VERA 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-10

• We are a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. Our flagship commercial product is TRUTAKNATM (atacicept-vymj), an inhibitor of B-cell activating factor (BAFF) and A Proliferation-Induci…

• On July 7, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to TRUTAKNA. The accelerated approval is based on a prespecified interim analysis of the ongoing ORIGIN Phase 3 trial (ORIGIN 3) in which participants treated with TRUTAKNA achieved a 46% reduction in proteinur…

• TRUTAKNA is a soluble recombinant fusion protein containing the human transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to BAFF and APRIL, the two key cytokines that activate B cells and drive IgAN pathophysiology. In IgAN, activated B cells prod…

• We believe that atacicept has pipeline-in-a-molecule potential, with potential application in multiple diseases. In the Phase 2 PIONEER clinical trial, for which we expect to report additional results in the fourth quarter of 2026, we are evaluating atacicept in a broader population of IgAN patients…

• We currently have only one product approved for commercial sale and expect to record limited revenue from product sales during the third quarter of 2026. Our ability to generate revenue sufficient to achieve profitability, if ever, will depend on the

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• We are a biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases. Our lead product candidate, atacicept, is currently being evaluated for the treatment of immunoglobulin A nephropathy (IgAN) and other autoimmune kidne…

• The ORIGIN Phase 2b clinical trial evaluated the safety and efficacy of atacicept in 116 participants with IgAN and reported positive results at 24 weeks in January 2023, 36 weeks in June 2023, and 96 weeks in October 2024. The trial remained blinded through 36 weeks, after which all participants we…

• We believe that atacicept has pipeline-in-a-molecule potential, with potential application in multiple diseases. Based on data from the ORIGIN Phase 2b trial, the FDA granted Breakthrough Therapy Designation to atacicept for the treatment of IgAN. We have also committed to providing long-term access…

• antibody-associated vasculitis (AAV), lupus nephritis (LN), Sjogren’s disease, systemic lupus erythematosus (SLE), systemic sclerosis, generalized myasthenia gravis, and idiopathic thrombocytopenic purpura.

• We do not have any product candidates approved for commercial sale, and we have not generated any revenue from product sales. Our ability to generate revenue sufficient to achieve profitability, if ever, will depend on the successful development and eventual commercialization of one or more of our p…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• we held limited funds and future obligations denominated in foreign currencies. As such, a 10.0% increase or decrease in current exchange rates would not have a material effect on our financial results.

相对上期新增的文字 · 来源:10-Q · 2026-08-10

• which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned. Moreover, it is particularly difficult to estimate with certainty our future expenses given the dynamic nature of our bu…

• We have incurred losses and negative cash flows from operations. As a company which received its first FDA accelerated approval for a product in July 2026, we expect to continue to incur significant losses at least until we successfully commercialize a

• product. Successful commercialization of a product is not guaranteed and may never be achieved. As a result, there is a possibility that the company may never be profitable.

• Our ability to generate revenue from product sales and achieve profitability depends on our ability, alone or with our collaboration partners, to successfully commercialize our lead product and complete the development of, and obtain the regulatory approvals necessary to commercialize our product ca…

• stock to decline. Additionally, if we raise any additional debt financing, the terms of such additional debt could further restrict our operating and financial flexibility.

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• given the dynamic nature of our business and the macroeconomic and geopolitical environment generally. We anticipate that our expenses will increase substantially if, and as, we:

• We have incurred losses and negative cash flows from operations. As a development stage company, we expect to incur significant and increasing losses at least until regulatory approval is granted for our product candidates. Regulatory approval is not guaranteed and may never be obtained. As a result…

• Our ability to generate revenue from product sales and achieve profitability depends on our ability, alone or with our collaboration partners, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize

• our product candidates. Our ability to generate revenue from product sales depends heavily on our and our potential future collaborators’ success in:

• Risks related to the discovery, development and commercialization of our product candidates

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• (1) The shares that may be sold under the Rule 10b5-1 trading plan may be reduced by the number of shares sold to satisfy tax withholding obligations upon vesting of certain restricted stock units covered by the plan.