Praxis(US:PRAX)2025-08-04 12:33Financial Performance - The company reported a net loss of $140.4 million for the six months ended June 30, 2025, with an accumulated deficit of $977.2 million[104]. - Net loss for the three months ended June 30, 2025, was $71.1 million, compared to a net loss of $32.7 million for the same period in 2024, representing a 117.5% increase[122]. - Total operating expenses for the three months ended June 30, 2025, were $76.1 million, a 101.5% increase from $37.8 million in the same period of 2024[122]. - Total operating expenses for the six months ended June 30, 2025, were $150.8 million, a 88.1% increase from $80.2 million in the same period of 2024[127]. - For the six months ended June 30, 2025, net cash used in operating activities was $107.7 million, primarily due to a net loss of $140.4 million, partially offset by $17.8 million in changes in operating assets and liabilities[143]. - During the same period in 2024, net cash used in operating activities was $48.1 million, driven by a net loss of $72.2 million, with $2.2 million in changes in operating assets and liabilities[144]. Research and Development - Research and development expenses for the three months ended June 30, 2025, totaled $63.0 million, a significant increase from $27.3 million in the same period of 2024[113]. - Total research and development expenses for the six months ended June 30, 2025, were $123.8 million, compared to $54.2 million in the same period of 2024[113]. - Research and development expenses increased by $35.7 million to $63.0 million for the three months ended June 30, 2025, primarily driven by a $32.0 million increase related to the Cerebrum™ platform[124]. - The company anticipates nominating a development candidate for PRAX-100 by mid-2025 and for PRAX-080 and PRAX-090 by the end of 2025[102]. - The ENERGY program for vormatrigine includes five studies, with the EMPOWER study initiated in Q3 2024 and the POWER1 study currently enrolling[97]. - The FDA granted breakthrough therapy designation for relutrigine in July 2025 for seizures associated with SCN2A and SCN8A developmental and epileptic encephalopathies[98]. - The company employs a "virtual" research and development model, relying heavily on external consultants and organizations for clinical activities[103]. Cash and Financing - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities of $446.6 million, expected to fund operations into 2028[108]. - The company raised $1.2 billion in aggregate cash proceeds from various transactions since inception through June 30, 2025[134]. - Net cash provided by financing activities for the six months ended June 30, 2025, was $82.9 million, consisting mainly of net proceeds from at-the-market offerings[146]. - For the same period in 2024, net cash provided by financing activities was $399.1 million, primarily from follow-on public offerings and a collaboration agreement[147]. - Cash, cash equivalents, and marketable securities as of June 30, 2025, amounted to $446.6 million[134]. - The company expects substantial increases in expenses related to ongoing research and development activities, anticipating continued operating losses and negative cash flows for the foreseeable future[148]. - As of June 30, 2025, the company believes its cash, cash equivalents, and marketable securities will be sufficient to fund operations into 2028, although this estimate is based on potentially incorrect assumptions[149]. Collaboration and Revenue - The company has entered into a Collaboration Agreement with UCB Biopharma SRL, recognizing $0.4 million and $0.8 million of collaboration revenue for the three and six months ended June 30, 2024, respectively[109]. - Collaboration revenue decreased by $0.4 million to $0 during the three months ended June 30, 2025, due to the completion of research service obligations under the Collaboration Agreement with UCB[123]. Risks and Future Outlook - The company faces risks related to product development and potential collaborations, which may impact the timing and amounts of capital outlays and operating expenses[150]. - The company does not currently have any committed external sources of funds, and market volatility could adversely affect its ability to access capital when needed[152]. - The company anticipates an increase in general and administrative expenses in the future to support growth in research and development activities and potential commercialization[117]. - General and administrative expenses rose by $2.5 million to $13.1 million for the three months ended June 30, 2025[126].