Curis(CRIS) - 2025 Q2 - Quarterly Report

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 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 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 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) 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] - 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] Condensed Consolidated Statements of Cash Flows 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] Notes to Condensed Consolidated Financial Statements 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] - 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] - 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] A subsequent offering in July 2025 raised an additional $6.0 million[81] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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] - 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][149] - 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][149] 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 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] Item 4. Controls and Procedures 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] - 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] 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 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] - 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][164] - 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][168][173] Item 5. Other Information 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] Item 6. Exhibits This section lists the exhibits filed with the Form 10-Q, including corporate documents, an employment agreement, and various certifications