Board renewal and recently assembled clinical advisory team enhance leadership capabilities as “East-to-West” strategy and AD-214 are progressed.
Key highlights
• Expanded advisor network engaged to support “East to West” cellular therapy strategy
• First non-binding term sheet executed for “East to West” cellular therapy strategy
• AD-214 partnering to be supported by new advisors, stronger execution capabilities and new data from continuous manufacturing improvement program
• New AdAlta Board members appointed, strategic review nearing completion
AdAlta Limited (ASX:1AD) (“AdAlta” or “the Company”), developer of next generation protein and cell therapeutic products, is pleased to announce its Appendix 4C cash flow report for the quarter ended 31 December 2024 (Q2 FY25), along with the following financial and operational update.
The quarter focussed on increasing the Company’s “bench strength” with two new Non-executive Directors appointed to the AdAlta Board and additional advisors engaged. This enhanced leadership team will bolster AdAlta’s ability to execute growth plans for both the Company’s “East to West” cellular immunotherapy strategy and AD-214, its first in class anti-fibrotic drug candidate.
At the same time, AdAlta executed its first non-binding term sheet to in-license its first cellular immunotherapy asset, and new data from the Company’s continuous manufacturing improvement program has meaningfully added to the AD-214 value proposition for partners.
The Company’s cash balance as at the end of December 2024 was $1.63 million (compared to the cash position at 30 September 2024 of $1.91 million). AdAlta repaid its Victorian Government R&D Cash Flow Loan Facility in full during Q2 FY25.
Reflecting on the quarter, AdAlta’s CEO and Managing Director, Dr Tim Oldham commented:
“The December 2024 quarter saw AdAlta successfully undertake Board renewal and assemble a world-class clinical advisory team. All the new appointees have joined to help realise the patient impact and upside potential in both our lead drug candidate AD-214 and the Company’s exciting “East to West” strategy. These highly qualified individuals enhance the Company’s ability to further progress its growth strategy.
“The clinical advisory team now includes two very well credentialled consultant Chief Medical Officers who will help AdAlta deliver on its oncology cell therapy and fibrosis strategies.. Board renewal adds additional positive momentum, with recently appointed Directors Michelle Burke and Iain Ross further strengthening our strategy and change capabilities. Collectively, all are already helping review and refine our strategy.
“The signing of our first non-binding term sheet to in-license an asset as part of our “East to West” cell therapy strategy was a crucial step in building this business. We are now focussing our efforts on securing additional term sheets to build our pipeline and validate the potential scalability of this exciting growth strategy.
“While AD-214 partnering is taking longer than we had hoped, we continue positive discussions with a number of new and continuing parties and are encouraged by the recent licensing of Mediar Therapeutic’s IPF candidate by Eli Lilly. Data generated during the December quarter showed the potential both for AD-214 to be formulated for subcutaneous administration and for our continuous manufacturing improvement strategies to further drive down cost of goods. This will support partnering discussions for this important drug candidate."
About us:
About AdAlta
AdAlta Limited is a clinical stage drug development company headquartered in Melbourne, Australia. The Company is using its proprietary i body® technology platform to solve challenging drug targeting problems and generate a promising new class of single domain antibody enabled protein and cell therapeutics with the potential to treat some of today’s most challenging medical conditions.
The i-body® technology mimics the shape and stability of a unique and versatile antigen binding domain that was discovered initially in sharks and then developed as a human protein. The result is a range of unique proteins capable of interacting with high selectivity, specificity and affinity with previously difficult to access targets such as G-protein coupled receptors (GPCRs) that are implicated in many serious diseases. i-bodies are the first fully human single domain antibody scaffold and the first based on the shark motif to reach clinical trials.
AdAlta’s lead i-body® enabled candidate is AD-214. At any time, 500,000 patients with lung fibrosis (IPF) face death from inability to breath, despite spending US$4.3 billion per year on pharmaceutical therapies. Fibrosis can affect all organ systems and around 45% of all western country deaths have a fibrotic disease component. AD-214 is taking a wholly new approach to treat IPF and other fibrotic diseases. AD-214 is a first in class (first to utilize this mode of action) molecule and has been shown to be safe in Phase I clinical studies and effective in multiple animal and laboratory models of fibrotic disease. In accord with its business model, AdAlta is creating a private, unlisted subsidiary called AdSolis to advance AD-214 into Phase II clinical trials through licensing and/or third party investment.
AdAlta believes that the i-body® technology is ideally suited for use in the creation of advanced cellular immunotherapies for cancer and that this field represents an opportunity to expand its clinical stage pipeline.It has entered a Memorandum of Understanding with SYNthesis BioVentures to investigate the formation of a jointly owned entity, to be called AdCella, that, once established, will provide innovative cellular immunotherapies originating in Asia with a pathway to western regulated markets via Australian clinical trials and further enhancement with AdAlta’s i-body® technology. It has appointed Cell Therapies Pty Ltd, Australia’s leading manufacturer of cell and gene therapies, as AdCella’s preferred manufacturer.
The Company is also entering collaborative partnerships to advance the development of its i-body® platform. It has a collaboration with Carina Biotech to codevelop precision engineered, i-body® enabled CAR-T cell therapies (i-CAR-T) to bring new hope to patients with cancer. It has an agreement with GE Healthcare to co-develop i-bodies as diagnostic imaging agents (i-PET imaging) against Granzyme B, a biomarker of response to immuno-oncology drugs, a program now in preclinical development.
AdAlta’s strategy is to maximise the products developed using its next generation i-body® platform by discovering and developing selected i-body® enabled product candidates against GPCRs implicated in fibrosis, inflammation and cancer; and partnering with other biopharmaceutical companies to develop product candidates against other classes of receptor, in other indications, and in other product formats.
To learn more please visit: www.adalta.com.au
Contact details:
AdAlta Limited (ASX:1AD)
Tim Oldham
CEO & Managing Director
+61 3 9479 5159
[email protected]
Media & Investor Enquiries
The Capital Network
Julia Maguire
+61 2 7257 7338
[email protected]
