Praxis(PRAX) - 2025 Q4 - Annual Results

Financial Performance - The company reported a net loss of $303.3 million for the year ended December 31, 2025, compared to a net loss of $182.8 million in 2024[14]. - Net loss for the year ended December 2025 was $303,268,000, which is a 66% increase from the net loss of $182,819,000 in 2024[31]. - Net loss per share attributable to common stockholders was $13.48 for 2025, compared to $10.21 for 2024, indicating a 32% increase in loss per share[31]. - Collaboration revenue was $0 for the year ended December 2025, down from $8,553,000 in 2024, indicating a decline in collaboration activities[31]. - Total operating expenses for the year ended December 2025 were $326,198,000, a significant increase of 56% from $208,718,000 in 2024[31]. Cash and Investments - As of December 31, 2025, Praxis had $926.1 million in cash and investments, an increase of $456.6 million from $469.5 million in 2024, primarily due to net proceeds from a public offering[9][11]. - Cash and cash equivalents increased to $357,329,000 in December 2025 from $215,372,000 in December 2024, a growth of 66%[29]. - Marketable securities rose to $568,759,000 in December 2025, up from $254,156,000 in December 2024, representing a 124% increase[29]. - Total assets increased to $937,907,000 in December 2025 from $483,110,000 in December 2024, representing a growth of 94%[29]. Research and Development - Research and development expenses for the fourth quarter of 2025 were $77.5 million, up from $56.3 million in the same quarter of 2024, with a total of $267.1 million for the year[12]. - Research and development expenses rose to $267,115,000 for the year ended December 2025, up 75% from $152,413,000 in 2024[31]. - Praxis plans to nominate a development candidate for each of its three early-stage antisense oligonucleotide therapeutic initiatives in the first half of 2026[10]. Drug Development and Commercialization - Praxis submitted two new drug applications (NDA) for ulixacaltamide and relutrigine to the FDA, with pre-launch activities expected to accelerate through 2026[1][3]. - Ulixacaltamide is the first investigational therapy to show positive results in a Phase 3 program for essential tremor, with over 200,000 patients expressing interest in the Essential3 program[4][6]. - The revenue potential of the four assets in development, including ulixacaltamide and relutrigine, is estimated to exceed $20 billion[3]. - Enrollment in the EMERALD study for broad developmental and epileptic encephalopathies (DEEs) is expected to be completed in the second half of 2026[10]. - Praxis is preparing for the commercial launch of relutrigine, including hiring key commercial roles and building inventory[10]. - The POWER1 Phase 3 study for focal onset seizures completed enrollment and exceeded its original target, with topline results expected in Q2 2026[10].