AdAlta

DR TIM OLDHAM

CEO & MANAGING DIRECTOR

(ASX:1AD)

◾ Company Name: AdAlta ◾ Company ASX code: 1AD ◾ Key areas: Biotechnology, antibodies, i-body technology, fibrotic diseases, immuno-oncology ◾ Key Personnel: Dr Tim Oldham, CEO & Managing Director | Dr Claudia Gregorio-King, Vice President, Clinical Product Development | Dr Patrick James, Director Product and Platform Development. ◾ Locations: Victoria, Australia ◾ Market Cap as of 15/09/22: $16.02M ◾ 52 Week share price as of 15 September: $0.042 - $0.099 ◾ Company Website: adalta.com.au

COMPANY PROFILE

We have heard plenty about antibodies these past few years – but one Australian biotech company is going a step beyond in the fight against today’s most challenging and pervasive medical problems.

Antibodies are natural proteins that react when a foreign agent, such as a virus, enters the body. They bind to these invasive species, eliminate them, and strengthen the body’s response to future infections.

AdAlta is a clinical stage drug development company that uses its i-body technology to create new medicines to treat diseases unserved by traditional antibody technologies. This includes fibrotic diseases and cancers.

The novel technology, currently being used in clinical trials of AdAlta’s lead drug AD-214, is described as “producing next generation human protein therapeutics”.

“The i-body is a human protein scaffold, engineered to mimic the structure and binding properties of very small, ‘single domain’ antibodies, originally found in sharks,” says Dr Tim Oldham, AdAlta CEO and managing director.

“AdAlta’s engineering enables the i-bodies to engage and bind in unique ways with the particular target that is causing the disease.

“The result is a range of unique drug candidates capable of interacting with high selectivity, specificity and affinity with previously difficult to access targets such as G-protein coupled receptors (GPCRs), implicated in many serious diseases.”

Phase I clinical studies of Adalta’s lead asset, AD-214, for intravenous use in fibrotic diseases were successfully completed last year. The company is now developing a more patient-convenient and cost-effective inhaled version, specifically for Idiopathic Pulmonary Fibrosis (IPF).

“IPF is degenerative and fatal. It affects about five million people globally, and claims more lives annually than prostate cancer and almost as many as breast cancer,” Dr Oldham says. “It is an important market because IPF is life threatening: most patients survive less than four years from diagnosis, despite two currently available therapies generating about $3 billion per year in sales.”

In addition to IPF, AdAlta has also generated data in the areas of eye and kidney fibrosis, creating multiple potential partnership opportunities ahead of Phase II trials. It is soon to report new preclinical data across the three areas.

“It is clear that there is substantial interest in our first in class approach to fibrosis across all indications – lung, eye and kidney. Demonstrating efficacy across a range of fibrotic diseases positions AdAlta well to progress separate partnering discussions for each indication of AD-214 from mid FY2023.”

In cancer, AdAlta hopes to bring new hope to patients through collaborative partnerships in the field of cellular immunotherapy. One is with Carina Biotech, developing precision engineered, i-body enabled CAR-T cell therapies (immune cells engineered to be able to seek out and destroy cancer cells).

“Our collaboration with Carina has the potential to make breakthrough therapies available to a wider range of patients with solid cancers,” Dr Oldham says.

“Together, we have demonstrated that we can successfully create i-CAR-T cells for the first of up to five targets and we anticipate commencing work on additional targets in the coming year.”

Another collaboration is with GE Healthcare, to develop i-bodies as diagnostic imaging agents against Granzyme B, a biomarker of response to immuno-oncology drugs.

These recent collaboration successes enabled AdAlta to recently launch a business development campaign to identify additional partners who could benefit from, and potentially fund the application of i-bodies for additional uses in cellular immunotherapy programs.

KEY INVESTMENT HIGHLIGHTS

JUNE 14, 2022: European patent for lead program, AD-214 “CXCR4 binding molecules” granted, adding to existing protection in Australia, China, India, Singapore and US. JULY 4, 2022: Imminent report on significant new pre-clinical data for multiple fibrosis diseases for lead drug, AD-214. Outcomes inform next steps for manufacturing and partnering discussions. JULY 25, 2022: Immuno-oncology collaboration with Carina Biotech continues to build the first of five CAR-T cell targets, with a business development campaign launched to identify additional partners.