<SEC-DOCUMENT>0001193125-19-310666.txt : 20191211
<SEC-HEADER>0001193125-19-310666.hdr.sgml : 20191211
<ACCEPTANCE-DATETIME>20191211061118
ACCESSION NUMBER:		0001193125-19-310666
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20191211
FILED AS OF DATE:		20191211
DATE AS OF CHANGE:		20191211

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			KAZIA THERAPEUTICS LTD
		CENTRAL INDEX KEY:			0001075880
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		FISCAL YEAR END:			0630

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-29962
		FILM NUMBER:		191278891

	BUSINESS ADDRESS:	
		STREET 1:		LEVEL 5
		STREET 2:		20 GEORGE STREET
		CITY:			HORNSBY NSW
		STATE:			C3
		ZIP:			2077
		BUSINESS PHONE:		01161298780088

	MAIL ADDRESS:	
		STREET 1:		LEVEL 5
		STREET 2:		20 GEORGE STREET
		CITY:			HORNSBY NSW
		STATE:			C3
		ZIP:			2077

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	NOVOGEN LTD
		DATE OF NAME CHANGE:	19981228
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>d845316d6k.htm
<DESCRIPTION>FORM 6-K
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<HTML><HEAD>
<TITLE>Form 6-K</TITLE>
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<Center><DIV STYLE="width:8.25in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>Form 6-K
</B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF FOREIGN PRIVATE ISSUER </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO RULE 13a-16 OR 15d-16 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>For the month of December, 2019 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission File Number
<U>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</U> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>Kazia
Therapeutics Limited </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Translation of registrant&#146;s name into English) </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Three International Towers Level 24 300 Barangaroo Avenue Sydney NSW 2000 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of principal executive office) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether
the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">Form
20-F&nbsp;&nbsp;&#9745;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Form 40-F&nbsp;&nbsp; &#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark if
the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):&nbsp;&nbsp;&#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Note</B>: Regulation S-T Rule
101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by
check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):&nbsp;&nbsp;&#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Note</B>:
Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which
the registrant is incorporated, domiciled or legally organized (the registrant&#146;s &#147;home country&#148;), or under the rules of the home country exchange on which the registrant&#146;s securities are traded, as long as the report or other
document is not a press release, is not required to be and has not been distributed to the registrant&#146;s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on
EDGAR. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark if the registrant by furnishing the information contained in this form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934. Yes&nbsp;&nbsp;&#9744;&nbsp;&nbsp;&nbsp;&nbsp; No&nbsp;&nbsp;&#9745; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">If
&#147;yes&#148; is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b) </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURE </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Kazia Therapeutics Limited</B> <B></B>(Registrant) </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Kate Hill </U></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kate Hill </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Company Secretary </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Date 11&nbsp;December 2019 </P>
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<IMG SRC="g845316page3.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">ASX RELEASE </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">11&nbsp;December 2019 </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>KAZIA INITIATES
PREPARATORY ACTIVITIES TO BRING <FONT STYLE="white-space:nowrap">GDC-0084</FONT> INTO </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>GBM AGILE, AN INTERNATIONAL PHASE II / III
STUDY IN GLIOBLASTOMA </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Sydney, 11</B><B></B><B>&nbsp;December 2019</B> &#150; Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian
oncology-focused biotechnology company, is pleased to announce that it&#146;s lead program, <FONT STYLE="white-space:nowrap">GDC-0084,</FONT> has been selected to join GBM AGILE, an international,
<FONT STYLE="white-space:nowrap">academic-led,</FONT> multi-drug adaptive phase II / III study in glioblastoma. It is expected that data from GBM AGILE will be used to seek marketing approval for <FONT STYLE="white-space:nowrap">GDC-0084</FONT> from
FDA and other regulatory agencies. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Key Points </B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">GBM AGILE (NCT03970447) is an adaptive &#145;master protocol&#146; study, in which different drug candidates can
be tested for potential use in glioblastoma </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Study is designated phase II / III and data from it is considered acceptable for product registration purposes by
US FDA </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
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<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Kazia has entered into a preliminary agreement to commence planning and
<FONT STYLE="white-space:nowrap">set-up</FONT> activities for inclusion of <FONT STYLE="white-space:nowrap">GDC-0084</FONT> in GBM AGILE, with a view to commencing recruitment in Q2 / Q3 CY2020, subject to a definitive agreement
</P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Kazia plans to participate in GBM AGILE in place of a <FONT STYLE="white-space:nowrap">company-run</FONT>
registration study, and GBM AGILE will serve as the <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">path-to-market</FONT></FONT> for <FONT STYLE="white-space:nowrap">GDC-0084</FONT> </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Study is expected to recruit up to 200 patients into the <FONT STYLE="white-space:nowrap">GDC-0084</FONT> arm
</P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dr Timothy Cloughesy, GBM AGILE Global Principal Investigator, commented, &#147;we see an urgent need for new therapies in
glioblastoma, and GBM AGILE has been designed to provide an opportunity for industry to test new therapeutic agents in a cutting-edge, registration-level study, at considerably lower cost and in a faster time than would typically be possible for a
company-driven study. <FONT STYLE="white-space:nowrap">GDC-0084</FONT> has the potential to become an important treatment option for brain cancer, and this study is the best way to definitively determine its efficacy in this challenging
disease.&#148; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">GBM AGILE is sponsored and administered by the Global Coalition for Adaptive Research (GCAR), a
<FONT STYLE="white-space:nowrap">non-profit</FONT> organization which includes many of the world&#146;s leading scientists and clinicians in the field of brain cancer (www.gcaresearch.org). </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The study commenced recruitment of its first investigational arm in June 2019. GBM AGILE is designed as a
&#145;master protocol&#146; study, into which different drug candidates can be placed for testing against a common control arm. It is an &#145;adaptive study&#146;, utilizing Bayesian statistical techniques to dynamically adjust the number of
patients in a given arm according to emerging signals of activity. This minimizes redundant patient recruitment, saving cost and time. The primary endpoint is overall survival (OS), which is considered the &#145;gold standard&#146; for the approval
of new cancer therapies by FDA and other regulatory agencies. Participating drugs are first examined in a stage 1 (phase II) component, which then progresses seamlessly into a stage 2 (phase III) component once
<FONT STYLE="white-space:nowrap">pre-defined</FONT> efficacy hurdles are met. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dr James Garner, Kazia CEO, commented, &#147;GBM AGILE offers three
enormous advantages to Kazia. First, the highly innovative adaptive design allows us to test <FONT STYLE="white-space:nowrap">GDC-0084</FONT> in the fastest and most cost-effective way possible. Second, the considerable technical, scientific, and
operational capability in GCAR gives us access to resources that we could never hope to draw upon otherwise. Third, the quality of the study, and the caliber of the participating sites, means that <FONT STYLE="white-space:nowrap">GDC-0084</FONT>
will have the best possible opportunity to demonstrate its potential. No company our size could run a study like this single-handedly, so we have adopted GBM AGILE as our primary
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">path-to-market</FONT></FONT> strategy for <FONT STYLE="white-space:nowrap">GDC-0084.&#148;</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dr Garner was speaking from the inaugural International Glioblastoma Drug Development Summit in Boston, MA, where Kazia is an invited speaker. The Summit has
convened many of the leading researchers, clinicians, and industry participants in the field of glioblastoma to discuss new approaches to the development of novel therapies. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">GBM AGILE has the potential to test new drug candidates in several different patient subgroups. In addition to the newly-diagnosed unmethylated group, which
Kazia has already identified as the primary target population, the intent is to also test <FONT STYLE="white-space:nowrap">GDC-0084</FONT> in recurrent patients. The company may consider future use in newly-diagnosed methylated patients in
consultation with clinicians as further data becomes available. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia and GCAR have entered into a preliminary agreement to begin <FONT
STYLE="white-space:nowrap">set-up</FONT> work for inclusion of <FONT STYLE="white-space:nowrap">GDC-0084</FONT> in GBM AGILE, and it is expected that this work will take approximately four to six months. The proceeds of Kazia&#146;s recent
institutional financing round will be used to support these activities. Patient recruitment is expected to begin in Q2 / Q3 CY2020, and will be contingent upon execution of a definitive agreement between the parties. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dr Meredith Buxton, COO of GCAR, added, &#147;the future of drug development requires new approaches, particularly in challenging diseases such as
glioblastoma. GBM AGILE is scientifically rigorous, highly efficient, and statistically innovative, and has been designed to provide the best possible platform to generate new treatment options for patients. We look forward to working with the Kazia
team to bring <FONT STYLE="white-space:nowrap">GDC-0084</FONT> into the study as swiftly as possible.&#148; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">[ENDS] </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Kazia Therapeutics Limited </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Our lead program is <FONT
STYLE="white-space:nowrap">GDC-0084,</FONT> a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to treat glioblastoma, the most common and most aggressive form of primary brain cancer in adults. Licensed from
Genentech in late 2016, <FONT STYLE="white-space:nowrap">GDC-0084</FONT> entered a phase II clinical trial in 2018. Interim data was reported in November 2019, and further data is expected in 1H 2020. <FONT STYLE="white-space:nowrap">GDC-0084</FONT>
was granted orphan designation for glioblastoma by the US FDA in February 2018. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">TRX-E-002-1</FONT></FONT></FONT> (Cantrixil), is a third-generation benzopyran molecule with activity against cancer stem cells and is being developed to treat ovarian cancer. <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">TRX-E-002-1</FONT></FONT></FONT> is currently undergoing a phase I clinical trial in Australia and the United States. Interim data was presented at the ESMO Congress in September 2019, and
the study remains ongoing. Cantrixil was granted orphan designation for ovarian cancer by the US FDA in April 2015. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This announcement was authorized for
release to the ASX by James Garner, Chief Executive Officer, Managing Director. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This announcement contains forward-looking statements. Forward-looking
statements (as defined under Private Securities Litigation Reform Act of 1995) are not guarantees, and they involve risks, uncertainties and assumptions. Although we make such statements based on assumptions that we believe to be reasonable, there
can be no assurance that actual results will not differ materially from those expressed in the forward-looking statements. We caution investors not to rely unduly on any forward-looking statements and urge you to carefully consider the risks
described in our previous filings. We expressly disclaim any obligation to update any forward-looking statement in the event it later turns out to be inaccurate, whether as a result of new information, future events or otherwise. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Q&amp;A </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>In addition to GBM AGILE, will Kazia also conduct its own registration study for <FONT STYLE="white-space:nowrap">GDC-0084,</FONT> as previously described
to the market? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">No. Our anticipated participation in GBM AGILE represents a change in strategy for the <FONT STYLE="white-space:nowrap">GDC-0084</FONT>
program. Kazia&#146;s original intent had been to execute a pivotal study of its own to seek registration for <FONT STYLE="white-space:nowrap">GDC-0084.</FONT> That study was well-advanced in design, and key features have previously been shared with
investors. However, after detailed due diligence, the company has formed a view that the opportunity to participate in GBM AGILE represents a superior path forward for <FONT STYLE="white-space:nowrap">GDC-0084,</FONT> and so we have reoriented our
development plan accordingly. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">GBM AGILE is in several respects a more robust and comprehensive study than that originally planned by Kazia. Moreover, the
innovative design means that it can be performed at a substantially lower cost than the study previously planned by Kazia. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia has been very successful
in following a partnership-driven model of clinical development for the <FONT STYLE="white-space:nowrap">GDC-0084</FONT> asset, which has allowed us to deploy a broad-based clinical program of vastly greater quality and reach than would ordinarily
be possible for a company our size. Four clinical collaborations have already been launched under this innovative operating model. GBM AGILE represents the latest embodiment of that strategy. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>What are the key differences between GBM AGILE and Kazia&#146;s previously planned pivotal study? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">There are substantial differences in approach between the studies, which cannot be easily summarized, but some of the most pertinent points of comparison
include:- </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="1%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt"><I>Primary Endpoint</I> &#150; GBM AGILE uses overall survival (OS) as a primary endpoint, whereas the Kazia
study had planned to use progression-free survival (PFS). While PFS is highly likely to be an approvable endpoint in this indication, OS is generally considered more robust and is the &#145;gold standard&#146; for approval of new cancer drugs.
</P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="1%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt"><I>Number of Treated Patients</I> &#150; Kazia&#146;s study was expected to administer <FONT
STYLE="white-space:nowrap">GDC-0084</FONT> to 114 patients (with a further 114 patients recruited to a comparator arm). GBM AGILE will treat up to 200 patients with the drug, potentially providing a more substantial database, although the exact
number will be adjusted dynamically throughout the course of the study. </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="1%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt"><I>Patient Population</I> &#150; Kazia had planned to focus purely on newly-diagnosed glioblastoma patients with
the unmethylated MGMT promotor, who are effectively resistant to temozolomide, the existing standard of care. GBM AGILE will recruit these patients to the <FONT STYLE="white-space:nowrap">GDC-0084</FONT> arm, but will also include recurrent
patients, who have experienced disease progression after treatment with temozolomide. Should <FONT STYLE="white-space:nowrap">GDC-0084</FONT> prove efficacious in both populations, it will allow for a larger commercial market on approval.
</P></TD></TR></TABLE>
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<Center><DIV STYLE="width:8.25in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>What does it mean to say that GBM AGILE is an &#145;adaptive&#146; study? And what is a &#145;master
protocol&#146; study? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Conventional clinical trials define a target number of patients at the outset, based on certain assumptions around treatment
effect, <FONT STYLE="white-space:nowrap">drop-out</FONT> rate, etc. Often, the number of patients ends up greater or less than were actually required, leading to inefficiency and, on occasion, the failure of potentially efficacious drugs. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">An adaptive study is one that dynamically adjusts the number of patients in the study according to emerging data, so that only the number necessary to answer
the question are recruited. This is considered a more efficient approach to drug development, and one that has received considerable interest and support from clinicians, industry, and regulatory agencies. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">A master protocol study is one that allows for testing of more than one investigational drug, and will typically open and close different arms over time as
different drugs enter and leave the study. It provides considerable operational efficiency, particularly in less common diseases such as glioblastoma. <FONT STYLE="white-space:nowrap">GDC-0084</FONT> is already participating in a similar trial
&#150; the Alliance study in brain metastases (NCT03994796), which currently includes three experimental arms. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>What does this mean for Kazia&#146;s
current phase II study of <FONT STYLE="white-space:nowrap">GDC-0084</FONT> in glioblastoma? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia and GCAR are of the opinion that the evidence
currently in hand is sufficient to warrant moving forward with GBM AGILE, and so the current phase II study is not considered rate-limiting for the transition to a pivotal study. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">However, emerging data from the phase II study remains important to the broader development of <FONT STYLE="white-space:nowrap">GDC-0084</FONT> and may help
to inform statistical calculations and operational matters relating to GBM AGILE. Kazia intends to continue with the phase II study as planned, and will continue to report new data as it becomes available. In the meantime, <FONT
STYLE="white-space:nowrap">set-up</FONT> and preparatory work will commence in parallel for GBM AGILE, allowing Kazia to realize significant operational efficiencies. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>How did Kazia become aware of GBM AGILE, and what has been the process to get to this point? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">A number of clinicians who are currently participating in Kazia&#146;s phase II study of <FONT STYLE="white-space:nowrap">GDC-0084</FONT> in glioblastoma have
leadership roles in GBM AGILE. They have recommended inclusion of <FONT STYLE="white-space:nowrap">GDC-0084</FONT> and have facilitated the necessary introductions and relationships. Kazia recently presented
<FONT STYLE="white-space:nowrap">GDC-0084</FONT> data to GCAR&#146;s Arm Selection Committee and was invited to join the study shortly thereafter. </P>
</DIV></Center>


<p Style='page-break-before:always'>
<HR SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">


<Center><DIV STYLE="width:8.25in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>How confident is Kazia that data from GBM AGILE will be acceptable to regulatory agencies for product
registration? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">GCAR has consulted extensively with FDA and with other national regulatory agencies. FDA has indicated that it expects data from GBM
AGILE to be suitable for product registration, should efficacy be demonstrated, and assuming that other matters such as manufacturing and preclinical toxicology are of appropriate standard. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><FONT STYLE="white-space:nowrap">GDC-0084</FONT> will be the second drug to join GBM AGILE. Does this mean that only one drug can be successful, and that <FONT
STYLE="white-space:nowrap">GDC-0084</FONT> will have to show superiority to other agents? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">No. The study is designed to compare participating drug
candidates against a common control arm, but not to make drug-versus-drug comparisons. It is possible that several successful drug candidates will eventually emerge from the GBM AGILE study, and this could only be of benefit to patients. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">For comparative purposes, a total of approximately twenty new drugs have been approved in lung cancer over the past decade. Kazia hopes and expects that a
number of new drugs will become available for patients with glioblastoma over the next few years, and the company intends to do everything possible to ensure that <FONT STYLE="white-space:nowrap">GDC-0084</FONT> is one of them. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Is it expected than an additional study will be required, either subsequent to or in parallel with GBM AGILE, in order to achieve regulatory approval?
</B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">No. It is anticipated that GBM AGILE will serve as a single pivotal study for registration of <FONT STYLE="white-space:nowrap">GDC-0084.</FONT> Kazia
may nevertheless consider other clinical trial opportunities in due course to expand the potential use of <FONT STYLE="white-space:nowrap">GDC-0084,</FONT> but it does not anticipate that another substantial evidence study would be on the critical
path for regulatory approval in glioblastoma. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><FONT STYLE="white-space:nowrap">Academic-led</FONT> studies can sometimes be operationally challenging.
How confident is Kazia in GCAR&#146;s ability to execute this complex study? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia has conducted extensive discussions with the GCAR team and believes
that it brings world-class professionalism to the study. GCAR has engaged IQVIA, one of the world&#146;s leading contract research organisations, to execute the study, and has selected top tier sites to participate. The enterprise is profoundly
motivated by the desire to accelerate availability of new treatment options for patients with glioblastoma, a commitment which Kazia wholly shares. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>How much will GBM AGILE cost? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia will fund the
participation of <FONT STYLE="white-space:nowrap">GDC-0084</FONT> in GBM AGILE through a commercial agreement with GCAR. However, the adaptive design, and the economies released by shared infrastructure and a common control arm, mean that the cost
of participation will be very substantially lower than the cost of a comparable standalone, <FONT STYLE="white-space:nowrap">company-run</FONT> study. The commercial terms remain confidential. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>How will Kazia fund GBM AGILE? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The proceeds of
Kazia&#146;s recent institutional placement will allow the company to execute <FONT STYLE="white-space:nowrap">start-up</FONT> and preparatory work, which is expected to take four to six months. As with previous studies, Kazia will consider all
options to fund the study to completion, noting that the funding requirement will be very substantially lower than would otherwise have been the case. </P>
</DIV></Center>


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<Center><DIV STYLE="width:8.25in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>What will be the key milestones associated with GBM AGILE? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia is not yet in a position to provide definitive guidance on operational milestones. However, the company hopes to begin recruitment of patients to the
study in Q2 / Q3 CY2020. The duration of the study thereafter will depend, among other factors, on the number of patients ultimately recruited, in accordance with the adaptive design. Kazia expects to provide further detail on milestones in due
course. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In addition to the ongoing phase II study in glioblastoma, and the planned involvement in GBM AGILE, Kazia has four other ongoing clinical
studies in different forms of brain cancer that will also be reporting data periodically. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Will Australian sites participate in the study? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">GBM AGILE is an international study, and it is expected that Australia will participate. Kazia anticipates that the
<FONT STYLE="white-space:nowrap">GDC-0084</FONT> arm will initially open in the United States, and the company is presently seeking Federal grant funding through the Medical Research Future Fund (MRFF) to facilitate inclusion of Australian sites.
</P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Does the engagement with GBM AGILE mean that Kazia no longer expects to partner <FONT STYLE="white-space:nowrap">GDC-0084</FONT> prior to launch?
</B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">No. Kazia continues to believe that <FONT STYLE="white-space:nowrap">GDC-0084</FONT> is a highly attractive asset to pharma partners, and continues to
engage actively with a number of companies. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia believes that the best way to realise commercial value for shareholders is to keep all options open,
and so the company is proceeding with GBM AGILE as a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">path-to-market,</FONT></FONT> in parallel with its partnering activities. Should a partnering transaction occur, it is entirely
feasible that Kazia&#146;s involvement with GBM AGILE could be transitioned in whole or in part to another company at any point during the study. </P>
</DIV></Center>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
