Praxis(US:PRAX)2025-11-05 13:03Financial Performance - Praxis reported a net loss of $73.9 million for Q3 2025, compared to a net loss of $51.9 million in Q3 2024, reflecting an increase in operating expenses[13] - Net loss for the three months ended September 30, 2025, was $73,934,000, compared to a net loss of $51,910,000 for the same period in 2024, reflecting a 42% increase in losses[29] - The net loss per share attributable to common stockholders increased from $2.75 in Q3 2024 to $3.36 in Q3 2025[29] - The accumulated deficit increased from $836,740,000 on December 31, 2024, to $1,051,097,000 on September 30, 2025, indicating a rise of approximately 25%[27] - The company reported no collaboration revenue for the three months ended September 30, 2025, compared to $302,000 in Q3 2024[29] - Other income for the three months ended September 30, 2025, was $4,425,000, slightly down from $4,925,000 in Q3 2024[29] Research and Development - Research and development expenses increased to $65.8 million in Q3 2025 from $41.9 million in Q3 2024, primarily due to a $21.7 million increase in the Cerebrum™ platform[11] - Research and development expenses increased by 57% from $41,881,000 in Q3 2024 to $65,797,000 in Q3 2025[29] - The company has four clinical-stage product candidates in its diversified CNS portfolio[21] Cash and Assets - As of September 30, 2025, Praxis had $389.2 million in cash, cash equivalents, and marketable securities, down from $469.5 million at the end of 2024[8] - Total assets decreased from $483,110,000 on December 31, 2024, to $396,388,000 on September 30, 2025, representing a decline of approximately 18%[27] Clinical Trials and Programs - Ulixacaltamide demonstrated a mean improvement of 4.3 points in the modified Activities of Daily Living 11 (mADL11) at Week 8 in the Essential3 program, with statistical significance (p<0.0001)[3] - In the second pivotal study of ulixacaltamide, 55% of patients maintained their response compared to 33% in the placebo group (p=0.037)[4] - The POWER1 study for vormatrigine has completed recruitment, with topline results expected in the first half of 2026, while POWER2 is expected to be fully enrolled in the second half of 2026[2] - Praxis plans to conduct an interim analysis of the EMBOLD study for relutrigine in Q4 2025, which may support an NDA submission in early 2026 if successful[2] - Approximately 20,000 patients have been attracted to the ENERGY program recruitment initiative for epilepsy studies, supporting patient identification[4] Regulatory Designations - The company has received Orphan Drug Designation and Breakthrough Therapy Designation for relutrigine and elsunersen from the FDA, indicating significant potential in treating rare diseases[18][19] Operating Expenses - Total operating expenses rose from $57,137,000 in Q3 2024 to $78,359,000 in Q3 2025, marking an increase of about 37%[29] - The weighted average common shares outstanding increased from 18,884,562 in Q3 2024 to 21,977,268 in Q3 2025, a rise of approximately 16%[29]