Financial Performance - The company recorded a net income of $4.2 million for the year ended December 31, 2023, due to a gain on the sale of a non-financial asset of $47.6 million[136]. - For the three months ended September 30, 2025, the company reported a net income of $8.2 million, driven by $21.5 million in revenue and a $12.5 million gain on the sale of a non-financial asset[136]. - The company has an accumulated deficit of $156.5 million as of September 30, 2025, with net losses of $38.1 million and $51.1 million for the nine months ended September 30, 2025, and 2024, respectively[138]. - Revenue for the three months ended September 30, 2025, was $21.5 million, a significant increase from $0.2 million in the same period of 2024[169]. - For the nine months ended September 30, 2025, revenue reached $21.8 million, compared to $0.9 million for the same period in 2024[169]. - $21.3 million of the total revenue for the three and nine months ended September 30, 2025, was generated from research activities performed for Novo under the Novo Collaboration Agreement[170]. - The net loss for the three months ended September 30, 2025, was $8.2 million, a decrease in loss compared to $20.5 million in the same period of 2024[168]. - The company reported a net loss of $38.1 million for the nine months ended September 30, 2025, compared to a net loss of $51.1 million in 2024, a 25.5% improvement[180]. Collaboration Agreements - The company received a one-time, non-refundable upfront payment of $195.0 million from the Novo Collaboration Agreement, recorded as deferred revenue[144]. - The company is eligible for up to approximately $498.0 million in milestone payments from the Novo Collaboration Agreement, along with tiered royalties based on global product sales[144][145]. - The company received a one-time, non-refundable upfront payment of $195.0 million in July 2025 as part of the Novo Collaboration Agreement[182]. Research and Development - The company plans to initiate a Phase 1 clinical trial for SEP-479 in the first half of 2026, pending completion of preclinical studies and regulatory submissions[131]. - The Phase 1 clinical trial for SEP-631 is expected to enroll up to approximately 150 healthy adult volunteers, with initial data anticipated in the first half of 2026[132]. - The company has incurred significant operating losses since inception, with expectations to continue incurring substantial expenditures for product development and operational activities[137]. - The company expects research and development expenses to increase substantially in absolute dollars as it continues to invest in product candidates and clinical trials[157]. - Research and development expenses for the three months ended September 30, 2025, were $24.3 million, up from $17.8 million in the same period of 2024, reflecting an increase of $6.4 million[168]. - For the nine months ended September 30, 2025, research and development expenses were $65.7 million, up from $46.0 million in 2024, marking a 42.5% increase[172]. - The company anticipates initiating a Phase 1 clinical trial for SEP-479 in the first half of 2026, following the completion of preclinical studies and regulatory submissions[173]. Operating Expenses - General and administrative expenses for the three months ended September 30, 2025, were $7.1 million, an increase of $2.2 million from $4.9 million in the same period of 2024[168]. - General and administrative expenses are also expected to increase significantly as the company expands its headcount to support business growth[162]. - General and administrative expenses rose to $7.1 million for the three months ended September 30, 2025, compared to $4.9 million in 2024, a 44.9% increase[174]. - The company recorded a gain of $12.5 million on the sale of a non-financial asset, impacting total operating expenses for the three months ended September 30, 2025[168]. Cash and Financing - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $561.6 million, expected to fund operations through at least 2029[182]. - Net cash provided by operating activities was $125.2 million for the nine months ended September 30, 2025, compared to a net cash used of $46.5 million in 2024[184]. - The company completed its IPO in October 2024, raising net proceeds of $302.8 million from the sale of 18.4 million shares[140]. - The company completed its IPO in October 2024, resulting in net proceeds of $302.8 million after total offering costs of $28.4 million[193]. - The company has historically financed operations primarily through convertible promissory notes, convertible preferred stock, and the recent IPO[193]. Accounting and Compliance - There have been no material changes to the company's critical accounting policies and estimates during the nine months ended September 30, 2025[196]. - Revenue is recognized under ASC 606 when the customer obtains control of the promised goods or services[197]. - The company qualifies as an "emerging growth company" under the JOBS Act, allowing it to delay the adoption of new accounting standards[199]. - The company may continue to qualify as a "smaller reporting company" if certain revenue and market value thresholds are met[199]. Strategic Focus - The company is focused on establishing collaborations for favorable terms and scaling up clinical, regulatory, and manufacturing capabilities[194]. - Future commercialization activities will require expenses for sales, marketing, manufacturing, and distribution capabilities[194]. - The company has devoted resources to developing product candidates and preparing for clinical trials[193]. - The company has engaged in collaboration activities and established arrangements for the manufacture of product candidates[193].
Septerna, Inc.(SEPN) - 2025 Q3 - Quarterly Report