<SEC-DOCUMENT>0001193125-19-298976.txt : 20191125
<SEC-HEADER>0001193125-19-298976.hdr.sgml : 20191125
<ACCEPTANCE-DATETIME>20191125061319
ACCESSION NUMBER:		0001193125-19-298976
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20191125
FILED AS OF DATE:		20191125
DATE AS OF CHANGE:		20191125

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:		191243635

	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>d839687d6k.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 November, 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 25&nbsp;November 2019 </P>
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<IMG SRC="g839687g43z13.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">25 November
2019 </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>POSITIVE INTERIM EFFICACY DATA FROM <FONT STYLE="white-space:nowrap">GDC-0084</FONT> PHASE II STUDY </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>IN GLIOBLASTOMA RELEASED AT SNO CONFERENCE </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Sydney, 25</B><B></B><B>&nbsp;November 2019</B> &#150; Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology
company, is pleased to share with investors interim data from its ongoing phase II study of <FONT STYLE="white-space:nowrap">GDC-0084</FONT> in glioblastoma, the most common and most aggressive form of primary brain cancer. This data is the subject
of a poster presentation at the annual meeting of the Society for Neuro-Oncology (SNO), held in Phoenix, AZ from 20 &#150; 24&nbsp;November 2019. </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">Data from first nine patients in the study; total study will be around 29 patients </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">Median progression-free survival (PFS) calculated at 8.4 months, implying that
<FONT STYLE="white-space:nowrap">GDC-0084</FONT> may delay progression of glioblastoma </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="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">Median overall survival (OS) could not yet be calculated due to insufficient death events on study. 75% of
evaluable patients remained alive at analysis <FONT STYLE="white-space:nowrap">cut-off</FONT> date </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<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">As reported in May 2019, a maximum tolerated dose (MTD) of 60mg was established, which is higher than the 45mg
dose determined in an earlier phase I study in late-stage patients </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Nine patients participated in Stage 1 of the study, of which eight
were evaluable for efficacy. Progression-free survival (PFS) in this initial group of patients was determined to be 8.4 months. The existing standard of care, temozolomide, has a reported PFS of around 5.3 months<SUP
STYLE="font-size:85%; vertical-align:top">1</SUP>, although cross-study comparisons must always be treated with caution. Overall survival (OS) could not yet be calculated, with 75% of evaluable patients still alive at the <FONT
STYLE="white-space:nowrap">cut-off</FONT> date for analysis. In aggregate, these early results provide a strong signal that <FONT STYLE="white-space:nowrap">GDC-0084</FONT> may provide clinical benefit in this patient population. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The safety of <FONT STYLE="white-space:nowrap">GDC-0084</FONT> was also broadly consistent with prior experience, with hyperglycaemia (raised blood sugar),
oral mucositis (mouth ulcers), and rash among the most common drug-related toxicities. Two dose-limiting toxicities (DLTs) were observed at a dose of 75mg, and these were hyperglycaemia and oral mucositis. </P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">1</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">ME Hegi, <FONT STYLE="white-space:nowrap">A-C</FONT> Desirens, T Gorlia, et al. <I>N Engl J Med</I> (2005); <FONT
STYLE="white-space:nowrap">352:997-1003</FONT> </P></TD></TR></TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman"><B>Board of Directors</B> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman"><B>Mr Iain Ross </B>Chairman,<B> </B>Non-Executive Director </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman"><B>Mr
Bryce Carmine </B>Non-Executive Director </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman"><B>Mr Steven Coffey </B>Non-Executive Director </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman"><B>Dr James Garner </B>Chief Executive Officer, Managing Director </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Professor Patrick Wen from Dana-Farber Cancer Institute, who was the lead author on the poster presentation,
commented, &#147;there is an urgent need for new therapies in glioblastoma. <FONT STYLE="white-space:nowrap">GDC-0084</FONT> has the potential to be an important new addition to the treatment of this very challenging disease. My colleagues and I
look forward to examining further data as the study progresses.&#148; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia CEO, Dr James Garner, added, &#147;this is early &#145;first look&#146; data
from the study, representing around a third of the total patients to be enrolled, but it has already exceeded our expectations. We see a clear signal that <FONT STYLE="white-space:nowrap">GDC-0084</FONT> is providing clinical benefit in this group
of patients. Although it has not yet been possible to calculate overall survival, the fact that the majority of patients in the first stage of the study remain alive more than a year after diagnosis suggests that a meaningful OS benefit may emerge
as the study matures. That would be a remarkable finding.&#148; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The poster can be downloaded from Kazia&#146;s website via: <U><FONT
STYLE="white-space:nowrap">https://www.kaziatherapeutics.com/researchpipeline/gdc-0084</FONT></U>. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Next Steps </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Stage 2 of the study continues to enrol patients, and further data is expected early in calendar 2020. In addition to this ongoing phase II study in
glioblastoma, <FONT STYLE="white-space:nowrap">GDC-0084</FONT> is also the subject of four other ongoing clinical trials in DIPG and brain metastases, several of which are also expected to report interim data during the early part of calendar 2020.
Given the early positive signal from this study, Kazia intends to accelerate activities to initiate a pivotal study for registration in calendar 2020 and will share more detailed plans with shareholders in the near future. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Investor Conference Call </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia is pleased to invite
investors to attend a conference call to discuss the results further. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The call will be held on Tuesday 26&nbsp;November 2019 at 9:00am, Sydney time
(AEDT), which is 2pm on Monday 25&nbsp;November 2019 in San Francisco (PST) and 5pm on Monday 25&nbsp;November 2019 in New York (EST). <FONT STYLE="white-space:nowrap">Dial-in</FONT> details are provided below:- </P>
<P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top">Australian toll free:</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">1800 123 296</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP>Australian&nbsp;local&nbsp;(Sydney):</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">+61 2 8038 5221</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Hong Kong:</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">3008 2034</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">New Zealand:</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">0800 452 782</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Singapore:</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">800 616 2288</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">United Kingdom:</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">0808 234 0757</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">United States:</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">1855 293 1544</TD></TR>
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<TD VALIGN="top">Conference ID:</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">5796625</TD></TR>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Professor Ben Ellingson Delivers Oral Presentation on Analysis of Phase I Imaging Data </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In addition to the poster presentation for the ongoing phase II study, Professor Ben Ellingson, Director of the UCLA Brain Tumor Imaging Laboratory, was
invited to give an oral presentation at the SNO conference on a retrospective analysis of the phase I study of <FONT STYLE="white-space:nowrap">GDC-0084</FONT> in recurrent glioma that was completed by Genentech. Professor Ellingson&#146;s
presentation was voted the winner of the Neuro-Imaging Abstract Award, in recognition both of his work&#146;s technical excellence and scientific innovation. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Professor Ellingson&#146;s analysis showed that specific changes on MRI and PET scans correlated closely with the concentration of <FONT
STYLE="white-space:nowrap">GDC-0084</FONT> in the patient&#146;s blood. Moreover, the data showed that this specific signature on MRI and PET scans was associated with longer progression-free survival (PFS). The importance of this data is that it
strengthens the empirical connection between the concentration of <FONT STYLE="white-space:nowrap">GDC-0084,</FONT> its effect on the biology of the tumour, and the clinical outcome for the patient. This strongly supports Kazia&#146;s understanding
of the mechanism of action of <FONT STYLE="white-space:nowrap">GDC-0084</FONT> and provides further confirmation that the drug is active. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">[ENDS] </P> <P STYLE="margin-top:18pt; 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 multiforme, 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>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>CLINICAL TRIAL SUMMARY </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><B>Study Title</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">A Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of the PI3K/mTOR Inhibitor <FONT STYLE="white-space:nowrap">GDC-0084</FONT> Administered to Patients With Glioblastoma Multiforme Characterized by Unmethylated <FONT
STYLE="white-space:nowrap">O6-methylguanine-methyltransferase</FONT> Promoter Status Following Surgical Resection and Standard Concomitant Chemoradiation Therapy With Temozolomide</TD></TR>
<TR STYLE="font-size:1pt">
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<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><B>Phase of Development</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">Phase II</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
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<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><B>Investigational Product</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">Paxalisib <FONT STYLE="white-space:nowrap">(GDC-0084)</FONT></TD></TR>
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<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><B>Disease Area</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">Newly-diagnosed glioblastoma (GBM) (WHO grade IV glioma)</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><B>Registration</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">NCT03522298</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><B>Study Description</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This is a <FONT STYLE="white-space:nowrap">two-part</FONT> study intended to support transition from an advanced recurrent disease population
(as investigated in the phase I study) to newly-diagnosed patients (the target population for commercial launch). It is designed in two stages:-</P> <P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Stage 1</B> &#150; a dose escalation component to establish a maximum tolerated dose (MTD) and recommended dose for further study in newly-diagnosed
patients; groups of patients will be administered increasing doses of <FONT STYLE="white-space:nowrap">GDC-0084</FONT> until unacceptable toxicity is encountered</P> <P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman"><B>Stage 2</B> &#150; a dose expansion cohort, in which all patients will be treated at the MTD, and which is designed to elicit confirmatory signals of
clinical efficacy</P></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><B>Number of Subjects</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Stage 1</B> &#150; 9 patients (enrolment complete)</P> <P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman"><B>Stage 2</B> &#150; 20 patients (enrolment ongoing)</P></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><B>Study Design</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This is a <FONT STYLE="white-space:nowrap">single-arm,</FONT> exploratory study.</P>
<P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Stage 1 is designed as a standard &#145;3+3&#146; dose escalation protocol. The first
cohort of 3 patients receive 60mg of <FONT STYLE="white-space:nowrap">GDC-0084,</FONT> once daily in capsule form. If this dose is tolerated for at least 28 days, an additional 3 patients will receive 75mg, and subsequent cohorts may increase at
15mg intervals until unacceptable toxicity occurs. If a dose-limiting toxicity (DLT) is observed in a given cohort, it will be expanded to 6 patients, and if two DLTs are observed at a given dose level then the previous dose will be declared the
MTD.</P> <P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman">Stage 2 will enroll all patients at the MTD. Half of the patients will receive <FONT
STYLE="white-space:nowrap">GDC-0084</FONT> with food, and half on an empty stomach, in order to assess potential food effects.</P></TD></TR></TABLE>
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<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><B>Patient Population</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">All patients had newly-diagnosed glioblastoma, which had been treated with surgery and radiotherapy according to the <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> &#145;Stupp regimen&#146;.</P> <P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman">All patients had unmethylated MGMT promotor status, which renders them essentially resistant to temozolomide, the only
<FONT STYLE="white-space:nowrap">FDA-approved</FONT> drug treatment for newly-diagnosed glioblastoma. This group represents approximately two thirds of the total GBM population.</P></TD></TR>
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<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><B>Endpoints</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">The primary endpoint of Stage 1 was safety and tolerability, since it is a dose escalation study. PFS and OS were included as exploratory efficacy endpoints.</TD></TR>
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<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><B>Participating Centres</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>UCLA &#150; Jonsson Comprehensive Cancer Center</B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Los Angeles, CA</P> <P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>University of Colorado Cancer Center</B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Denver, CO</P>
<P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Dana-Farber Cancer Institute</B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Boston, MA</P> <P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Massachusetts General Hospital</B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Boston, MA</P>
<P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>John Theurer Cancer Center</B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Hackensack, NJ</P> <P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Stephenson Cancer Center</B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Oklahoma City, OK</P>
<P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>MD Anderson Cancer Center</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman">Houston, TX</P></TD></TR>
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<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><B>Start Date</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">First Patient In: September 2018</TD></TR>
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<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><B>Expected Completion</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">1H CY2020</TD></TR>
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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>The study has reported a progression-free survival (PFS) of 8.4 months. How should this result be interpreted? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The study had enrolled glioblastoma patients with an unmethylated MGMT promotor. The unmethylated MGMT promotor is a genetic marker that is associated with
near total resistance to temzolomide, the only <FONT STYLE="white-space:nowrap">FDA-approved</FONT> pharmacological treatment for newly-diagnosed glioblastoma. Approximately <FONT STYLE="white-space:nowrap">two-thirds</FONT> of all glioblastoma
patients have an unmethylated MGMT promotor. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">For comparative purposes, in this group of patients, temozolomide improves PFS from 4.4 months to 5.3 months<SUP
STYLE="font-size:85%; vertical-align:top">2</SUP>. It is difficult to precisely compare results between studies, due to differences in patient population, background standard of care, and calculation methodology, but the magnitude of the difference
in this case suggests that treatment with <FONT STYLE="white-space:nowrap">GDC-0084</FONT> is associated with a clinically beneficial treatment effect. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Other studies of temozolomide in this patient group have reported a &#145;headline&#146; PFS of between
5.1<SUP STYLE="font-size:85%; vertical-align:top">3</SUP> and 7.3<SUP STYLE="font-size:85%; vertical-align:top">4</SUP> months, although much of this variability is attributable to differences in study design and calculation methodology. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Given these considerations, it is not yet possible to precisely quantify the potential treatment advantage of <FONT STYLE="white-space:nowrap">GDC-0084</FONT>
versus temozolomide. However, Kazia considers that the present results constitute a strong qualitative signal that the drug may provide benefit. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>What
sort of improvement in PFS likely be enough for regulatory approval and for widespread use of the commercial product? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This is early interim data, and
potential regulatory approval will almost certainly depend on the findings of a larger, randomised pivotal study. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">However, a number of <FONT
STYLE="white-space:nowrap">FDA-approved</FONT> and commercially successful cancer treatments have demonstrated relatively modest improvements in PFS. For example:- </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" NOWRAP STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman"><B>Drug</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman"><B>Indication</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman"><B>PFS Improvement</B></P></TD></TR>


<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom">Avastin (bevacizumab)</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">Metastatic colorectal cancer</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">6.2 <FONT STYLE="FONT-FAMILY:'WINGDINGS 3'">&#103;</FONT> 10.6 months</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom">Avastin (bevacizumab)</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">Recurrent ovarian cancer</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">3.4 <FONT STYLE="FONT-FAMILY:'WINGDINGS 3'">&#103;</FONT> 6.8 months</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom">Abraxane (paclitaxel)</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">Pancreatic cancer</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">3.7 <FONT STYLE="FONT-FAMILY:'WINGDINGS 3'">&#103;</FONT> 5.5 months</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom">Nexavar (sorafenib)</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">Liver cancer</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">2.8 <FONT STYLE="FONT-FAMILY:'WINGDINGS 3'">&#103;</FONT> 5.5 months</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom">Stivarga (regorafenib)</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">Metastatic colorectal cancer</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">1.7 <FONT STYLE="FONT-FAMILY:'WINGDINGS 3'">&#103;</FONT> 1.9 months</TD></TR>
</TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>(all figures taken from product Prescribing Information. Nexavar figure is <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">time-to-progression</FONT></FONT> rather than PFS) </I></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:8.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000;width:11%">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:85%; vertical-align:top">2</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">ME Hegi, <FONT STYLE="white-space:nowrap">A-C</FONT> Desirens, T Gorlia, et al. <I>N Engl J Med</I> (2005); <FONT
STYLE="white-space:nowrap">352:997-1003</FONT> </P></TD></TR></TABLE>
<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="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:85%; vertical-align:top">3</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">MR Gilbert, MH Wang, KD Aldape, et al. <I>J Clinical Oncol</I> (2013); 31:4085-4091 </P></TD></TR></TABLE>
<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="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:85%; vertical-align:top">4</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">MR Gilbert, JD Dignam, TS Armstrong, et al. <I>N Engl J Med</I> (2014);
<FONT STYLE="white-space:nowrap">370:699-708</FONT> </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>How robust is the comparison to data from previous clinical studies? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Ideally, the gold standard for definitive determination of efficacy is a randomized, controlled trial (RCT), in which patients are randomly allocated to
receive either the treatment under investigation (in this case, <FONT STYLE="white-space:nowrap">GDC-0084),</FONT> or a comparator of some kind (either placebo or an existing treatment). The investigational treatment is then compared with exactly
matched patients in the same clinical trial. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">However, in common with the majority of cancer studies at this stage of development, the present study only
contains a single arm and all patients receive <FONT STYLE="white-space:nowrap">GDC-0084.</FONT> The reasons for this approach are various, and include both ethical and operational considerations. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">As such, the emerging data must necessarily be compared to results from previous studies to assess treatment effect, and this reliance on &#145;historical
controls&#146; is also standard practice in the development of new cancer drugs. Such comparisons are of course imperfect: there are often differences in the way that studies have been run, the statistical calculation of endpoints, and the
composition patient population. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Nevertheless, the natural history of glioblastoma is generally well-understood, and there have not been significant
improvements in the prognosis of the disease since the Hegi paper was published. In this context, Kazia considers the emerging data from this study to be a positive signal. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Are the results statistically significant? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">&#145;Statistical significance&#146; is a mathematical term that refers specifically to a comparison between different arms in a single study. In common with
most oncology studies at this stage of development, this study is only a <FONT STYLE="white-space:nowrap">single-arm</FONT> study and so it is not possible to formally assess statistical significance. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>What is the difference between progression-free survival (PFS) and overall survival (OS)? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">For a given patient, progression-free survival (PFS) describes the time until either progression of the disease (recurrence or growth of the tumour) or death,
whichever is first. Overall survival (OS) describes the time until death from any cause. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In clinical trials of experimental cancer drugs, median PFS and
median OS are commonly used as endpoints. The median PFS is the time point at which 50% of patients have progressed or died. For example, a median PFS of 5.4 months means that half of the patients will progress in less than 5.4 months and half will
last longer. The median is used in preference to the more common mean because it reduces the impact of outliers. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In general, OS is regarded by regulatory
agencies as the &#145;gold standard&#146; for approval of new cancer therapies. However, PFS is a faster and arguably more sensitive measure, and is often predictive of OS. Consequently, PFS is finding increasing favour for oncology clinical trials
and has been the basis of approval for a number of commercial products. PFS is less robust than OS in that it requires interpretation of MRI scans to determine progression, but it is arguably more specific in that it is not affected by treatments
that are administered following progression. </P>
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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>Overall survival (OS) could not be calculated. Does that mean
<FONT STYLE="white-space:nowrap">GDC-0084</FONT> does not show a survival benefit? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">No. Six of eight evaluable patients remain alive at the time of
analysis <FONT STYLE="white-space:nowrap">cut-off</FONT> (late October 2019), and so a median figure (representing the point at which half of patients are deceased) has not yet occurred. Given the small number of death events, it is not possible to
use parametric techniques to extrapolate an OS figure at this stage. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The majority of these patients continue to be actively followed up and one patient
remains on study drug after more than sixteen months of continuous treatment. It will be possible to determine an OS figure once 50% of patients are deceased. Given the duration of treatment and <FONT STYLE="white-space:nowrap">follow-up</FONT> to
date, it is likely that this will compare favourably to historical controls. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">For future comparison, the Hegi paper reports an improvement in OS from 11.8
months to 12.7 months for treatment with temozolomide in newly-diagnosed patients with unmethylated MGMT promotor status. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Why was one of the nine
patients withdrawn from the study, and what is the impact on the results? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">One patient was poorly compliant with study procedures and a decision was
made by the Principal Investigator to withdraw that patient from the study. Since the patient&#146;s exposure to <FONT STYLE="white-space:nowrap">GDC-0084</FONT> was confined to a matter of days, and given that any data associated with this patient
was considered questionable, they have been excluded entirely from this analysis. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia has conducted sensitivity analyses to explore the impact of
including all available data from this patient versus removing them from the analysis, and the impact on PFS and OS is negligible. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Is this final data
from this part of the study? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">No. This is an early interim analysis. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The majority of the 9 patients in Stage 1 remain in <FONT STYLE="white-space:nowrap">follow-up</FONT> for survival, and so further data from the group of
patients will be available at a future date. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The study is currently enrolling an additional 20 patients to Stage 2, a dose expansion cohort, and this
data will also be reported at a future date. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The final results of the study may change as additional patients are included in the analysis, and as
additional data is collected from these patients over time. </P>
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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>How do these patients compare to those envisaged for Stage 2 and for the pivotal study? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The patients in both stages of this study are exactly consistent in all material respects with the target population of the planned pivotal study:
newly-diagnosed GBM patients with an unmethylated MGMT promotor (i.e. resistant to temozolomide). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In Stage 1 of this study, 3 of the 9 patients received
a dose of 60mg, and 6 of the 9 patients received a dose of 75mg. The higher dose was subsequently determined to be poorly tolerated. This is an expected finding &#150; the intention of a dose escalation study is to push the dose to the limit to
determine how much can safely be administered. However, the consequence is that some of the patients receiving 75mg may have terminated treatment early due to side effects, and therefore received less overall benefit from treatment with <FONT
STYLE="white-space:nowrap">GDC-0084.</FONT> In Stage 2, all patients will receive the 60mg dose, which is expected to be well-tolerated, and this may be associated with greater efficacy. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In the planned pivotal study, it is expected that all patients will also receive the 60mg dose. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>How does this study compare to the phase I study performed by Genentech? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Prior to Kazia&#146;s licensing of the <FONT STYLE="white-space:nowrap">GDC-0084</FONT> asset, Genentech completed a phase I dose escalation study
(NCT01547546). There are important differences between this study and the phase I study:- </P> <P STYLE="font-size:12pt;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">The phase I included patients with both grade III and grade IV glioma. Glioblastoma is essentially equivalent to
grade IV glioma. This study has only enrolled patients with glioblastoma (grade IV glioma). </P></TD></TR></TABLE> <P STYLE="font-size:12pt;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">The phase I patients were very advanced and had failed on average three prior lines of therapy, making them an
extremely treatment-resistant group. The present study has enrolled newly-diagnosed patients who are expected to respond better to treatment. </P></TD></TR></TABLE> <P STYLE="font-size:12pt;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">The phase I study included patients with both methylated and unmethylated MGMT promotor status. The unmethylated
MGMT promotor is associated with a worse prognosis. This study has only enrolled patients with unmethylated MGMT promotor status. </P></TD></TR></TABLE> <P STYLE="font-size:12pt;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">The phase I study did not report PFS or OS. </P></TD></TR></TABLE>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>This is described as a phase IIa study. Does that mean that a phase IIb study is required before <FONT STYLE="white-space:nowrap">GDC-0084</FONT> can
commence a phase&nbsp;III study? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">No. The &#145;phase&#146; nomenclature is largely a matter of industry convention and is regarded as increasingly <FONT
STYLE="white-space:nowrap">old-fashioned.</FONT> It has limited regulatory significance. Kazia expects that the next study of <FONT STYLE="white-space:nowrap">GDC-0084</FONT> in GBM will be a pivotal study for registration, or what FDA would refer
to as a &#145;substantial evidence&#146; study. This may be designated phase II or phase III, or some combination thereof. </P>
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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>When will the pivotal study start? Is it necessary to complete the current study prior to starting the
pivotal study? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The pivotal study is expected to commence in CY2020. While certain data from the current study is required for the pivotal study, it is
not necessary for the current study to be fully completed prior to initiation of the pivotal study. Kazia considers that the positive signals seen to date are sufficient for internal decision-making purposes and is therefore accelerating planning
for the proposed pivotal study. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Is it possible to seek registration for <FONT STYLE="white-space:nowrap">GDC-0084</FONT> on the basis of this data,
given the unmet need in glioblastoma? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The present data is likely insufficient for registration. Kazia anticipates that a randomized controlled study
against temozolomide will be required to achieve registration, with either OS or PFS as a primary endpoint. Moreover, new cancer drugs typically require several hundred patients of data prior to registration and
<FONT STYLE="white-space:nowrap">GDC-0084</FONT> has, to date, been administered to a little fewer than 100 patients. However, the signal seen here does suggest the possibility of a smaller pivotal study, or an adaptive design, which may reduce the
total number of patients required relative to the company&#146;s initial forecasts. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>What does this data mean for the other ongoing studies of <FONT
STYLE="white-space:nowrap">GDC-0084?</FONT> </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In addition to this clinical trial, four other studies with
<FONT STYLE="white-space:nowrap">GDC-0084</FONT> are underway in DIPG and in brain metastases. Each of these diseases are different, and so success or failure in one study does not guarantee a corresponding result in the other studies. However, the
positive signals seen here provide strong evidence that <FONT STYLE="white-space:nowrap">GDC-0084</FONT> is clinically active, which may be taken to increase the likelihood of success in the other ongoing studies. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>What is the competitive landscape for glioblastoma? How do these results compare to other drugs in development for the disease? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia is not presently aware of any investigational new drug in the global pipeline which is (a)&nbsp;in active development for single-agent adjuvant use in
newly-diagnosed glioblastoma patients, (b)&nbsp;further advanced than <FONT STYLE="white-space:nowrap">GDC-0084,</FONT> and (c)&nbsp;which shows superior evidence of activity on currently available data. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>What is the level of partnering interest for <FONT STYLE="white-space:nowrap">GDC-0084?</FONT> Is Kazia in discussion with pharma partners? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia expects <FONT STYLE="white-space:nowrap">GDC-0084</FONT> to be a highly attractive asset to pharmaceutical companies. The company has proactively been
making potential future partners aware of the <FONT STYLE="white-space:nowrap">GDC-0084</FONT> story for some time and will be discussing this data with interested parties in coming weeks, and at the JP Morgan conference in San Francisco in January.
While no specific transaction is currently on foot, Kazia will continue to cultivate interest in the <FONT STYLE="white-space:nowrap">GDC-0084</FONT> program, with the aim of maximizing long-term shareholder value. </P>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
