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Kodiak(KOD) - 2025 Q1 - Quarterly Report
KodiakKodiak(US:KOD)2025-05-14 20:34

PART I. FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) The unaudited financial statements for Q1 2025 reveal a net loss of $57.5 million and reduced cash, raising substantial doubt about the company's going concern ability Condensed Consolidated Balance Sheets The balance sheet as of March 31, 2025, shows a decline in total assets and stockholders' equity, primarily due to reduced cash and cash equivalents | | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $138,851 | $168,074 | | Total current assets | $142,685 | $171,936 | | Total assets | $297,909 | $335,578 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $30,876 | $25,573 | | Total liabilities | $189,067 | $185,290 | | Total stockholders' equity | $108,842 | $150,288 | Condensed Consolidated Statements of Operations and Comprehensive Loss The statement of operations for Q1 2025 reports an increased net loss of $57.5 million, primarily driven by higher research and development expenses | | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :--- | :--- | :--- | | Research and development | $43,644 | $29,931 | | General and administrative | $15,429 | $16,124 | | Total operating expenses | $59,073 | $46,055 | | Loss from operations | ($59,073) | ($46,055) | | Net loss | ($57,461) | ($43,039) | | Net loss per common share | ($1.09) | ($0.82) | Condensed Consolidated Statements of Stockholders' Equity Stockholders' equity significantly declined to $108.8 million by March 31, 2025, primarily due to the quarterly net loss - Stockholders' equity fell by $41.4 million during Q1 2025, from $150.3 million to $108.8 million, mainly due to the quarterly net loss26 Condensed Consolidated Statements of Cash Flows Net cash used in operating activities for Q1 2025 was $29.1 million, contributing to a significant decrease in total cash and equivalents | | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($29,077) | ($39,600) | | Net cash used in investing activities | ($270) | ($166) | | Net cash provided by financing activities | $124 | $38 | | Net decrease in cash | ($29,223) | ($39,728) | Notes to Unaudited Condensed Consolidated Financial Statements The notes detail liquidity concerns, a $1.9 million lease impairment, and increased R&D expenses, raising substantial doubt about the company's going concern - The company's existing cash and cash equivalents may not be sufficient to meet anticipated operating and capital expenditure requirements for the next 12 months, raising substantial doubt about its ability to continue as a going concern35 - In March 2025, the company subleased its building at 1200 Page Mill Road, which triggered a review and resulted in a non-cash lease impairment expense of $1.9 million4260 R&D Expense Category | R&D Expense Category | Q1 2025 (in thousands) | Q1 2024 (in thousands) | | :--- | :--- | :--- | | Tarcocimab program | $14,276 | $5,969 | | KSI-501 and KSI-101 programs | $4,217 | $2,221 | | ABC Platform and other | $5,645 | $2,586 | | Payroll and personnel | $14,270 | $14,359 | | Facilities and other | $5,236 | $4,796 | | Total R&D Expenses | $43,644 | $29,931 | Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses clinical program progress, a $13.7 million increase in R&D expenses, and reiterates substantial doubt about the company's ability to continue as a going concern - The company is focused on three clinical programs: tarcocimab (anti-VEGF), KSI-501 (anti-IL-6, VEGF-trap bispecific conjugate), and KSI-101 (anti-IL-6, VEGF-trap bispecific protein) for retinal diseases828384 - Key clinical milestones include completing enrollment for the Phase 3 GLOW2 study (tarcocimab), with topline data expected in Q1 2026, and actively enrolling the Phase 3 DAYBREAK study (tarcocimab and KSI-501), with data expected in Q2 2026899395 Expense Category | Expense Category | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | Research and development | $43,644 | $29,931 | $13,713 | | General and administrative | $15,429 | $16,124 | ($695) | | Net loss | ($57,461) | ($43,039) | ($14,422) | - The company has substantial doubt about its ability to continue as a going concern, with current cash and cash equivalents of $138.9 million expected to fund operations only into 2026117118 Item 3. Quantitative and Qualitative Disclosures About Market Risk No material changes to the company's market risk disclosures were reported for the three months ended March 31, 2025 - There were no material changes to the company's market risk disclosures during the three months ended March 31, 2025132 Item 4. Controls and Procedures Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025134 - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls135 PART II. OTHER INFORMATION Item 1. Legal Proceedings The company reports no pending legal claims or actions expected to have a material adverse effect on its financial condition or operations - As of the date of the report, the company is not involved in any legal proceedings that could have a material adverse effect on its business137 Item 1A. Risk Factors The company faces significant risks including its going concern status, dependence on clinical trial success, intense competition, and complex regulatory and manufacturing challenges - The company's financial condition raises substantial doubt about its ability to continue as a going concern due to a history of significant net losses and the need for additional financing to complete development and commercialization349350 - The company's prospects are heavily dependent on the clinical success of its tarcocimab, KSI-501, and KSI-101 product candidates, and past positive results are not predictive of future outcomes141142 - Kodiak faces significant competition from large pharmaceutical companies like Roche and Regeneron, whose products Vabysmo and Eylea HD are already approved and have gained significant market share for treating retinal diseases177178 - The company relies on third-party manufacturers for its product candidates, which creates risks related to supply chain disruptions, regulatory compliance (cGMP), and manufacturing scale-up186255 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities or use of proceeds were reported during the period - None386 Item 3. Defaults Upon Senior Securities The company reports no defaults upon its senior securities - None387 Item 4. Mine Safety Disclosures This item is not applicable to the company's business operations - None388 Item 5. Other Information No directors or officers adopted or terminated Rule 10b5-1 trading plans during Q1 2025 - During Q1 2025, no directors or officers adopted or terminated any Rule 10b5-1 trading plans or similar arrangements389 Item 6. Exhibits This section lists exhibits filed with the 10-Q report, including corporate governance documents and Sarbanes-Oxley Act certifications - The report includes required exhibits such as corporate governance documents and officer certifications under the Sarbanes-Oxley Act (SOX 302 and 906)391