AdAlta

Webinars

Updates

Home

Why Invest

Announcements

Lora

upload.jpg

Special report: AdAlta has released its Q2 FY25 report with the developer of next-generation protein and cell therapeutic products saying the quarter focused on increasing bench strength with two new board members and additional advisors engaged.

AdAlta (ASX:1AD) said the enhanced leadership team would 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.

The East to West cellular immunotherapy strategy is part of AdAlta’s push to gain a strong foothold in the rapidly growing market of cellular immunotherapies – living drugs based on engineered human cells – which are working to transform outcomes in blood cancer.

The company said during 2024, the US Food and Drug Administration approved the first T-cell immunotherapies for solid cancers, opening the door to a larger market.

In October 2024, AdAlta inked its first non-binding term sheet with a Chinese company for a CAR-T cell therapy product that has demonstrated safety and potential efficacy in small clinical trials in advanced gastric cancers along with potential in treating other gastrointestinal cancers.

AdAlta said Asia, particularly China, was leading innovation in the field with 40% of companies and 60% of trials in the field. 1AD is aiming to be a conduit for these products to western regulated markets with its East to West strategy providing a pathway for clinic-ready assets in the region.

By licensing or acquiring global (outside Asia) commercialisation rights to these products in return for conducting initial clinical trials for western-regulated markets in Australia, AdAlta said it could add significant value to these assets for both itself and its licensing partners.

The company believes with its world-class, FDA- and EMA-recognised immunotherapy research, manufacturing, and clinical trial capabilities, it can offers a cost-effective gateway for these Asian companies to access the West.

AdAlta maintains an active deal pipeline with more than 10 products being actively monitored.

The company anticipates executing additional non-binding term sheets during Q3 FY25.

AdAlta’s lead product, AD-214, is a first in class, next generation antibody therapeutic for the treatment of fibrotic diseases including lung fibrosis (specifically Idiopathic Pulmonary Fibrosis (IPF) and Interstitial Lung Disease (ILD)) and kidney fibrosis.

The company said it continued to maintain an active pipeline of potential investors and licensing partners for AD-214 to finance progression of the drug into phase II clinical studies in IPF or kidney fibrosis and development of a patient preferred subcutaneous format.

AdAlta said each of the potential partnerships currently being explored were all advancing at different paces and with different structures.

“The value large pharma companies place on novel fibrosis assets was further reinforced by the announcement on 10 January 2025 that Eli Lilly would pay Mediar Therapeutics US$99 million in upfront and near-term payments and up to US$687 million for IPF asset MTX-463 that is, like AD-214, poised to enter Phase II clinical trials,” AdAlta said.

In October 2024, AdAlta announced the appointment of Dr Kevin Lynch MD as consultant CMO supporting the company’s cell therapy strategy.

AdAlta said Lynch had more than 25 years’ clinical development experience in oncology and haematology across multiple markets when combined with his networks will support the company’s asset selection and associated execution strategies.

During the quarter AdAlta also appointed leading IPF clinicians Professors Tamera Corte, Toby Maher, Philip Molyneaux, and Marlies Wijsenbeek-Lourens to join existing Scientific Advisory Board member Dr Steve Felstead on a new AD-214 Clinical Advisory Board.

IPF researcher Professor Gisli Jenkins will also join AdAlta as a translational science advisor.

A US-based consultant CMO for AD-214 is also joining AdAlta in 2025, bringing more than 30 years’ experience as a board-certified and practicing pulmonary physician.

AdAlta said the consultant has extensive clinical development, regulatory and medical affairs experience, including leadership roles supporting approval, post-approval and indication extension for both currently marketed drugs for IPF.

New Life Sciences LLC made a second investment of $580,000 following an institutional investment agreement inked in April 2024.

AdAlta said in November more than 25 million shares were issued to the Meurs Group under a similar investment agreement.

AdAlta said NLSC could make a third investment of up to $700,000 before May 7 2025, with a fourth only made by mutual agreement before this date.

Q2 FY25 saw net operating cash inflows of ~$569,000, comprising $1.77m inflows from the R&D Tax Incentive rebate in respect of FY24 and normal operating outflows of ~$1.205m, which were lower than the prior quarter.

AdAlta said operating cash outflows for Q2 FY25 included a continued reduction in R&D development expenditure and increased business development and due diligence costs.

The company said future cash requirements were anticipated to continue to decline until potential transactions in respect of  AD-214 and the East to West cellular immunotherapy strategy become reality.

During the quarter the company repaid in full the $1.4 million balance of the Victorian Government R&D cash flow loan facility.

The cash balance at the end of the December 2024 quarter was $1.63m, down from $1.91 million at the end of the previous quarter.

CEO and managing director Dr Tim Oldham said Q2 FY25 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,” he said.

“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. “

AdAlta boosts leadership in Q2 FY25 to support growth strategy