Financial Performance - The company has not yet generated any revenue from product sales and did not recognize any revenue for the three and nine months ended September 30, 2025, or 2024 [109]. - The accumulated deficit as of September 30, 2025, was $162.2 million [134]. - Interest income decreased to $2.0 million for the three months ended September 30, 2025, down from $2.7 million in 2024, a decrease of $0.7 million [126]. Research and Development - Total research and development costs for the three months ended September 30, 2025, were $10.99 million, compared to $9.73 million for the same period in 2024, reflecting an increase of 13% [114]. - Research and development expenses for PIPE-791 were $4.47 million for the three months ended September 30, 2025, compared to $2.71 million in 2024, indicating a 65% increase [114]. - For the nine months ended September 30, 2025, research and development expenses totaled $38.8 million, an increase of $13.4 million from $25.4 million in 2024 [127]. - The company plans to initiate a global Phase 2 clinical trial for PIPE-791 in idiopathic pulmonary fibrosis (IPF) in Q4 2025, with topline data expected in the first half of 2026 [96]. - PIPE-307 has fully enrolled its Phase 2 VISTA trial for relapse-remitting multiple sclerosis (RRMS), with topline data anticipated in Q4 2025 [97]. - The company has completed a Phase 1 clinical trial of PIPE-791 and a Phase 1b trial to inform dose selection for future trials [96]. Operating Expenses - The company expects to incur significant increases in operating expenses as it continues clinical trials and seeks regulatory approvals for its drug candidates [101]. - General and administrative expenses rose to $3.9 million for the three months ended September 30, 2025, compared to $3.2 million in 2024, reflecting a $0.7 million increase [125]. - General and administrative expenses for the nine months ended September 30, 2025, were $12.1 million, up from $8.4 million in 2024, marking a $3.7 million increase [129]. - Total operating expenses for the three months ended September 30, 2025, were $14.9 million, an increase of $1.96 million from $13.0 million in 2024 [123]. - The company expects operating expenses to significantly increase due to drug candidate development, regulatory approvals, and expansion of operations, with a total estimated capital requirement that may vary materially [142]. Cash and Financing - Net cash used in operating activities was $42.3 million for the nine months ended September 30, 2025, compared to $22.6 million in the same period of 2024 [139]. - The company had cash, cash equivalents, and marketable securities of $182.4 million as of September 30, 2025 [135]. - The company raised approximately $19.0 million in net proceeds from the sale of 3,241,110 shares of Class A common stock during the three months ended September 30, 2025 [136]. - The company may finance cash needs through public or private equity or debt financings, which could dilute stockholder ownership and involve restrictive covenants [143]. - Future capital requirements will depend on various factors, including clinical trial costs, regulatory review outcomes, and manufacturing expenses [155]. Accounting and Compliance - The company is classified as an "emerging growth company" and can delay adopting new accounting standards until certain conditions are met, potentially until December 31, 2029 [153]. - The company is also a "smaller reporting company," allowing it to take advantage of scaled disclosures as long as market value and revenue criteria are met [154]. - Management's financial statements are prepared in accordance with U.S. GAAP, requiring estimates and judgments that may differ from actual results [150]. - The company has not experienced material changes to critical accounting estimates from the previous fiscal year [151]. - The company has no off-balance sheet arrangements as defined by SEC rules [148].
Contineum Therapeutics, Inc.(CTNM) - 2025 Q3 - Quarterly Report