<SEC-DOCUMENT>0001193125-21-347172.txt : 20211203
<SEC-HEADER>0001193125-21-347172.hdr.sgml : 20211203
<ACCEPTANCE-DATETIME>20211203062253
ACCESSION NUMBER:		0001193125-21-347172
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20211203
FILED AS OF DATE:		20211203
DATE AS OF CHANGE:		20211203

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:		211468661

	BUSINESS ADDRESS:	
		STREET 1:		THREE INTERNATIONAL TOWERS LEVEL 24,
		STREET 2:		300 BARANGAROO AVENUE
		CITY:			SYDNEY NSW
		STATE:			C3
		ZIP:			2000
		BUSINESS PHONE:		01161298780088

	MAIL ADDRESS:	
		STREET 1:		THREE INTERNATIONAL TOWERS LEVEL 24,
		STREET 2:		300 BARANGAROO AVENUE
		CITY:			SYDNEY NSW
		STATE:			C3
		ZIP:			2000

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	NOVOGEN LTD
		DATE OF NAME CHANGE:	19981228
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>d217978d6k.htm
<DESCRIPTION>FORM 6-K
<TEXT>
<HTML><HEAD>
<TITLE>Form 6-K</TITLE>
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<Center><DIV STYLE="width:8.25in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>Form 6-K
</B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF FOREIGN PRIVATE ISSUER </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO RULE 13a-16 OR 15d-16 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>For the month of December, 2021 </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 3 December 2021 </P>
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<IMG SRC="g217978dsp3.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">3&nbsp;December
2021 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>KAZIA ANNOUNCES POSITIVE FINAL DATA FROM PHASE II CLINICAL STUDY </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>OF PAXALISIB IN NEWLY DIAGNOSED GLIOBLASTOMA </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Sydney, 3</B><B></B><B>&nbsp;December 2021</B> &#150; Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is
pleased to announce positive final data from a phase II clinical study of paxalisib as first line therapy in patients with glioblastoma (NCT03522298). The results confirm the previously reported safety and efficacy profile with paxalisib in this
high unmet need disease. </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="2%" 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">The study recruited 30 patients with newly diagnosed glioblastoma and unmethylated MGMT promotor status, a
genetic profile which confers primary resistance to temozolomide, the only existing <FONT STYLE="white-space:nowrap">FDA-approved</FONT> drug treatment for first line treatment. </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="1%">&nbsp;</TD>
<TD WIDTH="2%" 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">60mg once daily was identified as the maximum tolerated dose (MTD) and selected for future studies.
</P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
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<TD WIDTH="1%">&nbsp;</TD>
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<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) in the
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">intent-to-treat</FONT></FONT> (ITT) population (n=30) was 15.7 months (11.1 &#150; 19.1), which compares very favourably to 12.7 months historically reported with temozolomide in this
patient group.<SUP STYLE="font-size:85%; vertical-align:top">1</SUP> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Median progression-free survival (PFS) in the ITT population was 8.4 months (6.6 &#150; 10.2), representing a
substantial increment over the comparable figure of 5.3 months associated with temozolomide. </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">In the modified ITT (mITT) population (n=27), which includes only those patients evaluable for efficacy, OS
increased to 15.9 months (12.8 &#150; 19.1). </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">The safety profile of paxalisib was highly consistent with previous clinical studies: hyperglycaemia, oral
mucositis, and skin rash were among the most common drug-related toxicities. </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="1%">&nbsp;</TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Kazia expects to receive a final clinical study report in 1Q CY2022 and intends to seek publication of these data
in a peer-reviewed scientific journal thereafter. </P></TD></TR></TABLE> <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>
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<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:8pt; font-family:Times New Roman; " ALIGN="left">ME Hegi et al. (2005)<I>&nbsp;N Engl J Med</I>. <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">Kazia CEO, Dr James Garner, commented, &#147;We are delighted to report positive final data from the
completed phase II study of paxalisib. The data continue to demonstrate a clear efficacy signal and favourable safety profile, suggesting a meaningful advantage over temozolomide, the existing standard of care, and validating our decision last year
to join the GBM AGILE pivotal study. We have gleaned invaluable insights from this trial, and we are tremendously grateful to the investigators and to the patients who participated. Our task now, as we move rapidly toward a potential marketing
authorization, is to confirm and quantify the benefit associated with paxalisib in glioblastoma patients. This indeed is the focus of our participation in GBM AGILE, which commenced recruiting to the paxalisib arm in January 2021. We are
increasingly also exploring additional patient populations for which a brain penetrant PI3K/mTOR inhibitor may provide significant advantages over the standard of care.&#148; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Professor Patrick Wen, Principal Investigator at Dana Farber Cancer Institute, commented &#147;We are pleased to see the phase II study of paxalisib
successfully completed. This data supports the inclusion of paxalisib in the GBM AGILE study, which has recently expanded to Canada. Glioblastoma remains a disease in urgent need of new therapeutic options, and we look forward to seeing further data
for paxalisib from GBM AGILE in due course.&#148; </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Clinical Trial Design </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The phase II study of paxalisib was an adaptive trial, conducted in two stages. The first stage sought to determine the most appropriate dose in newly
diagnosed patients. The second stage was intended to provide additional information on dosing and to seek a preliminary efficacy signal in order to <FONT STYLE="white-space:nowrap">de-risk</FONT> transition to a larger, pivotal study. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Consistent with these objectives, the primary objective of the study was to evaluate the safety and tolerability of paxalisib in patients with newly diagnosed
glioblastoma. The secondary objectives included typical pharmacokinetic parameters, and efficacy endpoints including overall survival (OS) and progression-free survival (PFS). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The phase II study was conducted in 30 patients at six centres in the United States. It was a single arm study in which all patients received paxalisib as a
monotherapy. As such, all data must be interpreted in the context of historical comparators. Specifically, Kazia has referred to the pivotal study of temozolomide, the only existing <FONT STYLE="white-space:nowrap">FDA-approved</FONT> drug for this
patient population. Such comparisons are always inexact, and this study was not designed either to precisely quantify the benefit associated with paxalisib or to demonstrate statistical significance. Rather, these are among the objectives of the
ongoing GBM AGILE pivotal trial. </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">On the
basis of earlier interim analyses of this study, Kazia made the decision in 4Q CY2020 to commence participation in the GBM AGILE pivotal study. This global trial recruited its first patient to the paxalisib arm in January 2021 and recruitment is
ongoing. Kazia provisionally expects indicative data in CY2023. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Seven other studies of paxalisib are ongoing in other forms of primary brain cancer and in various forms of
cancer that has metastasized to the brain. The company is working with investigators to crystalise the timing of initial data read-outs from these studies. Kazia had expected at least two further read-outs by the end of CY2021. Clinicians have now
indicated that data early in CY2022 is most likely. The company will continue to keep shareholders closely informed as it receives further feedback from investigators. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Having successfully concluded the phase II study in glioblastoma, the investigators are composing a manuscript for submission and publication to a
peer-reviewed academic journal in 2022. Once the data has been more thoroughly analysed, Kazia expects to share further detail with investors as it becomes available. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>For More Information, Please Contact:- </B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top"><I><U>In the United States:</U></I></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><U><I>In Australia:</I></U></TD></TR>
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<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
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<TD VALIGN="top">Joe Green</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">Jane Lowe</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Edison Investor Relations</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">IR Department</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"><U>jgreen@edisongroup.com</U></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><U>jane.lowe@irdepartment.com.au</U></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Phone: +1 <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">646-653-7030</FONT></FONT></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">Phone: +61 411 117 774</TD></TR>
</TABLE> <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 (NASDAQ: KZIA; ASX: KZA) is an oncology-focused drug development company, based in Sydney, Australia. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Our lead program is paxalisib, a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat glioblastoma, the most common
and most aggressive form of primary brain cancer in adults. Licensed from Genentech in late 2016, paxalisib commenced recruitment to GBM AGILE, a pivotal study in glioblastoma, in January 2021. Eight additional studies are active in various forms of
brain cancer. Paxalisib was granted Orphan Drug Designation for glioblastoma by the US FDA in February 2018, and Fast Track Designation for glioblastoma by the US FDA in August 2020. In addition, paxalisib was granted Rare Pediatric Disease
Designation and Orphan Designation by the US FDA for DIPG in August 2020. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which
was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided compelling evidence of synergy with immuno-oncology agents. A phase I study commenced recruitment in
November 2021. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">For more information, please visit <U>www.kaziatherapeutics.com</U> or follow us on Twitter @KaziaTx. </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="35%"></TD>

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<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"><B>Study Title</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3">Safety, Pharmacokinetics, and Efficacy of Paxalisib <FONT STYLE="white-space:nowrap">(GDC-0084)</FONT> in Newly-Diagnosed Glioblastoma</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="4"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"><B>Phase of Development</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3">Phase II</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="4"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"><B>Investigational Product</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3">Paxalisib <FONT STYLE="white-space:nowrap">(GDC-0084)</FONT></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="4"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"><B>Disease Area</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3">Newly diagnosed glioblastoma with unmethylated MGMT promotor status (representing resistance to temozolomide)</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="4"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"><B>Registration</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3">NCT03522298</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="4"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"><B>Study Description</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3">This is an exploratory study to identify the optimal dose for further investigation, further characterise the safety profile in newly diagnosed patients, and to seek preliminary signals of efficacy.</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="4"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"><B>Number of Subjects</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3">30 patients</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="4"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"><B>Study Design</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3"> <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> study, in which all patients received paxalisib.</P>
<P STYLE="font-size:12pt; 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> is a dose escalation component, designed to determine the maximum
tolerated dose in newly diagnosed patients.</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> is an expansion cohort,
designed to provide further safety and pharmacokinetic data, explore the effect of taking paxalisib with food versus on an empty stomach, and to identify preliminary signals of clinical efficacy.</P></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="4"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"><B>Patient Population</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3">Newly diagnosed glioblastoma with unmethylated MGMT promotor status</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="4"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"><B>Endpoints</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3">The primary endpoints of this study were safety and tolerability.</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="4"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"><B>Start Date</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3">May 2018</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="4"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"><B>End of Recruitment</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3">February 2020</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>How much confidence do these results provide in relation to the likely outcome of the GBM AGILE study? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This phase II study is exploratory in nature, and was designed to provide, among other information, a preliminary signal of clinical efficacy in order to <FONT
STYLE="white-space:nowrap">de-risk</FONT> further development. In Kazia&#146;s view, the final data clearly provides that signal, and strongly suggests that paxalisib improves the clinical outcome for patients with newly diagnosed glioblastoma. On
that basis, the decision in 4Q CY2020 to move the drug into a pivotal study appears to be fully validated. Kazia remains of the view that the probability of technical success in GBM AGILE remains favourable and is largely unchanged for better or for
worse on the basis of the final data from the phase II study. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This phase II study was not designed to precisely quantify the benefit that paxalisib
provides in this patient population. Kazia has consistently stated that this question can only be meaningfully resolved by a larger, randomised controlled study. This is, in effect, the role of the GBM AGILE trial, which commenced recruitment to the
paxalisib arm in January 2021. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>How do the final results compare to previous interim analyses from this study? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The progression-free survival (PFS) observed in this study is highly consistent with previous interim analyses, which have reported median PFS of 8.4 &#150;
8.5 months. The overall survival (OS) of 15.7 months seen in the final data is modestly lower than the interim result of 17.4 months reported at the Society for Neuro-Oncology Annual Meeting in November 2020. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On initial examination, it appears that several of the last few patients recruited to the study experienced rapidly progressive disease, thereby pulling down
the overall result. In open label studies such as this one, clinicians do sometimes recruit more challenging patients in the later part of the study, and Kazia intends to examine this hypothesis in further discussion with investigators. However, the
final figure of 15.7 months continues to represent a substantial increment over the existing standard of care, which is associated with a median OS of 12.7 months in this patient group and should therefore be considered a very encouraging result.
</P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Are the OS and PFS data statistically significant? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In clinical trials, the concept of &#145;statistical significance&#146; refers to the likelihood that the difference between two arms of the study is due to
chance rather than to the effects of the therapy under investigation. Since this was a <FONT STYLE="white-space:nowrap">single-arm</FONT> study, statistical significance is not applicable here. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Did the study meet its primary objective? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Yes. The
primary objective of this study was safety and tolerability, and that outcome was fully met. While several efficacy endpoints were included as secondary objectives, there were no specific <FONT STYLE="white-space:nowrap">pre-defined</FONT> hurdles
for those outcome measures. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>What is the difference between the ITT and mITT populations? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">&#145;intent-to-treat&#146;</FONT></FONT> (ITT) population of a clinical trial typically
captures all patients who provided informed consent to participate, regardless of how much study drug they received (or even if they received any at all), and irrespective of how much data they provided. In this study, the ITT population includes
all 30 patients who were enrolled. Most endpoints are derived from the ITT population, since it provides the broadest dataset and minimises the risk of bias associated with the exclusion of individual patients. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Clinical studies commonly also examine a modified ITT (mITT) or efficacy evaluable (EE) population, which typically includes only those patients who provide
data that is likely to be meaningful, and which is included as a sensitivity analysis. In this study, Kazia has separately conducted all analyses on an mITT population of 27 patients, who received at least one dose of paxalisib and provided at least
one efficacy assessment. In this group, the OS improves from 15.7 months to 15.9 months. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Is the Hegi paper the most appropriate historical control for
the phase II GBM study? It was published fifteen years ago and the outcomes for GBM may have improved in that time. </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In general, there is limited
evidence of an improvement in GBM prognosis since the approval of temozolomide in the late 1990s. A recent meta-analysis found no convincing trend over time<SUP STYLE="font-size:85%; vertical-align:top">2</SUP>. In addition, few studies of newly
diagnosed patients separately report data for patients with unmethylated MGMT promotor status, and so their results cannot readily be compared to the results of this study. In general, other studies have reported median overall survival between 11.2
and 13.8 months for unmethylated patients treated with temozolomide, the existing standard of care. Kazia is not aware of any study reporting median overall survival with temozolomide which is comparable to the figure of 15.7 months seen with
paxalisib in this study, which supports a positive interpretation of this data. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Overall Response Rate (ORR) is a common endpoint for phase II oncology
trials. Why has that not been reported in this study? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">ORR is a common exploratory endpoint in phase II cancer studies. In essence, it measures the
change in size of a tumour while a patient undergoes treatment. Meaningful shrinkage is described as &#145;response&#146;. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In this study, the majority of
patients had undergone complete surgical resection prior to study entry and so had no measurable tumour at baseline. It is impossible to measure shrinkage from a baseline of zero, and so ORR is not a viable endpoint for this study. PFS and OS are
considered stronger and more meaningful endpoints, because they represent more patient-relevant outcomes. </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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<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:8pt; font-family:Times New Roman; " ALIGN="left">L Marenco-Hillenbrand, O Wijesekera, P Suarez-Meade, et al. <I>Journal of Neurology</I> (2020). <FONT
STYLE="white-space:nowrap">147:297-307</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"><B>Why did this study only contain a single arm, when randomised data is considered more reliable? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This study was intended to serve several purposes. The primary objective was to determine the most appropriate dose in newly diagnosed patients, and this task
only requires a <FONT STYLE="white-space:nowrap">single-arm</FONT> design. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Although the trial also included exploratory, efficacy endpoints, these were
signal-seeking in intent, and the study was not intended to provide definitive quantification of clinical efficacy. Kazia viewed the efficacy components of this study as a <FONT STYLE="white-space:nowrap">de-risking</FONT> step, prior to committing
substantial investment toward a pivotal study. A well-powered, randomised study would have provided greater <FONT STYLE="white-space:nowrap">de-risking,</FONT> but at very substantially greater cost, and so the company took the view that the <FONT
STYLE="white-space:nowrap">single-arm</FONT> study design represented the optimal balance between cost and risk reduction, with the randomised design deferred to a pivotal study. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>How does the safety profile reported in the phase II GBM study compare to <FONT STYLE="white-space:nowrap">FDA-approved</FONT> PI3K inhibitors? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Paxalisib appears to have a very favourable safety profile for use in advanced cancer. The key toxicities observed with the drug include hyperglycaemia, oral
mucositis (mouth ulcers), rash, and fatigue. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">While hyperglycaemia is a common side effect of all drugs inhibiting PI3K&#945;, the rates of serious
hyperglycaemia seen with paxalisib are approximately half those seen with comparable agents. Rash and mucositis are believed to be primarily mTOR-driven toxicities, and so are not directly comparable with approved PI3K inhibitors, which do not have
mTOR activity. Other less common, but serious, toxicities that have been seen with other agents, such as pneumonitis, infection, liver toxicity, hypertension, and GI toxicity, have not been seen with paxalisib. On present evidence, the drug has the
potential to achieve a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">best-in-class</FONT></FONT> safety profile. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>If GBM AGILE
demonstrated an improvement in overall survival associated with paxalisib of approximately three months (the difference between this result and the historical data for temozolomide), what would this mean for paxalisib&#146;s commercial prospects?
</B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">For newly diagnosed patients, the only existing <FONT STYLE="white-space:nowrap">FDA-approved</FONT> <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">standard-of-care</FONT></FONT> drug treatment is temozolomide. In this patient population (those with unmethylated MGMT promotor status), temozolomide is associated with an improvement in survival from 11.8 to 12.7 months,
or about four weeks. Although this study was not designed to precisely quantify treatment benefit, the implicit survival extension associated with paxalisib would be approximately four times greater than the existing standard of care (four months
rather than four weeks). Before it lost patent protection, temozolomide achieved peak sales in excess of US$ 1&nbsp;billion per annum. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In the recurrent setting, Avastin (bevacizumab) is approved in certain markets. This drug has never
demonstrated any survival benefit in glioblastoma. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Primary market research commissioned by Kazia Therapeutics in
<FONT STYLE="white-space:nowrap">mid-2021</FONT> found that a survival benefit of 2.6 months versus standard of care would be expected to yield an adoption rate of 84% among clinicians in the United States. This is an exceptionally high market
penetration. A survival benefit of 7 months was associated with only an additional 10% adoption. In short, paxalisib has excellent commercial prospects if it is able to show any meaningful evidence of efficacy whatsoever in this patient population.
</P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>How do the final data from this study compare to other treatments in development for glioblastoma? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In general, it is extremely difficult to compare results across different phase II studies because they are conducted in different ways with slightly different
patient populations. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Two other therapies are under investigation in GBM AGILE alongside paxalisib: Bayer&#146;s regorafenib and Kintara
Therapeutics&#146; <FONT STYLE="white-space:nowrap">VAL-083.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In the REGOMA study of regorafenib in recurrent glioblastoma, treatment was
associated with a survival advantage of approximately 1.8 months in comparison to lomustine.<SUP STYLE="font-size:85%; vertical-align:top">3</SUP> No published data is available in newly diagnosed patients. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">For <FONT STYLE="white-space:nowrap">VAL-083,</FONT> interim data from two ongoing <FONT STYLE="white-space:nowrap">single-arm</FONT> phase II studies were
the subject of poster presentations <FONT STYLE="white-space:nowrap">(CTNI-21</FONT> and <FONT STYLE="white-space:nowrap">CTNI-26)</FONT> at the Society for Neuro-Oncology (SNO) Annual Meeting in November 2021.<SUP
STYLE="font-size:85%; vertical-align:top">4</SUP> The first of these reported OS of 19.1 months in an efficacy evaluable population of 25 patients from a study performed entirely in China. The second reported on 36 efficacy evaluable patients in a
single-centre study in the United States and determined an interim OS of 16.5 months. There are material differences in study design and patient population, but Kazia considers this second study to be more closely comparable to the paxalisib data.
Given the relatively small number of patients in each study, and consequently wide confidence intervals, the results may be considered approximately equivalent. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Few other drugs under investigation report data specifically in the newly diagnosed unmethylated population. In the universe that Kazia tracks, Inovio
reported interim data at SNO in November 2020 from a phase II study involving a combination of <FONT STYLE="white-space:nowrap">INO-5401</FONT> (a gene therapy encoding hTERT, WT1, and PSMA), <FONT STYLE="white-space:nowrap">INO-9012</FONT> (a gene
therapy encoding <FONT STYLE="white-space:nowrap">IL-12,</FONT> a <FONT STYLE="white-space:nowrap">T-cell</FONT> activator), and cemiplimab (a <FONT STYLE="white-space:nowrap">PD-1</FONT> inhibitor), delivered via intramuscular injection with
electroporation to achieve temporary blood-brain barrier penetration. This data reported median OS in 32 patients of 17.9 months.<SUP STYLE="font-size:85%; vertical-align:top">5</SUP> </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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<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:8pt; font-family:Times New Roman; " ALIGN="left">G Lombardi et al. (2019)<I>&nbsp;Lancet Oncol.</I> <FONT STYLE="white-space:nowrap">20(1):110-119</FONT>
</P></TD></TR></TABLE>
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<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:8pt; font-family:Times New Roman; " ALIGN="left">Kintara Therapeutics press release of 18&nbsp;November 2021 </P></TD></TR></TABLE>
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<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:8pt; font-family:Times New Roman; " ALIGN="left">Inovio press release of 20&nbsp;November 2021 </P></TD></TR></TABLE>
</DIV></Center>


<p style="margin-top:1em; margin-bottom:0em; page-break-before:always">
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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">In May 2019, Bristol Myers Squibb announced that a phase III study of Opdivo<SUP
STYLE="font-size:85%; vertical-align:top">&reg;</SUP> (nivolumab) in patients with newly diagnosed glioblastoma with unmethylated MGMT promotor status, the <FONT STYLE="white-space:nowrap">Checkmate-498</FONT> study, failed to meet its primary
endpoint of overall survival.<SUP STYLE="font-size:85%; vertical-align:top">6</SUP> </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>What would the approval of another novel glioblastoma therapy,
either before or after paxalisib, mean for paxalisib&#146;s commercial prospects? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Most cancers are treated with a wide range of therapies. For
example, in the last decade, around twenty new drugs have been approved by FDA for lung cancer. Almost no drug treatment is curative, and so clinicians typically use drugs in different sequences and combinations to maximise patient benefit. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">It is highly likely that this will also be the trajectory for glioblastoma. At present, there is only one <FONT STYLE="white-space:nowrap">FDA-approved</FONT>
drug for first line use, temozolomide. In a disease with as high an unmet need as glioblastoma, this represents an extraordinary paucity of treatment options. Kazia expects and hopes that multiple new therapies will become available over coming
years. In general, such therapies will be used in combination regimes, and so there is likely to be relatively less intense competition for market share. </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>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:8pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:85%; vertical-align:top">6</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman; " ALIGN="left">Bristol Myers Squibb press release of 9&nbsp;May 2019 </P></TD></TR></TABLE>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
