Paradigm expects to file its Investigational New Drug (IND) application with the FDA this quarter. The Company has begun the planning and start-up phase for Zilosul® and once the IND is open, study participants from the USA and Australia will be enrolled into Paradigm’s pivotal Phase 3 randomised double-blind, placebo controlled, multicentre, multinational clinical trial (PARA002). PARA002 will firstly determine the minimally effective dose and then investigate the safety and efficacy of Zilosul in subjects with osteoarthritis (Kellgren Lawrence Grade 2- 4). Paradigm is targeting enrolling the first patient for its clinical program in mid-2021. • PARA-008 is expected to achieve ethics approval and enroll the first patient in Q2 CY 2021. PARA-008 will evaluate key biomarkers in the blood and synovial fluid as indicators of the cartilage protective Mechanism of Action (MOA) of Zilosul® in patients with OA. This study will be conducted in Australia and will be a randomized, placebocontrolled study of n=60 subjects. Paradigm believes the results of this study will provide additional important data into the potential disease modifying effects of PPS and will support Paradigm’s submission to the TGA for Provisional Approval of Zilosul®. • Final WOMAC Pain and Function data for Paradigm’s Special Access Scheme (SAS) will be released this quarter. The final data for an additional 13 patients will bring the total data package to 89 patients who have had their clinical outcomes evaluated with the same WOMAC pain and function tools that will be the primary endpoint in Paradigm’s pivotal Phase 3 clinical trial. • MPS-I open label Phase 2 clinical trial will continue enrollment of up to 10 patients. Total patients enrolled will be dependent on patient’s ability to travel interstate to Adelaide to be treated at the Adelaide WCH. • The MPS-VI program continues to progress with Paradigm expecting during the current quarter to file a submission to the Brazilian Regulatory Authority, ANVISA. The Phase 2 double-blind placebo-controlled trial will evaluate PPS in MPS-VI patients who have residual pain and impaired functional symptoms associated with MPS-VI disease who have received ERT. This clinical trial will provide important comparator data of the effects of PPS on MPS-VI patients versus placebo. • Paradigm has received preliminary data in the research program investigating safety and efficacy of iPPS in a viral induced respiratory disease model. The company is working closely with the Menzies Health Institute researchers on this project and will conduct further experiments to gather additional information. The company will detail to the market once this data is available. • Phase 2A Viral Arthritis clinical trial manuscript is undergoing Peer Review and is expected to be published in early Q2, CY 2021.