Kazia Therapeutics : presents GDC-0084 at EANO

ASX RELEASE

20 September 2019

GDC-0084 PHASE II STUDY IN GLIOBLASTOMA PRESENTED AT EANO

CONFERENCE; PROGRESS UPDATE AND OUTLOOK FOR GDC-0084 PROGRAM

Sydney, 20 September 2019 - Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to provide investors with a poster presentation concerning its ongoing phase II study of GDC-0084 in glioblastoma. The poster will be presented at the 14th Annual Meeting of the European Association of Neuro- Oncology (EANO), which is being held in Lyon, France from 19-22 September 2019. The poster will be presented by Professor Patrick Wen from Dana-Farber Cancer Institute, and Dr Jeremy Simpson from Kazia.

Kazia CEO, Dr James Garner, commented, "this is a 'study design' poster, describing our approach to the development of GDC-0084, which provides us with a powerful opportunity to engage with clinicians and potential partners. We expect to be able to share initial data from the study this November, which will be an exciting landmark for the GDC-0084 program. In the meantime, our participation in EANO helps to raise awareness of the study in advance of that initial data read-out."

The poster is available via:https://www.kaziatherapeutics.com/researchpipeline/gdc-0084.

Progress Update

The EANO poster is presented in the context of strong progress across the GDC-0084 clinical program:-

• As announced to ASX on 12 September 2019, the first part of the phase I study of GDC-0084 in DIPG at St Jude Children's Research Hospital (NCT03696355) has successfully completed, establishing a pediatric maximum tolerated dose of 27 mg/m2. The study has begun recruitment of an expansion cohort, designed to see initial indications of efficacy.
• The phase I study of GDC-0084 in combination with radiotherapy in patients with brain metastases at Memorial Sloan-Kettering Cancer Center is progressing well through start-up activities and is expected to begin recruitment in the fourth quarter of calendar 2019.
• The phase II study of GDC-0084 in patients with brain metastases run by the Alliance for Clinical Trials in Oncology (NCT03994796) has opened to recruitment on schedule

Board of Directors

Mr Iain Ross Chairman, Non-Executive Director

Mr Bryce Carmine Non-Executive Director

Mr Steven Coffey Non-Executive Director

Dr James Garner Chief Executive Officer, Managing Director

at 86 hospitals across the United States. The Alliance study is primarily funded by the US National Cancer Institute and examines GDC-0084 alongside Eli Lilly's abemaciclib and Roche / Genentech's entrectinib.

• As announced to ASX on 23 August 2019, the World Health Organisation (WHO) has selected 'paxalisib' as the provisional International Non-Proprietary Name (INN) for GDC-0084. Subject to final confirmation, this name will be formally adopted at the end of 2019 and Kazia will phase out public use of the GDC-0084 code number.

Outlook

The company has had an abstract accepted for presentation at the 24th Annual Meeting of the Society for Neuro-Oncology (SNO), which will take place in Phoenix, AZ from 20-24 November 2019. It is expected that initial data from the ongoing phase II study of GDC-0084 in glioblastoma will be presented at this meeting.

In addition, an abstract on Dana-Farber Cancer Center's trial of GDC-0084 in breast cancer brain metastases has been accepted to the San Antonio Breast Cancer Symposium. It will be presented by Dr Pablo Leone and colleagues in San Antonio, TX from 10-14 December 2019.

In parallel, several manuscripts relating to GDC-0084 have been submitted to academic journals, both by Kazia and by partners and collaborators, and Kazia looks forward to sharing these with investors in due course.

The company is in discussion with clinicians and potential collaborators regarding the strategy for further development of GDC-0084 in glioblastoma and expects to be in a position to report its plans by the end of calendar 2019. It is expected that the next step for GDC-0084 will be a pivotal study to seek marketing authorization from regulatory agencies such as the US FDA.

[ENDS]

About Kazia Therapeutics Limited

Kazia Therapeutics Limited (ASX: KZA, NASDAQ: KZIA) is an innovative oncology-focused biotechnology company, based in Sydney, Australia. Our pipeline includes two clinical-stage drug development candidates, and we are working to develop therapies across a range of oncology indications.

Our lead program is GDC-0084, a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to treat glioblastoma multiforme, the most common and most aggressive form of primary brain cancer in adults. Licensed from Genentech in late 2016, GDC- 0084 entered a phase II clinical trial in 2018. Initial safety data was released in May 2019, and further data is expected in 2H 2019. GDC-0084 was granted orphan designation for glioblastoma by the US FDA in February 2018.

TRX-E-002-1 (Cantrixil), is a third-generation benzopyran molecule with activity against cancer stem cells and is being developed to treat ovarian cancer. TRX-E-002-1 is currently undergoing a phase I clinical trial in Australia and the United States. Initial data was presented at the AACR annual conference in April 2019 and the study remains ongoing. Cantrixil was granted orphan designation for ovarian cancer by the US FDA in April 2015.