Ann: Annual General Meeting Presentation, page-22

Some notes from the AGM. Focus is on the new or the most important information. Company will be releasing a video soonish.

Takeaways / key-points

• Bisantrene is something very, very special ... consistently clears AML ...
  • AML trial after trial after trial @ average ~ 50% complete response
    • drugs have been approved by FDA at 21% complete response!
  • unfortunately forgotten due to pharma mergers
• New strategy = 20-fold expansion in market opportunity
  • Attract much larger partnership deal or takeover deal
• Can get early readout (1-2 months after treatment) on MRD = valuable for early approval or partnering
• Much lower risk of 5-path strategy
• Newsflow tempo of 5-path strategy
• Fast clinical outcomes from trials at much lower cost (trials focus in Australia), significant tax credits
• Volumes of Phase II and Phase III data will assist with approval

$1.7M cash (enough t0 get strategy started)

Robust commercial protection

• Original patents had long expired so a new patent position was created (for use in AML, in other cancers and in combination)
• Once product is approved by FDA, RACE gets 7 years exclusivity (effectively as good as a patent)
• Expecting more patents from new strategy

Rare Paediatric Disease Designation

• Paediatric AML only 700 patients per year in US
• Incentive or “Golden Ticket” via Priority Review Voucher (for drug companies to develop drugs for rare diseases)
  • Voucher grants 6-month accelerated review by FDA
  • Can be sold to other companies ( USD $75M to $150M )

Current path for AML is 7+3 induction chemotherapy plus stem cell transplant (requires a bone marrow transplant)

• Some patients aren’t well enough or fit for this treatment
• Treatment is not successful for everyone and some will relapse

Daniel Tillett (CSO)

• Background in biotech
• Due diligence systematically on every biotech company on the ASX
  • Saw this chart (below) … thought wow! Something special.
  • Consistently trial, after trial
  • Complete response = tumor cleared!
    • and in hard to treat relapse patients ... can actually cure
  • Amazing that a drug like this is not on the market
  • 2 french girls, went through many relapses, very, very ill and now still survive decades later after Bisantrene and bone marrow transplant

MRD Opportunity

• Bisantrene potentially the answer to remove residual cancer before Bone Marrow Transplant and significantly improve chances of survival
• Key opinion leaders very, very excited (could be major change for AML)
• 502 (b)(2) path allows historic data to back up case for accelerated approval ( reduced risk & time/effort )
• MRD can be measured ~ 1 month after treatment ( know early in treatment )
• can do multiple cycles (patients can tolerate Bisantrene)

Bisantrene combinations

• can decide in-vitro (in lab) which drugs Bisantrene works well with (can find synergy with other drugs in the market), potentially new treatment regimes
  • can explore this potential in other cancers

Path 1 - MRD

• Can use Phase II background data, don’t need to do Phase I trials (saves lots of time)
• Phase II approach to save money
• FDA now also approving drugs based on Phase II data (relatively small trials)
  • Know MRD status within 1-2 mths of Bisantrene treatment
  • Anything above a 10% improvement in survival generally approved
  • FDA assesses safety based on Phase II data

Path 2 – Adult R/R AML

• Relatively small trial (proof of concept to excite a partner)

Path 3 – Paediatric AML trial

• Lack of cardiotoxicity critical for children (Bisantrene doesn’t cause lifelong damage, Paediatricians excited by this)

Bisantrene stacks up very well against major chemo drug Doxorubicin (Bisantrane has lower cardiotoxicity).

Path 4 – Breast Cancer

• The Blue Sky
• Some breast cancers are well-treated and some breast-cancers not well-treated
• Big issue with current breast cancer treatment is cardiotoxicity (younger women)
• Even with wrong dose historically Bisantrene still worked!
• Attract a partner following trials

Path 5

• Low-cost in-vitro (in the lab)
• Attract a partner following trials

New strategy is much, much cheaper and faster and lower risk (5 shots on goal), any pathway alone could be a company-maker (no binary outcome)

ivosidenib suits only 8% of AML patients … sales US $300M per year …!


Bisantrene can be used on all AML cancers (not a targeted agent), hence much larger market