azercabtagene zapreleucel (PBCAR0191) / Precision BioSci, Imugene, TG Therap - LARVOL DELTA

Azer-cel, an allogeneic (allo) CD19 CAR T, in combination with low-dose interleukin-2 (IL-2) demonstrates clinical activity in patients with large B-cell lymphoma (LBCL) who relapsed after autologous (auto) CAR T (ASH 2025) - P1 | "Pts receivedlymphodepletion with fludarabine (30 mg/m²/day) and cyclophosphamide (750 mg/m²/day) for 3 days(Aug/Cy), followed by azer-cel infusion (500 × 10⁶ cells) on Day 0 and SC low-dose IL-2 (1 million IU daily)on Days 1-14. Azer-cel followed by low-dose SC IL-2 demonstrates encouraging clinical activity in pts withLBCL who relapsed after prior autologous CD19 CAR T therapy, which remains a significant unmetmedical need. Promising response and CR rates, early evidence of durability, robust CAR T-cell expansionand a manageable safety profile support further investigation of this regimen as a potential treatmentoption for these patients."

Clinical • Combination therapy • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Graft versus Host Disease • Hematological Malignancies • High-grade B-cell lymphoma • Immunology • Indolent Lymphoma • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma

Imugene launches $20 million capital raise to fund expansion of Azer Cel trials (BiotechDispatch) - "The funding includes a $12 million institutional placement and a share purchase plan that could raise up to eight million dollars from existing shareholders....The funds will primarily be used to expand the Phase 1b trial of Azer Cel, including expanding cohort 2 and introducing a new cohort evaluating the therapy in combination with a BTK inhibitor. The capital raising is also expected to extend the company's funding runway into the fourth quarter of 2026."

Financing • B Acute Lymphoblastic Leukemia • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Small Lymphocytic Lymphoma

Imugene reports strong early response rates for azer-cel in lymphoma study (Proactiveinvestors) - "Early data from the study showed a 100% overall response rate (ORR) in patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL), while patients with marginal zone lymphoma (MZL) recorded an 80% ORR, including several complete responses....The company also noted that enrolment in the CAR T-naïve expansion cohort is progressing more quickly than in the earlier cohort of patients whose disease had relapsed after prior CAR T therapy....The trial is currently enrolling patients at 10 clinical sites in the United States and five in Australia, with further updates expected as additional patients become evaluable and follow-up data matures."

P1 data • Trial status • Chronic Lymphocytic Leukemia • Marginal Zone Lymphoma • Small Lymphocytic Lymphoma

Precision BioSciences Receives $7.5M in Proceeds from TG Therapeutics for Azer-cel Clinical Milestone in Multiple Sclerosis (Businesswire) - "The milestone payment for azercabtagene zapreleucel (azer-cel) was triggered by progress of a Phase 1 clinical trial of azer-cel in progressive forms of multiple sclerosis (MS). As a result of this milestone event, Precision will receive $7.5 million in proceeds, inclusive of $5.25 million cash and $2.25 million for the purchase of 201,504 shares of Precision common stock by TG Therapeutics at $11.17 per share, pursuant to the terms of the companies’ license agreement."

Financing • Multiple Sclerosis

TG Therapeutics faces earnings test as Briumvi growth accelerates (Investing.com) - "The company already pre-announced preliminary fourth-quarter U.S. Briumvi sales of approximately $182 million, beating consensus estimates and reflecting 20% quarter-over-quarter growth...Investors will also press for updates on the subcutaneous formulation of Briumvi, which is more than 50% enrolled in Phase 3 trials with data expected by year-end 2026 or early 2027. Multiple catalysts throughout 2026 could further reduce patient burden, including mid-2026 Phase 3 ENHANCE top-line results, subcutaneous Briumvi Phase 3 data expected by year-end or first quarter 2027, and preliminary Phase 1 azer-cel data in progressive MS in the second half of 2026."

Clinical data • Sales • Multiple Sclerosis

PBCAR0191-01: Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL) (clinicaltrials.gov) - P1 | N=135 | Recruiting | Sponsor: Imugene Limited | Trial primary completion date: Jun 2025 ➔ Jun 2027

Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma • Small Lymphocytic Lymphoma

Imugene Ltd…has won crucial backing from the US Food and Drug Administration (FDA), with written minutes from a recent Type C meeting confirming support to advance its off-the-shelf CAR T candidate azercabtagene zapreleucel (azer-cel) into a registrational Phase 3 study. (Proactiveinvestors) - "The meeting, held on November 21, 2025, focused on the proposed pathway to registration for azer-cel in diffuse large B cell lymphoma (DLBCL). The FDA endorsed Imugene’s planned regimen for the pivotal program, which combines augmented lymphodepletion, a fixed dose of 500 million azer-cel cells and 14 days of low-dose subcutaneous interleukin-2 (IL-2). According to Imugene, the minutes provide 'clear alignment' across key elements of the late-stage strategy, including study design, patient population, endpoints and Chemistry Manufacturing Controls (CMC) expectations."

FDA event • Diffuse Large B Cell Lymphoma

Health Check: It’s thumbs up from the FDA for two ASX Car-T cancer drug developers (Stockhead) - "Imugene (ASX:IMU) is planning a phase III blood cancer trial, after the US Food and Drug Administration (FDA) delivered positive feedback on the company’s lead asset, Azer-cel. In effect, the agency has given its blessing to the structure and endpoints of the trial, which would be conducted to support US marketing approval application....The mooted study will enrol patients with advanced diffuse large B cell lymphoma (DLBCL), including those who have relapsed after previous autologous Car-T therapies....Imugene says the FDA is happy with the company’s proposed use of overall response rate (ORR) and progression-free survival (PFS) as endpoints."

FDA event • New P3 trial • Diffuse Large B Cell Lymphoma

Imugene lifts response rate to 82% in Phase 1b trial of azer-cel CAR-T therapy (Proactiveinvestors) - "The company said seven patients have achieved complete response to date, while durability continues to deepen across the cohort, including in those treated with the combination of azer-cel, lymphodepletion and interleukin-2 (IL-2). Average time to best response is one to three months....Imugene is actively enrolling at 10 trial sites in the US, with up to six Australian sites planned."

P1 data • Trial status • Diffuse Large B Cell Lymphoma

Imugene will hold an FDA Type C meeting in November to discuss pivotal-study design options for azer-cel in the CAR T-relapsed DLBCL setting, while also expanding the CAR T-naïve program to support potential registration across additional indications, including rare lymphomas. (Proactiveinvestors)

FDA event • Diffuse Large B Cell Lymphoma

Imugene abstract on azer-cel selected for oral presentation at ASH 2025 (Proactiveinvestors) - "Imugene says the abstract released overnight includes clinical activity and safety data from its azer-cel program, assessing azer-cel plus low-dose IL-2 in relapsed/refractory LBCL patients after prior autologous CAR-T therapy."

P1 data • Large B Cell Lymphoma

Imugene posts 83% response rate in CAR T-naïve lymphoma cohort (Proactiveinvestors) - "Of six evaluable patients with no prior CAR T treatment, five (83%) achieved an overall response, including three (50%) complete responses. Results from a sixth patient are pending. Ten patients have been treated so far in this cohort, spanning several rare and difficult-to-treat lymphoma subtypes such as Waldenström macroglobulinemia, marginal zone lymphoma and primary CNS lymphoma — areas where no CAR T therapies are currently approved."

P1 data • CNS Lymphoma • Marginal Zone Lymphoma • Waldenstrom Macroglobulinemia

2025 Remaining Pipeline Development Goals (GlobeNewswire) - "Commence patient enrollment into the Phase 3 pivotal program for subcutaneous BRIUMVI; Continue enrollment into the Phase 3 pivotal program based on the streamlined dosing regimens evaluated in the ENHANCE trial, evaluating a single Day 1 600 mg IV dose of BRIUMVI; Continue enrollment of participants into the ongoing clinical trial evaluating BRIUMVI in Myasthenia Gravis (MG); Continue enrollment of participants into the Phase 1 clinical trial evaluating azer-cel for the treatment of autoimmune diseases, beginning with progressive forms of MS; Present updated data at major medical conferences throughout the year."

Clinical data • Enrollment status • Immunology • Multiple Sclerosis • Myasthenia Gravis

Overall Response Rate (ORR) increases to 79% with two additional Partial Responses in azer-cel CAR T Phase 1b trial (Imugene Press Release) - P1/1b | N=129 | NCT03666000 | Sponsor: Imugene Limited | "Since then, two new patients have become evaluable for responses and both patients have achieved a Partial Response increasing the best ORR to 79% with eleven out of fourteen patients showing response to treatment. The duration of maintaining response continues to mature. These patients are being treated with azer-cel and interleukin 2 (IL -2); First patient dosed in 2024 remains cancer free at 15 months and ongoing with subsequent patients having durable responses at 3, 7, and 11 months+ and durability data continuing to mature; Trial now open to enrol into CAR T naïve niche indications in other lymphomas....Imugene is actively enrolling patients to the Phase 1b azer-cel trial at ten US sites with up to six sites in Australia planned..."

P1 data • Trial status • Diffuse Large B Cell Lymphoma

Imugene Announces Outstanding Response Rates from the Phase 1b Trial of the Azer-cel Allogeneic CAR T in 3L+ DLBCL (PRNewswire) - P1/1b | N=129 | NCT03666000 | Sponsor: Imugene Limited | "Since the February update, an additional 5 patients have been dosed, resulting in 2 Complete Responses (CR) and 3 Partial Responses (PR). 75% Overall Response rate (ORR): 6 total CR and 3 PR in Phase 1b trial of azer-cel, an allogeneic off-the-shelf CD19 CAR T therapy in relapsed diffuse large B-cell lymphoma (DLBCL), an aggressive type of blood cancer. First patient remains cancer free at 15 months and ongoing with additional patients having durable responses at 2, 5, and 11 months+ and durability data continuing to mature. Patients in the trial have previously failed at least 3 lines of therapy with many patients failing 4-6 lines of therapy....Additional update expected in coming months....Imugene will request a Type B (End of Phase 1) Meeting in Q4 2025, with the US FDA to present the data and to discuss designs for a pivotal / registrational trial for azer-cel."

FDA event • P1 data • Diffuse Large B Cell Lymphoma

A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: TG Therapeutics, Inc. | Initiation date: Jan 2025 ➔ May 2025

Trial initiation date • Immunology

Imugene secures FDA fast track designation for CAR T-cell therapy azer-cel to combat blood cancer (Proactiveinvestors) - "Imugene Ltd has garnered fast track designation from the US Food and Drug Administration (FDA) for its allogeneic CAR T-cell therapy, azer-cel (azercabtagene zapreleucel), in the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL)....This status provides Imugene with access to more frequent FDA interactions, rolling submission reviews and potential eligibility for Accelerated Approval and Priority Review....Clinical data from the ongoing Phase 1b trial has demonstrated promising results, particularly in patients who have failed multiple prior treatments, including autologous CAR T therapy."

Fast track • Diffuse Large B Cell Lymphoma

TG Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2024 Financial Results (GlobeNewswire) - "2025 Development Pipeline Anticipated Milestones: Commence pivotal program of subcutaneous ublituximab; Commence a pivotal program based on data from the ENHANCE trial with the goal of enhancing the patient experience on intravenous BRIUMVI; Enroll participants into the ongoing trial evaluating BRIUMVI in autoimmune diseases outside of MS; Enroll participants into the Phase 1 azer-cel trial in autoimmune disease, beginning with progressive forms of MS; Present updated data at major medical conferences throughout the year."

Clinical data • Enrollment status • New trial • Immunology • Multiple Sclerosis

MaxCyte Signs Strategic Platform License with TG Therapeutics to Advance its Autoimmune Cell Therapeutics Programs (GlobeNewswire) - "TG Therapeutics to use MaxCyte’s Flow Electroporation technology and ExPERT platform to support the development and commercialization of azer-cel, its allogeneic CD19 CAR T cell therapy program, for the treatment of autoimmune diseases....TG received clearance by the U.S. Food and Drug Administration (FDA) of an Investigational New Drug (IND) application for azer-cel in progressive forms of multiple sclerosis (MS) and is targeting commencement of a Phase 1 trial in 2025."

Licensing / partnership • New P1 trial • Immunology • Multiple Sclerosis

Azer-cel demonstrates two additional Complete Responses in CD19 CAR-T Phase 1b Trial with 57% Complete Response Rate (Imugene Press Release) - "Two additional Complete Responses (CRs) have been observed in Imugene’s Phase 1b trial of azer-cel, an allogeneic off-the-shelf CD19 CAR T therapy in relapsed/refractory diffuse large B-cell lymphoma (DLBCL), a type of blood cancer; Four out of seven patients (Cohort B, see ASX announcement 2 September 2024) have now achieved a complete response following treatment with azer-cel, lymphodepletion (chemotherapy), and low-dose interleukin 2 (IL-2); 13 US sites and up to 5 sites in Australia will actively enrol into the trial."

Trial status • Diffuse Large B Cell Lymphoma

A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: TG Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology

Administration of Low-Dose, Subcutaneous (SC) Interleukin-2 (IL-2) Markedly Enhances the Pharmacokinetic (PK) Profile of Azercabtagene Zapreleucel (azer-cel), an Allogeneic Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy, without Compromising Safety and Early Evidence of Clinical Activity in Patients with Diffuse Large B-Cell Lymphoma (DLBCL) Who Have Relapsed after Prior... (TCT-ASTCT-CIBMTR 2025) - P1 | "All patients received lymphodepletion with Aug/Cy (fludarabine 30 mg/m 2 /day and cyclophosphamide 750 mg/m 2 /day × 3 days) prior to azer-cel infusion (500 × 10⁶ cells) on Day 0. IL-2 markedly improved CAR T expansion (Figure 1) without impacting safety, with 3 CRs reported in 4 evaluable patients, and 1 with ongoing response past 120 days. Administration of low-dose IL-2 after treatment with azer-cel and Aug/Cy lymphodepletion may provide clinical benefit with predictable and manageable toxicity and markedly improved PK (~2 log increase in C max )."

CAR T-Cell Therapy • Clinical • PK/PD data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Bone Marrow Transplantation • Cytomegalovirus Infection • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • IL2

TG Therapeutics Provides Preliminary Fourth Quarter and Full Year 2024 Net Revenue and 2025 Anticipated Development Milestones (GlobeNewswire) - "BRIUMVI U.S. net product revenue expected to be $103.6 million and $310 million for the fourth quarter and full year of 2024, respectively....2025 Development Pipeline Anticipated Milestones: Commence pivotal program of subcutaneous BRIUMVI; Commence pivotal programs to consolidate the Day 1 and Day 15 dose of BRIUMVI, and to evaluate 30 minute BRIUMVI maintenance infusions; Enroll participants into the ongoing trial evaluating BRIUMVI in autoimmune diseases outside of Multiple Sclerosis (MS); Present updated data at major medical conferences throughout the year."

Clinical data • Enrollment status • New trial • Sales • Multiple Sclerosis

First Australian patient dosed in Phase 1b azer-cel clinical trial (Imugene Press Release) - "Imugene Limited...is pleased to announce that the first Australian patient has been dosed in the Phase 1b clinical trial of its allogeneic CAR T-cell therapy azer-cel (azercabtagene zapreleucel), at the Royal Prince Alfred Hospital (RPAH) in Sydney. The trial is focused on patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), one of the most challenging and aggressive forms of non-Hodgkin’s lymphoma."

Trial status • Diffuse Large B Cell Lymphoma

Imugene receives substantial capital injection; extends cash runway to end of 2025 in support of ongoing trials (Proactiveinvestors) - "Imugene Ltd...is positioned to raise up to A$46 million via the issue of convertible notes and warrants to CVI Investments, Inc. to support its clinical pipeline...Funds are to be put toward ongoing trials for IMU’s azer-cel, onCARlytics and VAXINIA programs, as the company anticipates key clinical data readouts in the coming 12 months....The issuance involves A$20 million of senior, unsecured, zero-coupon, convertible notes and up to a further A$26 million through the issue of unlisted warrants."

Clinical data • Financing • Hematological Malignancies • Solid Tumor