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Curis(CRIS) - 2025 Q4 - Annual Report
2026-03-24 21:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ________________________________ FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 128 Spring Street, Building C - Suite 500, Lexington, Massachusetts, 02421 (Address of principal executive offices) (Zip Code) 617-503-6500 For the fiscal year ended December 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Numbe ...
Curis targets full enrollment in PCNSL registrational study within 12–18 months while advancing CLL proof-of-concept (NASDAQ:CRIS)
Seeking Alpha· 2026-03-19 22:03
Earnings Call InsightsCuris targets full enrollment in PCNSL registrational study within 12–18 months while advancing CLL proof-of-conceptMar 19, 2026, 6:03 PM ETCuris, Inc. (CRIS) StockAI-Generated Earnings Calls InsightsCommentsEarnings Call Insights: Curis, Inc. (CRIS) Q4 2025 Management View James Dentzer, President and CEO, stated that "we continue to make steady progress in our TakeAim Lymphoma study in primary CNS lymphoma, one of the most rare and most difficult to treat of theNewsletters for Every ...
Curis(CRIS) - 2025 Q4 - Earnings Call Transcript
2026-03-19 21:32
Financial Data and Key Metrics Changes - Curis reported a net income of $19.4 million or $1.23 per share for Q4 2025, compared to a net loss of $9.6 million or $1.25 per share for the same period in 2024, primarily due to a $27.2 million one-time non-cash gain from the sale of Erivedge [10] - For the year ended December 31, 2025, the net loss was $7.6 million or $0.58 per share, a significant improvement from a net loss of $43.4 million or $6.88 per share in 2024 [10] - Research and development expenses decreased to $5.8 million in Q4 2025 from $9 million in Q4 2024, and for the year, they were $28.3 million compared to $38.6 million in 2024 [11] - General and administrative expenses also decreased to $2.9 million in Q4 2025 from $3.4 million in Q4 2024, totaling $14 million for the year compared to $16.8 million in 2024 [11] Business Line Data and Key Metrics Changes - The company is making progress in its Take Aim Lymphoma study for primary CNS lymphoma, with expectations for accelerated submissions to the FDA and EMA [4] - Curis is expanding studies of emavusertib into additional NHL subtypes, particularly focusing on its potential to change the treatment paradigm for CLL patients [5][6] Market Data and Key Metrics Changes - The company is actively enrolling patients in its registrational study for PCNSL, with expectations to complete enrollment within 12-18 months [23] - Initial data from the ongoing AML triplet study showed that five of eight evaluable patients achieved MRD conversion, indicating potential for deeper responses [8][9] Company Strategy and Development Direction - Curis is prioritizing its resources towards NHL studies, particularly PCNSL, while also initiating a proof of concept study in CLL [15] - The company aims to improve treatment outcomes by combining emavusertib with existing therapies to achieve deeper responses and potentially complete remission for patients [6][42] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in clinical trials and the potential for significant advancements in 2026, particularly in the registrational study for PCNSL and the proof of concept study in CLL [9] - The company anticipates no meaningful revenue in 2026 due to the cessation of cash flows from Erivedge, but believes it has sufficient cash to fund operations into the second half of 2027 [12][29] Other Important Information - Curis has received initial gross proceeds of $20.2 million from financing in January 2026, with expectations for additional proceeds from warrant exercises [12] Q&A Session Summary Question: How is the company prioritizing trial progress between pivotal PCNSL versus CLL and AML? - Management indicated that resources are being prioritized towards NHL, particularly PCNSL, while CLL is in the early stages of study [14][15] Question: Can you provide updates on enrollment for PCNSL? - Management stated that enrollment is on track, with expectations for full enrollment within 12-18 months [23] Question: Should revenue modeling for 2026 reflect no meaningful revenue? - Management confirmed that there will be no meaningful revenue in 2026, as cash flows from Erivedge have ended [29] Question: What kind of data should be expected at ASH 2026 regarding CLL? - Management indicated that they hope to present meaningful data at ASH, focusing on the potential for deeper responses in patients [39][40]
Curis(CRIS) - 2025 Q4 - Earnings Call Transcript
2026-03-19 21:32
Financial Data and Key Metrics Changes - Curis reported a net income of $19.4 million or $1.23 per share for Q4 2025, compared to a net loss of $9.6 million or $1.25 per share for Q4 2024, primarily due to a $27.2 million one-time non-cash gain from the sale of Erivedge [10] - For the year ended December 31, 2025, Curis reported a net loss of $7.6 million or $0.58 per share, an improvement from a net loss of $43.4 million or $6.88 per share for the same period in 2024 [10] - Research and development expenses decreased to $5.8 million in Q4 2025 from $9 million in Q4 2024, and for the year, they were $28.3 million compared to $38.6 million in 2024 [11] - General and administrative expenses also decreased to $2.9 million in Q4 2025 from $3.4 million in Q4 2024, totaling $14 million for the year compared to $16.8 million in 2024 [11] Business Line Data and Key Metrics Changes - The Take Aim Lymphoma study is progressing well, focusing on primary CNS lymphoma, with expectations for accelerated submissions in the U.S. and Europe [4][9] - Curis is exploring the potential of emavusertib to change treatment paradigms in CLL, aiming to improve upon the current standard of care with BTK inhibitors [5][6] Market Data and Key Metrics Changes - Enrollment in the Take Aim Lymphoma study is on track, with expectations for full enrollment within 12-18 months, potentially leading to data availability in 2027 [23] - The company is prioritizing NHL studies over AML, with a focus on registrational approval for PCNSL [15][16] Company Strategy and Development Direction - Curis aims to change the treatment paradigm for CLL by combining emavusertib with BTK inhibitors, targeting deeper responses and potential complete remission [6][7] - The company is actively engaging with key opinion leaders to expand studies into additional NHL subtypes, indicating a strategic focus on broadening its clinical research [5] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in clinical trials and the potential for significant advancements in 2026, particularly in the registrational study for PCNSL and the proof of concept study for CLL [9] - The management acknowledged the challenges in patient enrollment for PCNSL but remains confident in the study's trajectory [23] Other Important Information - Curis' cash and cash equivalents as of December 31, 2025, along with expected proceeds from financing, should support operations into the second half of 2027 [12] Q&A Session Summary Question: How is Curis prioritizing trial progress between pivotal PCNSL versus CLL and AML? - Management indicated that resources are being prioritized towards NHL, particularly PCNSL, while CLL is also a focus but at a smaller scale currently [14][15] Question: Can you provide updates on enrollment for PCNSL? - Management confirmed that enrollment is on track, with expectations for full enrollment within 12-18 months [23] Question: Should revenue modeling for 2026 reflect no meaningful revenue? - Management confirmed that there will be no meaningful revenue for 2026, as revenue effectively ended in November 2025 [29] Question: What kind of data should be expected at ASH 2026 for CLL? - Management stated that they hope to present meaningful data at ASH, focusing on the execution of the study and patient enrollment [38][40]
Curis(CRIS) - 2025 Q4 - Earnings Call Transcript
2026-03-19 21:30
Financial Data and Key Metrics Changes - Curis reported a net income of $19.4 million or $1.23 per share for Q4 2025, compared to a net loss of $9.6 million or $1.25 per share for Q4 2024, primarily due to a $27.2 million one-time non-cash gain from the sale of Erivedge [10] - For the year ended December 31, 2025, the net loss was $7.6 million or $0.58 per share, a significant improvement from a net loss of $43.4 million or $6.88 per share in 2024 [10] - Research and development expenses decreased to $5.8 million in Q4 2025 from $9 million in Q4 2024, and for the year, they were $28.3 million compared to $38.6 million in 2024 [11] - General and administrative expenses also decreased to $2.9 million in Q4 2025 from $3.4 million in Q4 2024, totaling $14 million for the year compared to $16.8 million in 2024 [11] Business Line Data and Key Metrics Changes - The Take Aim Lymphoma study in primary CNS lymphoma is progressing well, with expectations for accelerated submissions in the U.S. and Europe [4] - Initial data from the ongoing AML triplet study showed that 5 of 8 evaluable patients achieved MRD conversion, indicating potential effectiveness of the treatment combination [8][9] Market Data and Key Metrics Changes - The company is focusing on expanding emavusertib studies into additional NHL subtypes, particularly CLL, where current treatments have limitations [5][6] - The company is prioritizing NHL studies over AML due to resource allocation and the potential for registrational approval in PCNSL [14][15] Company Strategy and Development Direction - Curis aims to improve the treatment paradigm for CLL by combining emavusertib with BTKI regimens, targeting deeper responses and potential complete remission [6][39] - The company is actively engaging with clinical sites in the U.S. and Europe to advance its studies and expects to present initial data at the ASH annual meeting in December [7][9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in clinical trials and the potential for significant advancements in treatment options for patients with CLL and NHL [4][9] - The company anticipates no meaningful revenue in 2026 due to the cessation of cash flows from Erivedge, but is confident in its financial position to support operations into the second half of 2027 [12][27] Other Important Information - Curis has secured initial gross proceeds of $20.2 million from financing, which will support its operations and clinical trials [12] Q&A Session Summary Question: How is the company prioritizing trial progress between pivotal PCNSL versus CLL and AML? - Management indicated that resources are being prioritized towards NHL, particularly PCNSL, while CLL is in the early stages of study [14][15] Question: Can you provide updates on PCNSL enrollment? - Management confirmed that enrollment is on track, with expectations for full enrollment within 12-18 months [22] Question: Should revenue modeling reflect no meaningful revenue for 2026? - Management confirmed that there will be no meaningful revenue, as cash flows from Erivedge have ended [27][28] Question: What data should be expected at ASH 2026 for CLL? - Management stated that they hope to present meaningful data regarding the treatment's effectiveness, focusing on deepening patient responses [35][36]
Curis(CRIS) - 2025 Q4 - Annual Results
2026-03-19 20:09
Exhibit 99.1 PRESS RELEASE Curis Provides Fourth Quarter 2025 Business Update Management to host conference call today at 4:30 p.m. ET LEXINGTON, Mass., March 19, 2026 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, today reported its business update and financial results for the quarter ended December 31, 2025. Operational Highlights TakeAim Lymphoma TakeAim CLL • Curis ini ...
Curis GAAP EPS of $1.23 beats by $1.67, revenue of $1.14M misses by $2.11M (NASDAQ:CRIS)
Seeking Alpha· 2026-03-19 20:03
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Curis Provides Fourth Quarter 2025 Business Update
Prnewswire· 2026-03-19 20:00
Curis Provides Fourth Quarter 2025 Business Update Accessibility StatementSkip Navigation Management to host conference call today at 4:30 p.m. ET LEXINGTON, Mass., March 19, 2026 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, today reported its business update and financial results for the quarter ended December 31, 2025. Operational Highlights TakeAim Lymphoma Lakshmi Nay ...
Curis (NasdaqCM:CRIS) 2026 Extraordinary General Meeting Transcript
2026-03-17 16:02
Summary of Curis Special Meeting of Stockholders Company Overview - **Company**: Curis, Inc. (NasdaqCM: CRIS) - **Meeting Date**: March 17, 2026 - **Total Shares Outstanding**: 13,734,939 shares - **Shares Present for Voting**: 7,717,846 shares [7] Key Proposals and Voting Outcomes 1. **Authorized Share Proposal** - Proposal to increase the number of authorized shares of capital stock from 73,343,750 to 288,757,150 - Increase in authorized shares of common stock from 68,343,750 to 283,757,150 - **Outcome**: Approved by a majority of votes cast [13] 2. **Preferred Stock Conversion and Warrant Exercise Proposal** - Approval for the issuance of shares of common stock upon conversion of Series B preferred stock and exercise of Series A, B, and C warrants - **Outcome**: Approved by a majority of votes cast [13] 3. **2026 Incentive Plan Proposal** - Approval of the 2026 Incentive Plan - **Outcome**: Approved by a majority of votes cast [13] 4. **Adjournment Proposal** - Proposal to adjourn the meeting if necessary for further solicitation of proxies - **Outcome**: Approved by a majority of votes cast [13] Important Notes - The meeting was conducted virtually, and stockholders were encouraged to submit questions via a web portal [2][4] - The meeting included a formal voting process, with results to be reported in a Form 8-K within four business days [14] - Forward-looking statements were made, with a disclaimer regarding reliance on these statements due to potential material differences in actual results [5] Additional Information - The meeting was presided over by Jim Dentzer, President and CEO, with participation from other board members and legal counsel [2][3] - The quorum was confirmed with the presence of shares sufficient for conducting business [9]
Curis Announces Closing of Private Placement Totaling up to $80.8 Million in Gross Proceeds
Prnewswire· 2026-01-09 13:00
Core Viewpoint - Curis, Inc. has successfully closed a private placement financing, raising gross proceeds of up to $80.8 million, which will support the development of its lead drug emavusertib [1][2]. Group 1: Financing Details - The private placement included initial gross proceeds of approximately $20.2 million before placement agent fees and offering expenses [1]. - The financing was led by Nantahala Capital, Stonepine Capital Management, Pointillist Partners, LLC, and The Red Hook Fund, LP, along with participation from other institutional investors and members of the management team and board of directors [2]. Group 2: Company Overview - Curis, Inc. is focused on developing emavusertib, an orally available small molecule IRAK4 and FLT3 inhibitor [3]. - Emavusertib is currently being evaluated in clinical studies for various types of lymphoma and leukemia, including a Phase 1/2 study in combination with ibrutinib for relapsed/refractory primary central nervous system lymphoma and a Phase 2 study in chronic lymphocytic leukemia [3]. - The drug has received Orphan Drug Designation from the U.S. FDA and the European Commission for the treatment of primary central nervous system lymphoma, acute myeloid leukemia, and myelodysplastic syndromes [3].