Highlights
• Received FDA Orphan Drug Designation for AD-114 in IPF
• Positive Pre-clinical data showing AD-114 prevents fibrosis in a mouse model of liver fibrosis
• International biotech executive Dr Robert Peach joins the Board
• Commercialisation agreement with The Netherlands’s Crossbeta Biosciences to explore use of AdAlta’s technology as a treatment for Alzheimer’s disease
• Collaboration Agreement with Germany’s XL-Protein to extend the therapeutic action of AD-114
• Positive investor and pharma engagement at key International meetings
Summary of key developments
AdAlta continues to meet its commercial and development milestones and is making excellent progress towards its stated goal of initiating Phase I human clinical trials for its lead candidate AD-114 as a therapy for the unmet medical need of idiopathic pulmonary fibrosis (IPF), including securing Orphan Drug Designation from the FDA. The Company is also developing AD-114 for Non-alcoholic steatohepatitis (NASH), a pandemic, metabolic disease which has both inflammatory and fibrotic components.
Financial update
The Company remains in a solid cash position with about AU$8.77 million in cash in the bank at 31 December 2016. These funds are sufficient to continue to progress development of AdAlta’s lead candidate AD-114 to first human trials.
As expected, R&D expenditure for the quarter was AU$867K, representing an increase of 179% from AU$482K in the previous quarter. The Company expects this figure to remain at the current rate as a direct reflection of AdAlta’s manufacturing and preclinical activities and engagement with multiple suppliers who are helping lay the foundations for AdAlta’s clinical programs.
Aside from the rise in R&D expenditure, all other operating expenses remain the same as in previous quarters.
Personnel
In November US-based international biotechnology executive Dr Robert Peach joined the board as a non-executive director. Robert is a co-founder of Receptos Inc which is developing new drugs for autoimmune diseases. Receptos Inc was listed on NASDAQ before it was acquired by Celgene Corporation in 2015 for US$7.8 billion. AdAlta shareholders will benefit from his experience commercializing innovative new therapies for global markets.
Manufacturing and Operations? ?
During the quarter the Company announced two new agreements to license AdAlta’s proprietary technology, which further validate AdAlta’s technology. These agreements will help expand AdAlta’s clinical knowledge across a number of applications as well as deliver potential future royalties.
AdAlta’s agreement with the privately owned German company XL-Protein GmbH will extend the therapeutic action of our lead candidate AD-114 for idiopathic pulmonary fibrosis and other fibrotic and inflammatory diseases.
A commercialization agreement with Crossbeta Biosciences in The Netherlands is exploring use of AdAlta’s technology and its therapeutic and diagnostic potential as a treatment for Alzheimer’s disease and other neurodegenerative diseases. Importantly, AdAlta will receive royalties from commercially successful outcomes.
The formulation and manufacture of the Company’s lead i-body molecule by our partner FujiFilm Diosynth Biotechnologies in the United Kingdom is progressing to schedule to provide materials for our preclinical animal toxicology studies.
AdAlta continues to build a network of relationships with investors, collaborators and pharma through attendance at International meetings in Europe and the USA. Most recently, at Biotech Showcase in the US in January, there was interest from a number of companies.
Meeting our milestones
AdAlta continues to deliver on its projected development and commercial milestones.
International market interest in our valuable i-body technology platform continues to grow and we continue to attract commercially beneficial partnerships that validate our technology platform and its potential to address multiple medical needs caused by fibrosis.
The team is focused on delivery of clinical data that validates the safety and efficacy of the Company’s platform for idiopathic pulmonary fibrosis while simultaneously investigating its potential application in other major markets, including non-alcoholic steatohepatitis (NASH) and wet-AMD.
With the support of the Company’s shareholders, employees and partners, AdAlta is creating a commercially successful and growing enterprise.
The business is well positioned to continue to make clinical and commercial progress and AdAlta is grateful for the ongoing support of our shareholders.
