NKX019 / Nkarta Therap - LARVOL DELTA

NKX019 Clinical Program Progress and Upcoming Milestones (GlobeNewswire) - "Following engagement with the U.S. Food and Drug Administration, the patient-by-patient stagger was eliminated, accelerating the ability to dose escalate; Protocol amendments now allow for simultaneous dosing of multiple participants in parallel within each dose cohort; Ntrust-1 and Ntrust-2 enrollment process was streamlined to permit data from both studies to be utilized by a combined, iDSMB to inform dose escalation decisions; After unanimous clearance from the combined iDSMB, enrollment has begun in the second dose-escalation cohort; NKX019 clinical programs in autoimmune diseases continue to enroll patients. This includes Ntrust-1, Ntrust-2, and two investigator-sponsored trials; Preliminary data from the Ntrust-1 and Ntrust-2 clinical trials are expected to be presented at a medical conference in 2026."

P1/2 data • Trial status • ANCA Vasculitis • Immunology • Lupus • Lupus Nephritis • Scleroderma • Systemic Sclerosis

A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1) (clinicaltrials.gov) - P1/2 | N=96 | Recruiting | Sponsor: Nkarta, Inc. | Phase classification: P1 ➔ P1/2 | N=48 ➔ 96

Enrollment change • Phase classification • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease

A Phase 1 Study of NKX019, an Allogeneic Chimeric Antigen Receptor Natural Killer (CAR-NK) Cell Therapy in Patients with Systemic Lupus Erythematosus (ASH 2024) - P1 | "Whereas autologous CAR T cells depend on host cytokine surges induced by lymphodepletion, the membrane-bound IL-15 construct also enables the use of NKX019 without fludarabine-containing LD...The study will evaluate NKX019 dosed at 1 × 109 viable CAR+ NK cells administered on Days 0, 7, and 14 following single agent cyclophosphamide lymphodepletion...Subjects will be assessed for response based on SLEDAI or the European Alliance of Associations for Rheumatology (EULAR)/European Renal Association-European Dialysis and Transplantation Association (ERA-EDTA) criteria. Patient screening began in mid-2024."

Clinical • P1 data • Glomerulonephritis • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Oncology • Renal Disease • Rheumatology • Systemic Lupus Erythematosus • IL15 • IL2

Single Cell RNA and TCR Sequencing reveal candidate immune biomarkers of NKX019 clinical response in Non-Hodgkin Lymphoma (NHL) (SITC 2025) - P1 | "All procedures involving human participants complied with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Written informed consent was obtained from all individual participants before enrollment in the study"

Biomarker • Clinical • IO biomarker • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD4 • CD8 • IL15

A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2) (clinicaltrials.gov) - P1/2 | N=144 | Recruiting | Sponsor: Nkarta, Inc. | Phase classification: P1 ➔ P1/2 | N=72 ➔ 144

Enrollment change • Phase classification • ANCA Vasculitis • Immunology • Myositis • Scleroderma • Systemic Sclerosis • Vasculitis

NKX019, an allogeneic off-the-shelf CD19 targeting CAR-NK cell therapy, induces deep CD19+ B cell depletion in hematological malignancy and models of autoimmune disease (ACR Convergence 2025) - P1 | "In summary, non-clinical in vitro and in vivo data demonstrated that NKX019 effectively depletes CD19+ cells derived from AD patients and in CD19+ lymphoma models, respectively. In NHL patients, NKX019 induced robust B cell depletion followed by reconstitution of the B cell compartment. These data provide compelling support for NKX019 as a novel therapeutic approach for treatment of B-cell driven AD."

IO biomarker • B Cell Lymphoma • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL15

Nkarta Announces Poster Presentation at Upcoming American College of Rheumatology (ACR) Convergence Meeting (Yahoo Finance) - "Nkarta will present clinical data showing that the company’s investigational therapy, NKX019, achieved robust pathogenic B-cell depletion followed by reconstitution of the B cell compartment, consistent with immune reset in participants with non-Hodgkin lymphoma. Additionally, the company will share data from preclinical studies demonstrating that NKX019 effectively depletes pathogenic B cells in both in vivo lymphoma models and in vitro autoimmune disease models, traffics to lymphoid organs, and disseminates across multiple tissues."

Preclinical • Non-Hodgkin’s Lymphoma

NKX019 Clinical Program Progress and Upcoming Milestones (GlobeNewswire) - "NKX019 clinical programs in autoimmune diseases continue to enroll patients. This includes Ntrust-1, Ntrust-2 and two investigator-sponsored trials; Preliminary data from the Ntrust-1 and Ntrust-2 clinical trials is planned for release in the second half of 2025."

Enrollment status • P1 data • ANCA Vasculitis • Immunology • Inflammation • Lupus Nephritis • Myasthenia Gravis • Systemic Sclerosis • Vasculitis

NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With Autoimmune Disease (Ntrust-1) (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Nkarta, Inc. | N=21 ➔ 48

Enrollment change • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease

In clinical trials testing NKX019 in other autoimmune indications, the lymphodepletion regimen has been modified to include a combination of cyclophosphamide and fludarabine, which will be tested alongside the single cyclophosphamide regimen (Myasthenia Gravis News) - "Among those trials is Ntrust-1 (NCT06557265)...The new lymphodepletion regimen will also be tested in Ntrust-2 (NCT06733935)...Preliminary data from both studies are expected for the second half of this year, according to Nkarta."

P1 data • Trial status • ANCA Vasculitis • Inflammation • Lupus Nephritis • Systemic Sclerosis

Enrollment opens in Phase 1 trial of NKX019 cell therapy in gMG (Myasthenia Gravis News) - "Researchers at the University of California, Irvine, and the University of Kansas Medical Center are leading the open-label Phase 1 trial, which was given the go-ahead by the U.S. Food and Drug Administration late last year."

Trial status • Myasthenia Gravis

Nkarta Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Highlights (GlobeNewswire) - "Clinical Program Progress and Upcoming Milestones:...Preliminary clinical data from the Ntrust-1 and Ntrust-2 clinical trials is planned for the second half of 2025. The update is expected to include clinical response with available follow-up from a group of patients in the Ntrust-1 and Ntrust-2 studies."

P1 data • ANCA Vasculitis • Glomerulonephritis • Lupus Nephritis • Systemic Sclerosis

NKX019-101: NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With B-cell Cancers (clinicaltrials.gov) - P1 | N=150 | Active, not recruiting | Sponsor: Nkarta, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Aug 2024 ➔ Mar 2025

Enrollment closed • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Large B Cell Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Waldenstrom Macroglobulinemia

NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Participants With Immune-Mediated Diseases (Ntrust-2) (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Nkarta, Inc.

New P1 trial • ANCA Vasculitis • Immunology • Myositis • Scleroderma • Systemic Sclerosis • Vasculitis

Nkarta Announces…Opening of Enrollment for Ntrust-2 (GlobeNewswire) - "Nkarta, Inc...announced the opening of Ntrust-2 to enrollment...Ntrust-2 is a multi-center, open label, dose escalation clinical trial that builds on academic studies of durable, drug-free remissions in patients with autoimmune disease after CD19-targeted cell therapy. The trial will enroll patients with SSc, IIM or AAV into parallel cohorts. Per the trial protocol, patients receive NKX019 on Days 0, 3, and 7 following lymphodepletion with cyclophosphamide, an agent with an established safety profile across autoimmune diseases. The trial will assess the safety of NKX019 as well as its ability to enable long-term remissions via a 'reset' of the immune system through the elimination of pathogenic B cells.....Preliminary data from Ntrust-1 and Ntrust-2 are anticipated in 2025."

Clinical data • Enrollment open • ANCA Vasculitis • Immunology • Inflammation • Myositis • Scleroderma • Systemic Sclerosis

Nkarta Announces IND Clearance of Investigator-Sponsored Trial in Myasthenia Gravis... (GlobeNewswire) - "Nkarta, Inc...announced...the IND clearance for an investigator-sponsored trial (IST) that will evaluate NKX019, Nkarta’s allogeneic, CD19-directed chimeric antigen receptor (CAR) NK-cell therapy, in patients with myasthenia gravis (MG)...The IST will be led by researchers at the University of California, Irvine and the University of Kansas Medical Center...The dual-center, single-arm, open-label Phase 1 IST will be led by Ali A. Habib, M.D., Clinical Professor of Neurology at the University of California, Irvine (UCI), and other investigators....The IST is designed to enroll patients with myasthenia gravis and will evaluate safety and clinical outcomes. Translational and biomarker studies, including autoantibodies, cytokine profiles and pharmacokinetics are also planned. Patients will receive NKX019 on Days 0, 3 and 7 following single-agent lymphodepletion with cyclophosphamide."

IND • New P1 trial • Myasthenia Gravis

Nkarta Reports Second Quarter 2024 Financial Results and Corporate Highlights (GlobeNewswire) - "Autoimmune milestones 2024-2025: Initiation of patient enrollment in Ntrust-2 clinical trial expected by year-end 2024. Preliminary clinical data from Ntrust-1 and Ntrust-2 clinical trials planned for 2025."

New trial • P1 data • ANCA Vasculitis • Immunology • Lupus • Myositis • Small Lymphocytic Lymphoma • Systemic Lupus Erythematosus • Systemic Sclerosis

NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With Autoimmune Disease (Ntrust-1) (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Nkarta, Inc.

New P1 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

Nkarta Reports Second Quarter 2024 Financial Results and Corporate Highlights (GlobeNewswire) - "Mid-year update for NKX019 in non-Hodgkin lymphoma (NHL): Nkarta presented follow-up data from its Phase 1 clinical trial of NKX019 in relapsed/refractory NHL at the Pan Pacific Lymphoma Conference in July 2024, including follow-up on 4 patients who were retreated and re-entered complete response (CR), demonstrating the safety and encouraging effectiveness (4/4 CR) of retreatment....Nkarta has completed enrollment of patients into the 7-day dosing cohort in LBCL following CAR T and expects to announce data from this cohort in late-2024."

Enrollment status • P1 data • Non-Hodgkin’s Lymphoma

A Study of NKX019, a CD19 CAR NK Cell Therapy, in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Columbia University

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Nkarta Announces Initiation of Investigator-Sponsored Clinical Trial Evaluating NKX019 for Systemic Lupus Erythematosus (GlobeNewswire) - "Nkarta...today announced that researchers at Columbia University Irving Medical Center (CUIMC) have initiated an investigator-sponsored trial ('IST') of NKX019, Nkarta’s allogeneic, CD19-directed chimeric antigen receptor (CAR) NK-cell therapy in patients with systemic lupus erythematosus (SLE)....The CUIMC IST is designed to enroll up to 6 patients with SLE, regardless of renal involvement, and will evaluate safety and clinical outcomes in a potentially different population than Ntrust-1."

New trial • Systemic Lupus Erythematosus

Nkarta Launches Trial for CAR-NK Therapy NKX019 in Lupus and Gains Clearance for Separate Trial in Other Autoimmune Diseases (CGTLive) - "'People living with SSc have limited treatment options, especially treatments that target the whole patient and not just 1 organ system,' Elizabeth Volkmann, MD, MS...added to the statement.1 'The early results of studies using cell therapy in autoimmune diseases such as SSc are encouraging, and I look forward to seeing how these treatments affect outcomes for people living with this condition.'"

Video • Scleroderma • Systemic Sclerosis

Nkarta Initiates Clinical Trial of NKX019 in Lupus Nephritis with First Patient in Screening and Announces Pipeline Expansion to Additional Autoimmune Indications (GlobeNewswire) - "Clinical data from Ntrust-1 and Ntrust-2 planned for 2025....Nkarta...today announced the initiation of Ntrust-1, a multi-center clinical trial of NKX019 in lupus nephritis, with the first patient in screening. The company also announced the clearance by the U.S. Food and Drug Administration (FDA) of its second Investigational New Drug (IND) application for NKX019 in autoimmune disease....With this new IND, Nkarta plans to initiate Ntrust-2, an open-label, multi-center clinical trial of NKX019 for the treatment of systemic sclerosis (SSc, scleroderma), idiopathic inflammatory myopathy (IIM, myositis) and ANCA-associated vasculitis (AAV)."

Clinical data • IND • Trial status • ANCA Vasculitis • Immunology • Lupus Nephritis • Myositis • Scleroderma • Systemic Sclerosis

Nkarta Announces Pricing of $240 Million Underwritten Offering (GlobeNewswire) - "Nkarta, Inc...announced the pricing of an underwritten offering of 21,010,000 shares of its common stock at a price of $10.00 per share and pre-funded warrants to purchase 3,000,031 shares of common stock. The pre-funded warrants are being sold at a price of $9.9999 per warrant, which represents the per share offering price for the common stock less the $0.0001 per share exercise price....Nkarta intends to use the net proceeds from the offering to fund the continued research and clinical development of NKX019, the continued buildout of internal manufacturing capabilities, and for working capital and for general corporate purposes. The offering is expected to close on or about March 27, 2024, subject to customary closing conditions."

Financing • Oncology

NKX019-101: NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With B-cell Cancers (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Nkarta Inc. | Trial primary completion date: Dec 2023 ➔ Aug 2024

Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Waldenstrom Macroglobulinemia