September 24, 2017 12:44 PM ET

Biotechnology

Company Overview of AdAlta Limited

Company Overview

AdAlta Limited develops biological drugs for the treatment of underserved chronic diseases. The company focuses on developing its lead i-body drug candidate, AD-114, for the treatment of idiopathic pulmonary fibrosis and other fibrotic diseases. AdAlta Limited was incorporated in 2006 and is based in Melbourne, Australia.

Level 14

330 Collins Street

Melbourne, VIC 3083

Australia

Founded in 2006

Phone:

61 3 9479 5159

Key Executives for AdAlta Limited

CEO, MD & Executive Director
Total Annual Compensation: A$218.1K
Compensation as of Fiscal Year 2017.

AdAlta Limited Key Developments

Adalta Limited Announces Additional, Positive Safety Data of AD-114 in Non-Human Primates

AdAlta Limited announced the results of its third pre-clinical, safety study in non-human primates, to support the package of preclinical information required by potential pharmaceutical partners. The ascending, repeat-dose study examined the safety and pharmacokinetic activity of AdAlta's lead program, AD-114, when delivered daily for a period of seven days through subcutaneous and intravenous routes at multiple dose levels. Dosing was well tolerated at each of the levels with no study mortalities or adverse effects relating to AD-114.

AdAlta Limited Announces Consolidated Earnings Results for the Year Ended June 30, 2017

AdAlta Limited announced consolidated earnings results for the year ended June 30, 2017. For the full year, the company reported loss before income tax expense was AUD 2,832,517 against AUD 1,163,056 a year ago. Loss after income tax for the year was AUD 2,832,517 against AUD 1,163,056 a year ago. Net cash used in operating activities was AUD 3,726,823 against AUD 1,174,360 a year ago. Payments for property, plant and equipment was AUD 6,745. Payments for other assets were AUD 2,600. Basic loss per share was 3.15 cents against 32.59 cents a year ago. Revenue from ordinary activities was AUD 1,967,680 against AUD 746,948 a year ago.

AdAlta Limited Announces Results of Two Pre-Clinical

AdAlta Limited announced the results of two pre-clinical, non-human primate studies evaluating half-life and safety as well as an update on manufacturing progress. Significant progress has been made with the completion of a number of pre-clinical toxicology studies, core to AdAlta's human trials of AD-114. The Company's first non-human primate study, reviewing the pharmacokinetic activity of the i-body when delivered via two routes of administration, subcutaneous (SC) and intravenous (IV), has been completed ahead of time. The primary focus of the single dose study was to further understand the pharmacokinetics, or the way AD-114 is processed in the body via the different routes of administration. Preliminary clinical pathology safety readouts were also obtained. These measurements all demonstrated that the i-body was safe when dosed via either route. Preliminary data from a second non-human primate safety study has been received, also ahead of time. The second study was designed to find an appropriate dose range for the i-body when used in AdAlta's planned Phase I human clinical trial. This study evaluated three ascending doses of AD-114, measuring several safety parameters, including various hematology /blood evaluation readouts. The pharmacokinetic profile and receptor occupancy of AD-114 were also evaluated at the increasing doses. The drug was well tolerated and there were no adverse effects with increased doses of the i-body in non-human primates. Furthermore, no study mortalities or clinical signs relating to the increasing doses of AD-114 were observed.

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