AlloNK (GCC4001) / GC Biopharma, Artiva Biotherapeutics - LARVOL DELTA

RESULTS FROM THE DOSE-FINDING PART OF LuminICE-203 PHASE 2 STUDY: ACIMTAMIG (AFM13) IN COMBINATION WITH AlloNK (AB-101) IN PATIENTS WITH RELAPSED/ REFRACTORY HODGKIN LYMPHOMA (ICML 2025) - P2 | "Introduction: New therapeutic options are needed for patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL) who progress following standard systemic therapies including chemotherapy, brentuximab vedotin (BV), and checkpoint inhibitors. The combination of acimtamig and AlloNK has shown promising efficacy with a well-managed safety profile, indicating potential therapeutic benefits and offering hope for patients with R/R cHL who have exhausted standard-of-care treatment options."

Clinical • Combination therapy • P2 data • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • FCGR3A • TNFRSF8

A Multi-Center, phase 1/2 Trial of AlloNK® Cell Therapy ± Rituximab in Patients with Relapsed or Refractory Non‑Hodgkin Lymphoma (TCT-ASTCT-CIBMTR 2026) - P1/2 | "These findings support the safe administration of AlloNK with rituximab in outpatient settings for oncology and autoimmune indications. Efficacy and duration of response in patients with CD20 + R/R non-Hodgkin Lymphoma (NHL) B-cell depletion via ADCC Safety with AlloNK"

Clinical • P1/2 data • B Cell Lymphoma • Febrile Neutropenia • Graft versus Host Disease • Hematological Malignancies • Immunology • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • CD20

AB-101, an Off-the-Shelf NK Cell Therapy Administered in an Outpatient Community Rheumatology Practice, Is More Cost-Effective Than CAR-T Treatments for Rheumatologic Diseases (TCT-ASTCT-CIBMTR 2026) - "Methods The treatment regimen included lymphodepletion with cyclophosphamide and fludarabine, two doses of rituximab, and three weekly AB-101 infusions, all administered in an outpatient clinic at the practice. Provide evidence for the ability to utilize AB-101 in a community rheumatology practice, based on experience in an investigator-initiated clinical trial 3 . Demonstrate that ancillary costs associated with AB-101 treatment are lower compared to autologous CAR-T therapy, and manageable within existing rheumatology treatment infrastructure"

Clinical • Cost effectiveness • HEOR • Hematological Disorders • Hematological Malignancies • Inflammatory Arthritis • Leukemia • Lymphoma • Rheumatoid Arthritis • Rheumatology

INITIAL RESULTS OF THE LUMINICE-203 STUDY INVESTIGATING ACIMTAMIG WITH OFF-THE-SHELF ALLOGENEIC NATURAL KILLER CELLS (ALLONK®) IN RELAPSED OR REFRACTORY CLASSICAL HODGKIN LYMPHOMA (EBMT 2025) - P2 | "Background: Patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL) who progress following chemotherapy, brentuximab vedotin (BV) and PD-1 inhibitors require novel treatment options...After lymphodepletion treatment with fludarabine/cyclophosphamide (Days −5 to −3) AlloNK and acimtamig are co-administered on Days 1, 8, and 15, followed by acimtamig only on Days 22, 29 and 36 of a 58-day cycle, for up to 3 cycles... Acimtamig plus AlloNK exhibits promising efficacy and tolerability in heavily pretreated patients. Combining acimtamig with a scalable, off-the-shelf NK-cell product has the potential to address a high unmet need in patients with R/R cHL who otherwise have no SOC option. The study is ongoing"

Classical Hodgkin Lymphoma • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Infectious Disease • Lymphoma • Oncology • FCGR3A • TNFRSF8

ACIMTAMIG (AFM13) IN COMBINATION WITH ALLONK® (AB-101) IN PATIENTS WITH RELAPSED OR REFRACTORY CLASSICAL HODGKIN LYMPHOMA: RESULTS FROM THE DOSE FINDING PHASE OF THE LUMINICE-203 PHASE 2 STUDY (EHA 2025) - P2 | "Patients have exhausted standard of care therapies, including chemotherapy, brentuximab vedotin and PD-1 inhibitors. The combination of acimtamig and AlloNK® therapy demonstrates promising efficacy and a manageable safety profile, offering a potential benefit to patients with R/R cHL who have exhausted standard-of-care treatments"

Clinical • Combination therapy • P2 data • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • FCGR3A • TNFRSF8

Investigating the Novel Combination of the Innate Cell Engager (ICE®) Acimtamig with Off-the-Shelf Allogeneic Natural Killer Cells AlloNK® in Relapsed or Refractory Classical Hodgkin Lymphoma (R/R cHL): Initial Results of the Phase 2 Luminice-203 Study (ASH 2024) - P1/2, P2 | "Introduction : Patients (pts) with R/R cHL are in need of new treatment options, especially after failure of standard treatments including brentuximab vedotin (BV) and PD-1 inhibitors...After a standard lymphodepletion treatment regimen with fludarabine/cyclophosphamide (Days -5 to -3) pts receive AlloN- and acimtamig coadministered on days 1,8,15 followed by acimtamig only on days 22,29 and 36 of a 48-day cycle for up to 3 cycles...These early results are in line with previous data from study NCT04074746 which used fresh allogeneic NK cells thereby validating the co-administration approach of acimtamig with an off-the-shelf, allogeneic, cryopreserved NK cell product (AlloNK) in R/R cHL. This treatment has the potential to address a high unmet need in R/R cHL pts who have otherwise no SOC option."

P2 data • Classical Hodgkin Lymphoma • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Infectious Disease • Lymphoma • Oncology • FCGR3A • TNFRSF8

Results from the completed dose-finding part of phase 2 study of the innate cell engager acimtamig (AFM13) in combination with AlloNK (AB-101) in relapsed or refractory classical Hodgkin lymphoma (LuminICE-203). (ASCO 2025) - P2 | "All pts in the study were heavily pretreated with chemotherapy, brentuximab vedotin and PD-1 inhibitors; median (range) prior treatment lines was 4.5 (2–13), including previous stem cell transplant in 14 (58%) pts. Acimtamig in combination with AlloNK shows promising efficacy with a well-managed safety profile with the potential to address an unmet need in pts with R/R HL who have exhausted standard-of-care treatment options. Efficacy results of acimtamig plus AlloNK in pts with R/R HL."

Combination therapy • P2 data • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • FCGR3A • TNFRSF8

Artiva Biotherapeutics Announces Upcoming Presentations at the 2026 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR (Tandem Meetings) Highlighting Cost-Effectiveness of AlloNK in a Community Rheumatology Practice and Continued Durability of AlloNK in NHL (The Manila Times)

Clinical data • Non-Hodgkin’s Lymphoma • Rheumatology

AB-101-03: AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=51 | Active, not recruiting | Sponsor: Artiva Biotherapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

AFM13 in Combination with Allogeneic Natural Killer Cells (AB-101) in Relapsed or Refractory Hodgkin Lymphoma and CD30+ Peripheral T-Cell Lymphoma: A Phase 2 Study (LuminICE) (ASH 2023) - P2 | "AB-101 has demonstrated potent killing of tumor cell lines in vitro and in vivo, and preliminary results of a Phase 1/2 trial of AB-101 alone and in combination with rituximab in patients with R/R B cell non-Hodgkin lymphoma demonstrated AB-101 is well tolerated (Khanal et al...Patients aged ≥18 years are planned for enrolment and patients with R/R HL must have received at least two prior lines of therapy including prior combination chemotherapy, brentuximab vedotin (BV) and a checkpoint inhibitor...A run-in phase will assess two dose levels of AFM13 and AB-101 in 4 cohorts (Figure). A standard lymphodepletion regimen of fludarabine (30 mg/m2/day) and cyclophosphamide (300 mg/m2/day) will be administered IV from Day −5 to Day −3 at the start of each treatment cycle...In addition, an exploratory cohort (cohort 5) will begin enrolment of patients with CD30+ PTCL. Disease and efficacy assessments will be conducted at screening and on Day 43 (± 3 days) of each cycle."

Combination therapy • P2 data • B Cell Non-Hodgkin Lymphoma • Bone Marrow Transplantation • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Transplantation • ALK • FCGR3A • TNFRSF8

Artiva on track 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 1H 2026 (GlobeNewswire)

P1 data • Rheumatoid Arthritis

Artiva plans to conduct FDA regulatory interactions in 1H 2026 to align on the pivotal trial design for AlloNK in refractory RA (GlobeNewswire)

FDA event • Rheumatoid Arthritis

Artiva Biotherapeutics Announces Positive Initial Safety and Translational Data Supporting Deep B-Cell Depletion with AlloNK in Autoimmune Disease (GlobeNewswire) - "The treatment regimen was generally well tolerated. Most treatment-emergent adverse events (TEAEs) were Grade 1 or 2, transient, and consistent with expected effects of Cy and Flu conditioning; No AlloNK-related Grade 3+ TEAEs or serious adverse events were reported; As of the data cutoff date of October 1, 2025, all 23 patients with samples analyzed demonstrated non-quantifiable peripheral CD19+ B-cell levels by Day 13 of treatment, irrespective of baseline B-cell counts"

Lupus Nephritis • Rheumatoid Arthritis • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis

AlloNK (also known as AB-101) Updates (GlobeNewswire) - "Initial clinical response data from ongoing clinical trials for more than 15 refractory RA patients, including several with ≥6 months of follow-up, remain on track for 1H 2026; Artiva plans to engage with the FDA in 1H 2026 to align on the potential pivotal trial design for AlloNK in refractory RA."

Clinical data • FDA event • Rheumatoid Arthritis

Artiva Biotherapeutics to Host Virtual Event Discussing Initial Safety and Translational Data in up to 32 Patients with Autoimmune Disease Treated with AlloNK (GlobeNewswire) - "The virtual webcast will take place Wednesday, November 12, 2025, at 8 a.m. ET. Initial safety data for 32 patients with autoimmune disease treated with AlloNK + monoclonal antibody (mAb) therapy, highlighting a favorable tolerability profile observed to date and the feasibility of patient management in outpatient rheumatology clinics. Initial translational data highlighting uniform, consistent, deep B-cell depletion supporting AlloNK’s intended mechanism of action."

P1 data • Pemphigus Vulgaris • Rheumatoid Arthritis • Systemic Lupus Erythematosus

Artiva Biotherapeutics…announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to AlloNK (also known as AB-101) for the treatment of refractory rheumatoid arthritis (RA) in combination with rituximab and that the Company has prioritized refractory RA as the program’s lead indication (GlobeNewswire)

Fast track • Rheumatoid Arthritis

Upcoming Milestones (GlobeNewswire) - "(i) Company plans to share initial safety and translational data for over 20 patients treated with AlloNK + mAb across multiple autoimmune diseases in mid-November, including insights into the patient journey from community rheumatology sites...; (ii) Company on track to share clinical response data across dose levels from more than 15 refractory RA patients in 1H 2026; (iii) Company plans to conduct FDA regulatory interactions in 1H 2026 to align on the pivotal trial design for AlloNK in refractory RA."

FDA event • P1 data • Rheumatoid Arthritis

LuminICE-203: Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL (clinicaltrials.gov) - P2 | N=25 | Terminated | Sponsor: Affimed GmbH | N=154 ➔ 25 | Trial completion date: Nov 2027 ➔ Jun 2025 | Recruiting ➔ Terminated | Trial primary completion date: Apr 2026 ➔ Nov 2024; Due to sponsor decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • ALK • TNFRSF8

Artiva Biotherapeutics Reports Second Quarter 2025 Financial Results, Recent Business Highlights (GlobeNewswire) - "Upcoming Milestones: By Year-End 2025: (i) Initial safety and translational data for AlloNK + mAb across multiple autoimmune diseases from ongoing clinical trials and disclosure of lead indication for further development: Mechanistic and translational data for AlloNK in autoimmune diseases; Insights into tolerability of AlloNK + mAb, and the patient journey in community rheumatology sites, including the potential ease of use of conditioning regimens with cyclophosphamide and fludarabine...; (ii) 1H 2026: Initial clinical response data in the lead autoimmune indication from ongoing clinical trials with longer follow-up to inform registrational strategy."

Clinical data • Lupus Nephritis • Myositis • Rheumatoid Arthritis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis

Artiva Biotherapeutics Reports Second Quarter 2025 Financial Results, Recent Business Highlights (GlobeNewswire) - "AlloNK (also known as AB-101) Updates: (i) Over a dozen clinical sites active and enrolling across two company-sponsored trials in autoimmune diseases: the Phase 2a basket clinical trial and the Phase 1/1b clinical trial in systemic lupus erythematosus (SLE) with or without lupus nephritis (LN); (ii) First patient treated with AlloNK + rituximab in recently initiated global Phase 2a company-sponsored basket clinical trial for refractory rheumatoid arthritis (RA), Sjögren’s disease (SjD), idiopathic inflammatory myopathies (myositis, or IIM), and systemic sclerosis (scleroderma, or SSc); (iii) Over a dozen patients treated with AlloNK + monoclonal antibody (mAb) across refractory RA, SLE, LN, SjD, and SSc in the company-sponsored trials and an investigator-initiated basket trial."

Trial status • Lupus Nephritis • Myositis • Rheumatoid Arthritis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis

TRANSLATIONAL FINDINGS FROM THE PHASE 2 LUMINICE-203 STUDY OF ACIMTAMIG (AFM13) IN COMBINATION WITH ALLONK® (AB-101) IN PATIENTS WITH RELAPSED OR REFRACTORY CLASSICAL HODGKIN LYMPHOMA (R/R CHL) (EHA 2025) - P2 | "The correlative science analysis of acimtamig and AlloNK® combination showed a high CD16 RO and a PK profile as expected and comparable to acimtamig monotherapy. Furthermore, changes in cytokine levels and NK cell phenotype suggest an immune activation trend with potential therapeutic benefits for patients with R/R HL that encourages further investigation."

Clinical • Combination therapy • P2 data • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • FCGR3A • IL5 • NKG2D • TNFRSF8

AB-101 as Monotherapy and With Immunotherapy in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1/2 | N=45 | Active, not recruiting | Sponsor: Artiva Biotherapeutics, Inc. | Recruiting ➔ Active, not recruiting | N=108 ➔ 45 | Trial completion date: Nov 2024 ➔ Dec 2025

Enrollment change • Enrollment closed • Monotherapy • Trial completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AB-101-03: AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=51 | Recruiting | Sponsor: Artiva Biotherapeutics, Inc. | Trial completion date: Oct 2026 ➔ Aug 2027 | Trial primary completion date: Oct 2026 ➔ Aug 2027

Trial completion date • Trial primary completion date • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Combination of Acimtamig and AlloNK Effective in R/R Classical Hodgkin Lymphoma (Hematology Advisor) - P2 | N=154 | LuminICE-203 (NCT05883449) | Sponsor: Affimed GmbH | "Acimtamig combined with AlloNK is associated with an objective response rate (ORR) as high as 100% in heavily pretreated patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (HL), according to research presented at the ASCO Annual Meeting 2025. The findings are from the phase 2, open-label LuminICE-203 study (NCT05883449), which assessed the efficacy and safety of acimtamig combined with AlloNK in patients with R/R HL....Among all 4 patient cohorts, the ORR was 87.5%, with 14 (58.3%) complete responses. The AlloNK DL1 + 200 mg acimtamig cohort, AlloNK DL1 + 300 mg acimtamig cohort, and AlloNK DL2 + 300 mg acimtamig cohorts each had an ORR of 83.3%. The AlloNK DL2 + 200 mg acimtamig cohort had an ORR of 100%. Ten patient responses were ongoing, the researchers reported. The estimated 6-month progression-free survival rate was 61%."

P2 data • Hodgkin Lymphoma

Artiva Biotherapeutics Announces Longer-term Phase 1/2 Data Demonstrating Prolonged Durability for AlloNK in Combination with Rituximab in Patients with B-cell-Non-Hodgkin Lymphoma at the ASGCT 28th Annual Meeting (GlobeNewswire) - P1/2 | N=108 | NCT04673617 | Sponsor: Artiva Biotherapeutics, Inc. | "High Response Rates - 64% complete response (CR) rate (9/14) for AlloNK + RTX with patients who were naïve to prior CAR-T cell therapy. Patients received a median three prior lines and 13 out of 14 patients had aggressive B-NHL....Prolonged Durability Beyond 12 Months - Median duration of response (mDoR) not yet reached and is at least 19.4 months as of the March 7, 2025, data-cut in patients following treatment with AlloNK + RTX. Complete responses sustained in the majority of patients treated with AlloNK + RTX....Well-tolerated Safety Profile - AlloNK + RTX was well-tolerated among the 45 patients dosed."

P1/2 data • B Cell Non-Hodgkin Lymphoma