Ann: GDC 0084 update, page-2

GDC-0084 PROGRESS UPDATE: PHASE II STUDY REMAINS ON TRACK TO START BY END OF 2017
AFTER FDA CONSULTATION

Sydney, 25 September 2017 – Novogen Ltd (ASX: NRT; NASDAQ: NVGN), an Australian oncology drug development company, is pleased to provide an update on progress with its clinical-stage drug development candidate, GDC-0084. GDC-0084 was in-licensed from Genentech, Inc in October 2016, after it had completed a phase I clinical trial in advanced glioma. Novogen is taking GDC-0084 into a phase II clinical trial in the treatment of glioblastoma multiforme (GBM).

Key Highlights

• Highly constructive meeting held with US Food and Drug Administration (FDA) on 21 September in relation to the proposed phase II clinical study of GDC-0084; key features of study design remain substantially as proposed
• Phase II study in adult GBM patients remains on track to launch before the end of 2017
• Independently of FDA feedback, study design has been refined to include a lead-in component which aims to optimize dosing in the target population, leading to an earlier preliminary data read-out approximately 12-15 months after commencement, and substantial de-risking of the overall program
• Letter of Intent (LOI) signed with Chiltern Oncology, a leading international contract research organization, as part of study initiation activity