Ann: Olivia Newton-John Cancer Reseach Institute collaboration, page-29

PharmAust LimitedSupplementary Appendix 4E informationFor the year ended 30 June 2018

MPL’s presumed anticancer activity and has provided PharmAust with full confidence to explore thispotential in more formal clinical studies.

The trial showed that:

• for the first time, inhibition of the mTOR signaling pathway is associated with anticancerefficacy in dogs with naturally occurring cancers,

• six out of seven dogs administered gelatin encapsulated MPL liquid achieved stable disease,

• six out of seven dogs administered gelatin encapsulated MPL liquid achieved reductions intumour size,

• stable disease and reductions in tumour size were accompanied by a high MPL safety profile,

• administration of MPL was associated with reductions in PharmAust’s identified tumourmarker,

• due to poor palatability and a relatively low permissible dose, it was confirmed that MPL liquidis not an ideal formula for effectively administering MPL to canines with cancer,

• reformulation is required to realise MPL’s full anticancer potential, and

• progression to formal Phase I and Phase II clinical trials using reformulated MPL is warranted.

Successful Tablet ReformulationIn May 2018 PharmAust announced that it had successfully reformulated monepantel into a tablet.This tablet will replace MPL liquid for use in the upcoming formal Phase I and Phase II clinical trials.

Incollaboration with BRI Pharmaceutical Research and AVISTA Pharma Solutions, PharmAust showedthat a micronised tablet-based formulation was superior to MPL liquid in delivering monepantel at highdoses suitable for taking into dose escalation clinical studies in canines

. Since this time, and in furthercollaboration with BRI Pharmaceutical Research and Catalent Inc., PharmAust has optimised the presentation of the tablet so that it is now suitable for taking into Phase II clinical trials and coating withtaste enhacers.

Finalisation of the Formal Canine Clinical Phase I and II ProtocolsPharmAust has completed development of its Phase I and Phase II clinical trial study protocol for theuse of MPL as an anticancer agent in canines with naturally occurring cancers.

PharmAust hasincluded the use of the new tablet in the study designs as well as identified cancer targets of interest,received ethics approvals from relevant authorities and recruited veterinarians willing to participate inthese trials.