Subsequent Events |
3 Months Ended |
|---|---|
Mar. 31, 2026 | |
| Subsequent Events [Abstract] | |
| Subsequent Events | 12. Subsequent Events Third Amendment to Distribution Agreement with Fresenius Medical Care On April 21, 2026, the Company entered into the Third Amendment to its distribution agreement with Fresenius Medical Care. Pursuant to the amendment, the Company has the sole right to develop and commercialize, and conduct all regulatory matters relating to, the Distribution Product (as defined in the distribution agreement, as amended) on a worldwide basis. In connection with the reversion of ex-U.S. rights to the Company, the Company will pay Fresenius low-single-digit royalties on net sales of the Distribution Product outside the United States, subject to a two-year royalty-free period following launch of the Distribution Product in each applicable country. The Company will continue to pay royalties on net sales of the Distribution Product in the United States at rates ranging from mid-single digits to low double digits, and Fresenius remains obligated to support adoption of the Distribution Product as a standard of care in hemodialysis patients for which such use is supported by clinical results and health economic analyses. Workforce Reduction and Operating Cost Reduction Plan In May 2026, the Company implemented a plan to reduce its workforce by approximately 45 employees, defer additional planned new hires, and reduce other operating expenses. These reductions have been implemented thoughtfully, and the Company has retained key personnel, resources, and initiatives to meet its key corporate goals and milestones. These objectives include the continued growth of Symvess in the United States and the global commercial launch of Symvess outside of the United States, once approved; completion of the V012 Phase 3 pivotal trial of the ATEV in dialysis and the planned filing of a supplemental BLA with the FDA in the dialysis indication; and the commencement of a human study of the CTEV in CABG. The Company estimates that it will incur aggregate charges of approximately $0.8 million representing one-time cash expenditures for severance and other employee termination benefits, of which the majority is expected to be incurred during the second quarter of 2026. |