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- **One-Time Financial Boost**: Q4 2025 net income of $19.4M driven by a $27.2M gain from Erivedge sale, with no future revenue from the asset.
- **Top Priorities**: PCNSL registrational study and CLL proof-of-concept trial take precedence over AML.
- **CLL Potential**: Dual blockade of BCR and TLR pathways aims for complete remission in CLL, with initial data expected at ASH 2026.
- **AML Progress**: Triplet therapy achieved MRD conversion in 5/8 patients, highlighting disease-modifying potential.

**【Management Opening Remarks】**
- Diantha Duvall welcomed participants and emphasized the importance of forward-looking statements. She highlighted the availability of the press release and financial tables on the company’s website.
- The call featured updates from Jim Dentzer (CEO), Dr. Jonathan Zung (Chief Development Officer), and Dr. Ahmed Hamdy (Chief Medical Officer).

**【CEO Commentary】**
- **PCNSL Progress**: The TakeAim Lymphoma study for primary central nervous system lymphoma (PCNSL) is on track for regulatory submissions in the U.S. and Europe. Enrollment remains challenging but steady, with potential for full enrollment by mid-2027.
- **CLL Initiative**: A new proof-of-concept study combines emavusertib with BTK inhibitors to target deeper responses (e.g., complete remission) in chronic lymphocytic leukemia (CLL). Initial data expected at ASH 2026.
- **AML Update**: The AML triplet study (emavusertib + azacitidine + venetoclax) showed 5/8 patients achieving MRD conversion, highlighting potential for MRD-negative disease.

**【CFO Financial Commentary】**
- **Q4 2025 Financials**: Net income of $19.4 million ($1.23 per share) driven by a one-time $27.2 million gain from the sale of Erivedge to Oberland. 2025 annual net loss of $7.6 million reflects reduced R&D and G&A expenses.
- **Cash Position**: $20.2 million in initial PIPE financing proceeds, with potential for an additional $20.2 million from warrant exercises, supporting operations into H2 2027.
- **Revenue Outlook**: No meaningful future revenue from Erivedge following the sale of remaining royalties to Oberland.

**【Q&A Highlights】**
- **Trial Prioritization**: Resources are focused on PCNSL (registrational study) and CLL (proof-of-concept), with AML暂定为后期优先级.
- **PCNSL Enrollment**: Enrollment is unpredictable (1-3 patients/month), but on track for full enrollment by mid-2027.
- **CLL Study Status**: Site activation underway in the U.S. and Europe; first patient dosing expected soon, with ASH 2026 data anticipated.
- **AML Strategy**: Analyzing next steps post-positive initial data, with potential for expanded trials if resources allow.

Curis, Inc.(CRIS)-20260320-2025 Q4 Earnings call transcript

- **CLL Trial Launch**: Phase II study of emavusertib + BTKi in CLL patients with PR but no CR, targeting MRD negativity. Enrollment begins Q4 2025, data at ASH 2026.
- **AML MRD Success**: 4/8 patients achieved undetectable MRD within 8 weeks in triplet study; no disease progression.
- **Financial Stability**: $9.1M cash as of Q3; expects to fund operations into 2026.
- **FDA Alignment**: CLL protocol submissions aligned with FDA; PCNSL study on track for accelerated submissions.

**【Management Opening Remarks】**
- Diantha Duvall welcomed participants and provided access to the press release and financial tables.
- Reminder of forward-looking statements and SEC filing risks.
- Introduction of executives: Jim Dentzer (CEO), Dr. Jonathan Zung (CDO), and Dr. Ahmed Hamdy (CMO).

**【CEO Commentary】**
- **TakeAim Lymphoma Study Progress**: Single-arm Phase II study evaluating emavusertib + ibrutinib in PCNSL. FDA/EMA alignment for accelerated submissions expected in 12-18 months.
- **CLL Expansion**: Submitted protocol for proof-of-concept study in CLL patients on BTKi monotherapy with PR but no CR. Enrollment expected Q4 2025/Q1 2026, with data at ASH 2026.
- **AML Triplet Study**: Abstract released for emavusertib + azacitidine + venetoclax in AML. Early data: 4/8 evaluable patients achieved MRD undetectable within 5-8 weeks; no disease progression.

**【CFO Financial Commentary】**
- **Q3 2025 Financials**: Net loss $7.7M ($0.49/share) vs. $10.1M ($1.70/share) in Q3 2024. 9M 2025 loss $26.9M ($2.19/share) vs. $33.8M ($5.77/share).
- **R&D Expenses**: $6.4M (Q3) vs. $9.7M; $22.4M (9M) vs. $29.6M, driven by reduced clinical costs.
- **G&A Expenses**: $3.7M (Q3) vs. $3.8M; $11.2M (9M) vs. $13.4M.
- **Cash Position**: $9.1M as of Q3 end; expects to fund operations into 2026.

**【Q&A Key Highlights】**
- **CLL Study Design**: 40-patient Phase II targeting CR and MRD negativity. FDA-aligned endpoints with 100mg/200mg dose escalation.
- **Resource Allocation**: Prioritizing PCNSL and CLL trials; seeking capital raise by year-end.
- **Safety Profile**: No additive toxicities observed with ibrutinib; PK monitoring planned.
- **SNO Conference Expectations**: Posters on PCNSL and SCNSL; focus on 6-month data updates.

Curis, Inc. (CRIS) Q3 2025 Earnings Call Transcript

- **PCNSL Breakthrough**: Enrolling 30-40 patients for regulatory submissions; emavusertib + BTKi targeting complete remission in rare PCNSL.
- **CLL Innovation**: Launching study to achieve MRD-negative responses with emavusertib + BTKi; first patient in by year-end.
- **AML Superiority**: 38% CR vs 21% for gilteritinib; planning head-to-head registrational study.
- **Financial Stability**: $10.1M cash runway to Q1 2026; evaluating funding options amid biotech uncertainty.

**【CEO Commentary】**
- **PCNSL Progress**: TakeAim Lymphoma study enrolling 30-40 additional patients for NDA/EMA submissions. Emavusertib + BTKi aims for complete remission in ultra-rare PCNSL population.
- **CLL Expansion**: Launching proof-of-concept study (20-30 patients) to evaluate emavusertib + BTKi for MRD-negative responses. First patient in by end-2025, data mid-2026.
- **AML Efficacy**: 38% CR in relapsed/refractory AML vs 21% for gilteritinib. Planning registrational study vs gilteritinib in relapsed/refractory setting.
- **MDS Potential**: Exploring emavusertib + azacitidine combo after VERONA failure. Monotherapy active in high-risk MDS.
- **Frontline AML Triplet**: Phase I study with emavusertib, venetoclax, azacitidine. 7-day and 14-day dosing regimens completed; data at ASH 2025.

**【CFO Commentary】**
- **Q2 2025 Financials**: Net loss $8.6M (-27% YoY). R&D expenses $16M (-19.5% YoY), G&A $7.5M (-22.7% YoY) due to cost controls.
- **Cash Position**: $10.1M as of June 30, 2025, extended to Q1 2026 with $6M July offering. Evaluating further funding options.

**【Q&A Highlights】**
- **Enrollment Update**: PCNSL study on track with 30+ sites; no new sites needed. CLL study targeting post-BTKi patients regardless of therapy line.
- **Competitive Landscape**: Emavusertib positioning as BTKi adjunct; indifferent to BTK inhibition/degradation method. Monitoring tirabrutinib progress for potential combination.
- **FDA Engagement**: Positive discussions for PCNSL accelerated approval; unaffected by FDA administrative changes.
- **Financial Strategy**: Focused on capital efficiency; exploring dilutive/non-dilutive funding options beyond Q1 2026.

Curis, Inc. (CRIS) Q2 2025 Earnings Call Transcript

- **Breakthrough Lymphoma Data**: 4 complete remissions (including 2+ year durability) in relapsed PCNSL patients with emavusertib + ibrutinib combo.
- **AML Superiority**: 38% CR rate vs. 21% for gilteritinib in more pretreated patients, driven by IRAK4/FLT3 dual inhibition.
- **Stable Regulatory Path**: FDA/EMA alignment preserved despite agency changes; lymphoma NDA on track with 30-40 additional patients needed.
- **Financial Strength**: $20.3M cash runway to Q4 2025; cost reductions drive 9% YoY net loss improvement.


**【CEO Opening Remarks】**
- **New Leadership Addition**: Welcome of Dr. Ahmed Hamdy as Chief Medical Officer, bringing expertise in BTK inhibition and lymphoma drug development.
- **TakeAim Lymphoma Study Update**: 27 patients treated with emavusertib + ibrutinib combo:
  - 9/13 BTKI-experienced patients showed tumor burden reduction (6 objective responses, 4 CRs)
  - 5/6 BTKI-naive patients achieved tumor reduction (5 objective responses)
- **AML Progress**: Phase I study of emavusertib monotherapy in relapsed/refractory AML shows 38% composite CR rate vs. 21% for gilteritinib in less pretreated patients.
- **Frontline AML Triplet Study**: Phase I safety evaluation of emavusertib + venetoclax + azacitidine in MRD+ patients post-ven-aza CR. 7-day dosing cohort complete; 14-day cohort enrolling.

**【CFO Financial Update】**
- **Q1 2025 Financials**: Net loss of $10.6M (-9% YoY), R&D expenses $8.5M (-11% YoY), G&A $4.0M (-18% YoY) due to cost reductions.
- **Liquidity**: $20.3M cash as of March 2025, enabling operations into Q4 2025. March registered direct financing raised $8.8M net proceeds.

**【Q&A Key Points】**
- **Enrollment Strategy**: 37 active sites globally for lymphoma study; plans to add ~10-20 more sites to reach 30-40 additional patients needed for NDA.
- **FDA Collaboration**: Reassured regulatory path stability despite agency turmoil; FDA/EMA alignment maintained from pre-turmoil discussions.
- **AML Development**: Phase I triplet study safety data expected later 2025; no immediate plans for EMA AML filings beyond ongoing studies.
- **Mechanism Insights**: Emavusertib's dual IRAK4/FLT3 inhibition enables overcoming BTKI resistance via NF-κB pathway downregulation, independent of genetic mutations.


Curis, Inc. (CRIS) Q1 2025 Earnings Call Transcript

- **Regulatory Momentum**: EMA and FDA provide positive feedback for accelerated approval of emavusertib in PCNSL.
- **Clinical Excellence**: 6 CRs in BTKI experienced patients and 5 responses in naïve patients; 38% CR rate in AML vs. 21% for existing treatments.
- **Financial Security**: Extended cash runway to Q4 2025 with recent financings.
- **Strategic Growth**: Exploring partnerships and expanding AML studies for potential best-in-class FLT3 treatment.

**【CEO Summary Section】**
- **NHL Progress**: TakeAim Lymphoma study received positive feedback from EMA and FDA for accelerated approval. Clinical data shows 6/13 BTKI experienced patients achieved CRs, and 5/6 BTKI naïve patients had objective responses. Granted Orphan Drug Designation for PCNSL in both the U.S. and Europe.
- **AML Breakthrough**: ASH conference data shows 38% composite CR rate, superior to existing treatments (21% for gilteritinib). Initiated Triplet Study in Frontline AML with positive safety results.

**【CFO Financial Commentary】**
- **Q4 2024 Financials**: Net loss of $9.6 million, down from $117 million in 2023. R&D expenses decreased by $1 million YoY, G&A down by $2.5 million.
- **Cash Runway**: Extended to Q4 2025 due to $10.8 million and $10 million financings.

**【Q&A Key Highlights】**
- **Cash Management**: Burn rate of $10 million per quarter, runway to Q4 2025.
- **Partnership Discussions**: Active talks with potential partners for NHL and AML programs.
- **Enrollment Update**: 13 patients dosed at 100mg BID in PCNSL study. EMA and FDA expect similar data requirements for accelerated approval.
- **Future AML Studies**: Planning monotherapy extension in FLT3 and further Triplet Study data.

Actual											-5.6	-3.4	-2.2	-2.2	-2.2	-2.4	-2.4	-3	-3.6	-3.4	-2.8	-2.4	-2.4	-2.4	-2.13	-2.03	-2.05	-2.03	-1.7	-1.25	-1.25	-0.68	-0.49	1.23
Forecast												-3.7333	-2.6	-1.9	-1.84	-2.2	-2.6	-2.5333	-3.2	-3.32	-3.32	-2.6	-2.04	-2.36	-2.326	-2.1167	-2.0417	-1.7933	-1.83	-1.34	-1.106	-1.36	-0.578	-0.436
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	+8.93%	+15.38%	-15.79%	-19.57%	-9.09%	+7.69%	-18.42%	-12.50%	-2.41%	+15.66%	+7.69%	-17.65%	-1.69%	+8.43%	+4.10%	-0.41%	-13.20%	+7.10%	+6.72%	-13.02%	+50.00%	+15.22%	+382.11%

Actual	--	--	--	--	--	--	--	--	--	--	2.71M	2.36M	2.74M	3.02M	2.19M	2.29M	3.04M	3.13M	2.06M	2.39M	2.83M	2.89M	2.30M	2.20M	2.83M	2.70M	2.09M	2.55M	2.93M	3.35M	2.38M	2.75M	3.18M	1.14M
Forecast	--	--	--	--	--	--	--	--	--	--	--	2.76M	2.57M	2.84M	2.75M	2.48M	2.71M	2.96M	2.40M	2.62M	3.05M	3.19M	2.48M	2.47M	2.54M	3.02M	2.00M	2.06M	2.27M	2.21M	2.65M	2.64M	2.86M	3.25M
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	-14.64%	+6.78%	+6.49%	-20.45%	-7.68%	+12.27%	+5.92%	-14.45%	-8.58%	-7.28%	-9.37%	-7.36%	-11.11%	+11.54%	-10.81%	+4.24%	+23.37%	+29.26%	+51.34%	-10.23%	+4.17%	+11.05%	-64.98%

CRIS

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CRIS

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