<SEC-DOCUMENT>0001193125-21-320838.txt : 20211105
<SEC-HEADER>0001193125-21-320838.hdr.sgml : 20211105
<ACCEPTANCE-DATETIME>20211105061755
ACCESSION NUMBER:		0001193125-21-320838
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20211104
FILED AS OF DATE:		20211105
DATE AS OF CHANGE:		20211105

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:		211382220

	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>d379345d6k.htm
<DESCRIPTION>FORM 6-K
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<HTML><HEAD>
<TITLE>Form 6-K</TITLE>
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<Center><DIV STYLE="width:8.25in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>Form 6-K
</B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF FOREIGN PRIVATE ISSUER </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO RULE 13a-16 OR 15d-16 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>For the month of November, 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 4 November 2021 </P>
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<IMG SRC="g379345g1104095945329.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">4&nbsp;November
2021 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>KAZIA ENROLS FIRST PATIENT TO EVT801 PHASE I CLINICAL TRIAL </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Sydney, 4</B><B></B><B>&nbsp;November 2021</B> &#150; Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is
pleased to announce that it has commenced enrolment to a phase I clinical trial of EVT801, an investigational cancer therapy that Kazia licensed from Evotec SE in April 2021. </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="1%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">EVT801 is a small molecule inhibitor of VEGFR3, and acts by inhibiting lymphangiogenesis, the formation of new
lymphatic vessels around the tumour. It has shown compelling evidence of activity in a wide range of preclinical cancer models and appears broadly well-tolerated in animal toxicology studies. </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>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">Kazia licensed EVT801 from Evotec SE, an international drug discovery alliance and development partnership
company, in April 2021. </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="1%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">The phase I study will focus primarily on understanding the safety, tolerability, and pharmacokinetics of EVT801
across a range of doses. It is also designed to explore preliminary signals of clinical efficacy, and to investigate the biological activity of the drug via a rich suite of sophisticated biomarker analyses. </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="1%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">The lead clinical site in the study is L&#146;Institut Universitaire du Cancer de Toulouse Oncopole
(IUCT-Oncopole) in Toulouse, France. The lead investigator is Dr Carlos Gomez-Roca, a medical oncologist with a strong background in drug development and early phase clinical trials. </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="1%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">The phase I study is expected to recruit a maximum of 60 patients, with the actual number dependent on the
emergent safety profile of the drug. Timelines to completion will depend on the number of dose levels tested, and Kazia expects to provide further guidance on this as the study progresses. </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dr Carlos Gomez-Roca commented, &#147;We are pleased to now be enrolling patients to this phase I study of EVT801. Despite great progress in the treatment of
cancer over recent years, there remains a substantial need for new therapeutic options in a wide range of tumours. EVT801 has shown promising preclinical data, and we very much hope that it may now prove beneficial to our patients.&#148; </P>
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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, added, &#147;in the six months since we licensed EVT801, the Kazia and Evotec
teams have been working assiduously to execute a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-human</FONT></FONT> study of this very promising drug candidate. It has been a privilege to work with the team at the
IUCT-Oncopole site in Toulouse, which is one of the leading cancer centres in France, and we hope to add an additional centre in the new year. We are delighted that the study is now open to recruitment. All of us in Kazia firmly believe that EVT801
has enormous potential as a novel cancer therapy, and we look forward to working closely with the investigators to explore that potential.&#148; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dr Cord
Dohrmann, Chief Scientific Officer of Evotec SE, said, &#147;We are very excited to see EVT801 proceed to the clinic. The Phase I clinical trial will be conducted by Evotec, under the sponsorship of Kazia, at the renowned IUCT-Oncopole in Toulouse.
Evotec will support the management of the Phase I clinical trial with analyses and biomarker development, which we anticipate will yield important data for the validation of the approach and to further contribute to the development of robust patient
stratification strategies for the further clinical evaluation of EVT801.&#148; </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Phase I Study Design </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The phase I study of EVT801 is designed in two stages. The first stage is a multiple ascending dose (MAD) study, which is designed to determine the maximum
tolerated dose (MTD) and recommended phase II dose (RP2D) for EVT801. Patients in the study will receive EVT801 at low doses, and this will be progressively escalated in subsequent cohorts as the safety profile of the drug is determined. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The second stage of the study will recruit twelve patients, of whom six will have been diagnosed with renal cell carcinoma and six with soft-tissue sarcoma.
All twelve patients will receive EVT801 at the RP2D determined in the first stage. These patients will participate in intensive analyses to better understand the biochemical activity of the drug. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In addition to conventional measures of safety, efficacy, and pharmacokinetics, the phase I study will employ cutting edge biomarker technologies to provide
early insights into the activity of EVT801. A rich program of tissue and blood biomarker analyses has been developed by Evotec scientists, in collaboration with the team at Oncopole. It is expected that these analyses will help to better understand
the effects of the drug in human subjects and may also help to identify the most responsive patients and provide early predictors of clinical efficacy. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia is also collaborating with Radiomics, an imaging analysis organisation based in Belgium, to apply sophisticated
<FONT STYLE="white-space:nowrap">AI-based</FONT> analyses to the CT and MRI scans collected during the study. Proprietary machine-learning algorithms developed by Radiomics can provide exceptionally detailed insights into the behaviour of the tumour
while on treatment, and this information may help to predict and understand clinical response. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Clinical Sites </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The lead site in the study is the Institut Universitaire du Cancer de Toulouse Oncopole (IUCT-Oncopole) in Toulouse, France. IUCT-Oncopole combines several
leading clinical cancer treatment facilities with a world-class research infrastructure, on an integrated campus that brings together public and private stakeholders, including industry participants. The centre treats more than 10,000 new patients
each year, and more than one in eight patients are enrolled in clinical studies. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The lead investigator for the study is Dr Carlos Gomez-Roca, medical
oncologist and Chair of the Early Phase Unit at IUCT-Oncopole, Dr Gomez-Roca&#146;s clinical research is focused on development of targeted therapies and immuno-oncology drugs. He is a member of ESMO, ASCO, FITC and AACR, and has contributed to more
than 60 peer-reviewed publications, including as first or second author, in journals such as the <I>Journal of Clinical Oncology</I> and <I>Annals of Oncology</I>. </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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<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"><U><I>In the United States:</I></U></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><U><I>In Australia:</I></U></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">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>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Kazia Therapeutics Limited </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia Therapeutics Limited (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>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Evotec SE </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Evotec is a life science company with a
unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company&#146;s multimodality platform comprises a unique combination of innovative technologies,
data and science for the discovery, development, and production of <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> and
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">best-in-class</FONT></FONT> pharmaceutical products. Evotec leverages this &#147;Data-driven R&amp;D Autobahn to Cures&#148; for proprietary projects and within a network of partners
including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology,
oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading <FONT STYLE="white-space:nowrap">co-owned</FONT> pipeline for innovative therapeutics and has <FONT
STYLE="white-space:nowrap">to-date</FONT> established a portfolio of more than 200 proprietary and <FONT STYLE="white-space:nowrap">co-owned</FONT> R&amp;D projects from early discovery to clinical development. Evotec operates globally with more
than 4,000 highly qualified people. The Company&#146;s 14 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com and follow us on Twitter
@Evotec and LinkedIn. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>CLINICAL TRIAL SUMMARY </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top"><B>Study Title</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3">A Phase 1, <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">First-in-Human,</FONT></FONT> Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of EVT801 in Patients with Advanced
Solid Tumours</TD></TR>
<TR STYLE="font-size:1pt">
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<TD HEIGHT="16" COLSPAN="4"></TD></TR>
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<TD VALIGN="top"><B>Investigational Product</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3">EVT801 (oral selective VEGFR3 inhibitor)</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">Advanced solid tumours</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">TBD</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="4"></TD></TR>
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<TD VALIGN="top"><B>Principal Investigator and Site</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">Dr Carlos Gomez-Roca</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman"><I>Institut
Claudius Regaud&#151;IUCT Oncopole</I></P></TD></TR>
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<TD HEIGHT="16" COLSPAN="4"></TD></TR>
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<TD VALIGN="top"><B>Study Description</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3">This study is a phase I, <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-human</FONT></FONT> trial to establish the safety profile and dosing of EVT801.</TD></TR>
<TR STYLE="font-size:1pt">
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<TD HEIGHT="16" COLSPAN="2"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD></TR>
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<TD VALIGN="top"><B>Number of Subjects</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><B>Stage 1</B> &#150; up to 48 patients</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><B>Stage 2</B> &#150; 12 patients</TD></TR>
<TR STYLE="font-size:1pt">
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<TD HEIGHT="16" COLSPAN="4"></TD></TR>
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<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 an open-label, <FONT STYLE="white-space:nowrap">single-arm</FONT> trial. The study comprises two stages, which will run
sequentially.</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> &#150; a multiple ascending dose
(&#145;escalation&#146;) component. Enrolment will initially be via single-patient cohorts, expanding to a conventional 3+3 design once toxicity is encountered.</P> <P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman"><B>Stage 2</B> &#150; an expansion cohort for biomarker exploration.</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">Stage 1 will enroll patients with advanced solid tumours that are resistant or refractory to existing therapies. Stage 2 will enroll patients with renal cell carcinoma or soft-tissue sarcoma.</TD></TR>
<TR STYLE="font-size:1pt">
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<TD HEIGHT="16" COLSPAN="4"></TD></TR>
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<TD VALIGN="top"><B>Endpoints</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">The primary endpoints of the study are safety and tolerability. The study will also assess key pharmacokinetic parameters to
inform subsequent development of EVT801.</P> <P STYLE="font-size:12pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman">The study will explore preliminary signs
of clinical efficacy, principally via measurement of Overall Response Rate (ORR). The study also includes a comprehensive suite of biomarker analyses, comprising blood, tissue, and imaging data, which will be used to better understand the activity
of the drug.</P></TD></TR>
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<TD HEIGHT="16" COLSPAN="4"></TD></TR>
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<TD VALIGN="top"><B>Start Date</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3">First Patient In: November 2021</TD></TR>
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<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="4"></TD></TR>
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<TD VALIGN="top"><B>Duration</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3">Provisionally anticipated to be approximately two years, but will be more precisely assessed once study is well underway.</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>What is the mechanism of action of EVT801? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Rapidly
growing cancers require a substantial supply of nutrients, and so the tumour is obliged to generate new blood vessels (angiogenesis) and lymphatic vessels (lymphangiogenesis) to provide for its needs. Drugs which disrupt angiogenesis have been shown
efficacious in a range of solid tumours, and several products are approved by FDA. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">EVT801 is a small-molecule inhibitor of vascular endothelial growth
factor receptor 3 (VEGFR3). VEGFR3 is integrally involved in lymphangiogenesis, the formation of new lymphatic vessels around a growing tumour. By inhibiting this target, EVT801 is expected to prevent the tumour from establishing and maintaining the
network of lymphatic vessels required to sustain growth. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In addition, emerging data has shown that drugs targeting VEGF receptors can change the balance
of immune cells in and around the tumour.<SUP STYLE="font-size:85%; vertical-align:top">1</SUP> It is therefore anticipated that EVT801 may potentiate the activity of immuno-oncology therapies such as Keytruda<SUP
STYLE="font-size:85%; vertical-align:top">&reg;</SUP> (pembrolizumab), Opdivo<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> (nivolumab), and Yervoy<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> (ipilimumab). </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>What are similar products in this class of therapies, and how does EVT801 compare? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The first mainstream pharmaceutical product to target angiogenesis was Avastin (bevacizumab), which was brought to market by Genentech in 2004. It is currently
approved by FDA for the treatment of a wide range of cancers, including colorectal cancer, lung cancer, recurrent glioblastoma, cervical cancer, ovarian cancer, renal cell carcinoma (kidney cancer), and liver cancer.<SUP
STYLE="font-size:85%; vertical-align:top">2</SUP> Avastin has sales of approximately US$ 7&nbsp;billion per annum.<SUP STYLE="font-size:85%; vertical-align:top">3</SUP> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Avastin acts via inhibition of vascular endothelial growth factor (VEGF), a signalling protein that it is intimately involved in angiogenesis. Several
pharmaceutical products are available which target the VEGF receptors (VEGFR), which are embedded on the surface of cells and which bind to circulating VEGF to trigger angiogenesis. These drugs are often referred to as &#145;angiokinase
inhibitors&#146; and an abbreviated listing is provided below. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="26%"></TD>

<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="25%"></TD>

<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="31%"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; "><B>Manufacturer</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Product</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Targets</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Indications</B></P></TD></TR>


<TR BGCOLOR="#cceeff" 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">Bayer</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<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">Nexavar (sorafenib)</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<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">VEGFR,&nbsp;PDGFR,&nbsp;RAF&nbsp;kinases</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">Liver cancer; renal cancer; thyroid cancer</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">Pfizer</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<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">Sutent (sunitinib)</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<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">VEGFR, PDGFR</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Renal cancer; GIST</P></TD></TR>
<TR BGCOLOR="#cceeff" 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">Novartis</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<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">Votrient (pazopanib)</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<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">VEGFR, PDGFR, FGFR, <FONT STYLE="white-space:nowrap">c-Kit</FONT></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Renal cancer; soft-tissue sarcoma</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">Pfizer</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<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">Inlyta (axitinib)</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<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">VEGFR, PDGFR, <FONT STYLE="white-space:nowrap">c-Kit</FONT></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Renal cancer</P></TD></TR>
<TR BGCOLOR="#cceeff" 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">Exelixis</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<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">Cometriq (cabozantinib)</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<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"><FONT STYLE="white-space:nowrap">c-Met,</FONT> VEGFR2, AXL, RET</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">Thyroid cancer; renal cancer; liver cancer</TD></TR>
</TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:8.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000;width:11%">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:85%; vertical-align:top">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">C Tacconi et al. <I>Cancer Research</I> 2019;79:4196&#150;210 </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:8pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:85%; vertical-align:top">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"><FONT STYLE="white-space:nowrap">FDA-approved</FONT> Prescribing Information </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:8pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:85%; vertical-align:top">3</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman; " ALIGN="left">Forbes, 17&nbsp;January 2020 </P></TD></TR></TABLE>
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<Center><DIV STYLE="width:8.25in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">EVT801 is distinguished from all marketed angiokinase inhibitors by its high degree of specificity for
VEGFR3. One consequence of this is that EVT801 is likely to act predominantly via inhibition of lymphangiogenesis rather than angiogenesis, and this may be associated with less development of drug resistance. More importantly, the selectivity of
EVT801 is expected to result in a lower incidence of toxicity compared to existing therapies. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Are there other selective VEGFR3 inhibitors on market or
in development? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">To Kazia&#146;s knowledge, there are no selective VEGFR3 inhibitors in clinical development in the global pipeline, and none have been
approved for marketing by regulatory agencies. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">A monoclonal antibody targeting VEGFR3 was previously developed through to phase I clinical trials by
Lilly. LY3022856 (also referred to as <FONT STYLE="white-space:nowrap">IMC-3C5)</FONT> was found to be well-tolerated but showed limited evidence of clinical activity in phase I.<SUP STYLE="font-size:85%; vertical-align:top">4</SUP> This program was
discontinued by Lilly following completion of phase I. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia has carefully evaluated the <FONT STYLE="white-space:nowrap">IMC-3C5</FONT> data prior to <FONT
STYLE="white-space:nowrap">in-licensing</FONT> EVT801 from Evotec. Research has shown that VEGFR3 activation requires the presence of VEGFR2, forming a <FONT STYLE="white-space:nowrap">three-way</FONT> complex between VEGF, VEGFR2, and VEGFR3
(heterodimerisation).<SUP STYLE="font-size:85%; vertical-align:top">5</SUP> To be successful, a new drug needs to block both the VEGFR2-VEGFR3 complex and the VEGFR3-VEGFR3 homodimer. <FONT STYLE="white-space:nowrap">IMC-3C5</FONT> only blocks the
homodimer, but not the heterodimer, and the company believes that this is the primary reason for its failure in the clinic. EVT801 is able to block both homodimer and heterodimer. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>In which tumour types is EVT801 expected to ultimately be used? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The phase I study will be conducted in patients with &#145;advanced solid tumours&#146;, a group which comprises patients with any <FONT
STYLE="white-space:nowrap">non-haematological</FONT> malignancy which has spread (&#145;metastasised&#146;) and which is resistant to existing treatment. This very broad patient population is typical for <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">&#145;first-in-human&#146;</FONT></FONT> studies of a new cancer drug. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The study includes an expansion cohort which will
specifically examine the activity of the drug in renal cell carcinoma (cancer of the kidney) (RCC) and soft-tissue sarcoma (STS). These cancers have been chosen because they are generally responsive to existing angiokinase inhibitors, and they also
provide rich opportunity to better understand the biological activity of EVT801. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The eventual commercial indication for the drug may include these
groups, but it may also include other cancer types such as lung cancer, bowel cancer, or liver cancer. Kazia expects to consider the promising target populations after completion of phase I, in consultation with clinicians and advisors. </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%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:85%; vertical-align:top">4</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman; " ALIGN="left">MW Saif et al. (2016)<I>&nbsp;Cancer Chemotherapy and Pharmacology.</I> 78:815&#150;824 </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:8pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:85%; vertical-align:top">5</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman; " ALIGN="left">A Alam et al. (2004)<I>&nbsp;Biochemical and Biophysical Research Communications</I>. <FONT
STYLE="white-space:nowrap">324(2):909-915</FONT> </P></TD></TR></TABLE>
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<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"><B>Will EVT801 be combined with paxalisib? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia does not at this stage plan to combine EVT801 with paxalisib. The two drug candidates are independent within Kazia&#146;s pipeline, and there is limited
scientific data at present to support the combination. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">However, it is anticipated that both drugs will be used substantially in combination with other
drugs. In the case of EVT801, the most promising combination agents are likely to be immuno-oncology therapies such as Keytruda<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> (pembrolizumab), Opdivo<SUP
STYLE="font-size:85%; vertical-align:top">&reg;</SUP> (nivolumab), and Yervoy<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> (ipilimumab). </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Why is the study being conducted in two stages? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The
primary purpose of a phase I study is to understand the safety, tolerability, pharmacokinetics, and dosing of a new drug. Stage 1 of the EVT801 phase I study is designed primarily to support this purpose. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In addition, Kazia has emphasised a substantial &#145;translational medicine&#146; component in the design of the study. The objectives here are to better
understand the intricate biological activity of the drug so as to better inform its use, and to <FONT STYLE="white-space:nowrap">de-risk</FONT> its further development. Stage 2 is designed primarily to support that purpose. However, both Stages will
collect full safety and pharmacokinetic data, as well as providing biomarker analyses, and so there is considerable overlap in practice. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Kazia
previously alluded to a planned third stage. Why has this not been included? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia had originally envisaged combination with immuno-therapy to
represent a third stage of the study, which would have taken place after completion of Stage 1. During regulatory review, the French competent authority raised operational questions in relation to this stage which may require some time to fully
resolve. As a result, Kazia has temporarily removed the third stage of the study in order not to delay the first two stages. In parallel to Stage 1, the company will discuss Stage 3 with clinicians and regulatory advisors and consider how best to <FONT
STYLE="white-space:nowrap">re-introduce</FONT> this component at a later date. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Kazia licensed EVT801 from Evotec in April 2021. How has it been
possible to commence a clinical trial so quickly after completion of the licensing transaction? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">While conducting due diligence and negotiating the
license agreement, Kazia began planning a potential phase I study in parallel and at risk. As a consequence, work was able to commence almost immediately after contract execution. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Moreover, the study is being implemented by Evotec, in a very tightly integrated collaboration with Kazia, and the efficiencies of this innovative operating
model have allowed for considerable acceleration of the program. In addition, had manufactured investigational product prior to the licensing transaction, and that material will now be used in the phase I study, substantially reducing timelines.
</P>
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<Center><DIV STYLE="width:8.25in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Why is the study being performed in France? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In general, France is a highly attractive location for clinical trials, with first-class medical infrastructure, high-quality data, and a well-designed
regulatory environment. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In the case of the EVT801 study, initiating clinical development in France was considered to provide considerable timing
advantages relative to commencing elsewhere. In addition, the <FONT STYLE="white-space:nowrap">co-location</FONT> of Evotec laboratories on the Oncopole campus allows for rapid, real-time performance of sensitive biomarker analyses that would be
challenging with an international study. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia anticipates the inclusion of other countries later in the clinical development. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Why did Kazia select Evotec as the clinical CRO for this study? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Although the licensing agreement between Kazia and Evotec envisages ongoing collaboration between the two companies, Kazia has no contractual obligation to
work with Evotec on any specific project. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In the case of the phase I study, Kazia sought proposals from several CROs in a competitive bidding process.
Evotec was selected on the basis of the extensive experience of its clinical team, the high degree of senior management engagement, the availability of resources proximal to, and with experience of, the chosen clinical sites, and its competitive
cost. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The selection of Evotec as the clinical CRO has yielded great efficiencies in the conduct of the study, since there is substantial familiarity with
EVT801 in that organisation. In particular, the rich program of biomarker work that has been included in the study benefits greatly from close integration between the clinical CRO and Evotec&#146;s own laboratories. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>What is the nature of the biomarker work in this study? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">As part of the study, Kazia will examine a comprehensive suite of &#145;biomarkers&#146;, sophisticated laboratory assessments designed to better understand
how EVT801 works in human patients, how the most responsive patients may be selected, and how the greatest efficacy may be obtained from the drug. In broad terms, the biomarkers fall into three main categories. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">First, analyses of tumour tissue samples will be performed, primarily with the objective of identifying responsive patients. This work will be conducted by
Evotec scientists. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Second, analysis of blood samples during the study will be conducted to understand how EVT801 is modifying the behaviour of the tumour
and of the patient&#146;s immune system. This work will also be led by Evotec scientists, in collaboration with a research team at Oncopole. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Third, CT
scans from the study will be subjected to &#145;artificial intelligence&#146; (AI) analysis to better detect the effects of the drug on the tumour. This work will be performed by Radiomics, an <FONT STYLE="white-space:nowrap">AI-powered</FONT>
analysis and consulting firm based in Belgium. </P>
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<Center><DIV STYLE="width:8.25in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>What is the projected cost of this study? </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In common with most biotech companies, Kazia does not itemise specific <FONT STYLE="white-space:nowrap">per-project</FONT> costs. In general, phase I studies
have a wide range of potential costs, due to the fact that they can recruit variable numbers of patients. However, the overall costs of the project are considered highly cost-effective in the context of industry benchmarks. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>When is initial data expected? </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia expects to provide
regular updates to the market on operational progress with the study. Provisionally, initial data is anticipated within <FONT STYLE="white-space:nowrap">12-18</FONT> months of study commencement. </P>
</DIV></Center>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
