Imugene Ltd (ASX:IMU, OTC:IUGNF)’s September quarter was defined by accelerating clinical momentum in its lead CAR-T program, a disciplined portfolio refocus, and a bolstered balance sheet following a successful capital raise and an FY24 R&D tax refund.
81% overall response rate
Late in the period, the company reported an updated 81% overall response rate in its Phase 1b trial of azer-cel (azercabtagene zapreleucel) for relapsed/refractory DLBCL, with 13 of 16 patients responding, including seven complete responses and six partial responses.
Responses have tended to arrive early — typically within one to three months — and several have proven durable. One patient first treated with azer-cel plus IL-2 in 2024 remains cancer-free beyond 18 months, while others are maintaining outcomes beyond five, six and 15 months. Two responders progressed to allogeneic stem cell transplant, underscoring the potential for azer-cel to serve as a bridge to longer-term disease control.
The following schematic visualises best responses and durability across the cohort, highlighting multiple complete responses persisting well past 140–560 days.
US and Australian recruitment continues
Recruitment continued across 10 US and five Australian sites, and the protocol expanded to include CAR-T-naïve B-cell malignancies — an important commercial setting given access and manufacturing constraints with autologous therapies.
After quarter-end, Imugene disclosed early results from this expansion:
- among six evaluable, heavily pre-treated but CAR-T-naïve patients, overall response rate was 83% with a 50% complete response rate;
- 10 patients have now been treated across DLBCL, FL, CLL/SLL, MZL, WM and PCNSL.
The following figure summarises these best responses and their emerging durability, and the company noted faster enrolment than in the CAR-T-relapsed DLBCL cohort, supporting a potentially accelerated path.
Milestone concentration
Strategically, management is channelling investment toward programs with nearer-term clinical and commercial milestones.
In practice, that means prioritising azer-cel while exploring partnerships or other external pathways for the CF33 oncolytic virotherapy and onCARlytics assets. Internal spend on these programs will be moderated while options such as out-licensing or joint ventures are assessed.
Runway strengthens
Financially, Imugene strengthened its runway. The company raised A$24.9 million via a A$22.5 million institutional placement and a A$2.42 million share purchase plan, both at A$0.33 per share, with attaching listed options (A$0.43 exercise, March 30, 2026) and a “piggyback” option feature (A$0.86 exercise, June 30, 2028).
In July it also received a A$5.87 million R&D tax refund (including A$85,000 interest) under Australia’s R&D incentive scheme. Quarter-end cash was A$32.4 million.
Net operating cash outflow was A$12.57 million, a 3% improvement quarter-on-quarter, with direct R&D representing 77% of operating costs.
Cost discipline is evident: staff payments fell 10% quarter-on-quarter and 47% year-on-year, while corporate and administration costs rose 21% versus the June quarter due to share consolidation and capital-raising activity but remained 33% lower than the prior-year period. Management estimates funding through to mid-2027 and flagged intent to initiate a pivotal azer-cel trial in calendar 2026.
Overall, the quarter advanced the clinical case for an allogeneic, off-the-shelf CD19 CAR-T, tightened portfolio focus around nearer-term value catalysts, and left Imugene better funded to pursue a pivotal study while seeking partners for non-core assets.