<SEC-DOCUMENT>0001193125-23-268217.txt : 20231101
<SEC-HEADER>0001193125-23-268217.hdr.sgml : 20231101
<ACCEPTANCE-DATETIME>20231101161759
ACCESSION NUMBER:		0001193125-23-268217
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20231101
FILED AS OF DATE:		20231101
DATE AS OF CHANGE:		20231101

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:		231368497

	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
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<FILENAME>d571163d6k.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 November, 2023 </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&#8194;&#9745;&#8195;&#8195;&#8195;&#8195; Form
<FONT STYLE="white-space:nowrap">40-F&#8194;&#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):&#8194;&#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):&#8194;&#9744; </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:3.0pt;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 November 1, 2023, Kazia Therapeutics Limited (the &#147;Company&#148;) issued an ASX release titled, &#147;Kazia Therapeutics
Provides Preliminary Update From Ongoing Phase 2 Study of Paxalisib In Primary CNS Lymphoma,&#148; regarding a preliminary update from the Company&#146;s ongoing Phase 2 clinical trial (NCT04906096) evaluating paxalisib monotherapy treatment in
patients with relapsed/refractory primary central nervous system lymphoma (r/r&nbsp;PCNSL). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">This is an open-label Phase 2 clinical trial,
led by Dr. Lakshmi Nayak MD, of the Dana-Farber Cancer Institute in Boston, MA. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Eligible patients with r/r PCNSL will be administered
paxalisib as monotherapy for up to 24 months, in an initial dosing regimen of 60mg daily, which is similar to the dosing regimen used for paxalisib clinical trials in other adult brain cancers. The objectives of the study are to assess the clinical
efficacy and safety of paxalisib in up to twenty-five (25) patients with r/r PCNSL based on objective response rate (ORR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS). To date, fourteen (14) patients have
been enrolled in the study. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Clinical activity has been preliminarily observed in enrolled patients, including partial responses and
stable disease. Although early clinical activity was observed in some patients, several heavily pretreated r/r PCNSL patients experienced treatment-related adverse events that resulted in dose reductions and, in some cases, early termination from
the study. As such, the protocol is being optimized by the investigator to initiate starting doses at 15mg twice a day or 30mg once a day with the goal of improving the durability of clinical benefit and overall tolerability. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">A copy of the ASX 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, including Exhibit 99.1, other than the quotes of Dr. John
Friend, into the Company&#146;s registration statement on Form F-3 (File No. 333-259224). </P> <P STYLE="margin-top:24pt; 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></TD>

<TD VALIGN="bottom" WIDTH="4%"></TD>
<TD WIDTH="93%"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="bottom" NOWRAP ALIGN="center" STYLE="border-bottom:1.00pt solid #000000"><B>Exhibit</B></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>


<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP>99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d571163dex991.htm">ASX Announcement of Kazia Therapeutics Limited dated November&nbsp;1, 2023 </A></TD></TR>
</TABLE>
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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 WIDTH="100%"></TD></TR>


<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"><B>Kazia Therapeutics Limited</B> (Registrant)</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">Karen Krumeich</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Chief Financial Officer</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">Date: 1 November 2023</TD></TR>
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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="g571163g1022083623949.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">01 Nov 2023 </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>KAZIA THERAPEUTICS PROVIDES PRELIMINARY UPDATE </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>FROM ONGOING PHASE 2 STUDY OF PAXALISIB IN PRIMARY CNS LYMPHOMA </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Sydney, 01 Nov 2023</B> &#150; Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is pleased to provide a
preliminary update from the ongoing investigator-initiated Phase 2 clinical trial (NCT04906096) evaluating paxalisib as monotherapy treatment in patients with relapsed/refractory primary central nervous system lymphoma (r/r PCNSL). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This is an open-label, Phase 2 clinical trial, led by Dr. Lakshmi Nayak MD, of the Dana-Farber Cancer Institute in Boston, MA. Eligible patients with r/r
PCNSL will be administered paxalisib as monotherapy for up to 24 months, in an initial dosing regimen of 60mg daily, which is similar to the dosing regimen used for paxalisib clinical trials in other adult brain cancers. The objectives of the study
are to assess the clinical efficacy and safety of paxalisib in up to twenty-five (25) patients with r/r PCNSL based on objective response rate (ORR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS). To date,
fourteen (14) patients have been enrolled in the study. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Clinical activity has been preliminarily observed in enrolled patients, including partial
responses and stable disease. Although early clinical activity was observed in some patients, several heavily pretreated r/r PCNSL patients experienced treatment-related adverse events consistent with those previously reported with paxalisib, that
resulted in dose reductions and, in some cases, early termination from the study. As such, the protocol is being optimized by the investigator to initiate starting doses at 15mg twice a day or 30mg once a day with the goal of improving the
durability of clinical benefit and overall tolerability. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">&#147;We are encouraged by the clinical activity preliminarily observed to date and agree with
the lead investigator to reduce the dose with the goal of improving tolerability and durability of response,&#148; stated Dr. John Friend, CEO Kazia Therapeutics. &#147;The investigator has enrolled over half the patients needed to complete this
study, and we look forward to receiving additional clinical updates in the future.&#148; </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Primary CNS Lymphoma </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Primary central nervous system lymphoma (PCNSL) is a rare, poor prognosis subtype of extranodal, non-Hodgkin&#146;s lymphoma (NHL), which accounts for 4% of
primary brain tumours. Approximately 90% of PCNSL cases are diffuse large-B cell lymphoma (DLBCL) in origin, with T-cell lymphoma, Burkitt&#146;s lymphoma and poorly characterized low-grade lymphoma representing a much smaller percentage of disease.
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Despite an aggressive approach to the initial treatment involving high-dose methotrexate-based chemotherapy,
whole-brain radiotherapy (WBRT) and autologous stem cell transplantation (ASCT), nearly 50% of patients recur after two years, with a third of patients becoming refractory early in the course of treatment. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Optimal therapy in the setting of either recurrence or treatment-refractoriness has not yet been established and most patients ultimately die of their
disease, underscoring the fact that PCNSL remains a major unmet need in oncology today. The treatment of r/r PCNSL has largely been based on the experience gathered in numerous small retrospective studies and a limited number of prospective clinical
trials. The clinical evidence from these approaches have demonstrated limited efficacy and durability. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Lymphoma outside the CNS has been a successful
&#145;use case&#146; for PI3K inhibitors, with four of the five FDA-approved therapies indicated for some form of the disease. There is a rationale for a brain-penetrant agent to examine CNS lymphoma, which is otherwise relatively treatment
resistant to existing therapies. </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, an investigational 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 2 study in glioblastoma reported early signals of clinical activity in 2021, and a pivotal study in
glioblastoma, 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 Food and Drug Administration (FDA) in February 2018, and Fast Track Designation (FTD)
for glioblastoma by the FDA in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumour brain metastases harbouring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted
Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma 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 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 www.kaziatherapeutics.com or follow us on Twitter @KaziaTx. </P>
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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"><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 and EVT801. Such statements are based on Kazia&#146;s current 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, related to Kazia&#146;s executive leadership changes, and 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 <FONT STYLE="white-space:nowrap">form&nbsp;20-F</FONT> with the United States Securities and Exchange Commission (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> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This announcement was authorized for release by Dr John Friend, CEO. </P>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
