Arovella Therapeutics Ltd is fully funded for Phase 1 clinical trials for its lead program ALA-101 after it secured firm commitments for a $20 million placement at $0.17 per share during the December quarter.
The company had a strong cash position of $11.8 million as of December 31, 2024, bringing the pro-forma cash balance to $30.6 million post-placement.
Funds raised will support Arovella’s first-in-human clinical trial for ALA-101, a CAR-iNKT cell therapy targeting CD19-positive blood cancers, as well as its solid tumour programs, including the CLDN18.2-CAR-iNKT therapy for gastric cancer, and its IL-12-TM armouring technology.
The placement was backed by a $15 million cornerstone investment from an Australian private investor, alongside contributions from institutional and sophisticated investors, including Pengana Capital Group.
Towards ALA-101 Phase 1 trial
It has been a busy few months for the company.
During the second quarter of FY25, Arovella established a Clinical Advisory Board (CAB) to optimise its trial design ahead of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA).
The board includes:
- Dr Salvatore Fiorenza, deputy director and Cell Therapy lead at Epworth Healthcare;
- Professor Sattva Neelapu, Professor and deputy chair at the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center; and
- Dr Debora Barton, a medical oncologist who is also a non-executive director at Arovella.
The CAB will provide expert clinical insight and strategic advice focusing on CD19-positive haematological malignancies (blood cancers), as Arovella looks to file its IND and start its first-in-human phase 1clinical trial for ALA-101.
The company has continued its engagement with key opinion leaders and progressed GMP manufacturing and non-clinical studies required for regulatory submission.
In the remainder of FY2025, Arovella aims to complete clinical batch manufacturing of ALA-101 and secure IND approval, paving the way for patient dosing and initial clinical data generation. The company also anticipates delivering proof-of-concept data for its solid tumour programs, expanding its iNKT platform.
With strong financial backing and a defined clinical roadmap, Arovella is well-positioned to advance its next-generation cell therapies towards key milestones in 2025.
Read more: Arovella Therapeutics fully funded to complete Phase 1 clinical trial for ALA-101
Grants show confidence
Arovella received A$3.3 million as part of its financial year 2024 Research and Development (R&D) Tax Incentive refund. The rebate follows an advanced overseas finding for eligible expenditures under the Australian Government’s R&D Tax Incentive program, which provides cash refunds of 43.5–48.5% on eligible R&D costs.
G-Rex® grant funding
During the quarter, Arovella also secured funding through the G-Rex® Grant Program, a US$20 million initiative backed by ScaleReady, Wilson Wolf, Bio-Techne® and CellReady™. The program aims to support the global cell and gene-modified cell therapy community.
Arovella has been awarded up to US$150,000 in equipment, consumables and consultation over 18 months. The company will use the grant to refine its clinical manufacturing process using G-Rex® closed-system bioreactors, which are widely employed in closed cell therapy manufacturing.
The data generated will contribute to optimising Arovella’s proprietary manufacturing processes and integrating improvements into additional programs.
MST Access research report on Arovella
In December, MST Access published a research report providing an in-depth analysis of Arovella Therapeutics, including its investment case, technologies and market potential.
The report can be accessed at: https://www.arovella.com/analyst-coverage.