APPENDIX 4C – MARCH 2017 QUARTER  Treatment of patients with...

APPENDIX 4C – MARCH 2017 QUARTER
 Treatment of patients with NOX66 commences
 Clinical-stage status achieved within 7 months of IPO
 Clinical strategy designed to deliver proof-of-concept data by end of 2017
 ‘Smarter’ form of idronoxil identified
 Non-oncology pipeline commences.

Noxopharm Ltd is pleased to release its Appendix 4C for the quarter ended 31st March, 2017. Since the release of the prior quarter results, the Company has:

 Embarked on a significant clinical trial program for its lead drug product, NOX66, embracing an eventual 7 Phase 1a, 1b and 2a clinical studies, the majority of which will be underway by mid-2017;
 Adopted a clinical trial strategy designed to deliver proof-of-concept data for NOX66 by end of 2017 and to have identified and implemented 1-2 registration studies by end of 2018;
 Commenced treatment of patients in the first of these clinical trials which focuses on using NOX66 to boost the efficacy of chemotherapy;
 Begun putting in place the necessary steps for large-scale production of NOX66;
 Made additional staff and contractor appointments to ensure that this expanding clinical trial program is fully resourced;
 Appointed a Director of Regulatory Affairs to prepare the Company for registration studies;
 Relocated to larger offices in response to growing infra-structure needs;
 Announced the identification of idronoxil-C as the active form of idronoxil delivered by NOX66 and lodged a provisional patent application covering this development;
 Developed and initiated a strategic R&D plan around idronoxil-C and its development into 2nd generation specific dosage formulations to complement NOX66. Studies in collaboration with Monash University and assisted by a Federal Government Grant;
 Commenced pre-clinical studies of NOX66 in the treatment of brain cancers (both primary and secondary) as a result of the breakthrough finding that NOX66 delivers idronoxil across the blood-brain barrier;
 Identified 2 first-in-class compounds that block the pathology of excitotoxicity associated with brain injury and embarked on a major collaboration with UNSW in the first of a non-oncology pipeline.

The Board remains pleased with the Company’s progress. The Company continues to execute its plans in accordance with the program set out in its Prospectus. Importantly, it should be noted that both its technology platforms and clinical programs are much further advanced than anticipated.

The Board also wants to emphasise that the current clinical trials program, while extensive, is both manageable and within budget: the clinical trials being undertaken generally involve modest patient numbers (10-40 patients), radiotherapy trials are of relatively short duration (3 months), and a number of the trials are Investigator Initiated Trials requiring minimal funding by the Company. Fully recruited, the current program would comprise approximately 170 patients. The proposed program of 7 clinical trials broadly covers the use of NOX66 in combination with chemotherapy or radiotherapy or both, and involves a range of different cancer types, maximizing the ability of the Company to identify the preferred routes to market. This is a deliberate strategy to allow the development of NOX66 to be condensed to a two-step process that anticipates seeing it in registration studies in 2019.

One of the unintended consequences of the NOX66 drug delivery platform has been the ease with which idronoxil is delivered across the blood-brain barrier. This in turn has opened the door to the delivery of isoflavonoid molecules across the blood-brain barrier for indications other than cancer. The excitotoxicity (stroke, concussion) project is the first of those opportunities to be taken up, with the Company excited by the opportunity. A second program involving isoflavonoid drugs targeting another component of neurodegenerative diseases is about to commence. Despite the undoubted commercial significance of these two programs, the Board nevertheless believes that it is more appropriate that Noxopharm focus on its oncology assets given their nearer term commercial potential and currently is reviewing ways to monetize the value of these non-oncology assets.