Praxis(PRAX) - 2025 Q1 - Quarterly Report

Financial Performance - The company reported a net loss of $69.3 million for the three months ended March 31, 2025, with an accumulated deficit of$906.0 million[101]. - Net loss for the three months ended March 31, 2025, was $69.3 million, compared to a net loss of$39.6 million for the same period in 2024[120]. - Net cash used in operating activities for the three months ended March 31, 2025, was $53.0 million, compared to$20.9 million for the same period in 2024[135]. - Total operating expenses for the three months ended March 31, 2025, were $74.7 million, up from$42.3 million in 2024[120]. - Collaboration revenue decreased by $0.4 million to$0 for the three months ended March 31, 2025, due to the completion of research service obligations under the Collaboration Agreement with UCB[121]. Research and Development - Research and development expenses for the three months ended March 31, 2025, totaled $60.8 million, a significant increase from$27.0 million in the same period of 2024[112]. - The Cerebrum™ platform incurred $42.8 million in research and development expenses for the first quarter of 2025, compared to$12.9 million in the prior year[112]. - Research and development expenses increased by $33.8 million to$60.8 million for the three months ended March 31, 2025, primarily driven by increased spending on the Cerebrum™ platform[122]. - The company plans to initiate the Phase 3 registrational study for elsunersen (formerly PRAX-222) in mid-2025, with topline results expected in the first half of 2026[99]. - The EMPOWER study for vormatrigine in epilepsy patients was initiated in Q3 2024, with topline results expected by mid-2025[97]. - The company anticipates nominating a development candidate for PRAX-100 by mid-2025, with additional candidates expected by the end of 2025[99]. - The company relies on external consultants and organizations for its research and development activities, operating in a "virtual" model since inception[100]. - The Independent Data Monitoring Committee recommended stopping the ulixacaltamide study for futility, but the company will continue both studies to completion[97]. Financial Position and Resources - The company has cash, cash equivalents, and marketable securities of $472.0 million as of March 31, 2025, expected to fund operations into 2028[106]. - Cash, cash equivalents, and marketable securities as of March 31, 2025, totaled$472.0 million[126]. - The company expects substantial increases in expenses related to ongoing research and development activities, particularly for clinical trials[139]. - The company anticipates that its cash resources will be sufficient to fund operations into 2028, based on current estimates[140]. - The company currently lacks committed external sources of funds, which may impact its ability to access capital during market volatility[145]. - If additional funds are raised through collaborations or licensing, the company may have to relinquish valuable rights to its technologies or future revenue streams[146]. - The company raised $1.2 billion in aggregate cash proceeds from various transactions since inception through March 31, 2025[126]. Accounting and Risk - The management's financial analysis is based on condensed consolidated financial statements prepared under U.S. GAAP, requiring estimates and assumptions that may differ from actual results[147]. - There have been no changes to critical accounting policies from those described in the Annual Report on Form 10-K filed on February 28, 2025, except as disclosed in the quarterly report[148]. - Recently issued accounting standards are not expected to have a material impact on the company's financial statements or operations[149]. - The company is exposed to market risk related to interest rate changes, but an immediate change of 100 basis points would not materially impact its financial position[150].