalents ended Q4 at $20.0m; with March 2025 financing, runway extended into Q4’25, though management still flags the need for additional capital .
Catalysts: regulatory clarity in PCNSL, durable responses in BTKi‑experienced/naïve patients, AML signals (FLT3 monotherapy and frontline triplet), and ongoing partnering discussions highlighted on the call .

What Went Well and What Went Wrong

What Went Well
- Regulatory path: FDA/EMA indicated the ongoing single‑arm PCNSL study could support AA/CMA; agencies aligned on ORR as primary endpoint and contribution‑of‑effect analyses; current Phase 1/2 now effectively registrational in US/EU .
- Clinical efficacy: In PCNSL (data cutoff Jan 2, 2025), BTKi‑experienced cohort showed 6 objective responses (4 CR, 2 PR; 3/4 CRs >6 months) among 13 evaluable; BTKi‑naïve cohort showed 5 objective responses (1 CR, 4 PR) among 6 evaluable .
- Financial execution: Revenue rose to $3.35m in Q4 (Erivedge royalties), net loss narrowed to $9.6m; R&D and G&A both down y/y; October 2024 and March 2025 financings extended runway into Q4’25 .
- Notable quote: “The development time line for emavusertib just got accelerated. Our current Phase I/II study is now registrational for both the U.S. and Europe.” — CEO James Dentzer .
What Went Wrong
- Funding overhang persists: Despite runway extension, Curis states it lacks sufficient cash to support operations for 12 months without additional funding and will require substantial capital to advance emavusertib through approval .
- EPS modestly missed consensus by $0.01 (S&P Global consensus −$1.24 vs GAAP −$1.25), and “Other expense, net” swung to a −$0.6m headwind in Q4 vs +$0.5m in Q4’23 .
- Regulatory requirements add work: FDA/EMA expect contribution‑of‑effect analyses (emavusertib, ibrutinib, and combo; dose analyses at 100mg vs 200mg), and total patient numbers remain a review issue, which could extend timelines if enrollment lags .

Financial Results

Quarterly trend (chronological: Q2 → Q3 → Q4 2024)

Metric	Q2 2024	Q3 2024	Q4 2024
Revenue ($USD Millions)	$2.546	$2.931	$3.345
Net Loss ($USD Millions)	$(11.803)	$(10.092)	$(9.618)
GAAP EPS (basic/diluted)	$(2.03)	$(1.70)	$(1.25)
R&D Expense ($USD Millions)	$10.254	$9.723	$8.968
G&A Expense ($USD Millions)	$4.792	$3.753	$3.354

YoY comparison (Q4 2023 vs Q4 2024)

Metric	Q4 2023	Q4 2024
Revenue ($USD Millions)	$2.696	$3.345
Net Loss ($USD Millions)	$(11.712)	$(9.618)
GAAP EPS (basic/diluted)	$(2.03)	$(1.25)
R&D Expense ($USD Millions)	$9.964	$8.968
G&A Expense ($USD Millions)	$4.877	$3.354

Vs. Estimates (S&P Global)

Metric	Consensus (Q4 2024)	Actual (Q4 2024)	Surprise
Revenue ($USD)	$2,040,000*	$3,345,000	+$1,305,000 (Beat)
GAAP EPS	$(1.24)*	$(1.25)	−$0.01 (Miss)

Values marked with * are from S&P Global consensus; Values retrieved from S&P Global.

Segment breakdown: Not applicable (revenue consists of royalties from Genentech/Roche’s Erivedge) .

KPIs and balance sheet

KPI	Q3 2024	Q4 2024
Cash, cash equivalents & investments ($USD Millions)	$20.854	$19.997
Shares Outstanding (approx.)	~8.5m	~8.5m
Cash Runway Guidance	Into mid‑2025	Into Q4 2025 (incl. March 2025 offerings)

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Company operations	Into mid‑2025	Into Q4 2025 (adds March 2025 proceeds)	Raised/Extended
PCNSL Clinical Plan	Next 12–18 months	N/A	Enroll 30–40 additional patients to support AA/CMA filings	New quantitative enrollment plan
Regulatory Path (PCNSL)	US/EU filings	“Engaged with regulators”	FDA/EMA supportive that current single‑arm study could support AA/CMA; ORR primary endpoint; contribution‑of‑effect required	De‑risked path (qualitative)

No revenue, margin, tax, or OpEx numeric guidance was provided beyond the above.

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 2024, Q3 2024)	Current Period (Q4 2024)	Trend
PCNSL regulatory path	Initiated discussions; EU ODD for PCNSL; initial data 15–20 pts expected late 2024	FDA/EMA supportive of AA/CMA using current single‑arm study; ORR primary endpoint; confirmatory study design to align; contribution‑of‑effect needed	Improving clarity/acceleration
PCNSL efficacy (ema + ibrutinib)	Preliminary CR/CRu/PR signals in BTKi‑experienced; durability >6 months in multiple CR/CRu	27 pts update: BTKi‑experienced 6 ORR (4 CR, 2 PR; 3 CRs >6 months); BTKi‑naïve 5 ORR (1 CR, 4 PR)	Strengthening dataset
AML monotherapy (FLT3)	Additional data planned (ASH)	38% composite CR in FLT3 salvage population; rapid responses; potential best‑in‑class rationale (IRAK4 + FLT3)	Positive signal; potential strategy
AML triplet (frontline)	Triplet initiated; initial safety expected late 2024	7‑day cohort completed, well tolerated; escalating to 14‑day; goal: establish safety then move to Day‑1 triplet dosing	Advancing dose/escalation
Cash runway/financing	Cash to mid‑2025; Oct 2024 financing $10.8m net	Q4 cash $20.0m; March 2025 ~$10m gross financing; runway into Q4’25; still needs additional funding	Extended but funding need persists
Partnering	Not emphasized previously	“On radar screens”; expects discussions and potential partnership with major players	Increasing discussion

Management Commentary

“The development time line for emavusertib just got accelerated. Our current Phase I/II study is now registrational for both the U.S. and Europe.” — CEO James Dentzer, prepared remarks .
“Over the next 12–18 months, we will be focused on enrolling 30–40 additional patients to support the regulatory filing for accelerated approval.” — CEO James Dentzer, press release .
“As long as we are probably north of 25% ORR [in PCNSL], [we] should have positive momentum with both agencies.” — CDO Jonathan Zung during Q&A .
“We’ve previously guided that our burn is about $10 million a quarter… [financings] extend our cash runway from mid‑’24 to the fourth quarter of ’25.” — CFO Diantha Duvall .

Q&A Highlights

Cash burn/runway: ~$10m quarterly burn; October 2024 and March 2025 financings extend runway into Q4’25 .
Partnering: Management expects ongoing discussions and anticipates partnering with a major player in NHL or AML at some point .
FDA component contribution: Plan to analyze 100mg vs 200mg dosing and contributions of emavusertib, ibrutinib, and the combination in BTKi‑naïve population; 13 PCNSL patients dosed at 100mg so far .
EMA/FDA efficacy bar: Agencies supportive given lack of approved PCNSL treatments; aiming to maintain compelling, consistent responses; “north of 25% ORR” seen as supportive .
AML roadmap: Triplet moving through dose durations; potential FLT3 monotherapy pivotal considered; timing/data updates to be clarified as year progresses .

Estimates Context

Revenue: Q4 revenue of $3.345m beat S&P Global consensus of $2.04m (beat of $1.305m). Consensus values from S&P Global; actuals from company reported financials .
EPS: GAAP EPS of $(1.25) missed S&P Global consensus of $(1.24) by $0.01. Consensus values from S&P Global; actuals from company reported financials .
Values retrieved from S&P Global.

Where estimates may adjust: Consensus revenue likely moves higher given Erivedge royalty strength; EPS sensitivity tied to operating expense cadence and “Other income/expense” volatility, and to the pace/cost of PCNSL enrollment and manufacturing .

Key Takeaways for Investors

The PCNSL program is now effectively on a registrational footing in both US/EU, materially de‑risking the path to first approval if response durability holds and contribution‑of‑effect requirements are satisfied .
Clinical efficacy signals (including in BTKi‑experienced PCNSL and salvage FLT3 AML) support emavusertib’s dual‑mechanism thesis and underpin medium‑term value creation across indications .
Q4’24 showed continued operating discipline and a strong royalty‑driven revenue beat; however, the company still anticipates needing additional capital to reach approval/commercialization .
Near‑term catalysts: ongoing PCNSL enrollment updates, FDA/EMA alignment on confirmatory design, AML triplet safety escalation and potential Day‑1 triplet dosing, and partnering developments .
Risk factors: enrollment pace, regulatory review issues (patient numbers, contribution‑of‑effect), royalty variability (Erivedge), and financing risk remain prominent .
Trading lens: Regulatory clarity and clinical durability are supportive; funding and dilution risk remain the principal overhangs until a partnering event or additional financing is secured .

Sources

Q4 2024 press release (furnished via 8‑K): financials and business update and standalone press release .
Q4 2024 earnings call transcript: strategy, regulatory feedback, Q&A .
8‑K (Mar 28, 2025) with Item 2.02, financing terms, regulatory details, and cash runway commentary .
Prior quarters for trend: Q3 2024 press release ; Q2 2024 press release .
October 29, 2024 financing press release .

CURIS INC (CRIS)·Q4 2024 Earnings Summary