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

A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: TG Therapeutics, Inc. | Trial completion date: Jan 2030 ➔ Jan 2029 | Trial primary completion date: Dec 2027 ➔ Dec 2026

Trial completion date • Trial primary completion date • Immunology • CNTN1

Safety and efficacy of Azer-cel, an allogeneic CD19 CAR T for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia not previously exposed to autologous CAR T therapy. (ASCO 2026) - P1 | "Patients received lymphodepletion with fludarabine (30 mg/m²/day) and cyclophosphamide (750 mg/m²/day) (Aug/Cy) for 3 days, followed by azer-cel infusion (500×106 cells) on Day 0 and subcutaneous low-dose IL-2 (1 million IU daily) for 14 days. Azer-cel in autologous CAR T-naïve patients demonstrates promising clinical activity across a broad range of CD19+ B-cell malignancies, including MZL and CLL. Encouraging response rates, robust CAR T-cell expansion, and a manageable safety profile support further investigation."

CAR T-Cell Therapy • Clinical • B Cell Lymphoma • Chronic Lymphocytic Leukemia • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Primary Central Nervous System Lymphoma • Small Lymphocytic Lymphoma • Waldenstrom Macroglobulinemia

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

Present preliminary Phase 1 azer-cel data in Progressive MS in the second half of 2026 (GlobeNewswire)

P1 data • Immunology • Multiple Sclerosis

Imugene reports second complete response in azer-cel BTKi cohort (Proactiveinvestors) - "The latest response was recorded in the first mantle cell lymphoma (MCL) patient treated in the azer-cel Phase 1b study. The patient had previously received and failed BTKi therapy before achieving a complete response at the Day 28 assessment....The result comes close after Imugene reported its first complete response in the concurrent BTKi cohort, highlighting a second early response in a patient group that has relapsed on or is refractory to BTKi therapy."

P1 data • Mantle Cell Lymphoma

Imugene reports first complete response in azer-cel BTKi cohort (Proactiveinvestors) - "The first patient in the cohort, who had follicular lymphoma and had previously failed BTKi therapy, achieved a complete response at the Day 28 assessment...The result is significant as all patients enrolled in the concurrent BTKi cohort have relapsed on or are refractory to BTKi therapy, which is widely used across multiple B-cell malignancies...Imugene noted some patients develop resistance to BTK inhibitors over time, leaving them with limited treatment options. The cohort is evaluating whether concurrent dosing of azer-cel with a BTKi can restore or enhance therapeutic activity in this setting....To date, four patients have been dosed in the concurrent BTKi combination cohort, including the first patient with mantle cell lymphoma. Imugene said it would provide further updates as more data becomes available and the dataset matures."

P1 data • Trial status • Follicular Lymphoma • Mantle Cell Lymphoma

Imugene has secured U.S. FDA Fast Track Designation for its off-the-shelf CD19-directed CAR T therapy azer-cel in two blood cancer indications, relapsed or refractory CLL/SLL and MZL (TipRanks) - "The designation follows encouraging Phase 1b basket study data showing a 100% overall response rate in CAR T-naive CLL/SLL patients and an 83% response rate in MZL, including four complete responses, among heavily pre-treated cohorts."

Fast track • Chronic Lymphocytic Leukemia • Marginal Zone Lymphoma • Small Lymphocytic Lymphoma

Imugene doses first patient in BTKi combination cohort for azer-cel study (Proactiveinvestors) - "The patient, treated at Baylor University in Texas, has mantle cell lymphoma (MCL) and had previously failed BTKi therapy, a common treatment approach across several B-cell blood cancers."

Trial status • Mantle Cell Lymphoma

Imugene reports strong early responses to Azer-cel in CAR-T naïve blood cancer patients (BiotechDispatch) - "Among the 16 evaluable patients, the overall response rate was 81 per cent with responses observed across several disease subtypes. Reported response rates included 60 per cent in DLBCL, with one complete response and two partial responses. A 100 per cent response rate in MZL with three complete responses and one partial response, 100 per cent in CLL with three partial responses, 50 per cent in PCNSL with one partial response and 100 per cent in both FL and WM, with one complete response in FL and one partial response in WM."

P1 data • Chronic Lymphocytic Leukemia • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Marginal Zone Lymphoma • Waldenstrom Macroglobulinemia

A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: TG Therapeutics, Inc. | N=32 ➔ 100 | Trial completion date: Jan 2029 ➔ Jan 2030 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Enrollment change • Trial completion date • Trial primary completion date • Immunology

Long-term Follow-up (LTFU) of Participants Who Received Azer-Cel (clinicaltrials.gov) - P=N/A | N=32 | Not yet recruiting | Sponsor: TG Therapeutics, Inc.

New trial • Immunology

2026 Development Pipeline Anticipated Milestones (Yahoo Finance) - "Announce topline Phase 3 data for ENHANCE trial combining Day 1 and Day 15 doses of IV BRIUMVI mid-year 2026; Present preliminary Phase 1 azer-cel data in Progressive MS in the second half of 2026; Announce topline Phase 3 data for subcutaneous BRIUMVI (ublituximab) year-end 2026/first quarter 2027; Commence a potentially registration-directed trial for BRIUMVI in Myasthenia Gravis (MG); Commence additional exploratory studies for BRIUMVI and azer-cel in autoimmune disease (outside MS)."

New trial • P1 data • P3 data: top line • Immunology • Multiple Sclerosis • Myasthenia Gravis

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