PEER-REVIEWED PUBLICATION SUPPORTS PPS AS A POTENTIAL DISEASE MODIFYING THERAPY FOR RRV-INDUCED ARTHRALGIA KEY HIGHLIGHTS

• Paradigm’s successful Phase 2A Ross River Virus clinical trial results have been peerreviewed and published online in the journal, BMC Musculoskeletal Disorders.

• The data show that iPPS is well tolerated and showed improvements in joint symptoms and the objective measures of hand grip strength and disease biomarkers in subjects with Ross River Virus-induced arthritis.

• The potential for disease modification is demonstrated by statistically significant reductions in cartilage destruction enzymes in the iPPS group compared to the placebo group as measured by novel biomarkers, including COMP and CTX-II.

• Findings support continued evaluation of PPS as a disease modifying therapy for the improvement of RRV-induced arthralgia and other viral arthralgias.

• Currently no vaccine is available to protect against RRV infection nor is there specific treatment to reduce the duration of symptoms or alter the course of the disease1 .

• • Australian infectious disease physicians will be able to provide iPPS through the TGA Special Access Scheme (SAS) for patients with chronic RRV-induced arthritis where there are no other treatment options. Access will be available in Q2 CY 2021 as a payfor-use program, providing a path to first revenues for Paradigm.

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

• Pain reduction in 89 SAS 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 a very consistent reduction in pain of nearly 50%.

• The cumulative patient data collected includes new data on 13 patients and previously reported data on 76 patients.

• The upcoming Phase 3 clinical trial (PARA-002) primary endpoint 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 patients in; night-time pain (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.

PARADIGM RECEIVES POSITIVE FEEDBACK FROM FDA TYPE C MEETING

Paradigm Receives Written Response from Type-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 trial study participants in its OA Clinical Program. • Details of all clinical studies and study participant numbers will be presented at Paradigm’s Inaugural R&D Day.

• FDA provided guidance regarding the pivotal study design for Zilosul® and expectations for a future New Drug Application (NDA) submission.

PARADIGM (ASX: PAR) REPORTS: 65% PAIN REDUCTION IN OA PATIENTS TREATED UNDER THE US FDA EXPANDED ACCESS PROGRAM KEY HIGHLIGHTS •

65% mean reduction in WOMAC pain from baseline across total patient population (n=10) using WOMAC Pain Subscale.

• WOMAC pain results were reported at week 12 (day 81-83).

• All patients in the program reported meaningful improvementsin WOMAC Pain, Function and NRS pain (77.79% reduction).

• The WOMAC pain score which is a composite of 5 pain subgroups demonstrated pain reductions across patients in; pain walking on flat surface (61.6%), pain on stairs (57.6%), night pain (69.7%), pain sitting (61.6%) and pain standing (68.3%). • Patients in the EAP treated with Paradigm’s Phase 3 product was well tolerated with no serious Adverse Events (AE’s) reported.

• Expanded Access Program Results Presentation released.

• Paradigm has also released a Results Video which include testimonialsfrom patients who participated in this program. Paradigm Biopharmaceuticals Ltd (ASX: PAR) is pleased to announce a mean pain reduction of 65% at week 12 (Day 81-83), across the ten patients treated with Zilosul® under the FDA approved Expanded Access Program (EAP) in the US. 65% Reduction (from baseline) in WOMAC Pain “Oral NSAID treatment and potent oral opioids (such as oxycodone) reduced pain with similar effect ie of around a 30% reduction in the patients’ pain. In short, each of these medications helped reduce pain, with similar reported effects. The finding on average of 30% reduction in pain is very consistent with studies of many treatments for chronic pain1 ”. A review of many clinical studies (meta-analysis) using the WOMAC pain scale conclude “NSAIDs and opioids offer similar pain relief in OA patients of roughly 30% reduction from baseline2 ”.

Paradigm Biopharmaceuticals to be added to S&P/ASX 300 Index