AdAlta Limited provided an update on its lead program, AD-214, a first in class antifibrotic. AdAlta has made substantial progress expanding the potential disease areas (indications) and routes of delivery for AD-214. Considering available manufacturing and toxicology study slots and return on investment, AdAlta is now progressing four strategic priorities for AD-214.

Prioritise clinical development of AD-214 for lung, kidney and eye fibrosis. Pre-clinical data and partnering discussions over the next six months to guide final choice of indication for next clinical trial. Progress injectable (intravenous/IV for lung, kidney fibrosis and intravitreal/IVT for eye fibrosis) routes of administration.

Continue investment in manufacturing and formulation improvement strategies. Leverage progress in the development of an inhaled format of AD-214 for partnering for lung fibrosis. Several disease area opportunities - all with unmet need: To prioritise indications and routes of administration, AdAlta considered the unmet needs in each disease area and the competitive landscape.

Also considered was the data, available or pending, supporting use of AD-214 in each indication, and the time and cost to progress each indication and route of administration to clinical proof of concept. AdAlta has compelling pre-clinical data using the IV version of AD-214 in lung and kidney fibrosis. Like lung fibrosis, kidney fibrosis is an area of high unmet need with a less competitive landscape.

Progress to Phase II proof of concept studies using the IV version is underpinned by previously completed Phase I studies and encouraging progress made identifying opportunities to increase manufacturing yields and reduce liver clearance. Intravitreal (IVT) AD-214 could address an attractive, very underserved market in eye fibrosis with significant early stage partnering interest and a more favourable competitive landscape. Previous encouraging pre-clinical studies using the earlier version of the product, AD-114, are being replicated and extended using AD-214, with results due in the next six months.

IVT AD-214 (intravitreal) could be progressed separately to IV AD-214 (intravenous) through engagement with partners, or by AdAlta directly. It has the potential to achieve clinical proof of concept via Phase I studies. Recent collaboration with GPCR Therapeutics for oncology Oncology is now the largest therapeutic market globally.

The application of CXCR4 antagonists such as AD-214 to treat cancer is attracting significant interest. The recently announced collaboration with GPCR Therapeutics Inc. represents a cost-effective way for AdAlta to progress an oncology pipeline. Inhaled AD-214 - valuable data package for potential partners: AdAlta has now demonstrated the delivery of AD-214 via inhalation and the potential to reduce collagen deposition in cultured lung tissue.

The additional time and cost to complete preclinical development and safety studies for IPF, coupled with the competitive clinical trial landscape has led the Company to focus resources on injectable formats and make the inhalation program available to lung fibrosis partners to progress. Next steps: AD-214 milestones in the next six months now include: Commencement of manufacturing of AD-214 for extended-dose toxicology studies; Additional pre-clinical results in eye and kidney fibrosis; Further details on clinical program indication and design; Continuation of partnering outreach for IV AD-214 in lung and kidney fibrosis.