We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. (Incorporated in Delaware)

Our product candidates are derived from donor cells (allogeneic) rather than a patient’s own cells (autologous) and are pre-manufactured, stored frozen and ready to ship to a patient’s treatment location, making them what we believe to be “off-the-shelf.” 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 systemic lupus erythematosus (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 in heavily pre-treated patients naïve 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. We expect to report initial data on autoimmune indications from at least one of our Phase 1/1b trial or the basket IIT in the first half of 2025.

To our knowledge, AlloNK was the first allogeneic, off-the-shelf NK cell therapy candidate to receive Investigational New Drug application (IND) clearance to be administered to a patient with an autoimmune disease in a U.S. clinical trial, and to receive United States Food and Drug Administration (FDA) Fast Track designation in an autoimmune disease. Additionally, to our knowledge AlloNK is the first allogeneic NK cell therapy candidate in the United States to receive IND clearance for a basket trial in autoimmune diseases, and specifically the first to be evaluated in rheumatoid arthritis (RA), pemphigus vulgaris (PV) and the anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV) subtypes granultomatosis with polyangiitis (GPA) / microscopic polyangiitis (MPA), which we are exploring through a basket IIT. We believe as we continue to execute on our strategic plan that these critical first mover advantages will solidify our leadership in multiple autoimmune diseases with high unmet need. Receiving IND clearance and any special designations, such as Fast Track designation, does not guarantee an accelerated review of AlloNK or increase the likelihood of approval of AlloNK by the FDA. Given our early stage of development, it will take several years before we complete clinical development and receive regulatory approval of AlloNK or any of our product candidates, if at all.

Note: Net loss as well as collaboration and licensing revenue are for the 12 months that ended March 31, 2024.

(Note: Artiva Biotherapeutics, Inc. priced its IPO at $12.00 – $2.00 below the bottom of its $14.00-to-$16.00 range – and upsized the deal at pricing to 13.92 million shares – up from 8.7 million shares in the prospectus – to raise $167.04 million on Thursday night, July 18, 2024. Background: Artiva Biotherapeutics, Inc. disclosed terms for its IPO in an S-1/A filing dated July 15, 2024: 8.7 million shares at a price range of $14.00 to $16.00 to raise $130.5 million.)

(Note: Artiva Biotherapeutics, Inc. revived its IPO plans with a new S-1 filing dated June 28, 2024, without disclosing terms. The S-1 filing followed a confidential IPO filing dated May 3, 2024.)

(History: Artiva Biotherapeutics withdrew its IPO plans in a letter to the SEC dated Nov. 1, 2022. The underwriters for the withdrawn IPO were Goldman Sachs/ Cowen and Company/ Evercore/Wedbush Securities . Note: Artiva Biotherapeutics, Inc. filed confidentially for an IPO on March 2, 2021; filed its S-1 on April 8, 2021, and most recently amended its S-1 with an S-1/A filing dated June 6, 2022. No terms have been filed yet, though, for this IPO.)