Imugene Limited reports a narrower half-year loss as it advances its promising azer-cel CAR T therapy with strong clinical results and FDA backing, supported by a $25 million capital raise.
- Net loss reduced by 22% to $37.8 million
- Azer-cel Phase 1b trial shows 82% overall response rate in tough lymphoma cases
- FDA validates key azer-cel trial design and regulatory pathway
- Expanded trial cohort to CAR T-naïve lymphoma patients with 83% early response
- Raised $25 million through institutional placement and share purchase plan
Financial Performance and Cost Management
Imugene Limited has reported a reduced net loss of $37.82 million for the half-year ended 31 December 2025, down 22% from the previous corresponding period. This improvement is largely attributed to significant cost-cutting measures, including halving its employee headcount to around 15 and scaling back clinical trial and research expenditures across most of its pipeline programs. Despite these savings, the company faced increased amortisation charges and milestone payments related to its azer-cel program.
Clinical Advances with Azer-cel CAR T Therapy
At the heart of Imugene’s progress is its azer-cel allogeneic CD19 CAR T cell therapy targeting relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The Phase 1b trial has delivered an impressive 82% overall response rate, including seven complete and seven partial responses among heavily pre-treated patients. Notably, the first patient dosed in 2024 remains cancer-free after more than 22 months, underscoring the therapy’s potential durability.
Building on this momentum, Imugene expanded the trial to include CAR T-naïve patients, those who have not previously received CAR T therapy, across several rare lymphoma subtypes. Early data from this cohort shows an encouraging 83% response rate, suggesting azer-cel’s broader applicability and supporting a faster, more cost-effective regulatory pathway.
Regulatory Validation and Strategic Collaborations
Imugene secured a positive outcome from a recent FDA meeting, which endorsed critical elements of the azer-cel development strategy. The FDA agreed on the dosing regimen, patient population, and clinical endpoints, paving the way for a pivotal trial. This regulatory alignment is a significant milestone, reducing uncertainty and enhancing the program’s attractiveness to investors and partners.
In parallel, Imugene entered a strategic collaboration with JW Therapeutics to advance its onCARlytics oncolytic virus program. This partnership aims to combine Imugene’s virus platform with JW’s CAR T therapy infrastructure to target difficult solid tumours, potentially opening new therapeutic avenues while reducing Imugene’s capital expenditure.
Capital Raising and Financial Position
To support its clinical programs and extend its operational runway, Imugene successfully raised approximately $25 million through an institutional placement and a share purchase plan. The company also amended $2.5 million of its convertible notes to improve cash flow management. Despite these efforts, cash reserves declined to $14.1 million as at 31 December 2025, reflecting ongoing investment in R&D.
While the company acknowledges material uncertainty regarding its going concern status due to cash burn and reliance on future capital raises, management remains confident in meeting obligations through cost controls and planned fundraising.
Leadership and Outlook
During the period, Chief Operating Officer Dr Bradley Glover stepped down, with the company assuring no disruption to ongoing operations. Looking ahead, Imugene plans further FDA interactions and clinical updates later in the year, with a clear focus on advancing azer-cel toward pivotal trials and leveraging partnerships to maximise its pipeline’s value.
Bottom Line?
Imugene’s clinical progress and FDA validation mark a pivotal phase, but sustaining momentum hinges on successful capital raises and trial outcomes.
Questions in the middle?
- Will Imugene secure additional funding to sustain its clinical programs beyond the next 12 months?
- How will the expanded CAR T-naïve trial cohort impact the timeline and regulatory strategy for azer-cel?
- What are the commercial prospects and timelines for the onCARlytics collaboration with JW Therapeutics?