AdAlta Limited reported a $2.44 million loss for H1 FY26 while progressing a key CAR-T therapy collaboration and raising $2.8 million in capital. The company’s ‘East to West’ immunotherapy strategy gains momentum with regulatory tailwinds and cost efficiencies.
- Half-year loss narrowed slightly to $2.44 million
- Entered collaboration with Shanghai Cell Therapy Group for CAR-T therapy BZDS1901
- Raised $2.8 million in placements during the period
- Reduced operating costs by 31% through cost management
- Received R&D tax incentives and FDA manufacturing flexibility supports pipeline
Financial Performance and Strategic Progress
AdAlta Limited has reported a half-year loss of $2.44 million for the six months ending 31 December 2025, a modest improvement from the $2.58 million loss recorded in the previous corresponding period. Despite the ongoing losses, the company has made significant strides in advancing its clinical-stage biotechnology programs and strengthening its financial position.
The company’s revenues from ordinary activities declined slightly to $306,150, reflecting the early-stage nature of its operations. However, AdAlta has successfully reduced its quarterly cash operating costs by 31%, demonstrating disciplined cost management amid a challenging biotech funding environment.
‘East to West’ Cellular Immunotherapy Collaboration
A highlight of the period was the formal launch of AdAlta’s subsidiary AdCella Pty Ltd’s ‘East to West’ cellular immunotherapy strategy. This innovative approach integrates Asia’s advanced T cell therapy developments with Australia’s clinical and manufacturing capabilities to accelerate the development of novel CAR-T therapies for solid cancers.
Central to this strategy is the Development and Collaboration Agreement signed with Shanghai Cell Therapy Group Co Ltd (SHcell) to co-develop BZDS1901, a first-in-class PD1 armoured mesothelin-targeting CAR-T therapy. BZDS1901 has shown promising clinical responses in advanced mesothelioma patients, with response rates significantly exceeding current standards of care. The therapy’s rapid, low-cost, non-viral manufacturing process positions it well for scalability and commercialisation.
Capital Raising and Financial Position
During the half-year, AdAlta raised $2.8 million through placements, including $1.6 million at market pricing and a further $1.2 million raised post-period at a 67% premium. These funds support the ongoing development of the AdCella pipeline and milestone payments under the SHcell collaboration.
The company also received $0.93 million in R&D tax incentive refunds related to FY25, including a favourable Advance Overseas Finding for offshore CAR-T development expenses. This refund, combined with the repayment of a $0.47 million R&D loan facility and the completion of investment obligations, has improved the company’s balance sheet. As at 31 December 2025, AdAlta held cash reserves of $1.58 million.
Pipeline Assets and Regulatory Tailwinds
Beyond cellular immunotherapies, AdAlta continues to advance its proprietary i-body® technology assets. AD-214, targeting fibrotic diseases such as idiopathic pulmonary fibrosis and kidney fibrosis, is poised for out-licensing discussions to fund Phase 2 trials. WD-34, an i-body® candidate for malaria prophylaxis, remains in preclinical development with ongoing efforts to secure funding and partnerships.
Notably, recent US FDA regulatory updates easing manufacturing requirements for cell and gene therapies align well with AdCella’s scalable, automated manufacturing strategy. This regulatory flexibility is expected to reduce development costs and timelines, enhancing the commercial viability of AdAlta’s pipeline.
Outlook and Challenges
Looking ahead, AdAlta aims to secure additional third-party financing for AdCella, complete FDA pre-IND meetings, and progress clinical trials for BZDS1901. The company also continues to engage potential partners for its i-body® assets, although timing and outcomes remain uncertain.
While the group remains in a net liability position, management expresses confidence in its ability to continue as a going concern, supported by capital raising, collaborations, and R&D incentives. However, the path to commercial success will require navigating clinical, regulatory, and financing risks inherent in early-stage biotech development.
Bottom Line?
AdAlta’s strategic collaborations and capital raises underpin cautious optimism amid ongoing losses and execution risks.
Questions in the middle?
- How will AdAlta manage cash flow and financing needs as clinical programs advance?
- What are the timelines and milestones for BZDS1901’s FDA IND submission and Phase 1 trial?
- When might partnerships or licensing deals for AD-214 and WD-34 materialise?