3rd February2021

Patients under the TGA SAS program with OA knee pain continue to experience consistentpain reduction and improvement in function.

KEY HIGHLIGHTS

• Pain reduction in 89SAS patients (13 new patient data) being treated using the Phase 3 product (Zilosul®) are consistent with prior reports under TGA SAS.
• The chronic pain response as measured by the WOMAC pain score demonstrated a mean reduction of 49.6%.
• After 89 SAS treated patients, the pain reducing effects of Zilosul®,in subjects with knee OA as measured using the WOMAC pain score, shows avery consistent reduction in pain of nearly 50%.
• The cumulative patient data collected includes new data on 13patients and previously reported data on 76patients.
• The upcoming Phase 3 clinical trial (PARA-002) primary end point will assess change in WOMAC pain and WOMAC function from baseline.
• Paradigm previously reported data on the first 76 patients of this cohort, with the mean reduction being 47.3%(Refer announcement 1st October 2020).
• The WOMAC pain score which is a composite of 5 pain subgroups demonstrated pain reductions across patientsin; night-timepain (64.6%); sitting (57.6%), standing (52%), walking on flat surface (48%) and pain on stairs (41.5%).
• WOMAC reduction from baseline scores were observed at day 84 or week 12 after the first Zilosul®injection.
• PPS remains well tolerated across SAS and Paradigm’s other development programs.
• SAS program is expected to commence in Q3 CY2021 under pay-for-use program, once the first pivotal study has completed recruitment in Australia.

18th December 2020

Paradigm Receives Written Response fromType-C Meeting with FDA Regarding Development of Zilosul® for OA

KEY HIGHLIGHTS

• Paradigm has received written feedback from the Type-C meeting with the FDA and Paradigm confirms it will proceed to an Investigational New Drug(IND) submission in Q1 CY 2021.
• Paradigm confirms the same clinical trial protocol will be used in the USA, Europe and Australia potentially enabling registrations in multiple jurisdictions saving time and money.
• To achieve regulatory harmonization across the FDA and EMA, Paradigm will increase the proposed number of clinical trials tudy participants in its OA Clinical Program.
• Details of all clinical studies and study participant numbers will be presented at Paradigm’sInaugural R&D Day.
• FDA provided guidance regarding the pivotal study design for Zilosul® and expectations for a future New Drug Application (NDA) submission.