<SEC-DOCUMENT>0001193125-20-099846.txt : 20200407
<SEC-HEADER>0001193125-20-099846.hdr.sgml : 20200407
<ACCEPTANCE-DATETIME>20200407060609
ACCESSION NUMBER:		0001193125-20-099846
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20200407
FILED AS OF DATE:		20200407
DATE AS OF CHANGE:		20200407

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:		20778326

	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>d914526d6k.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 April, 2020 </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 7 April 2020 </P>
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<IMG SRC="g914526g0306042232324.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:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">7&nbsp;April
2020 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>KAZIA&#146;S PAXALISIB SHOWS POSITIVE OVERALL SURVIVAL SIGNAL </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>IN PHASE II GLIOBLASTOMA STUDY </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B><I>Overall survival (OS) of 17.7 months, vs. 12.7 months for existing standard of care </I></B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B><I>Longest-treated patient remains progression-free 19 months after diagnosis </I></B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Sydney, 7</B><B></B><B>&nbsp;April 2020</B> &#150; Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology
company, is pleased to share positive interim data from its ongoing phase II study of paxalisib (formerly <FONT STYLE="white-space:nowrap">GDC-0084)</FONT> in glioblastoma, the most common and most aggressive form of primary brain cancer. </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>
<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">Interim analysis of Part A (escalation cohort) (n=9) showed median overall survival (OS) of 17.7 months,
representing a clinically meaningful extension of life when compared to the 12.7 months associated with the existing standard of care, temozolomide </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">Interim analysis of all evaluable patients (Part A = 9; Part B = 21) shows median progression-free survival (PFS)
of 8.5 months, broadly in line with previous analysis, and comparing favourably to the 5.3 months associated with temozolomide </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">The longest-treated patient remains progression-free 19 months after diagnosis </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">Approximately half the enrolled patients remain on drug and both OS and PFS figures may further improve as the
trial progresses toward conclusion </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">Kazia expects to present further data in 2H CY2020 and final data in 1H CY2021 </P></TD></TR></TABLE>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Summary of Paxalisib Data in Comparison to Temozolomide (existing standard of care) </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" ALIGN="center">


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<TD WIDTH="50%"></TD>

<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="24%"></TD>

<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="24%"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Temozolomide<BR></B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B></B><FONT STYLE="white-space:nowrap">(FDA-approved</FONT> treatment)<B></B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Paxalisib</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B></B>(interim phase II data)<B></B></P></TD></TR>


<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"><B>Progression-Free Survival (PFS)</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><I>Measures ability of a drug to slow growth of a tumour</I></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center">5.3 months</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center">8.5 months</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></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"><B>Overall Survival (OS)</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><I>Measures ability of a drug to prolong life</I></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center">12.7 months</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center">17.7 months</TD></TR>
</TABLE>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia CEO, Dr James Garner, commented, &#147;this is an excellent result, and we are delighted with the
emerging data. The &#145;gold standard&#146; for any new cancer treatment is the ability to extend life - an especially challenging goal in a disease such as glioblastoma - and this data provides our first evidence that paxalisib may achieve this
objective in a very challenging patient population.&#148; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">He continued, &#147;there have not been any new drug treatments for newly-diagnosed
glioblastoma patients for over twenty years, and we aspire to change that situation. We believe that paxalisib is rapidly becoming one of the most promising drug candidates in the global pipeline for this very challenging disease and we will be
working strenuously to make it available to patients as quickly and efficiently as possible. The study continues to follow a number of patients who remain on treatment, and we currently expect to report a further data
<FONT STYLE="white-space:nowrap">read-out</FONT> in the second half of the year.&#148; </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Background </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The reported overall survival (OS) figure of 17.7 months represents a strong signal of clinical efficacy. The existing,
<FONT STYLE="white-space:nowrap">FDA-approved</FONT> standard of care, temozolomide, is associated with an OS of 12.7 months in this patient population<SUP STYLE="font-size:85%; vertical-align:top">1</SUP>. Comparison between different studies is
always imprecise, but the magnitude of the numerical difference provides powerful evidence that treatment with paxalisib may extend life in this patient group. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The reported progression-free survival (PFS) figure of 8.5 months is slightly better than the figure of 8.4 months previously reported in November 2019.
Temozolomide is associated with a PFS of 5.3 months in this patient population. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Before losing patent protection, temozolomide achieved peak sales in
excess of US$ 1&nbsp;billion per annum, which provides an indication of the commercial opportunity associated with a new treatment for glioblastoma. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Thirty patients were enrolled to this study, comprising 9 in Part A, and 21 in Part B. Data reported here are provisional figures from Part A (for OS) and
from the entire study population (for PFS), but may change as ongoing patients proceed through the study. The study has been conducted at leading centers of excellence in the United States. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The safety of paxalisib remained broadly consistent with prior experience, with hyperglycaemia (raised blood sugar), oral mucositis (mouth ulcers), and <FONT
STYLE="white-space:nowrap">low-grade</FONT> rash among the most common drug-related toxicities. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In addition to this phase II study in glioblastoma, four
other studies are underway with paxalisib in different forms of brain cancer, and it is anticipated that several of these will provide initial efficacy data during CY 2020. </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">1</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>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This data had been accepted for presentation at the annual meeting of the American Association of Cancer
Research (AACR) in San Diego, CA from 24 <FONT STYLE="white-space:nowrap">-29</FONT> April 2020. However, given the cancellation of the AACR meeting due to the <FONT STYLE="white-space:nowrap">COVID-19</FONT> outbreak, Kazia has determined to
provide an update to investors via this ASX announcement. </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">The phase II study remains ongoing, with approximately half of the total enrolled patient population still receiving drug at the time of analysis and a number
of additional patients still in <FONT STYLE="white-space:nowrap">follow-up.</FONT> At this stage, Kazia expects to present further data in 2H CY2020, and final data in 1H CY2021. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">As disclosed in December 2019, Kazia has meanwhile begun preparatory activities, in parallel to completion of this phase II study, to bring paxalisib into the
international platform study, GBM AGILE, which is intended to provide data to support FDA approval for paxalisib in glioblastoma. This work has been proceeding on schedule, and Kazia continues to expect first patient in to the paxalisib arm in 2H
CY2020. </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">An investor
conference call will be held on Thursday 9&nbsp;April 2020 at 8:30am, Sydney time (AEDT), which is 3:30pm on Wednesday 8&nbsp;April 2020 in San Francisco (PST), 6:30pm on Wednesday 8&nbsp;April 2020 in New York (EST), and 6:30am on Thursday
9&nbsp;April 2020 in Hong Kong SAR (HKT) to allow for further discussion of these results. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Participants will need to
<B><U><FONT STYLE="white-space:nowrap">pre-register</FONT></U></B> for the call via the following link: </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U><FONT STYLE="white-space:nowrap">https://s1.c-conf.com/DiamondPass/10005482b-invite.html</FONT> </U></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Click the &#145;Register Now&#146; button and follow the prompts to complete <FONT STYLE="white-space:nowrap">pre-registration.</FONT> You will then receive a
calendar invite with dial in numbers, a passcode and a PIN to dial into the conference call. </P> <P STYLE="margin-top:18pt; 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
paxalisib (formerly <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, paxalisib entered a phase II clinical trial in 2018. Interim data was reported in April 2020, and further data is expected in 2H 2020. Paxalisib 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 document was authorized for release to the ASX by James Garner, 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"><B>CLINICAL TRIAL SUMMARY </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%"> <P STYLE=" margin-top:0pt; margin-bottom:1pt; margin-left:2%; text-indent:-2%; font-size:10pt; font-family:Times New Roman"><B>Study Title</B> </P></TD>
<TD>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></TABLE>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%"> <P STYLE=" margin-top:0pt; margin-bottom:1pt; margin-left:2%; text-indent:-2%; font-size:10pt; font-family:Times New Roman"><B>Phase of Development</B> </P></TD>
<TD>Phase II </TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%"> <P STYLE=" margin-top:0pt; margin-bottom:1pt; margin-left:2%; text-indent:-2%; font-size:10pt; font-family:Times New Roman"><B>Investigational Product</B> </P></TD>
<TD>Paxalisib <FONT STYLE="white-space:nowrap">(GDC-0084)</FONT> </TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%"> <P STYLE=" margin-top:0pt; margin-bottom:1pt; margin-left:2%; text-indent:-2%; font-size:10pt; font-family:Times New Roman"><B>Disease Area</B> </P></TD>
<TD>Newly-diagnosed glioblastoma (GBM) (WHO grade IV glioma) </TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%"> <P STYLE=" margin-top:0pt; margin-bottom:1pt; margin-left:2%; text-indent:-2%; font-size:10pt; font-family:Times New Roman"><B>Registration</B> </P></TD>
<TD>NCT03522298 </TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%"> <P STYLE=" margin-top:0pt; margin-bottom:1pt; margin-left:2%; text-indent:-2%; font-size:10pt; font-family:Times New Roman"><B>Study Description</B> </P></TD>
<TD>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:- </TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"><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 </TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"><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 </TD></TR></TABLE>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%"> <P STYLE=" margin-top:0pt; margin-bottom:1pt; margin-left:2%; text-indent:-2%; font-size:10pt; font-family:Times New Roman"><B>Number of Subjects</B><B></B> </P></TD>
<TD><B>Stage 1</B> &#150; 9 patients (enrolment complete) </TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"><B>Stage 2</B> &#150; 21 patients (enrolment complete) </TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%"> <P STYLE=" margin-top:0pt; margin-bottom:1pt; margin-left:2%; text-indent:-2%; font-size:10pt; font-family:Times New Roman"><B>Study Design</B> </P></TD>
<TD>This is a <FONT STYLE="white-space:nowrap">single-arm,</FONT> exploratory study. </TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">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. </TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">Stage 2 will enroll all patients at the MTD. Half of the patients will receive paxalisib with food, and half on an empty stomach, in order to assess potential food effects. </TD></TR></TABLE>
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<TD WIDTH="38%"> <P STYLE=" margin-top:0pt; margin-bottom:1pt; margin-left:2%; text-indent:-2%; font-size:10pt; font-family:Times New Roman"><B>Patient Population</B> </P></TD>
<TD>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;.
</TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top">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. </TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%"> <P STYLE=" margin-top:0pt; margin-bottom:1pt; margin-left:2%; text-indent:-2%; font-size:10pt; font-family:Times New Roman"><B>Endpoints</B> </P></TD>
<TD>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></TABLE>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top">The primary endpoints of Stage 2 were PFS and OS. </TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%"> <P STYLE=" margin-top:0pt; margin-bottom:1pt; margin-left:2%; text-indent:-2%; font-size:10pt; font-family:Times New Roman"><B>Participating Centres</B> </P></TD>
<TD><B>UCLA &#150; Jonsson Comprehensive Cancer Center</B> </TD></TR></TABLE> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:38%; font-size:10pt; font-family:Times New Roman">Los Angeles, CA </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"><B>University of Colorado Cancer Center</B> </TD></TR></TABLE> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:38%; font-size:10pt; font-family:Times New Roman">Denver, CO </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"><B>Dana-Farber Cancer Institute</B> </TD></TR></TABLE> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:38%; font-size:10pt; font-family:Times New Roman">Boston, MA </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"><B>John Theurer Cancer Center</B> </TD></TR></TABLE> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:38%; font-size:10pt; font-family:Times New Roman">Hackensack, NJ </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"><B>Stephenson Cancer Center</B> </TD></TR></TABLE> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:38%; font-size:10pt; font-family:Times New Roman">Oklahoma City, OK </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"><B>MD Anderson Cancer Center</B> </TD></TR></TABLE> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:38%; font-size:10pt; font-family:Times New Roman">Houston, TX </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%"> <P STYLE=" margin-top:0pt; margin-bottom:1pt; margin-left:2%; text-indent:-2%; font-size:10pt; font-family:Times New Roman"><B>Start Date</B> </P></TD>
<TD>First Patient In: September 2018 </TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="38%"> <P STYLE=" margin-top:0pt; margin-bottom:1pt; margin-left:2%; text-indent:-2%; font-size:10pt; font-family:Times New Roman"><B>End of Recruitment</B> </P></TD>
<TD>Last Patient In: February 2020 </TD></TR></TABLE>
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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>What is the significance of the data reported here? How should these results be interpreted? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia has previously referred to the published paper by Hegi et al. on temozolomide, which reports a median PFS of 5.3 months and a median OS of 12.7 months<SUP
STYLE="font-size:85%; vertical-align:top">2</SUP>. This paper remains the definitive reference point for this patient population when treated with temozolomide, the existing standard of care. In effect, it shows that patients receiving standard
treatment will typically progress in about 5.3 months and will pass away in little over a year. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The current phase II study of paxalisib has reported a
PFS of 8.5 months and an OS of 17.7 months. Comparisons between studies are always confounded by differences in patient population, study design, calculation methodology, and other variables. However, the magnitude of these differences strongly
suggests that paxalisib is offering superior benefit to patients. Were this difference in OS to be replicated in a randomized, controlled trial, the magnitude of improvement would represent approximately a 40% increase in life expectancy. As
previously noted, the precise quantification of this benefit will be the focus of the planned GBM AGILE study. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">OS has long been considered the &#145;gold
standard&#146; measure of effectiveness for a new cancer drug<SUP STYLE="font-size:85%; vertical-align:top">3</SUP>, although a number of novel therapies have been approved in recent years without demonstrating an OS benefit. The implication that
paxalisib may be able to achieve this objective provides a powerful endorsement to its further development. </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>Is it possible that this study could provide a basis for product approval without conducting a further pivotal study? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">While these data are highly encouraging, Kazia expects that confirmation from a larger number of patients in a randomized, controlled trial will be required to
secure product approval from FDA and other regulatory agencies. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In December 2019, Kazia announced that it had begun setup work to bring paxalisib into
GBM AGILE, an ongoing platform study designed to provide data for registration of new drugs in glioblastoma. Our plan is to use GBM AGILE as a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">path-to-market</FONT></FONT> for
paxalisib, and recruitment is expected to commence in 2H CY2020. </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">US Food and Drug Administration. <I>Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
&#150; Guidance for Industry</I> (December 2018) </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 would a survival benefit of this magnitude compare to other cancer drugs, and would it be sufficient
to engage the support of clinicians and payors? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Each disease is specific, and so it is difficult to compare the potential efficacy of paxalisib with
other drugs in other disease areas. Nevertheless, Kazia takes the view that, if paxalisib continued to demonstrate in a pivotal study an OS improvement of approximately this magnitude, both in proportional and absolute terms, it would provide the
basis of a highly competitive commercial product. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">For reference, the OS benefit associated with a number of
<FONT STYLE="white-space:nowrap">FDA-approved</FONT> and commercially successful cancer treatments are indicated below:- </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" ALIGN="center">


<TR>

<TD WIDTH="35%"></TD>

<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="32%"></TD>

<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="31%"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; "><B>Drug</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Indication</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>OS 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">15.6 <FONT STYLE="FONT-FAMILY:'WINGDINGS 3'">&#103;</FONT> 20.3 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 glioblastoma</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">(no improvement)</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">6.7 <FONT STYLE="FONT-FAMILY:'WINGDINGS 3'">&#103;</FONT> 8.5 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">7.9 <FONT STYLE="FONT-FAMILY:'WINGDINGS 3'">&#103;</FONT> 10.7 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">5.0 <FONT STYLE="FONT-FAMILY:'WINGDINGS 3'">&#103;</FONT> 6.4 months</TD></TR>
</TABLE> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>(all figures taken from product Prescribing Information) </I></P>
<P STYLE="margin-top:18pt; 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 randomised, controlled trial (RCT), in which patients are randomly allocated to
receive either the treatment under investigation (in this case, paxalisib), 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 paxalisib. The reasons for this approach are various, and include both ethical and operational considerations. A recent published analysis determined that more than 60% of oncology studies are
<FONT STYLE="white-space:nowrap">single-arm</FONT> rather than RCT<SUP STYLE="font-size:85%; vertical-align:top">4</SUP>. Moreover, a separate analysis demonstrated that success in a <FONT STYLE="white-space:nowrap">single-arm</FONT> phase II study
was strongly predictive of subsequent success in a phase III study, and that an RCT phase II study was not superior to a <FONT STYLE="white-space:nowrap">single-arm</FONT> design<SUP STYLE="font-size:85%; vertical-align:top">5</SUP>. </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="line-height:8.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000;width:11%">&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="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">BR Hirsch et al. <I>JAMA Intern Med</I>. <FONT STYLE="white-space:nowrap">(2013);173(11):972-979</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">5</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">JG Monzon et al. <I>Eur J Cancer</I>. (2015);51(17):2501-2507 </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">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>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. Similarly, the median OS is the time point at which 50% of patients have passed away. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>These are interim data. Is it expected that the headline figures (PFS of 8.5 months and OS of 17.7 months) may change substantially in subsequent
read-outs? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">As additional patients complete their participation, it is possible that these data points will change, either for the better or otherwise.
The PFS data matures more quickly than the OS data, since patients typically progress before passing away, and so this data point may be considered more stable. The fact that inclusion of additional patients in the PFS analysis does not materially
change the figure may be interpreted as validating. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Why was one of the 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 paxalisib 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>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: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">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>
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<Center><DIV STYLE="width:8.25in" align="left">

<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: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">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: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">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>What are the next steps for the paxalisib program, and what does this data mean for GBM AGILE, the planned pivotal study? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This phase II study remains ongoing. At present, Kazia expects to report further interim data in 2H CY2020, and final data in 1H CY2021. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In the meantime, as previously indicated, Kazia has begin preparatory work associated with the addition of paxalisib to the ongoing GBM AGILE study in
glioblastoma. GBM AGILE is a platform study that is being run independently of any one company, under the leadership of many of the leading world experts in the field. It is designed to provide data to support registration of new drugs in
glioblastoma and is strongly supported by the US FDA. It is expected that GBM AGILE will recruit up to 200 patients on paxalisib, in a randomized, controlled trial against temozolomide, the existing standard of care. The patient population will be
highly consistent with that examined in this phase II study, and the primary endpoint will be overall survival. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">For clarity, GBM AGILE has been adopted
in place of a previously-planned company-sponsored phase III study, and it is expected that it will provide the <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">path-to-market</FONT></FONT> for the commercial product. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Investors are referred to Kazia&#146;s announcement in December 2019 and its investor newsletter in March 2020 for additional information. At present, Kazia
expects that GBM AGILE will begin recruiting paxalisib patients in 2H CY2020, prior to finalization of the ongoing phase II study. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>How is progress on
the other paxalisib clinical trials? </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 paxalisib are underway in DIPG and in brain
metastases. All of these studies have recruited patients. Kazia is working with investigators in the hope of providing interim data from several of these studies during CY2020 and will update investors accordingly in due course. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>What are Kazia&#146;s plans for publication of final data from this study? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia expects that final data from this phase II study will be published in a peer-reviewed journal in CY2021, after completion of all analyses. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In the meantime, the phase I study originally conducted by Genentech has been accepted for publication by the journal <I>Clinical Cancer Research</I>, and
publication is expected soon. In addition, the post hoc analysis of imaging data from that study by Professor Ben Ellingson at UCLA has separately been accepted for publication in the same journal. Professor Ellingson&#146;s work was previously the
subject of a <FONT STYLE="white-space:nowrap">prize-winning</FONT> oral presentation at the Society for Neuro-Oncology annual meeting in November 2019, as announced at the time by Kazia. </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>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 paxalisib, 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 paxalisib? 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 continues to entertain exploratory discussion with several potential partners for the paxalisib asset. The timing and terms of any future transaction
will be designed to ensure the most expeditious development of the drug, and the optimal return to Kazia shareholders. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Does Kazia expect this or other
studies to be affected by the ongoing <FONT STYLE="white-space:nowrap">COVID-19</FONT> outbreak? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia works with large, world-class,
highly-experienced partners in the conduct of its studies, and each of these collaborators have put in place measures to mitigate the impact of <FONT STYLE="white-space:nowrap">COVID-19.</FONT> At this stage, we see minor operational disruption, but
no suggestion that the timelines or data integrity of our clinical studies are likely to be fundamentally affected. We will continue to keep investors informed as the situation develops. </P>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
