<SEC-DOCUMENT>0001193125-22-270337.txt : 20221027
<SEC-HEADER>0001193125-22-270337.hdr.sgml : 20221027
<ACCEPTANCE-DATETIME>20221027072108
ACCESSION NUMBER:		0001193125-22-270337
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20221027
FILED AS OF DATE:		20221027
DATE AS OF CHANGE:		20221027

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:		221334904

	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>
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<TYPE>6-K
<SEQUENCE>1
<FILENAME>d408347d6k.htm
<DESCRIPTION>FORM 6-K
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<HTML><HEAD>
<TITLE>Form 6-K</TITLE>
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<Center><DIV STYLE="width:8.5in" 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 <FONT
STYLE="white-space:nowrap">6-K</FONT> </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 <FONT STYLE="white-space:nowrap">13a-16</FONT> OR
<FONT STYLE="white-space:nowrap">15d-16</FONT> </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 October, 2022 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission File Number <FONT STYLE="white-space:nowrap">000-29962</FONT> </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&nbsp;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 <FONT STYLE="white-space:nowrap">20-F</FONT> or Form <FONT
STYLE="white-space:nowrap">40-F.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">Form
20-F&nbsp;&nbsp;&nbsp;&#9745;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Form <FONT STYLE="white-space:nowrap">40-F&nbsp;&nbsp;&nbsp;&#9744;</FONT> </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 <FONT STYLE="white-space:nowrap">6-K</FONT> in paper as permitted by Regulation <FONT
STYLE="white-space:nowrap">S-T</FONT> Rule 101(b)(1):&nbsp;&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 <FONT
STYLE="white-space:nowrap">6-K</FONT> in paper as permitted by Regulation <FONT STYLE="white-space:nowrap">S-T</FONT> Rule 101(b)(7):&nbsp;&nbsp;&nbsp;&#9744; </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>INFORMATION CONTAINED IN THIS FORM <FONT STYLE="white-space:nowrap">6-K</FONT> REPORT
</B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On October&nbsp;27, 2022, Kazia Therapeutics Limited (the &#147;Company&#148;) issued an press release titled, &#147;Kazia&#146;s
Paxalisib Demonstrates Positive Monotherapy Efficacy Signals in Preclinical Models of Melanoma.&#148; A copy of this release is attached hereto as Exhibit&nbsp;99.1 and is incorporated herein by reference. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The Company hereby incorporates by reference the information contained herein into the Company&#146;s registration statement on <FONT
STYLE="white-space:nowrap">Form&nbsp;F-3</FONT> (File <FONT STYLE="white-space:nowrap">No.&nbsp;333-259224).</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B><U>EXHIBIT LIST
</U></B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="93%"></TD></TR>
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<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>Exhibit</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman"><B>Description</B></P></TD></TR>


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<TD VALIGN="top" NOWRAP>99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d408347dex991.htm">Press Release of Kazia Therapeutics Limited dated October&nbsp;27, 2022 </A></TD></TR>
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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="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<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"><B>Kazia</B><B> Therapeutics Limited</B> (Registrant)</P></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></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:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Karen Krumeich</P></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">Karen Krumeich</P></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">Chief Financial Officer</P></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD></TR>
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<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">Date: October&nbsp;27, 2022</P></TD></TR>
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<TYPE>EX-99.1
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<DESCRIPTION>EX-99.1
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="right"><B>Exhibit 99.1 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt;margin-bottom:0pt">


<IMG SRC="g408347g1027043754109.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">PRESS RELEASE </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">October 27<SUP
STYLE="font-size:75%; vertical-align:top">th</SUP>, 2022 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>KAZIA&#146;S PAXALISIB DEMONSTRATES POSITIVE MONOTHERAPY EFFICACY SIGNALS IN
PRECLINICAL MODELS OF MELANOMA </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Sydney, October 27</B><B><SUP STYLE="font-size:75%; vertical-align:top">th</SUP></B><B>, 2022</B> &#150; Kazia
Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is pleased to announce the presentation of new data from an ongoing research collaboration with the Huntsman Cancer Institute at the University of Utah in
Salt Lake City, UT. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">A poster presentation by Dr Gennie Parkman and colleagues, working in the laboratory of Professor Sheri Holmen, has shown paxalisib
to be active <I>in vitro</I> and <I>in vivo</I> against a range of preclinical models of metastatic melanoma, the most aggressive form of skin cancer. Dr Parkman&#146;s data suggested substantial activity for paxalisib as monotherapy, and greater
activity in combination with MEK and BRAF inhibitors, two classes of drugs that are commonly used for a substantial proportion of melanoma patients. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">&#147;This is among the most promising single agent data that we have seen in our research,&#148; commented Professor Sheri Holmen, lead investigator on the
project. &#147;Despite the widespread adoption of immunotherapy in recent years, there remains substantial unmet need in melanoma, particularly in those patients who develop brain metastases. We look forward to exploring the potential of paxalisib
further in our research, and hopefully seeing the drug transition to a clinical trial in the near future.&#148; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">A copy of Dr Parkman&#146;s poster is
available via the Kazia website. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The research by the University of Utah team was presented at the
19<SUP STYLE="font-size:75%; vertical-align:top">th</SUP> International Congress of the Society for Melanoma Research, held in Edinburgh, Scotland from October 17<SUP STYLE="font-size:75%; vertical-align:top">th</SUP> &#150; 20<SUP
STYLE="font-size:75%; vertical-align:top">th</SUP>, 2022. The collaboration remains ongoing, with additional preclinical studies anticipated as a prelude to potential future clinical trials. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Key Points </B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Approximately 100,000 Americans are diagnosed with invasive melanoma each year. It is the fifth most common
cancer in the US, and one of the most common cancers in young adults. Despite marked progress in treatment of the disease, around 7,500 patients die from melanoma in the US each year. </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Approximately 50% of melanoma cases harbor a genetic mutation known as BRAF. Such patients are often treated with
a combination of two drugs, known as a MEK inhibitor and a BRAF inhibitor respectively. </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Despite receiving BRAF / MEK inhibitor therapy, most patients eventually progress. Activation of the PI3K / Akt /
mTOR pathway, which is the target of paxalisib, has been identified as a key resistance mechanism to these therapies, and has also been found to promote brain metastases. </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">&#147;We are honored to be collaborating with Professor Holmen&#146;s team at the Huntsman Cancer Institute,&#148; commented Dr James Garner, Chief Executive
Officer at Kazia. &#147;Although brain cancer, in various forms, has been the primary focus of paxalisib&#146;s clinical development thus far, we have always believed that the drug offers the potential to treat cancers that metastasize to the brain,
and indeed cancers outside the central nervous system. This promising data from one of the leading US melanoma research centers points towards an important new opportunity for paxalisib. We look forward to working closely with the team to move this
collaboration forward.&#148; </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Melanoma </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Approximately 1 in 50 people will be diagnosed with melanoma during their lifetime. Most cases are localized to the skin and can be cured through surgical
resection. However, about 20% of cases spread (metastasize) and require more complex and ongoing treatment. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Melanoma represents approximately 1% of all
skin cancers, but accounts for the majority of deaths from skin cancer. For melanoma that is confined to the skin at the time of diagnosis, the five-year survival rate is 99.5%. However, for melanoma that has spread to distant sites (metastatic
melanoma), the five-year survival rate falls to 32%. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Approximately 50% of patients harbour activating mutations in the BRAF gene. Such patients are
typically treated with the combination of a BRAF inhibitor and a MEK inhibitor. The most common drugs used are Tafinlar<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (dabrafenib) /
Mekinist<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (trametinib) (manufactured by Novartis), Braftovi<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (encorafenib) /
Mektovi<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (binimetinib) (manufactured by Pfizer), and Zalboraf<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (vemurafenib) /
Cotellic<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> (cobimetinib) (manufactured by Genentech). The introduction of such targeted therapies has improved the average survival of patients with BRAF-mutant metastatic melanoma from
approximately 6 months to approximately 24 months. However, there remains a need for additional therapeutic options to further improve survival. </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">Kazia anticipates further data from the ongoing collaboration with the Huntsman Cancer Institute in CY2023. Depending on the results, Kazia may
evaluate future opportunities to launch a clinical trial of paxalisib in melanoma. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">A broad clinical program exploring paxalisib in multiple forms of
brain cancer is ongoing. During 2022, two ongoing clinical trials of paxalisib in the treatment of brain metastases have reported positive interim results and have graduated to expansion cohorts. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In addition, six other clinical trials of paxalisib in other forms of adult and pediatric brain cancer are ongoing, with multiple data read-outs anticipated
throughout CY2023. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>For More Information, Please Contact:- </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Jane Lowe </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">IR Department </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>jane.lowe@irdepartment.com.au </U></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Phone: +61 411 117 774 </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Kazia Therapeutics Limited </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia Therapeutics
Limited (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 multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A
completed phase II study in glioblastoma reported promising signals of efficacy in 2021, and a pivotal study for registration, GBM AGILE, is ongoing, with final data expected in CY2023. Other clinical trials are ongoing in brain metastases, diffuse
midline gliomas, and primary CNS lymphoma, with several of these having reported encouraging interim data. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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, and for atypical teratoid / rhabdoid tumours (AT/RT) in June 2022 and July 2022, respectively. </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:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Forward-Looking Statements </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This announcement may contain
forward-looking statements, which can generally be identified as such by the use of words such as &#147;may,&#148; &#147;will,&#148; &#147;estimate,&#148; &#147;future,&#148; &#147;forward,&#148; &#147;anticipate,&#148; or other similar words. Any
statement describing Kazia&#146;s future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward-looking statements, including, but not limited to, statements
regarding: the timing for results and data related to Kazia&#146;s clinical and preclinical trials, and Kazia&#146;s strategy and plans with respect to its programs, including paxalisib. Such statements are based on Kazia&#146;s expectations and
projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including
risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, and the related to the impact of global economic conditions. These and other risks and uncertainties are described
more fully in Kazia&#146;s Annual Report, filed on form <FONT STYLE="white-space:nowrap">20-F</FONT> with the SEC, and in subsequent filings with the SEC. Kazia undertakes no obligation to publicly update any forward-looking statement, whether as a
result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement. </P>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
