research reports and media, page-630

Apologies if someone else has posted this updated Bell Potter info.

16 April 2020Paradigm Biopharmaceuticals (PAR)iPPS Takes Another Step Forward

RecommendationBuy(unchanged)Price$1.77Valuation$2.79(previously $2.96)

BELL POTTER SECURITIESACTED AS LEAD MANAGER OF THE COMPANY'S 2019 CAPITAL RAISE FOR $78M AND APRIL 2020 CAPITALRAISE FOR $35MAND RECEIVED FEES FOR THAT SERVICE.Page 1(1m)(3m)(12m)Price (A$)2.123.101.86Absolute (%)-11.1-39.21.6Rel market (%)-13.9-18.413.6SpeculativeSee key risks on Page 9 and Biotechnology Risk Warning on Page 12. Speculative securities may not be suitable for Retail Clients.Regulatory Pathway Clearing

The recent market announcements and capital raise by PAR have provided significant clarity to numerous aspects of the company’s development pathway for Zilusol.In our view the most important aspect of the announcement was the FDA’s views on the unique characteristics of the iPPS molecule produced by BenePharma. Their product is the only product which may be used in the phase 3 clinical trials, notwithstanding that PPS is off patent and that iPPS is seeking to be repurposed. The agency recognises the unique moieties of the BenePharma molecule and as such, any competitor contemplating a future generic is highly unlikely to be successful in the United States.Paradigm will now proceed with the submission of the IND later this calendar year followed by two phase 3 studiescommencing in 2021. The pivotal study will be conducted in the US and include 750 subjects while the confirmatory study of 400 subjects is likely to run in Europe and possibly Australia. The two studies will run concurrently, costing ~$80m.The primary and secondary endpoints of the phase 3 studies will largely mimic the end points from the earlier phase IIb study. The inclusion criteria for the phase 3 study has been simplified to include knee osteoarthritis subjectswith Kellgren Lawrence scores of 2, 3 or 4. The previous reference to numerical rating score has been dropped, hence simplify the outcomes.Maintain Buy Rating PAR has completed a $35m capital raise to fully fund the clinical program over the next30 months. Headline results from the phase 3 are due to readout in 2H CY2022. Our price target is reduced by 6% reflecting the dilution. Changes to earnings reflect the higher than expected cost of the clinical program