Praxis(US:PRAX)2025-11-05 13:04Financial Performance - The company reported a net loss of $214.4 million for the nine months ended September 30, 2025, with an accumulated deficit of $1.1 billion[104]. - Net loss for the three months ended September 30, 2025, was $73.9 million, an increase of $22.0 million compared to the net loss of $51.9 million for the same period in 2024[122]. - Total operating expenses for the nine months ended September 30, 2025, were $229.2 million, an increase of $91.9 million compared to $137.3 million for the same period in 2024[126]. - For the nine months ended September 30, 2025, the company reported a net cash used in operating activities of $172.7 million, primarily due to a net loss of $214.4 million[144]. - Financing activities provided net cash of $89.7 million for the nine months ended September 30, 2025, a decrease from $400.6 million in the same period of 2024[147]. Research and Development - Research and development expenses for the three months ended September 30, 2025, totaled $65.8 million, compared to $41.9 million for the same period in 2024, reflecting a 57% increase[112]. - Research and development expenses increased by $93.5 million to $189.6 million for the nine months ended September 30, 2025, with significant contributions from the Cerebrum™ platform[129]. - The company expects to incur significant expenses and operating losses as it advances multiple clinical trials and expands its pipeline[104]. - The company anticipates substantial increases in expenses related to ongoing research and development, particularly for clinical trials of its product candidates[148]. - The company relies on external consultants and organizations for its research and development activities, operating under a "virtual" model[103]. Cash and Financing - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities of $389.2 million, expected to fund operations into 2028[107]. - The company raised $1.2 billion in aggregate cash from various financing activities since inception[132]. - In September 2025, the company entered into a Sales Agreement to offer up to $250.0 million of common stock, issuing 119,364 shares for net proceeds of $5.8 million during the nine months ended September 30, 2025[139]. - In October 2025, the company completed a public offering of 3,527,072 shares at a price of $157.00 per share, generating approximately $567.0 million in net proceeds after expenses[140]. - As of September 30, 2025, the company believes its cash, cash equivalents, and marketable securities, along with proceeds from the October 2025 offering, will fund operations into 2028[149]. Collaboration and Revenue - Collaboration revenue decreased by $0.3 million to $0 for the three months ended September 30, 2025, due to the completion of obligations under the Collaboration Agreement with UCB[123]. - Other income for the nine months ended September 30, 2025, was $14.8 million, an increase of $2.7 million compared to $12.1 million for the same period in 2024[130]. Product Development and Programs - The ulixacaltamide program announced positive topline results in October 2025, with a Type B pre-NDA meeting scheduled for Q4 2025[96]. - The vormatrigine program initiated the ENERGY program, which includes five studies, with topline results from the RADIANT study expected in December 2025[97]. - The relutrigine program received breakthrough therapy designation from the FDA for seizures associated with SCN2A and SCN8A developmental and epileptic encephalopathies[98]. - The company plans to nominate development candidates for three earlier stage ASOs in the first half of 2026[102]. General and Administrative Expenses - General and administrative expenses decreased by $2.7 million to $12.6 million for the three months ended September 30, 2025[125]. - The company anticipates an increase in general and administrative expenses in the future to support growth in research and development activities[118]. Market Risks - The company acknowledges the risks associated with product development and potential collaborations, which may affect its capital outlays and operating expenses[150]. - 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[159].