ADDED
Solely for the purposes of this disclosure, shares of common stock held by executive officers, directors and certain stockholders of the Registrant as of such date have been excluded because such holders may be deemed to be affiliates.
We are substantially dependent on the success of our lead product candidate, AlloNK, which is in clinical development.
Current clinical data regarding the efficacy of NK cell therapies against autoimmune diseases are limited, raising uncertainties about the therapeutic benefits of treatments like AlloNK for conditions such as rheumatoid arthritis (RA), Sj gren s disease, idiopathic inflammatory myopathies, systemic sclerosis, systemic lupus erythematosus (SLE), lupus nephritis (LN), and other autoimmune diseases.
iv International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
We have built and are operating our own clinical manufacturing facility and may decide to operate our manufacturing facility at commercial scale, but we could experience manufacturing problems such as delays or quality issues, and/or we could be required to or choose to modify our manufacturing processes, which could result in delays in the development or commercialization of our product candidates or otherwise harm our business.
Our lead product candidate, AlloNK (also known as AB-101), is an allogeneic, non-genetically modified, cryopreserved NK cell therapy designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of monoclonal antibodies (mAbs) to drive B-cell depletion.
We are currently evaluating AlloNK in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases, including a company-sponsored basket trial across autoimmune diseases that includes rheumatoid arthritis (RA) and Sj gren s disease (SjD).
We are prioritizing refractory RA as our lead indication for AlloNK development.
We expect to share initial clinical response data across dose levels from more than 15 refractory RA patients, several of whom will have 6 months or more follow up, in the first half of 2026.
In addition, we plan to conduct FDA regulatory interactions in the first half of 2026 to align on the pivotal trial design for AlloNK in refractory RA.
REMOVED
We are early in our development efforts and are substantially dependent on the success of our lead product candidate, AlloNK, which is in early clinical development.
Current clinical data regarding the efficacy of NK cell therapies against autoimmune diseases are limited, raising uncertainties about the therapeutic benefits of treatments like AlloNK for conditions such as SLE, LN, RA, PV, GPA / MPA and other autoimmune diseases.
iv Our collaboration agreements with Affimed GmbH, a subsidiary of Affimed N.V.
We could experience manufacturing problems, and/or we could be required to or choose to modify our manufacturing processes, which could result in delays in the development or commercialization of our product candidates or otherwise harm our business.
We currently rely on GC Cell for the manufacturing of certain of our product candidates.
While we have built our own clinical manufacturing facility and may decide to operate our manufacturing facility at commercial-scale, we may encounter delays, quality or other issues if and when we begin to use our manufacturing facility for supply, and will continue to rely on GC Cell at least partially for manufacturing of our product candidates in the near term.
Our lead product candidate, AlloNK, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs) in an ongoing Phase 1/1b trial in SLE with or without lupus nephritis (LN) and a basket investigator-initiated trial (IIT) in multiple autoimmune indications.
Seminal peer-reviewed clinical studies using autologous CD19 chimeric antigen receptor (CAR) T-cell therapy (auto-CAR-T) for the treatment of autoimmune diseases have demonstrated that deep B-cell depletion in the periphery and in the lymphoid tissue can lead to drug free disease remission.
We have already demonstrated that AlloNK in combination with rituximab was able to drive deep B-cell depletion in the periphery and observed complete responses (CRs) in heavily pre-treated patients na ve to auto-CAR-T in our ongoing Phase 1/2 clinical trial in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (B-NHL).
We believe the preliminary results from our Phase 1/2 clinical trial evaluating AlloNK in combination with rituximab in patients with B-NHL provide a readthrough to autoimmune disease because efficacy in both diseases appears to be accomplished with a shared mechanism of action involving B-cell depletion in the periphery and in the lymphoid tissues, followed by an immunological reset and B-cell reconstitution.