ADDED
As of March 18, 2026, the number of outstanding shares of the registrant s common stock, par value $0.0001 per share, wa s 71,290,490 .
Examples of these forward-looking statements include, but are not limited to, statements concerning our financial and business performance, including our future funding requirements, our position, plans, strategies, and timelines (including the availability of disclosure of clinical data from our clinical trials) for the continued and future clinical development and commercial potential of our product candidates and the therapeutic potential, accessibility, tolerability, advantages, and safety profile of NK cell therapies, including NKX019 for the treatment of autoimmune diseases.
We have developed proprietary technologies designed to generate an abundant supply of NK cells, increase NK cell recognition of target antigens, and enhance NK cell fitness to support scalable, off the shelf administration.
NKX019 is currently being studied in an ongoing Phase 1 clinical trial ("Ntrust-1") for lupus nephritis ("LN") and primary membranous nephropathy ("pMN") and a Phase 1 clinical trial ("Ntrust-2") for systemic sclerosis ("scleroderma"), idiopathic inflammatory myopathy ("myositis"), and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis ("AAV").
Ntrust-1 is a multi-center, open-label, dose-escalation Phase 1 clinical trial of NKX019 for LN and pMN.
Ntrust-2 is a multi-center, open-label, dose-escalation Phase 1 clinical trial of NKX019 for scleroderma, myositis, and AAV, which we believe maximizes the potential success of our clinical trials.
In May 2025, we announced the modification of the lymphodepleting conditioning ("LD") prior to administration of 1 NKX019 to use a combination of fludarabine ("Flu") and cyclophosphamide ("Cy"), with the option for patients with cytopenias to continue to receive Cy alone as modified LD, in both our Ntrust-1 clinical trial and our Ntrust-2 clinical trial.
At that time, we also announced that researchers at the University of California, Irvine initiated an IST of NKX019 in patients with MG.
In November 2025, we announced that deep B-cell depletion was observed in all patients treated to date who received NKX019 with LD using Flu and Cy versus partial B-cell depletion in patients receiving only Cy.
At the same time, we reported the implementation of a streamlined enrollment process that allows participant data from both the Ntrust-1 and Ntrust-2 clinical trials to be reviewed by a combined independent Data Safety Monitoring Board ( iDSMB ) to inform dose-escalation decisions.
REMOVED
As of March 21, 2025, the number of outstanding shares of the registrant s common stock, par value $0.0001 per share, was 70,957,554 .
We have developed proprietary technologies that enable us to generate an abundant supply of NK cells, increase NK-cell recognition of target antigens, enhance NK-cell fitness, and freeze, store, and thaw our engineered NK cells for off-the-shelf administration.
NKX019 is currently being studied in an ongoing Phase 1 clinical trial for lupus nephritis ("LN") and a Phase 1 clinical trial for systemic sclerosis ("scleroderma"), idiopathic inflammatory myopathy ("myositis"), and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis ("AAV").
In November 2024, we announced the first patient was dosed in our Ntrust-1 clinical trial ("Ntrust-1"), a multi-center, open-label, dose-escalation Phase 1 clinical trial of NKX019 for LN and the first patient was dosed in the IST of NKX019 for SLE at Columbia University Irving Medical Center.
In December 2024, we announced the opening to enrollment of our Ntrust-2 clinical trial ("Ntrust-2"), a multi-center, open-label, 1 dose-escalation Phase 1 clinical trial of NKX019 for scleroderma, myositis, and AAV and the clearance of an Investigational New Drug ("IND") application for an IST led by researchers at the University of California, Irvine and the University of Kansas Medical Center to evaluate NKX019 in patients with MG.
Five patients with severe refractory SLE with LN received an autologous CD19 CAR T-cell therapy following lymphodepleting conditioning ("LD") with fludarabine ("Flu") and cyclophosphamide ("Cy").
Our second facility is designed to manufacture additional clinical supply, including for pivotal clinical trials, and potential commercial supply of NKX019 or future product candidates.
We believe our current facilities will supply our anticipated non-pivotal and pivotal clinical trial needs, as well as our potential commercial launch needs Continue to advance our CAR NK platform.
We have been engaged in discovery and preclinical stage activities directed at expanding our pipeline of product candidates.
As part of our collaboration with CRISPR Therapeutics AG ("CRISPR"), we began development of an allogeneic, off-the-shelf CAR NK product candidate targeting the CD70 tumor antigen ("NKX070") for the treatment of solid and liquid tumors, and conducted discovery efforts for an allogeneic, off-the-shelf product candidate that comprises both engineered NK cells and engineered T cells ("NK+T") to take advantage of both the innate and adaptive immune systems.