Financial Data and Key Metrics Changes - Curis reported a net loss of $8.6 million or $0.68 per share for Q2 2025, compared to a net loss of $11.8 million or $2.03 per share for the same period in 2024, indicating an improvement in financial performance [11] - Research and development expenses decreased to $7.5 million in Q2 2025 from $10.3 million in Q2 2024, primarily due to lower employee-related costs and clinical expenses [11] - General and administrative expenses also decreased to $3.5 million in Q2 2025 from $4.8 million in Q2 2024, reflecting reduced employee-related and legal costs [12] Business Line Data and Key Metrics Changes - The company is focused on the "take aim lymphoma" study evaluating emigosertib in combination with ibrutinib for patients with primary CNS lymphoma (PCNSL), with plans to enroll 30 to 40 additional patients over the next 12 to 18 months [5][6] - In the AML segment, emivocertib showed a 38% composite complete response (CR) rate in relapsed/refractory AML patients with FLT3 mutations, compared to 21% for gilteritinib, indicating a competitive edge [8][9] Market Data and Key Metrics Changes - The company is exploring emivacertib's potential in high-risk myelodysplastic syndromes (MDS) following the failure of the Varonis study, which has generated interest in combining azacitidine with emivacertib [10] - The competitive landscape in CLL is evolving with the introduction of BTK degraders and next-generation BCL2 inhibitors, but the company believes there is still room for its combination therapy [18][20] Company Strategy and Development Direction - Curis aims to improve the standard of care for CLL and NHL patients by adding emivacertib to BTK inhibitors, potentially allowing patients to achieve deeper responses and reduce the risk of resistance [7] - The company is also planning a registrational study comparing emivacertib to gilteritinib in the relapsed/refractory AML setting, indicating a strategic focus on expanding its treatment options [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing discussions with the FDA and EMA regarding accelerated submissions for the lymphoma study, despite the current uncertain regulatory environment [39] - The company believes its lead indication in NHL, particularly in PCNSL where there are no approved drugs, positions it favorably for future growth [39] Other Important Information - Curis completed a registered direct offering and private placement in July 2025, raising approximately $6 million, which, along with existing cash, is expected to fund operations into 2026 [12] - The company has over 30 clinical sites open for patient enrollment in the lymphoma study, with expectations of enrolling one patient per site per year due to the ultra-rare nature of the indication [24] Q&A Session Summary Question: What do you think the bar would be for the BTK combination study in CLL? - Management believes that adding emivacertib to a commercially available BTK inhibitor can lead to minimal residual disease (MRD) negativity or complete remissions, addressing an unmet medical need in CLL [16][17] Question: Can you provide any color on enrollment progression for the lymphoma study? - Enrollment is steady but challenging due to the ultra-rare population, with expectations of one patient per site per year [24][30] Question: How do you plan to prioritize development between PCNSL and CLL? - The company is actively discussing how to allocate resources efficiently, given the compelling data and multiple potential studies [48] Question: What is the status of discussions with the FDA regarding accelerated approval? - Management confirmed that discussions with the FDA remain positive and aligned with key activities [39] Question: Are there any updates on the investigator-sponsored solid tumor studies? - There are no current updates, but the company is hopeful for data from at least one study this year [51]

PART I. FINANCIAL INFORMATION This part presents the unaudited financial statements, management's discussion, and market risk disclosures for the period ended June 30, 2025 [Item 1. Unaudited Financial Statements](index=6&type=section&id=Item%201.%20Unaudited%20Financial%20Statements) This section presents Curis, Inc.'s unaudited condensed consolidated financial statements, including a going concern warning, for the period ended June 30, 2025 [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, shows a significant decrease in cash and cash equivalents and total assets compared to December 31, 2024 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $10,138 | $19,997 | $(9,859) | | Total current assets | $14,419 | $26,385 | $(11,966) | | Total assets | $29,234 | $41,265 | $(12,031) | | Total current liabilities | $19,372 | $19,027 | $345 | | Total liabilities | $43,220 | $47,263 | $(4,043) | | Total stockholders' deficit | $(13,986) | $(5,998) | $(7,988) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three and six months ended June 30, 2025, the company reported a net loss of $8.6 million and $19.2 million, respectively, with reduced expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | YoY Change | H1 2025 | H1 2024 | YoY Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Revenues, net | $2,749 | $2,546 | +8.0% | $5,129 | $4,632 | +10.7% | | R&D Expenses | $7,458 | $10,254 | -27.3% | $15,997 | $19,871 | -19.5% | | G&A Expenses | $3,526 | $4,792 | -26.4% | $7,510 | $9,683 | -22.4% | | Loss from operations | $(8,251) | $(12,512) | -34.1% | $(18,408) | $(24,981) | -26.3% | | Net loss | $(8,593) | $(11,803) | -27.2% | $(19,209) | $(23,679) | -18.9% | | Net loss per share | $(0.68) | $(2.03) | - | $(1.82) | $(4.08) | - | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) The statement shows a significant increase in the accumulated deficit, widening the stockholders' deficit from $(6.0) million to $(14.0) million by June 30, 2025 - The total stockholders' deficit grew from **$(6.0) million** on December 31, 2024, to **$(14.0) million** on June 30, 2025[20](index=20&type=chunk) - During the first six months of 2025, the company raised capital through the issuance of common stock and warrants related to its March 2025 Offerings, contributing to an increase in additional paid-in capital[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities decreased to $15.3 million for the six months ended June 30, 2025, with financing activities providing $5.4 million Six-Month Cash Flow Summary (in thousands) | Cash Flow Activity | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(15,261) | $(24,367) | | Net cash provided by investing activities | $0 | $11,552 | | Net cash provided by (used in) financing activities | $5,402 | $(3,870) | | **Net decrease in cash** | **$(9,859)** | **$(16,685)** | - The company received net proceeds of **$9.4 million** from the issuance of common stock, pre-funded warrants, and common warrants in the first half of 2025[24](index=24&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail accounting policies, collaboration agreements, and a significant 'going concern' warning due to recurring losses and insufficient capital - The company has concluded that there is substantial doubt about its ability to continue as a going concern within one year, citing its cash balance of **$10.1 million** at June 30, 2025, recurring losses, and the need for substantial additional capital[33](index=33&type=chunk) - As of June 30, 2025, the company had an accumulated deficit of **$1.3 billion** and incurred a net loss of **$19.2 million** for the first six months of the year[32](index=32&type=chunk) - In March 2025, the company raised approximately **$8.8 million** in net proceeds through a registered direct offering and private placement of stock and warrants[78](index=78&type=chunk) A subsequent offering in July 2025 raised an additional **$6.0 million**[81](index=81&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses emavusertib development, reiterates going concern doubts, and highlights reduced operating expenses leading to a lower net loss - The company's primary focus is the development of emavusertib, an IRAK4 inhibitor, being evaluated in multiple clinical studies for lymphoma (PCNSL) and leukemia (AML, hrMDS)[100](index=100&type=chunk) - Management states that existing cash and cash equivalents of **$10.1 million** as of June 30, 2025, plus net proceeds of approximately **$6.0 million** from a July 2025 offering, are expected to fund operations only into the first quarter of 2026[108](index=108&type=chunk)[149](index=149&type=chunk) - The company acknowledges substantial difficulty in raising capital and warns that if sufficient funds are not available, it may have to delay or eliminate its R&D program, or evaluate alternatives including dissolution or bankruptcy[110](index=110&type=chunk)[149](index=149&type=chunk) Comparison of Operating Expenses (in thousands) | Expense Category | Q2 2025 | Q2 2024 | % Change | H1 2025 | H1 2024 | % Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Research & Development | $7,458 | $10,254 | (27)% | $15,997 | $19,871 | (19)% | | General & Administrative | $3,526 | $4,792 | (26)% | $7,510 | $9,683 | (22)% | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Curis, Inc. is not required to provide this information - The company is not required to provide disclosures about market risk[154](index=154&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - The CEO and CFO concluded that as of June 30, 2025, the company's disclosure controls and procedures were effective at the reasonable assurance level[157](index=157&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, these controls[158](index=158&type=chunk) PART II. OTHER INFORMATION This part addresses updated risk factors, other information, and a list of exhibits filed with the Form 10-Q [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) Updated risk factors include Nasdaq non-compliance, potential impacts from U.S. trade policy changes, and FDA disruptions affecting product approval - The company is not in compliance with the Nasdaq Capital Market's minimum market value of listed securities requirement (**$35 million**) and has until August 20, 2025, to regain compliance or face delisting[160](index=160&type=chunk) - Changes in U.S. trade policy, including tariffs on goods from China and Canada, could negatively impact the company's costs and supply chain, as it relies on CMOs in these regions[162](index=162&type=chunk)[164](index=164&type=chunk) - Potential disruptions at the FDA, such as funding cuts, Reduction in Force (RIF), and government shutdowns, could hinder the agency's ability to provide guidance and secure timely approval for the company's product candidates[167](index=167&type=chunk)[168](index=168&type=chunk)[173](index=173&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted or terminated a Rule 10b5-1 trading plan during the second quarter of 2025 - No directors or officers adopted or terminated any Rule 10b5-1 trading plans during the second quarter of 2025[176](index=176&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate documents, an employment agreement, and various certifications

Business Update and Outlook [Management Commentary](index=1&type=section&id=Management%20Commentary) Management discusses progress in the TakeAim Lymphoma study and a new combination trial for Chronic Lymphocytic Leukemia (CLL) - Curis is advancing its TakeAim Lymphoma study, enrolling both BTKi-experienced and BTKi-naïve PCNSL patients to support **accelerated approval filings**[2](index=2&type=chunk) - A new clinical study will evaluate emavusertib in combination with a BTK inhibitor for Chronic Lymphocytic Leukemia (CLL), aiming to enable **time-limited treatment**[2](index=2&type=chunk) [Operational Highlights](index=1&type=section&id=Operational%20Highlights) The company reports clinical program progress, including enrollment milestones and a financing that extended its cash runway [NHL/CLL Program](index=1&type=section&id=NHL%2FCLL%20Program) Curis is enrolling patients in its registrational TakeAim Lymphoma study and launching a new proof-of-concept CLL combination study - Continued enrollment in the TakeAim Lymphoma study for R/R PCNSL patients, which is designed to support registration with both the **FDA and EMA**[5](index=5&type=chunk) - A new proof-of-concept study will evaluate emavusertib combined with a BTKi in **20-30 patients** with R/R CLL, with the goal of achieving complete remission[5](index=5&type=chunk) [Leukemia Program](index=1&type=section&id=Leukemia%20Program) The company completed enrollment for its monotherapy leukemia study and is designing new registrational and combination trials - Enrollment is complete for the TakeAim Leukemia Phase 1/2 **monotherapy study** in R/R AML and R/R MDS[5](index=5&type=chunk) - The company is designing a head-to-head registrational trial of **emavusertib vs gilteritinib** in R/R AML[5](index=5&type=chunk)[6](index=6&type=chunk) - Data from the ongoing triplet study of emavusertib, venetoclax, and azacitidine in frontline AML is expected at the **ASH Annual Meeting in December**[13](index=13&type=chunk) [Corporate Developments](index=2&type=section&id=Corporate%20Developments) A recent financing extended the company's cash runway into the first quarter of 2026 - Completed a registered direct offering and private placement, extending the company's cash runway to **Q1 2026**[6](index=6&type=chunk) [Upcoming Milestones and Events](index=2&type=section&id=Upcoming%20Milestones%20and%20Events) The company anticipates releasing additional clinical data later this year and will present at two investor conferences in September 2025 - Additional data from the TakeAim Lymphoma study in R/R PCNSL patients is expected **later in the year**[7](index=7&type=chunk) - Curis will participate in two investor conferences in September 2025: the **Cantor Global Healthcare Conference** and the **H.C. Wainwright 27th Annual Global Investment Conference**[13](index=13&type=chunk) Financial Performance [Second Quarter 2025 Financial Results Summary](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results%20Summary) The company reported a reduced net loss and lower operating expenses for Q2 and H1 2025, with a cash runway extending into Q1 2026 Second Quarter 2025 vs 2024 | Financial Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Net Loss | ($8.6M) | ($11.8M) | Improved | | Net Loss Per Share | ($0.68) | ($2.03) | Improved | | Revenues | $2.7M | $2.5M | +8.0% | | R&D Expenses | $7.5M | $10.3M | -27.2% | | G&A Expenses | $3.5M | $4.8M | -27.1% | Six Months Ended June 30, 2025 vs 2024 | Financial Metric | Six Months 2025 | Six Months 2024 | Change | | :--- | :--- | :--- | :--- | | Net Loss | ($19.2M) | ($23.7M) | Improved | | Net Loss Per Share | ($1.82) | ($4.08) | Improved | | Revenues | $5.1M | $4.6M | +10.9% | | R&D Expenses | $16.0M | $19.9M | -19.6% | | G&A Expenses | $7.5M | $9.7M | -22.7% | - As of June 30, 2025, Curis had **$10.1 million** in cash and cash equivalents, with an additional **$6.0 million** in net proceeds from a July 2025 offering extending its cash runway into **Q1 2026**[14](index=14&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details revenues, operating expenses, and net loss for the three and six months ended June 30, 2025, and 2024 | (In thousands, except per share data) | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Revenues, net** | **$2,749** | **$2,546** | **$5,129** | **$4,632** | | Total operating expenses | $11,000 | $15,058 | $23,537 | $29,613 | | Loss from operations | ($8,251) | ($12,512) | ($18,408) | ($24,981) | | **Net loss** | **($8,593)** | **($11,803)** | **($19,209)** | **($23,679)** | | Net loss per share (basic and diluted) | ($0.68) | ($2.03) | ($1.82) | ($4.08) | [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's assets, liabilities, and stockholders' deficit as of June 30, 2025, compared to December 31, 2024 | (In thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $10,138 | $19,997 | | Total assets | **$29,234** | **$41,265** | | **LIABILITIES AND STOCKHOLDERS' DEFICIT** | | | | Total liabilities | $43,220 | $47,263 | | Total stockholders' deficit | ($13,986) | ($5,998) | | Total liabilities and stockholders' deficit | **$29,234** | **$41,265** | Corporate Information and Disclosures [About Curis, Inc.](index=3&type=section&id=About%20Curis%2C%20Inc.) Curis is a biotechnology company focused on developing emavusertib, an oral IRAK4 inhibitor for various cancers - Curis is a biotechnology company focused on developing **emavusertib**, an oral IRAK4 inhibitor, for various hematologic malignancies[16](index=16&type=chunk) - Emavusertib has received **Orphan Drug Designation** from both the FDA and European Commission for PCNSL, and from the FDA for AML and MDS[16](index=16&type=chunk) [Conference Call and Webcast Information](index=3&type=section&id=Conference%20Call%20and%20Webcast%20Information) Management scheduled a conference call and webcast on August 5, 2025, to discuss second-quarter results and business updates - A conference call was scheduled for **August 5, 2025**, at 8:30 a.m. ET to discuss the financial results and business update[15](index=15&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This legal disclaimer warns that the press release contains forward-looking statements subject to significant risks and uncertainties - The press release includes forward-looking statements concerning clinical development, regulatory timelines, and financial runway, which are **not guarantees of future performance**[17](index=17&type=chunk) - Key risks highlighted include potential for **adverse clinical trial results**, regulatory delays, competition, and the need to raise **substantial additional capital**[18](index=18&type=chunk)

Core Viewpoint - Curis, Inc. has announced a definitive agreement for a registered direct offering and concurrent private placement, aiming to raise approximately $7.0 million to support its research and development efforts [1][2]. Group 1: Offering Details - Curis will issue 1,538,460 shares of common stock at a market price, along with unregistered pre-funded warrants and common warrants [1]. - The pre-funded warrants will allow investors to purchase an additional 1,538,461 shares at an exercise price of $0.01, while common warrants will allow for the purchase of 3,076,921 shares at an exercise price of $2.15 [1]. - The combined purchase price for one share and the associated common warrant is $2.275, and for one pre-funded warrant and the associated common warrant is $2.265 [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for research, development, working capital, and other general corporate purposes [2]. Group 3: Closing and Agents - The registered direct offering and concurrent private placement are expected to close on or about July 3, 2025, pending customary closing conditions [2]. - Laidlaw & Company (U.K.) Ltd. and Jones are acting as placement agents for the offerings [3]. Group 4: Regulatory Information - The shares are being offered under a shelf registration statement filed with the SEC, and a prospectus supplement will be available on the SEC's website [4]. - The unregistered warrants are being offered under an exemption from registration requirements, and Curis will file a resale registration statement with the SEC for the underlying shares [5]. Group 5: Company Overview - Curis is focused on developing emavusertib, an orally available IRAK4 inhibitor, currently in various clinical studies for treating relapsed/refractory cancers [7][8]. - Emavusertib has received Orphan Drug Designation from the FDA for multiple cancer treatments [8].

Company Performance - Curis reported a quarterly loss of $1.25 per share, which was worse than the Zacks Consensus Estimate of a loss of $1.14, but an improvement from a loss of $2.05 per share a year ago, indicating a surprise of -9.65% [1] - The company posted revenues of $2.38 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 11.74% and showing an increase from $2.09 million in the same quarter last year [2] - Curis has surpassed consensus EPS estimates two times over the last four quarters and has topped consensus revenue estimates four times during the same period [2] Stock Outlook - Curis shares have declined approximately 19.9% since the beginning of the year, contrasting with the S&P 500's decline of -3.9% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the upcoming quarter is -$0.76 on revenues of $2.6 million, and for the current fiscal year, it is -$2.72 on revenues of $11.13 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Curis belongs, is currently ranked in the top 31% of over 250 Zacks industries, suggesting a favorable outlook for stocks in this sector [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors or through tools like the Zacks Rank [5][6]

Financial Data and Key Metrics Changes - Curis reported a net loss of $10.6 million or $1.25 per share for Q1 2025, compared to a net loss of $11.9 million or $2.05 per share for the same period in 2024, indicating an improvement in loss per share [12] - Research and development expenses decreased to $8.5 million in Q1 2025 from $9.6 million in Q1 2024, primarily due to lower employee-related costs [12] - General and administrative expenses also decreased to $4 million in Q1 2025 from $4.9 million in Q1 2024, attributed to lower employee-related costs and professional fees [12] - Cash and cash equivalents totaled $20.3 million as of March 31, 2025, with expectations to fund operations into Q4 2025 [13] Business Line Data and Key Metrics Changes - The Take Aim Lymphoma study is evaluating emavucertib in combination with ibrutinib in patients with relapsed/refractory primary CNS lymphoma (PCNSL), with 27 patients treated as of the latest data cutoff [8] - Among 20 BTKi experienced patients, 9 showed a reduction in tumor burden, including 6 objective responses, while 5 out of 7 BTKi naive patients also demonstrated a reduction [8] - In the AML segment, a 38% composite complete response (CR) rate was reported in a study involving patients with FLT3 mutations, showcasing the potential of emavucertib [10] Market Data and Key Metrics Changes - The company is focusing on expanding the use of emavucertib beyond primary CNS lymphoma into additional indications such as NHL, AML, and solid tumors [5] - The enrollment for the lymphoma study is ongoing, with 37 sites currently open across major centers in the U.S., Europe, and Israel [20] Company Strategy and Development Direction - Curis is prioritizing the PCNSL study while simultaneously advancing its AML studies, with a focus on safety and tolerability in frontline AML [18] - The company aims to enroll 30 to 40 additional patients for NDA submission in the lymphoma study, targeting 6 to 8 responses in that dataset [9] - The addition of Dr. Ahmed Hamdy to the executive team is expected to enhance the company's strategic direction in both lymphoma and AML [4][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the collaboration with the FDA, indicating no concerns about changes affecting their agreement despite industry turmoil [28] - The company is optimistic about the potential of emavucertib, particularly in combination therapies, and is focused on maximizing its utility across various indications [37] Other Important Information - Curis completed a registered direct financing and private placement in March 2025, raising approximately $8.8 million [13] - The company plans to provide additional updates on the Take Aim Lymphoma study at the upcoming ASH conference later this year [9] Q&A Session Summary Question: Positioning of lymphoma versus AML - Management confirmed that resources are primarily dedicated to the PCNSL study while also advancing AML studies, with a focus on safety and initial patient enrollment [18][22] Question: Enrollment and FDA discussions - Management stated that they are on track with enrollment and have no concerns regarding their agreement with the FDA, appreciating the timing of their collaboration [28] Question: Mutations affecting responses and EMA development steps - Management indicated it is too early to discuss specific mutations impacting responses, emphasizing the mechanism of action instead [34] - Future plans for AML development will be discussed after completing the ongoing triplet study [36]

Financial Data and Key Metrics Changes - Curis reported a net loss of $10.6 million or $1.25 per share for Q1 2025, compared to a net loss of $11.9 million or $2.05 per share for the same period in 2024, indicating an improvement in loss per share [12] - Research and development expenses decreased to $8.5 million in Q1 2025 from $9.6 million in Q1 2024, primarily due to lower employee-related costs [12] - General and administrative expenses also decreased to $4 million in Q1 2025 from $4.9 million in Q1 2024, attributed to lower employee-related costs and professional fees [12] - Cash and cash equivalents totaled $20.3 million as of March 31, 2025, with the company expecting this to support operations into Q4 2025 [13] Business Line Data and Key Metrics Changes - The Take Aim Lymphoma study is progressing, evaluating emavucertib in combination with ibrutinib in patients with relapsed/refractory primary CNS lymphoma [7] - As of January 2, 2025, 27 patients have been treated with the emavucertib and ibrutinib combination, showing promising results in tumor burden reduction [8] - In AML, a 38% composite complete response rate was observed in a study of 21 patients with FLT3 mutations treated with emavucertib, which is significantly higher than the 21% rate for gilteritinib [10] Market Data and Key Metrics Changes - The company is focusing on expanding the use of emavucertib beyond primary CNS lymphoma into additional indications such as NHL, AML, and solid tumors [5] - The enrollment for the lymphoma study is ongoing, with 37 sites currently open across the U.S., Europe, and Israel [20] Company Strategy and Development Direction - Curis is prioritizing the PCNSL study while also advancing its AML studies, with a focus on safety and tolerability in the frontline setting [18] - The company aims to enroll 30 to 40 additional patients for NDA submission in the lymphoma study, targeting six to eight responses in that dataset [9] - The addition of Dr. Ahmad Hamdi to the executive team is expected to enhance the company's strategic direction in expanding treatment options [4] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the collaboration with the FDA, indicating no concerns about changes affecting their agreement [28] - The company is optimistic about the potential of emavucertib in combination therapies and is focused on maximizing its utility across various indications [36] Other Important Information - Curis completed a registered direct financing and private placement in March 2025, raising approximately $8.8 million [13] - The company plans to provide additional updates on the Take Aim Lymphoma study at the ASH conference later this year [9] Q&A Session Summary Question: Positioning of lymphoma versus AML - Management is advancing both lymphoma and AML studies simultaneously, with more resources allocated to the PCNSL study due to its advanced stage [18] Question: Enrollment in lymphoma study and FDA conversations - Enrollment is on track with 37 sites open, and management is confident in their collaboration with the FDA [25][28] Question: Mutations affecting responses and AML development steps - It is too early to discuss specific mutations affecting responses; the focus is on the mechanism of action [33] - Future plans for AML development will be discussed after completing the ongoing triplet study [35]

Financial Position - Curis, Inc. reported an accumulated deficit of $1.3 billion as of March 31, 2025, with a net loss of $10.6 million for the three months ended March 31, 2025[109]. - The company has $20.3 million in cash and cash equivalents as of March 31, 2025, which is expected to fund operations into the fourth quarter of 2025[110]. - Cash used in operating activities decreased by $6.0 million to $7.3 million for the three months ended March 31, 2025, compared to $13.2 million in the same period in 2024[142]. - Cash provided by financing activities was $7.5 million for the three months ended March 31, 2025, primarily due to proceeds from the March 2025 Offerings[144]. - Cash and cash equivalents as of March 31, 2025, were $20.3 million, excluding restricted cash[133]. - The company has an accumulated deficit of approximately $1.3 billion as of March 31, 2025[145]. - The Put/Call Price related to the Oberland Purchase Agreement was approximately $108.2 million as of March 31, 2025[141]. - The company may face substantial difficulty in raising capital, which could adversely affect its business prospects and financial condition[147]. - The ability to raise additional funds will depend on financial, economic, and market conditions, many of which are outside the company's control[147]. - The company’s failure to achieve profitability could depress the market price of its common stock and impair its ability to raise capital[149]. Research and Development - Emavusertib (CA-4948) is being evaluated in multiple Phase 1/2 studies, including the TakeAim Lymphoma and TakeAim Leukemia studies, with preliminary clinical data provided in December 2023[103][104]. - Emavusertib has received Orphan Drug Designation from the FDA for the treatment of PCNSL, AML, and MDS, and from the European Commission for PCNSL[101]. - Research and development expenses primarily consist of costs incurred to develop emavusertib, including clinical trial costs and personnel expenses[115][117]. - The ongoing clinical trials for emavusertib are critical for the company's future operating results and depend on favorable data generation[112]. - The company expects substantial increases in research and development expenses as it advances emavusertib and other drug candidates[129]. - The company anticipates incurring substantial operating losses while developing and commercializing emavusertib[149]. - Future capital requirements may be affected by unanticipated costs in research and development, regulatory approvals, and commercialization activities[150]. - If sufficient funding is not obtained, the company may need to delay or eliminate its research and development programs[147]. Revenue and Expenses - Revenues increased by $0.3 million, or 14%, to $2.38 million for the three months ended March 31, 2025, compared to $2.08 million in the same period in 2024[125]. - Research and development expenses decreased by $1.1 million, or 11%, to $8.54 million for the three months ended March 31, 2025, primarily due to lower employee-related costs[128]. - General and administrative expenses decreased by $0.9 million, or 19%, to $3.98 million for the three months ended March 31, 2025, mainly due to reductions in employee-related and professional costs[130]. - Net loss for the three months ended March 31, 2025, was $10.62 million, a decrease of 11% from a net loss of $11.88 million in the same period in 2024[125]. - The company does not expect to generate revenues from direct product sales for several years, relying instead on royalty payments from Genentech's sales of Erivedge[114]. Strategic Partnerships and Collaborations - The company has entered into a collaboration agreement with Genentech for the commercialization of Erivedge, which is approved for advanced basal cell carcinoma[107]. - Curis Royalty received proceeds of $65.0 million from the Oberland Purchase Agreement, which involves the sale of future royalty rights[113]. - The company may explore strategic alternatives, including partnerships or asset divestitures, but there is no assurance of success[147].

Financial Performance - Curis reported a net loss of $10.6 million or $1.25 per share for Q1 2025, compared to a net loss of $11.9 million or $2.05 per share in Q1 2024[8]. - Revenues for Q1 2025 were $2.4 million, an increase from $2.1 million in Q1 2024, primarily from royalty revenues from Genentech/Roche's sales of Erivedge®[8]. - Research and development expenses decreased to $8.5 million in Q1 2025 from $9.6 million in Q1 2024, mainly due to lower employee-related costs[9]. - General and administrative expenses also decreased to $4.0 million in Q1 2025 from $4.9 million in Q1 2024, attributed to lower employee-related and consulting costs[9]. - Curis has approximately $20.3 million in cash and cash equivalents as of March 31, 2025, which is expected to support operations into Q4 2025[11]. - Curis completed a registered direct offering and private placement with net proceeds of approximately $8.8 million[7]. Clinical Development - The company is currently enrolling patients in the TakeAim Lymphoma study to enable accelerated approval filings for emavusertib in both the EU and US[3]. - Emavusertib has received Orphan Drug Designation for PCNSL in both the U.S. and Europe[5]. - The TakeAim Lymphoma study has provided data updates for 27 patients, including 20 BTK-experienced and 7 BTK-naïve patients[5]. - Curis aims to expand emavusertib's application beyond PCNSL into additional indications in NHL, AML, and solid tumors[4].

Company Overview - Curis, Inc. is a biotechnology company focused on the development of emavusertib (CA-4948), an orally available small molecule IRAK4 inhibitor [3] - Emavusertib is currently being evaluated in multiple clinical studies, including the Phase 1/2 TakeAim Lymphoma study for patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) and the Phase 1/2 TakeAim Leukemia study for patients with relapsed/refractory acute myeloid leukemia (AML) [3] - The drug has received Orphan Drug Designation from the U.S. FDA for the treatment of PCNSL, AML, and MDS, as well as from the European Commission for PCNSL [3] Upcoming Financial Results - Curis will report its first quarter 2025 financial and operating results on May 6, 2025, at 8:00 a.m. ET [1] - Management will host a conference call and simultaneous webcast on the same day at 8:30 a.m. ET [1][2] Collaboration and Licensing - Curis has an exclusive license to emavusertib through a collaboration with Aurigene established in 2015 [3] - The company licensed its rights to Erivedge® to Genentech, a member of the Roche Group, for the treatment of advanced basal cell carcinoma [3]