Curis(CRIS) - 2025 Q2 - Quarterly Results

Business Update and Outlook Management Commentary 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] - 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] Operational Highlights The company reports clinical program progress, including enrollment milestones and a financing that extended its cash runway NHL/CLL Program 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] - 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] Leukemia Program 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] - The company is designing a head-to-head registrational trial of emavusertib vs gilteritinib in R/R AML[5][6] - Data from the ongoing triplet study of emavusertib, venetoclax, and azacitidine in frontline AML is expected at the ASH Annual Meeting in December[13] Corporate Developments 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] Upcoming Milestones and Events 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] - 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] Financial Performance Second Quarter 2025 Financial Results Summary 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] Condensed Consolidated Statements of Operations 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 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. 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] - Emavusertib has received Orphan Drug Designation from both the FDA and European Commission for PCNSL, and from the FDA for AML and MDS[16] Conference Call and Webcast Information 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] Cautionary Note Regarding Forward-Looking Statements 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] - Key risks highlighted include potential for adverse clinical trial results, regulatory delays, competition, and the need to raise substantial additional capital[18]