Filed Pursuant to Rule 424(b)(3)
Registration
No. 333-276774
PROSPECTUS SUPPLEMENT
(to Prospectus datedFebruary 5, 2024)
4,755,556 American Depositary Shares representing 47,555,560 Ordinary Shares
Kazia Therapeutics Limited
This prospectus supplement is being filed to update and supplement the
information contained in the prospectus dated February 5, 2024 (the"Prospectus")
, which forms a part of our Registration Statement on Form
F-1
(Registration
No. 333-276774),
with the information contained in our currentreport on Form
6-K,
excluding the quote of Dr. John Friend contained in Exhibit 99.1 thereto,
furnished to the Securities and Exchange Commission on May 1, 2024 (the "May
1, 2024 Form
6-K").
Accordingly, we have attached the May 1, 2024 Form
6-K
to this prospectus supplement.
This prospectus supplement updates and supplements the information in the
Prospectus and is not complete without, and may not be delivered or utilized
exceptin combination with, the Prospectus, including any amendments or
supplements thereto. This prospectus supplement should be read in conjunction
with the Prospectus and if there is any inconsistency between the information
in the Prospectus and thisprospectus supplement, you should rely on the
information in this prospectus supplement.
The ADSs are listed on The Nasdaq Capital Market("Nasdaq") under the symbol
"KZIA." On April 30, 2024, the last reported sale price of the ADSs on Nasdaq
was $0.3348 per ADS.
Investing in our securities involves a high degree of risk. See "Risk Factors"
beginning on page 9 of the Prospectus and the "RiskFactors" in "Item 3. Key
Information--D. Risk Factors" of our most recent Annual Report on Form
20-F,
which is incorporated by reference in the Prospectus, as well as in any other
recentlyfiled reports and, if any, in any applicable prospectus supplement.
Neither the Securities and Exchange Commission nor any state securitiescommissio
n has approved or disapproved of these securities or passed upon the adequacy
or accuracy of the Prospectus or this prospectus supplement. Any representation
to the contrary is a criminal offense.
The date of this prospectus supplement is May 1, 2024
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
6-K
REPORT OFFOREIGN PRIVATE ISSUER
PURSUANT TO RULE
13a-16
OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of May, 2024
Commission File Number
000-29962
Kazia Therapeutics Limited
(Translation of registrant's name into English)
ThreeInternational Towers Level 24 300 Barangaroo Avenue Sydney NSW 2000
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form
20-F
or Form
40-F.
Form 20-F Form
40-F
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):
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):
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INFORMATION CONTAINED IN THIS FORM
6-K
REPORT
On May 1, 2024, Kazia Therapeutics Limited (the "Company") issued a press
release titled, "Kazia Reports SuccessfulStage 1 Completion of the EVT801
Phase 1 Clinical Trial in Advanced Cancer Patients." A copy of this release is
attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The Company hereby incorporates by reference the information contained herein,
including Exhibit 99.1, except for the quote of Dr. JohnFriend contained in
Exhibit 99.1, into the Company's registration statement on Form
F-3
(File
No. 333-259224
and
333-276091).
EXHIBIT LIST
Exhibit Description
99.1 Press Release of Kazia Therapeutics Limited dated May 1, 2024
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SIGNATURE
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.
Kazia Therapeutics Limited
(Registrant)
/s/ John Friend
John Friend
Chief Executive Officer
Date: 1 May 2024
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Exhibit 99.1
1 May 2024
KAZIA REPORTS SUCCESSFUL STAGE 1 COMPLETION OF THE EVT801
PHASE 1 CLINICAL TRIAL IN ADVANCED CANCER PATIENTS
Sydney, May 1, 2024 - Kazia Therapeutics Limited (NASDAQ: KZIA), a
biotechnology company specialising in oncology, is pleased to announce that
theSafety Review Team (SRT) of the EVT801 Phase 1 clinical trial has concluded
that the primary and secondary objectives of stage 1 of the trial have
successfully been met.
Consisting of the trial's lead investigators, independent medical monitor, and
key members from Kazia Therapeutics, the SRT has reviewed all preliminary
(non-final)
safety and pharmacokinetic (PK) data, and unanimously agreed that the maximal
tolerated dose (MTD) has been reached at 500mg twice a day (BID). Under the
condition that continuous monotherapyadministration will be used in future
clinical trials, 400mg BID was identified as the starting recommended phase 2
dose (RP2D).
A total of 26 patientsreceived EVT801 across six dosing cohorts ranging from
50mg daily to 500mg BID. In general, EVT801 was tolerated across all doses
with the majority of toxicities being mild to moderate and transient in
nature. Eleven different cancer types (ex.colon, renal cell, pancreatic) were
enrolled in the study, with advanced ovarian cancer being the most prevalent
(11 patients). These 11 patients had an average age of 67 years (range:
56-76)
and a median timefrom diagnosis of nine years.
Forty-six
percent (46%) of the ovarian cancer patients had stable disease or better for
at least three cycles of EVT801 therapy.
EVT801 is a highly selective small molecule VEGFR3 tyrosine kinase inhibitor
targeting tumour angiogenesis. Unlike traditional angiokinase inhibitors,
webelieve based on preclinical data that EVT801 has favorable immune activity
(reduces immunosuppressive cells and no impact on CD3+
T-cells
proliferation) and stabilizes tumor blood vessels, minimizing hypoxiaand
therefore decreases the potential for metastatic spread. The Phase 1 EVT801
monotherapy dose-finding trial targets patients with histologically confirmed
advanced or metastatic solid tumours that are unresponsive to standard
treatment, or forwhom no standard treatment is available or appropriate.
Kazia Therapeutics CEO, Dr. John Friend said: "We are extremely pleased that
theprimary and secondary end points of stage 1 of the Phase 1 clinical trial
have been met. The signals of clinical activity, especially in patients with
advanced ovarian cancer are highly encouraging as we continue to progress the
clinical developmentprogram for EVT801 as a potential
first-in-class
VEGFR3 inhibitor. With a median survival time of less than 4 years, there is a
large unmet need for new therapies inpatients with high-grade serous ovarian
cancer."
The Phase 1, open label study is designed to assess the safety, tolerability,
and PK of EVT801 inpatients with advanced or metastatic solid tumors
unresponsive to standard treatment, or for whom no standard treatment is
available or appropriate.
Primary Objective: .
To evaluate the safety and tolerability of EVT801
in subjects with advanced ormetastatic solid tumours.
.
To determine the MTD and / or a RP2D of EVT801 when administered
daily to subjects withadvanced or metastatic solid tumours.
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Secondary Objectives: .
To characterise the PK of EVT801 following administration in an oral capsuleformulation.
.
To identifyactive metabolites of EVT801 in plasma.
.
To determine preliminary
anti-tumour
activity of EVT801via assessment of overall response rate.
We look forward to sharing the final stage 1 data and next development steps
at an upcoming scientific conference in thesecond half of 2024.
About Kazia Therapeutics Limited
Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug
development company, based in Sydney, Australia.
Our lead program is paxalisib, an investigational brain-penetrant inhibitor of
the PI3K / Akt / mTOR pathway, which is being developed to treat multiple
formsof 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 inglioblastoma, GBM AGILE, is ongoing, with final data
expected in 1H2024. Other clinical trials are ongoing in brain metastases,
diffuse midline gliomas, and primary CNS lymphoma, with several of these
having reported encouraging interim data.
Paxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in
February 2018, and FTD for glioblastoma by the FDA in August 2020. Paxalisib
wasalso granted FTD in July 2023 for the treatment of solid tumour brain
metastases harboring PI3K pathway mutations in combination with radiation
therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation
and Orphan DrugDesignation by the FDA for diffuse intrinsic pontine glioma in
August 2020, and for atypical teratoid / rhabdoid tumours in June 2022 and
July 2022, respectively.
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
tobe active against a broad range of tumour types and has provided evidence of
synergy with immuno-oncology agents. Stage one of the Phase I study has been
completed and preliminary data is anticipated in CY2024.
For more information, please visit www.kaziatherapeutics.com or follow us on
Twitter @KaziaTx.
Forward-Looking Statements
This announcement may containforward-looking statements, which can generally
be identified as such by the use of words such as "may," "will," "estimate,"
"future," "forward," "anticipate," or other similar words. Anystatement
describing Kazia'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,
statementsregarding: the timing for results and data related to Kazia's
clinical and preclinical trials, Kazia's strategy and plans with respect to
its programs, including paxalisib and EVT801, the potential benefits of EVT801
as a VEGFR3 inhibitorand the potential market opportunity for EVT801. Such
statements are based on Kazia's current expectations and projections about
future events and future trends affecting its business and are subject to
certain risks and uncertainties thatcould cause actual results to differ
materially from those anticipated in the forward-looking statements, including
risks and uncertainties: associated with clinical and preclinical trials and
product development, related to regulatory approvals,and related to the impact
of global economic conditions. These and other risks
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and uncertainties are described more fully in Kazia's Annual Report, filed on
form
20-F
with the SEC, and in subsequent filings with the United StatesSecurities and
Exchange Commission. 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
placeundue reliance on these forward-looking statements, which apply only as
of the date of this announcement.
This announcement was authorized for release byDr John Friend, CEO.
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