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Imugene (IMU) investor relations material
Imugene Study update presentation summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Study design and patient population
Phase 1/1b study enrolled 25 adults with relapsed/refractory CD19+ B-cell malignancies, all CAR T-naive and with a median of 2 prior therapies.
Eligible diseases included DLBCL, MZL, CLL, FL, PCNSL, WM, and PMBCL.
Recommended phase 2 regimen: 500M CAR T cells, lymphodepletion, and low-dose SC IL-2.
Technology and manufacturing
Azer-cel is an allogeneic, off-the-shelf CAR T therapy using ARCUS gene editing for precise CD19 CAR insertion into the TRAC locus.
Non-integrating AAV vector minimizes off-target editing and allows efficient delivery.
Efficacy outcomes
Objective response rate (ORR) was high across all indications, with 100% ORR in CLL and MZL, and 79% in DLBCL/RT.
ORR among patients with indolent disease was 93%.
Ongoing responses and molecular disease burden reduction observed in MZL and CLL cohorts.
- Azer-cel showed robust efficacy in early trials, driving capital raises and strategic focus.IMU
Q3 2026 TU30 Apr 2026 - Net loss rose to $149.7M on higher R&D, with strong cash reserves and key clinical milestones ahead.IMU
H2 202427 Mar 2026 - Net loss improved 54% year-over-year as clinical programs advanced and new funding was secured.IMU
H2 202527 Mar 2026 - Net loss improved 22% to $37.8M, with strong clinical progress and ongoing funding needs.IMU
H1 20268 Mar 2026 - Clinical progress and cost reductions drive outlook, but funding runway remains tight.IMU
Q2 2026 TU8 Mar 2026 - Board changes, clinical advances, and financial strength drive strategic expansion in 2024.IMU
AGM 202414 Jan 2026 - Promising clinical data and FDA Fast Track status drive focus on registrational studies and partnerships.IMU
NWR Virtual Healthcare Conference26 Dec 2025 - FDA guidance de-risks azer-cel, enabling phase III entry and boosting commercial prospects.IMU
FDA Meeting Update9 Dec 2025 - Azer-cel trials achieved 81% response rate; $24.9M raised, cash at $32.4M.IMU
Q1 2026 TU7 Dec 2025
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