Financial Performance - Curis reported a net loss of $7.7 million or $0.49 per share for Q3 2025, an improvement from a net loss of $10.1 million or $1.70 per share in Q3 2024[12]. - Revenues for Q3 2025 were $3.2 million, up from $2.9 million in Q3 2024, with total revenues of $8.3 million for the nine months ended September 30, 2025, compared to $7.6 million for the same period in 2024[13]. - Curis reported net revenues of $3,176,000 for the three months ended September 30, 2025, an increase of 8.4% compared to $2,931,000 for the same period in 2024[26]. - Total operating expenses for the three months ended September 30, 2025, were $10,100,000, down 25.3% from $13,498,000 in the same period of 2024[26]. - The net loss for the three months ended September 30, 2025, was $7,729,000, a decrease of 23.5% compared to a net loss of $10,092,000 for the same period in 2024[26]. Expenses - Research and development expenses decreased to $6.4 million in Q3 2025 from $9.7 million in Q3 2024, totaling $22.4 million for the nine months ended September 30, 2025, down from $29.6 million in the same period in 2024[14]. - General and administrative expenses slightly decreased to $3.7 million in Q3 2025 from $3.8 million in Q3 2024, totaling $11.2 million for the nine months ended September 30, 2025, compared to $13.4 million in the same period in 2024[15]. Cash and Assets - Curis has cash and cash equivalents totaling $9.1 million as of September 30, 2025, which is expected to fund operations into Q1 2026[17]. - Curis's cash and cash equivalents decreased to $9,051,000 as of September 30, 2025, from $19,997,000 as of December 31, 2024[28]. - Total assets decreased to $27,641,000 as of September 30, 2025, from $41,265,000 as of December 31, 2024[28]. - Curis reported a weighted average of 15,680,178 common shares outstanding for the three months ended September 30, 2025[26]. Liabilities and Stockholders' Deficit - Total liabilities were $42,332,000 as of September 30, 2025, down from $47,263,000 as of December 31, 2024[28]. - Curis's total stockholders' deficit increased to $14,691,000 as of September 30, 2025, compared to $5,998,000 as of December 31, 2024[28]. Clinical Development - Curis is advancing clinical studies in PCNSL, CLL, and AML, with initial data from the frontline AML triplet study expected to be presented at the ASH annual meeting in December 2025[3]. - The company is initiating a Phase 2 study of emavusertib in combination with a BTK inhibitor in CLL, with the first patient expected to be dosed in late Q4 2025 or early Q1 2026[8]. - Curis aims to achieve accelerated approval for emavusertib in PCNSL in the US and Europe, having received orphan drug designation from both the FDA and EMA[8]. - Curis will present updated PCNSL and SCNSL data at the Society for Neuro-Oncology annual meeting in November 2026[19]. Competition and Risks - The company faces substantial competition and requires significant additional capital to fund its operations and development of emavusertib[23]. - The company may face risks related to regulatory approvals and potential adverse decisions from authorities, which could impact its business prospects[23]. Funding Activities - The company completed a registered direct offering and concurrent private placement to extend its cash runway into 2026[10].

Company Overview - Curis is at an exciting crossroads with a focus on one primary drug, an IRAK4 and FLT3 inhibitor, which is being developed for Non-Hodgkin Lymphoma (NHL) and Acute Myeloid Leukemia (AML) [3] - The company has a promising pipeline and is funding studies for solid tumors, primarily supported by the NIH [3] Drug Development - The drug has shown compelling proof-of-concept data in Primary Central Nervous System Lymphoma (PCNSL) with a study involving 34 patients [3] - The drug is designed to be an add-on therapy to BTK inhibitors, targeting the TLR pathway while BTK inhibitors block the BCR pathway, potentially leading to higher response rates and complete remission in NHL [4]

Core Insights - Curis is at a pivotal moment with a focus on a single drug, an IRAK4 and FLT3 inhibitor, which is central to its resources and strategy [3] - The drug is being developed for Non-Hodgkin Lymphoma (NHL) and Acute Myeloid Leukemia (AML), with promising proof-of-concept data in Primary Central Nervous System Lymphoma (PCNSL) involving 34 patients [3] - The approach combines the use of BTK inhibitors to block the BCR pathway and Curis's drug to inhibit the TLR pathway, potentially leading to improved response rates and complete remission in NHL [4] Company Overview - Curis is currently funding one primary drug while maintaining a pipeline of additional studies, particularly in solid tumors [3] - The focus on NHL is driven by the understanding that the disease is influenced by the NF-kappaB pathway, which is activated through BCR and TLR pathways [3][4] - The strategy involves targeting all NHL subtypes similarly to the approach taken with PCNSL, aiming for enhanced therapeutic outcomes [4]

Core Insights - Curis is focusing on emavusertib, a first-in-class IRAK4 inhibitor, which has shown promising proof-of-concept data in treating various cancers, including lymphoma, leukemia, and solid tumors [3][4]. Company Overview - Curis has a broad pipeline of novel cancer therapies, with a particular emphasis on emavusertib, which has demonstrated significant improvements over standard care in clinical studies [3]. - The leadership team at Curis is highly experienced, with each member having over 20 years of experience in drug development at notable biotech companies [5]. Clinical Data - The proof-of-concept studies for emavusertib include data from 34 patients with primary central nervous system lymphoma (PCNSL) and 21 patients with acute myeloid leukemia (AML), both showing significant efficacy [3]. - The results from the PCNSL study suggest potential effectiveness in other non-Hodgkin lymphoma (NHL) subtypes, including chronic lymphocytic leukemia (CLL) [4]. - The findings in relapsed/refractory AML indicate confidence in the drug's potential application in frontline AML treatment [4].

Core Insights - Curis is focusing on emavusertib, a first-in-class IRAK4 inhibitor, which shows promise in treating various cancers including lymphoma, leukemia, and solid tumors [3][4] - The company has reported proof-of-concept data from studies involving 34 patients with primary central nervous system lymphoma (PCNSL) and 21 patients with acute myeloid leukemia (AML), both showing significant improvements over standard care [3][4] - Curis believes that the positive results from these studies indicate potential efficacy in other subtypes of non-Hodgkin lymphoma (NHL) and frontline AML [4] Company Expertise - Curis boasts a highly experienced leadership team, with each member having over 20 years of experience in drug development at notable biotech firms such as Dicerna, Biogen, BMS, and Merck [5] - The addition of Dr. Ahmed Handy, who has experience in developing BTK inhibitors, is expected to enhance the company's efforts in chronic lymphocytic leukemia (CLL) [5]

Curis FY Conference Summary Company Overview - **Company**: Curis (NasdaqCM:CRIS) - **Focus**: Development of novel cancer treatments, particularly emiflucertib, an IRAK4 inhibitor with applications in lymphoma, leukemia, and solid tumors [2][3] Key Points on Emiflucertib - **Proof of Concept**: - Data from 34 patients with Primary CNS Lymphoma (PCNSL) and 21 patients with Acute Myeloid Leukemia (AML) show significant improvement over standard care [2] - Confidence in efficacy extends to other Non-Hodgkin Lymphoma (NHL) subtypes, including Chronic Lymphocytic Leukemia (CLL) [2][3] - **Mechanism of Action**: - Emiflucertib targets IRAK4, which downregulates NF-kappa B, a key driver in CLL and NHL [5] - Combination therapy with BTK inhibitors enhances treatment efficacy [4][5] - **Market Opportunity**: - BTK inhibitors represent an $11 billion industry, growing at 20% annually, but have limitations such as incomplete responses and side effects [7][8] - Emiflucertib aims to provide a better safety profile and the potential for complete responses [8][14] Clinical Development - **Clinical Trials**: - Designed for accelerated filing, focusing on dose escalation and combination therapy [9][10] - Early data shows promising activity in PCNSL, with plans to expand into other NHL subtypes [10][13] - **Safety Profile**: - Treatment well tolerated with no dose-limiting myelosuppression observed [13][25] - **Regulatory Perspective**: - Increasing receptiveness from FDA and EMA towards Minimal Residual Disease (MRD) as a clinical endpoint [15] AML Insights - **Targeting FLT3 and IRAK4**: - Both are critical in AML, with emiflucertib showing potential to outperform current standards like gilteritinib [17][25] - Data indicates better outcomes in patients who have failed FLT3 inhibitors [25][27] - **Future Studies**: - Plans for a head-to-head registrational study against gilteritinib to establish emiflucertib as a best-in-class treatment for FLT3 AML [26][27] Solid Tumor Potential - **Research Expansion**: - Emiflucertib is being evaluated in five investigator-sponsored trials for solid tumors, with preliminary data expected soon [28] Financial Overview - **Funding**: - As of Q2, Curis has approximately $17 million in funding and a strong intellectual property position extending to 2035 [28] Conclusion - Curis is positioned to leverage its novel IRAK4 inhibitor, emiflucertib, to address significant unmet needs in the oncology market, particularly in NHL and AML, while also exploring opportunities in solid tumors [29][30]

Curis (CRIS) Conference Call Summary Company Overview - Curis is at a pivotal stage with a focus on a single drug, an IRAK4 and FLT3 inhibitor, primarily targeting Non-Hodgkin Lymphoma (NHL) and Acute Myeloid Leukemia (AML) [2][3] - The company has a promising pipeline and is conducting studies funded by the NIH in solid tumors [2] Key Drug Insights - The drug is being studied as an add-on therapy to BTK inhibitors, which block the BCR pathway, while Curis's drug targets the TLR pathway, potentially leading to higher response rates and complete remission [3] - Current proof-of-concept data in Primary CNS Lymphoma (PCNSL) shows an overall response rate (ORR) of 63% in a small patient population, compared to a historical ORR of 39% for BTK inhibitors [4][5] Clinical Development and Regulatory Strategy - Curis is pursuing accelerated approval based on a single-arm study, with pivotal status accepted by both the FDA and EMA [6][8] - The company aims to enroll between 45 to 60 patients, targeting an ORR of 20% to 22% to meet regulatory requirements [7][8] - Enrollment is expected to take 12 to 18 months, with plans for a confirmatory randomized study against ibrutinib [9][10] Challenges and Considerations - The ultra-rare nature of PCNSL presents challenges in patient recruitment, with a goal of one patient per site per year across 30 sites globally [9] - There is uncertainty regarding regulatory expectations, particularly concerning overall survival (OS) benefits in single-arm trials [11][12] Expansion into CLL - Curis is initiating a new trial in Chronic Lymphocytic Leukemia (CLL), which represents a larger market opportunity compared to PCNSL [25] - The company aims to combine its drug with BTK inhibitors to enhance efficacy and address unmet needs in CLL treatment [26][27] - The focus will be on patients who are on BTK inhibitors but have not achieved complete remission (CR) [30] Market Dynamics and Competitive Landscape - The CLL market is valued at approximately $11 billion, with BTK inhibitors being the standard of care [25] - Curis's approach aims to provide a time-limited treatment option, addressing the side effects associated with BTK inhibitors and offering a potentially better treatment paradigm [28][44] Clinical Endpoints and Future Directions - The company is considering minimal residual disease (MRD) negativity as a potential endpoint for regulatory approval, reflecting a shift in clinical trial design [32] - Curis plans to present interim data on its CLL trial by mid-year, with expectations of seeing early signs of efficacy [38][39] AML Development - Curis is also looking to combine its drug with azacitidine in AML, aiming for higher response rates and MRD negativity [46][47] - The focus will be on patient tolerability and regimen adjustments to ensure effective long-term treatment [47] Conclusion - Curis is strategically positioned to leverage its unique drug mechanism in both NHL and CLL, with a clear focus on regulatory pathways and market opportunities. The company is actively engaging with regulatory agencies to ensure alignment on clinical endpoints and trial designs, while also addressing the challenges of patient recruitment in rare diseases.

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)