Imugene’s Azer-cel Hits 100% Response in CLL/SLL and Raises $16M for Trial Expansion

Strong Clinical Signals from Azer-cel in Blood Cancers

Imugene Limited (ASX:IMU) has reported compelling early results from its Phase 1b azer-cel trial, with a 100% overall response rate (ORR) in Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma (CLL/SLL) and 80% ORR in Marginal Zone Lymphoma (MZL). The CAR T-naive cohort, comprising patients who had received multiple prior therapies, showed partial responses in all four evaluable CLL/SLL patients and a mix of complete and partial responses in four of five MZL patients. These outcomes, while preliminary and based on small numbers, suggest meaningful clinical activity in difficult-to-treat B-cell malignancies.

The trial’s basket design allows Imugene to focus on indications with the strongest signals, recently expanding to include a Bruton Tyrosine Kinase inhibitor (BTKi) combination arm and Mantle Cell Lymphoma (MCL) as a new indication. BTKis represent a $12 billion global market and are standard therapies in several B-cell cancers, making this combination a strategically relevant step. The company aims to prioritise indications that offer the clearest near-term regulatory and commercial pathways.

Capital Raise Supports Clinical Expansion and Cash Runway

To fund ongoing development, Imugene completed a $16 million capital raising comprising a $12 million two-tranche institutional placement and a $4 million Share Purchase Plan (SPP). The first placement tranche of $6.38 million was received within the quarter, with the second tranche and SPP proceeds arriving shortly after quarter-end. Participants received free attaching options exercisable through 2027 and piggyback options extending to 2029, potentially unlocking up to $20 million in additional funding if fully exercised.

This raise follows earlier efforts in March 2026 to secure $20 million in funding, including options and convertible notes restructuring to enhance financial flexibility. The capital injection extends Imugene’s funding runway into Q4 2026, although net cash used in operating activities remained high at $9.67 million for the quarter. The company also received an R&D tax refund of A$2.74 million, bolstering its cash position to nearly $6 million at quarter-end.

Strategic Focus Narrows to Azer-cel

Following a portfolio review, Imugene has ceased development of its CF33 (VAXINIA) program to concentrate resources on azer-cel, its lead allogeneic off-the-shelf CD19 CAR T cell therapy. This disciplined focus aligns with management’s view that azer-cel holds the strongest potential to create shareholder value, especially as it advances through clinical milestones and regulatory engagement.

Imugene’s azer-cel program has attracted media attention, including a national news story featuring a patient who achieved remission after being given limited treatment options, highlighting the therapy’s potential impact. Managing Director Leslie Chong has also actively promoted the program through industry summits and podcasts, reinforcing the company’s commitment to clinical progress and investor engagement.

Upcoming ASCO Presentation and Trial Milestones

Azer-cel data has been selected for oral presentation at the prestigious ASCO 2026 Annual Meeting in Chicago, scheduled for late May. This recognition, from a pool of over 8,500 abstracts, underscores the clinical interest in Imugene’s therapy and will provide a key platform to showcase updated trial results. The full abstract will be published on 21 May, with the oral presentation running from 29 May to 2 June.

Additional data from the CAR T-naive cohort is expected as more patients become evaluable, alongside enrolment updates for the BTKi combination arm. These milestones will be critical in validating azer-cel’s efficacy and informing potential regulatory pathways.

Financially, Imugene continues to manage its cash position carefully. Despite the recent capital raise, the company’s estimated funding runway is under two quarters, prompting ongoing efforts to optimise R&D spending and explore further financing options. The recent redemption and replacement of convertible notes with zero-coupon senior notes and issuance of warrants also reflect strategic debt management.

Imugene’s clinical progress, combined with its capital management and upcoming ASCO exposure, positions it at a pivotal juncture. However, the small patient numbers and early-stage data mean that the durability of responses and longer-term safety remain open questions. The success of the BTKi combination arm and the company’s ability to secure further funding will be key factors to watch in the coming months.

These developments build on the company’s earlier $20M capital raise and confirm its strategy to prioritise azer-cel’s clinical advancement following encouraging 100% response in CLL/SLL results.