Praxis(PRAX) - 2025 Q1 - Quarterly Results

Financial Performance - Praxis reported a net loss of $69.3 million for Q1 2025, compared to a net loss of$39.6 million in Q1 2024[12]. - Net loss for Q1 2025 was $69,296,000, compared to a net loss of$39,553,000 in Q1 2024, representing an increase in loss of approximately 75.3%[26]. - Net loss per share attributable to common stockholders increased from $2.84 in Q1 2024 to$3.29 in Q1 2025, a rise of about 15.8%[26]. - Accumulated deficit grew from $836,740,000 on December 31, 2024, to$906,036,000 on March 31, 2025, an increase of about 8.3%[24]. Research and Development - Research and development expenses increased to $60.8 million for Q1 2025, up from$27.0 million in Q1 2024, primarily due to increased expenses related to the Cerebrum™ platform[10]. - Research and development expenses increased to $60,806,000 in Q1 2025, up from$26,984,000 in Q1 2024, reflecting a rise of approximately 125.5%[26]. - Total operating expenses rose to $74,728,000 in Q1 2025, compared to$42,317,000 in Q1 2024, an increase of about 76.4%[26]. - Praxis plans to initiate pivotal studies for relutrigine and elsunersen by mid-2025, targeting developmental and epileptic encephalopathy[1]. Cash and Investments - Praxis reported cash and investments of $472 million as of March 31, 2025, maintaining a runway into 2028[1]. - Cash and cash equivalents decreased by$49,805,000, from $215,372,000 to$165,567,000, representing a decrease of about 23.1%[24]. - Total assets decreased from $483,110,000 on December 31, 2024, to$478,736,000 on March 31, 2025, a decline of approximately 0.8%[24]. Collaboration Revenue - Praxis did not recognize any collaboration revenue in Q1 2025, a decrease from $0.4 million in Q1 2024, due to the completion of obligations under an agreement with UCB[9]. - Collaboration revenue dropped to$0 in Q1 2025, down from $431,000 in Q1 2024, indicating a significant decline[26]. Clinical Studies and Results - The registrational cohort of the EMBOLD study is on track for topline results no later than the first half of 2026[2]. - Topline results for vormatrigine from the RADIANT study are expected by mid-2025, with additional results from the POWER1 study anticipated in the second half of 2025[2]. - The EMPOWER registrational study has over 3,000 patients registered to date, supporting recruitment for the RADIANT and POWER1 studies[5]. - The Phase 1 food effect study for vormatrigine demonstrated that food intake does not significantly impact its absorption, enhancing dosing flexibility[3]. - The Essential3 study for ulixacaltamide is expected to complete topline readout in Q3 2025, despite an interim analysis recommending study stoppage for futility[5]. Other Income - Other income increased from$2,333,000 in Q1 2024 to $5,432,000 in Q1 2025, reflecting an increase of approximately 133.5%[26].