<SEC-DOCUMENT>0001193125-20-065252.txt : 20200306
<SEC-HEADER>0001193125-20-065252.hdr.sgml : 20200306
<ACCEPTANCE-DATETIME>20200306172232
ACCESSION NUMBER:		0001193125-20-065252
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20200306
FILED AS OF DATE:		20200306
DATE AS OF CHANGE:		20200306

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:		20695863

	BUSINESS ADDRESS:	
		STREET 1:		LEVEL 5
		STREET 2:		20 GEORGE STREET
		CITY:			HORNSBY NSW
		STATE:			C3
		ZIP:			2077
		BUSINESS PHONE:		01161298780088

	MAIL ADDRESS:	
		STREET 1:		LEVEL 5
		STREET 2:		20 GEORGE STREET
		CITY:			HORNSBY NSW
		STATE:			C3
		ZIP:			2077

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	NOVOGEN LTD
		DATE OF NAME CHANGE:	19981228
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<FILENAME>d835313d6k.htm
<DESCRIPTION>FORM 6-K
<TEXT>
<HTML><HEAD>
<TITLE>Form 6-K</TITLE>
</HEAD>
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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 March, 2020 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission File Number
<U>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</U> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>Kazia
Therapeutics Limited </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Translation of registrant&#146;s name into English) </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Three International Towers Level 24 300 Barangaroo Avenue Sydney NSW 2000 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of principal executive office) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether
the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">Form
20-F&nbsp;&nbsp;&#9745;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Form 40-F&nbsp;&nbsp; &#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark if
the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):&nbsp;&nbsp;&#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Note</B>: Regulation S-T Rule
101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by
check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):&nbsp;&nbsp;&#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Note</B>:
Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which
the registrant is incorporated, domiciled or legally organized (the registrant&#146;s &#147;home country&#148;), or under the rules of the home country exchange on which the registrant&#146;s securities are traded, as long as the report or other
document is not a press release, is not required to be and has not been distributed to the registrant&#146;s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on
EDGAR. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark if the registrant by furnishing the information contained in this form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934. Yes&nbsp;&nbsp;&#9744;&nbsp;&nbsp;&nbsp;&nbsp; No&nbsp;&nbsp;&#9745; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">If
&#147;yes&#148; is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b) </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURE </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Kazia Therapeutics Limited</B> <B></B>(Registrant) </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Kate Hill </U></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kate Hill </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Company Secretary </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Date 6 March 2020 </P>
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<IMG SRC="g835313g0306042232324.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:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">6&nbsp;March
2020 </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>PAXALISIB PHASE II STUDY COMPLETES RECRUITMENT; </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>KAZIA TO PRESENT NEW DATA AT AACR CONFERENCE IN APRIL 2020 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Sydney, 6</B><B></B><B>&nbsp;March 2020</B> &#150; Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology
company, is pleased to provide an update to shareholders on recent progress with the development of paxalisib (formerly <FONT STYLE="white-space:nowrap">GDC-0084),</FONT> its clinical-stage program in brain cancer. </P>
<P STYLE="margin-top:12pt; 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">Recruitment of patients to phase II study in glioblastoma is now complete </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">New interim data to be presented at AACR in April 2020 </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">Good progress in <FONT STYLE="white-space:nowrap">set-up</FONT> work for GBM AGILE, with patient recruitment
planned to commence in 2H CY2020 </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia CEO, Dr James Garner, commented, &#147;It has been an exceptionally productive start to 2020 for
the paxalisib program, and we are delighted with progress. Our ongoing phase II study in glioblastoma has completed recruitment, well ahead of expectations, and we expect to report new interim data in April 2020 at the AACR conference. Meanwhile,
work is well underway to bring paxalisib into the GBM AGILE study, which is intended to provide a streamlined path to registration for the drug.&#148; </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Completion of Recruitment to Phase II Study </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia
commenced a phase II clinical trial in newly-diagnosed glioblastoma in 2018 (NCT03522298). The primary purpose of this study was to transition paxalisib from the very late-stage population that was studied in phase I to the newly-diagnosed patients
that represent the target population for the commercial product. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The final patient in this study commenced dosing on 27&nbsp;February 2020, and the study
is now closed to recruitment. In total, 30 patients were recruited at six sites in the United States: 9 in Part A (a dose escalation component to study dosing), and 21 in Part B (a dose expansion cohort to seek preliminary signals of efficacy). </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia reported <FONT STYLE="white-space:nowrap">top-line</FONT> safety data in May 2019. Specifically, a
maximum tolerated dose (MTD) of 60mg was determined for the newly-diagnosed population, which exceeded the previous MTD in late-stage patients of 45mg. The dose-limiting toxicities (DLTs) included oral mucositis (mouth ulcers) and hyperglycemia
(elevated blood sugar). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Initial efficacy data was presented in November 2019 at the Society for Neuro-Oncology (SNO) Annual Scientific Meeting in
Phoenix, AZ. This interim <FONT STYLE="white-space:nowrap">read-out</FONT> included data from the first nine patients enrolled to the study, representing the whole of Part A. A median progression-free survival (PFS) of 8.4 months was determined,
which compares favourably to the existing standard of care at 5.3 months. Overall survival (OS) could not be calculated since three-quarters of evaluable patients remained alive at the time of data <FONT STYLE="white-space:nowrap">cut-off.</FONT>
</P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>New Data to be Presented at AACR in April 2020 </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia is pleased to have been accepted for a poster presentation at the prestigious American Association for Cancer Research (AACR) annual meeting in San
Diego, CA. The conference will take place between 24 &#150; 29&nbsp;April 2020. The AACR meeting is one of the world&#146;s largest gatherings of cancer researchers and physicians, and also provides a rich opportunity for engagement with investors
and potential partners. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia anticipates that the AACR poster presentation will provide additional data from the ongoing phase II clinical study,
building on the promising signals that were reported in November 2019. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Progress Continues Across Broader Paxalisib Program </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In addition to the ongoing phase II study in glioblastoma, four additional studies are underway in other forms of brain cancer (NCT03994796, NCT03765983,
NCT03696355, and NCT04192981). All four studies are actively recruiting patients. Kazia looks forward to providing progress updates and, where possible, interim data from these studies throughout calendar 2020. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT STYLE="white-space:nowrap">Set-up</FONT> work is well advanced with GBM AGILE (NCT03970447), Kazia&#146;s planned pivotal study, which is expected to
provide the basis for an eventual product registration. At this stage, Kazia is planning to begin patient enrolment in the second half of calendar 2020. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">[ENDS] </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Kazia Therapeutics Limited </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kazia Therapeutics Limited (ASX: KZA, NASDAQ: KZIA) is an innovative oncology-focused biotechnology company, based in Sydney, Australia. Our pipeline includes
two clinical-stage drug development candidates, and we are working to develop therapies across a range of oncology indications. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Our lead program is
paxalisib <FONT STYLE="white-space:nowrap">(GDC-0084),</FONT> a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to treat glioblastoma, the most common and most aggressive form of primary brain cancer in adults.
Licensed from Genentech in late 2016, paxalisib entered a phase II clinical trial in 2018. Interim data was reported in November 2019, and further data is expected in 1H 2020. Paxalisib was granted orphan designation for glioblastoma by the US FDA
in February 2018. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">TRX-E-002-1</FONT></FONT></FONT>
(Cantrixil), is a third-generation benzopyran molecule with activity against cancer stem cells and is being developed to treat ovarian cancer.
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">TRX-E-002-1</FONT></FONT></FONT> is currently undergoing a phase I clinical trial in Australia and the United States. Interim data was presented at
the ESMO Congress in September 2019, and the study remains ongoing. Cantrixil was granted orphan designation for ovarian cancer by the US FDA in April 2015. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This announcement was authorized for release to the ASX by James Garner, Chief Executive Officer, Managing Director. </P>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
