Pre-Quotation Enclosure - Top 20 and Other Documents, page-11

Race Oncology Ltd (RAC) – Rediscovering ‘Bisantrene’ Anti-Cancer Drug

Company Snapshot
Shares on Issue: 52,687,501
Cash at listing: ~$4M


Company Summary

• RAC (formerly Coronado Resources Ltd which acquired 100% of the IP of Update Pharma Inc) will acquire patents for an anti-cancer drug called Bisantrene (the patents were acquired by Update Pharma Inc in 2014 and are valid until 2033)
• Bisantrene was lost in a series of big pharma mergers during the 1990’s and essentially forgotten until its recent discovery by the founders of Update Pharma
• Bisantrene is an anti-cancer drug used in chemotherapy, the highlights being:

o ~$200M already spent on the development of the drug in the 1980’s
o Over 44 clinical studies completed covering more than 2000 patients
o Was shown to possess a tolerable safety profile and useful therapeutic efficacy in several cancers, notably Acute Myeloid Leukaemia (AML)
o Approved for marketing in France for the treatment of AML in 1990
o Phase 2 ready upon the completion of a bridging study
o Holds ‘Orphan Drug Designation’ status

• RAC has established a ‘Freedom to Operate’ on Bisantrene and has filed patents over ‘Use, Formulation and manufacturing’ providing a robust commercial exclusivity
• Potential for larger medium-term sales from a clinical development program in the US, aimed at a general marketing approval for AML and other cancers plus the potential for early revenue under a paid Named Patient Program (NPP) in Europe

How it Works – Not a New Drug

• Bisantrene was first discovered by the pharmaceutical company Lederle (a division of American Cyanamid) in the 1980s
• Bisantrene is an anti-cancer drug similar to the widely used anthracyclines which are the largest selling and frontline chemotherapy drugs worldwide – it has a similar pattern of clinical activity to anthracyclines but lacks the serious side effect of Cardiac Toxicity, providing a greatly improved safety profile and is also less prone to drug-resistance
• It provides for a currently unmet and last line treatment option for patients who have developed anthracycline resistance or reached their dosage threshold

Market Size: AML – Named Patient Program

• AML is a deadly cancer for which there is no effective treatment available on the market
• Bisantrene has been in 5 Phase 2 trials for AML and demonstrated around 50% Complete Response rates in patients that have failed all other therapies and was approved in France for the treatment of AML
• RAC intends to commence its Named Patient Program (NPP) for AML treatment in France and other European markets initially, and then expand into the treatment of other cancers
• The NPP is projected to generate up to $50M in total revenues over 5 years (treatment per patient ~$40k), commencing within 18 months from listing