VERA 最新10-Q变化

相对上期新增的文字 · 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 also hold worldwide, exclusive development and commercial rights to MAU868, a potentially first-in-class monoclonal antibody to treat reactivated BK virus (BKV) infections, for which we completed a Phase 2 clinical trial in 2022. In January 2025, we acquired worldwide, exclusive development and c…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• We are a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases. Our lead product candidate, atacicept, a fully humanized TACI-Fc fusion protein that binds both B-cell activating factor (BAFF) and…

• The Phase 2b ORIGIN 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…

• Since our inception, we have devoted substantially all of our resources to our research and development efforts, pre-clinical studies and clinical trials, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative sup…

• continue our ongoing and planned development of our product candidates, atacicept, MAU868 and VT-109;

• conduct clinical trials and nonclinical studies for atacicept, MAU868 and VT-109;

相对上期新增的文字 · 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.

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• condition or results of operations. For more information regarding the 2025 Loan Agreement, see Note 6, Notes Payable, to our unaudited condensed financial statements.

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• initiate or continue nonclinical studies and clinical trials for our product candidates;

• 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:

• Moreover, nonclinical and clinical data are often susceptible to varying interpretations and analyses and many companies that believed their product candidates performed satisfactorily in nonclinical studies and clinical trials nonetheless failed to obtain FDA or comparable foreign regulatory author…

• candidates. To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potentia…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• continue our ongoing and planned research and development of atacicept for the treatment of IgAN and other indications;

• initiate or continue nonclinical studies and clinical trials for atacicept, MAU868, VT-109, and any additional product candidates that we may pursue in the future;

• continue our research and development of MAU868 for the treatment of BK viremia in kidney transplant recipients and other indications;

• advance our research and development of VT-109 in autoimmune-related conditions and other indications;

• 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, atacicept, MAU868, VT-109, and any future produc…