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KAZIA THERAPEUTICS LTD

KAZIA THERAPEUTICS LTDKZIA決算レポート

Nasdaq

Kazia Therapeutics Ltd is a clinical-stage biotechnology company focused on developing targeted oncology therapies. Its lead pipeline candidates address rare pediatric brain cancers and other hard-to-treat solid tumor indications, with core business operations across Australia, the United States, and European markets.

What changed in KAZIA THERAPEUTICS LTD's 20-F — 2023 vs 2024

Top changes in KAZIA THERAPEUTICS LTD's 2024 20-F

305 paragraphs added · 314 removed · 219 edited across 5 sections

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

65 edited+37 added−14 removed124 unchanged
Such litigation, if instituted against the Company, could cause it to incur substantial costs and divert management’s attention and resources. If the market price of the Company’s ADSs falls and remains below US$5.00 per share, under stock exchange rules, the Company’s stockholders will not be able to use such ADSs as collateral for borrowing in margin accounts.
Such litigation, if instituted against the Company, could cause it to incur substantial costs and divert management’s attention and resources. If the market price of the ADSs falls and remains below US$5.00 per share, under stock exchange rules, the Company’s stockholders will not be able to use such ADSs as collateral for borrowing in margin accounts.
Our ability to generate future revenues from commercializing product candidates depends heavily on: • successfully initiating and completing clinical trials of our product candidates; • the timing of the initiation and completion of preclinical studies and clinical trials; • the timing of patient enrollment and dosing in any future clinical trials; • the timing of the availability of data from clinical trials; • expectations about the successful completion of clinical trials; • obtaining regulatory and marketing approvals for product candidates for which we complete clinical trials; • the timing of expected regulatory filings; • expectations about approval by regulatory authorities of our drug candidates; 2 Table of Contents • the clinical utility and potential attributes and benefits of our product candidates, including the potential duration of treatment effects; • potential licenses of intellectual property and collaborations; • the commercialization of our product candidates, if approved; • expectations regarding expenses, ongoing losses, future revenue and capital needs; • our financial performance; • the length of time over which we expect our cash and cash equivalents to be sufficient; • our intellectual property position and the duration of our patent portfolio; • maintaining, protecting and expanding our intellectual property portfolio, and avoiding infringing on intellectual property of third parties; • establishing and maintaining successful licenses, collaborations and alliances with third parties; • developing a sustainable, scalable, reproducible and transferable manufacturing process for our product candidates; • establishing and maintaining supply and manufacturing relationships with third parties that can provide products and services adequate, in amount and quality, to support clinical development and commercialization of our product candidates, if approved; • launching and commercializing any product candidates for which we obtain regulatory and marketing approval, either by collaborating with a partner or, if launched independently, by establishing a sales, marketing and distribution infrastructure; • obtaining market acceptance of any product candidates that receive regulatory approval as viable treatment options; • the outcome of corresponding endeavors in respect of competitive or potentially competitive product candidates by other drug development companies; • obtaining favorable coverage and reimbursement rates for our products from third-party payers; • addressing any competing technological and market developments; • identifying and validating new product candidates; and • negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter.
Our ability to generate future revenues from commercializing product candidates depends heavily on: • successfully initiating and completing clinical trials of our product candidates; 2 Table of Contents • the timing of the initiation and completion of pre-clinical studies and clinical trials; • the timing of patient enrollment and dosing in any future clinical trials; • the timing of the availability of data from clinical trials; • expectations about the successful completion of clinical trials; • obtaining regulatory and marketing approvals for product candidates for which we complete clinical trials; • the timing of expected regulatory filings; • expectations about approval by regulatory authorities of our drug candidates; • the clinical utility and potential attributes and benefits of our product candidates, including the potential duration of treatment effects; • potential licenses of intellectual property and collaborations; • the commercialization of our product candidates, if approved; • expectations regarding expenses, ongoing losses, future revenue and capital needs; • our financial performance; • the length of time over which we expect our cash and cash equivalents to be sufficient; • our intellectual property position and the duration of our patent portfolio; • maintaining, protecting and expanding our intellectual property portfolio, and avoiding infringing on intellectual property of third parties; • establishing and maintaining successful licenses, collaborations and alliances with third parties; • developing a sustainable, scalable, reproducible and transferable manufacturing process for our product candidates; • establishing and maintaining supply and manufacturing relationships with third parties that can provide products and services adequate, in amount and quality, to support clinical development and commercialization of our product candidates, if approved; • launching and commercializing any product candidates for which we obtain regulatory and marketing approval, either by collaborating with a partner or, if launched independently, by establishing a sales, marketing and distribution infrastructure; • obtaining market acceptance of any product candidates that receive regulatory approval as viable treatment options; • the outcome of corresponding endeavors in respect of competitive or potentially competitive product candidates by other drug development companies; • obtaining favorable coverage and reimbursement rates for our products from third-party payers; • addressing any competing technological and market developments; • identifying and validating new product candidates; and • negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter.
Even if patents do successfully issue and even if such patents cover our product candidates, third parties may initiate opposition, interference, re-examination, post-grant review, inter partes review, nullification or derivation action in court or before patent offices or similar proceedings challenging the validity, enforceability or scope of such patents, which may result in the patent claims being narrowed or invalidated.
Even if patents do successfully issue and even if such patents cover our product candidates, third parties may initiate opposition, interference, re-examination, post-grant review, inter parties review, nullification or derivation action in court or before patent offices or similar proceedings challenging the validity, enforceability or scope of such patents, which may result in the patent claims being narrowed or invalidated.
Nasdaq Listing Rule 5550(a)(2) (the “Rule”) requires listed securities to maintain a minimum bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days.
Nasdaq Listing Rule 5550(a)(2) (the “Rule”) requires listed securities to maintain a minimum bid price of US$1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days.
In order for an Australian corporate taxpayer to carry forward and utilize tax losses, the taxpayer must pass either the continuity of ownership test, or, if it fails the COT, the same business test (“SBT”), or similar business test, in respect of relevant tax losses.
In order for an Australian corporate taxpayer to carry forward and utilize tax losses, the taxpayer must pass either the continuity of ownership test (the “COT”), or, if it fails the COT, the same business test (“SBT”), or similar business test, in respect of relevant tax losses.
Our failure to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on our business, results of operations and financial condition. 4 Table of Contents Risks Related to Our Business Operations We may not successfully engage in strategic transactions or enter into new collaborations, which could adversely affect our ability to develop and commercialize product candidates, impact our cash position, increase our expenses and present significant distractions to our management.
Our failure to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on our business, results of operations and financial condition. 5 Table of Contents Risks Related to Our Business Operations We may not successfully engage in strategic transactions or enter into new collaborations, which could adversely affect our ability to develop and commercialize product candidates, impact our cash position, increase our expenses and present significant distractions to our management.
The Company believes that the degree of market acceptance and its ability to generate revenues from such products will depend on a number of factors, including, but not limited to: • advancements in the treatment of cancer that make our treatments obsolete; • market exclusivity and competitor products; • timing of market introduction of the Company’s drugs and competitive drugs; • actual and perceived efficacy and safety of the Company’s drug candidates; 7 Table of Contents • prevalence and severity of any side effects; • potential or perceived advantages or disadvantages over alternative treatments; • strength of sales, marketing and distribution support; • price of future products, both in absolute terms and relative to alternative treatments; • the effect of current and future healthcare laws on the Company’s drug candidates; and • availability of coverage and reimbursement from government and other third-party payers.
The Company believes that the degree of market acceptance and its ability to generate revenues from such products will depend on a number of factors, including, but not limited to: • advancements in the treatment of cancer that make our treatments obsolete; • market exclusivity and competitor products; • timing of market introduction of the Company’s drugs and competitive drugs; • actual and perceived efficacy and safety of the Company’s drug candidates; • prevalence and severity of any side effects; • potential or perceived advantages or disadvantages over alternative treatments; • strength of sales, marketing and distribution support; • price of future products, both in absolute terms and relative to alternative treatments; • the effect of current and future healthcare laws on the Company’s drug candidates; and • availability of coverage and reimbursement from government and other third-party payers.
The financial statements have been prepared on a going concern basis, which contemplates continuity of normal activities and realization of assets and settlement of liabilities in the normal course of business.
The consolidated financial statements have been prepared on a going concern basis, which contemplates continuity of normal activities and realization of assets and settlement of liabilities in the normal course of business.
Following the completion of the delisting, the Company’s ordinary shares will only be capable of being traded on Nasdaq in the form of ADSs, which will require shareholders to transfer their ordinary shares to ADSs to trade on Nasdaq and engage a suitably qualified Australian broker or a U.S. based broker who is able to trade on Nasdaq, or by off-market, private transactions, which will require shareholders to identify and agree terms with potential purchasers of ordinary shares.
Following the completion of the delisting, the Company’s ordinary shares are only capable of being traded on Nasdaq in the form of ADSs, which will require shareholders to transfer their ordinary shares to ADSs to trade on Nasdaq and engage a suitably qualified Australian broker or a U.S. based broker who is able to trade on Nasdaq, or by off-market, private transactions, which will require shareholders to identify and agree terms with potential purchasers of ordinary shares.
Failure of one or both of these product candidates to show benefit to patients could materially and adversely affect the continuity of our business and our financial condition. The Company’s lead programs include paxalisib (formerly GDC-0084), a small molecule inhibitor of the PI3K/Akt/mTOR pathway, and EVT801, a small molecule selective inhibitor of vascular endothelial growth factor receptor 3 (VEGFR3).
Failure of one or both of these product candidates to show benefit to patients could materially and adversely affect the continuity of our business and our financial condition. The Company’s lead programs include paxalisib (formerly GDC-0084), a small molecule inhibitor of the PI3K/Akt/mTOR pathway, and EVT801, a small molecule selective inhibitor of vascular endothelial growth factor receptor 3 (“VEGFR3”).
These broad market and industry factors may materially affect the market price of the Company’s ordinary shares and ADSs regardless of its development and operating performance. In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted against that company.
These broad market and industry factors may materially affect the market price of the Company’s the ADSs regardless of its development and operating performance. In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted against that company.
Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA or other regulatory authority approval.
Moreover, pre-clinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorily in pre-clinical studies and clinical trials nonetheless failed to obtain FDA or other regulatory authority approval.
Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after achieving positive results in preclinical development or early-stage clinical trials, and we cannot be certain that we will not face similar setbacks.
Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after achieving positive results in pre-clinical development or early-stage clinical trials, and we cannot be certain that we will not face similar setbacks.
For example, the loss of clinical trial data from ongoing or future clinical trials or data from preclinical studies could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
For example, the loss of clinical trial data from ongoing or future clinical trials or data from pre-clinical studies could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
These factors raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued. The independent auditor’s report for the fiscal year ended 30 June 2023 included an explanatory paragraph in relation to the going concern uncertainty.
These factors raise substantial doubt about our ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. The independent auditor’s report for the fiscal year ended 30 June 2024 included an explanatory paragraph in relation to the going concern uncertainty.
These rules and regulations could also make it more difficult for us to attract and retain qualified members of our board of directors. 12 Table of Contents Australian takeover laws may discourage takeover offers being made for us or may discourage the acquisition of a significant position in our ordinary shares and ADSs.
These rules and regulations could also make it more difficult for us to attract and retain qualified members of our board of directors. Australian takeover laws may discourage takeover offers being made for us or may discourage the acquisition of a significant position in our ordinary shares and ADSs.
These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway or safety or efficacy observations made in clinical trials, including adverse events.
These setbacks have been caused by, among other things, pre-clinical findings made while clinical trials were underway or safety or efficacy observations made in clinical trials, including adverse events.
This may have the ancillary effect of entrenching our board of directors and may deprive or limit our shareholders’ and ADS holders’ opportunity to sell their ordinary shares and ADSs and may further restrict the ability of our shareholders and ADS holders to obtain a premium from such transactions. See Item 10.B “Additional Information – Memorandum and Articles of Association.”
This may have the ancillary effect of entrenching our board of directors and may deprive or limit our shareholders’ and ADS holders’ opportunity to sell their ordinary shares and ADSs and may further restrict the ability of our shareholders and ADS holders to obtain a premium from such transactions. See Item 10.B “Additional Information - Our Constitution.”
The rights of holders of ADSs with respect to the voting of ordinary shares and the right to receive certain distributions may be limited in certain respects by the deposit agreement entered into by us and The Bank of New York Mellon.
In certain circumstances, holders of ADSs may have limited rights relative to holders of ordinary shares. The rights of holders of ADSs with respect to the voting of ordinary shares and the right to receive certain distributions may be limited in certain respects by the deposit agreement entered into by us and The Bank of New York Mellon.
These products may compete with our product candidates, if approved, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. 9 Table of Contents Many companies have encountered significant problems in protecting and defending intellectual property rights around the world.
These products may compete with our product candidates, if approved, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. Many companies have encountered significant problems in protecting and defending intellectual property rights around the world.
We cannot predict the effect of the proposed delisting on the value of our ADSs, however the delisting may restrict the liquidity of these securities by providing only one market on which to trade our securities, which may impair the development or liquidity of an active trading market for the ADSs in the U.S.
The Company cannot predict the effect of the proposed delisting on the value of the ADSs, however the delisting may restrict the liquidity of these securities by providing only one market on which to trade the Company’s securities, which may impair the development or liquidity of an active trading market for the ADSs in the U.S.
The regulatory and compliance costs to us under U.S. securities laws, if we are required to comply with the reporting requirements applicable to a U.S. domestic issuer, would be significantly higher than the cost we would incur as a foreign private issuer.
The regulatory and compliance costs to us under U.S. 15 Table of Contents securities laws, if we are required to comply with the reporting requirements applicable to a U.S. domestic issuer, would be significantly higher than the cost we would incur as a foreign private issuer.
Such a delisting would have a negative effect on the price of our common stock, impair the ability to sell or purchase our common stock when persons wish to do so, and any delisting materially adversely affect our ability to raise capital or pursue strategic restructuring, refinancing or other transactions on acceptable terms, or at all.
Such a delisting would have a negative effect on the price of the Company’s securities, impair the ability to sell or purchase our 12 Table of Contents common stock when persons wish to do so, and any delisting materially adversely affect the Company’s ability to raise capital or pursue strategic restructuring, refinancing or other transactions on acceptable terms, or at all.
We are incorporated in Australia and are subject to the takeover laws of Australia. Among other things, we are subject to the Australian Corporations Act 2001, or the Corporations Act.
We are incorporated in Australia and are subject to the takeover laws of Australia. Among other things, we are subject to the Corporations Act.
In the event of a delisting, we would attempt to take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.
In the event of a delisting, the Company would attempt to take actions to restore its compliance with Nasdaq’s listing requirements, but the Company can provide no assurance that any such action taken by it would allow the ADSs to become listed again, stabilize the market price or improve the liquidity of the ADSs, prevent the ADSs from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.
See Item 10—Additional Information—Taxation, United States Federal Income Tax Consequences for a more complete discussion of the U.S. federal income tax risks related to owning and disposing of our ordinary shares or ADSs. Currency fluctuations may adversely affect the price of our ordinary shares, ADSs.
See Item 10-Additional Information-Taxation, United States Federal Income Tax Consequences for a more complete discussion of the U.S. federal income tax risks related to owning and disposing of our ordinary shares or ADSs.
However, this trend may not continue and may be reversed. We may lose our foreign private issuer status, which would then require us to comply with the Exchange Act’s domestic reporting regime and cause us to incur significant legal, accounting and other expenses. We are a foreign private issuer.
We may lose our foreign private issuer status, which would then require us to comply with the Exchange Act’s domestic reporting regime and cause us to incur significant legal, accounting and other expenses. We are a foreign private issuer.
Paxalisib (formerly GDC-0084) was granted orphan drug designation by the FDA in February 2018 for the treatment of glioblastoma, in August 2020 for the treatment of malignant glioma, which includes DIPG, a rare and highly aggressive childhood brain cancer, and in June 2022 for the treatment of atypical rhabdoid / teratoid tumors (AT/RT).
Paxalisib (formerly GDC-0084) was granted orphan drug designation by the FDA in February 2018 for the treatment of glioblastoma, in August 2020 for the treatment of malignant glioma, which includes diffuse intrinsic pontine glioma (“DIPG”), a rare and highly aggressive childhood brain cancer, and in June 2022 for the treatment of atypical rhabdoid / teratoid tumors (“AT/RT”).
Any of these outcomes could impair our ability to prevent competition from third parties. 8 Table of Contents If the patent applications we hold or have in-licensed with respect to our programs or product candidates fail to issue, or are revoked, if the breadth or strength of our patent protection is threatened, or if our patent portfolio fails to provide meaningful exclusivity for our product candidates, it could dissuade companies from collaborating with us to develop product candidates and threaten our ability to commercialize future products.
If the patent applications we hold or have in-licensed with respect to our programs or product candidates fail to issue, or are revoked, if the breadth or strength of our patent protection is threatened, or if our patent portfolio fails to provide meaningful exclusivity for our product candidates, it could dissuade companies from collaborating with us to develop product candidates and threaten our ability to commercialize future products.
The notice had no immediate effect on the listing or the trading of our common stock on The Nasdaq Capital Market. Pursuant to Nasdaq Marketplace Rule 5810(c)(3)(A), the notice letter stated that we had an initial compliance period of 180 calendar days to regain compliance with the minimum bid price requirement.
The notice had no immediate effect on the listing or the trading of the ADSs on The Nasdaq Capital Market. Pursuant to Nasdaq Marketplace Rule 5810(c)(3)(A), the notice letter stated that the Company had an initial compliance period of 180 calendar days, or until May 20, 2024, to regain compliance with the minimum bid price requirement.
The trading price of the Company’s ordinary shares and ADSs is highly volatile in response to various factors, many of which are beyond the Company’s control, including: • unacceptable toxicity findings in animals and humans; • lack of efficacy in human trials at Phase II stage or beyond; • announcements of technological innovations by the Company and its competitors; • new products introduced or announced by the Company or its competitors; • changes in financial estimates by securities analysts; • actual or anticipated variations in operating results; • expiration or termination of licenses, research contracts or other collaboration agreements; • conditions or trends in the regulatory climate in the biotechnology, pharmaceutical and genomics industries; • changes in the market values of similar companies; • changes in the broader macroeconomic environment; • the liquidity of any market for the Company’s securities; and • additional sales by the Company of its shares. 11 Table of Contents In addition, equity markets in general and the market for biotechnology and life sciences companies in particular, have experienced substantial price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of the companies traded in those markets.
The trading price of the ADSs is highly volatile in response to various factors, many of which are beyond the Company’s control, including: • unacceptable toxicity findings in animals and humans; • lack of efficacy in human trials at Phase II stage or beyond; • announcements of technological innovations by the Company and its competitors; • new products introduced or announced by the Company or its competitors; • changes in financial estimates by securities analysts; • actual or anticipated variations in operating results; • expiration or termination of licenses, research contracts or other collaboration agreements; • conditions or trends in the regulatory climate in the biotechnology, pharmaceutical and genomics industries; 13 Table of Contents • changes in the market values of similar companies; • changes in the broader macroeconomic environment; • the liquidity of any market for the Company’s securities; and • additional sales by the Company of its shares.
In the course of discovery, pre-clinical testing and clinical trials, the Company relies on third parties, including laboratories, investigators, clinical contract research organizations (“CROs”), and manufacturers, to perform critical services. For example, the Company relies on third parties to conduct all of its pre-clinical and clinical studies.
In the course of discovery, pre-clinical testing and clinical trials, the Company relies on third parties, including laboratories, investigators, clinical CROs, and manufacturers, to perform critical services. For example, the Company relies on third parties to 11 Table of Contents conduct all of its pre-clinical and clinical studies.
On December 9, 2022, we received a notice from the Nasdaq Listing Qualifications Department of The Nasdaq Capital Market (“Nasdaq”) informing us that because the closing bid price of our common stock had been below $1.00 per share for 30 consecutive business days, we no longer complied with the minimum bid price requirement for continued listing on The Nasdaq Capital Market.
On 20 November, 2023, the Company received a notice from the Nasdaq Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) informing the Company that because the closing bid price of the ADSs had been below US$1.00 per share for 30 consecutive business days, the Company no longer complied with the minimum bid price requirement for continued listing on The Nasdaq Capital Market.
The net losses we incur may fluctuate significantly from year to year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance. We have never generated any revenue from product sales and may never be profitable.
The net losses we incur may fluctuate significantly from year to year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance. We have a history of operating losses and we expect to continue to incur losses and may never be profitable.
We have devoted most of our financial resources to research and development, including our clinical development activities. To date, we have financed our operations primarily through the issuance of equity securities, research and development grants from the Australian government and payments from our collaboration partners.
As of 30 June 2024, we had accumulated losses of A$115.1 million. We have devoted most of our financial resources to research and development, including our clinical development activities. To date, we have financed our operations primarily through the issuance of equity securities, research and development grants from the Australian government and payments from our collaboration partners.
Furthermore, even if our patents and patent applications are unchallenged, they may not adequately protect our intellectual property, provide exclusivity for our product candidates or prevent others from designing around our claims.
Furthermore, even if our patents and patent applications are unchallenged, they may not adequately protect our intellectual property, provide exclusivity for our product candidates or prevent others from designing around our claims. Any of these outcomes could impair our ability to prevent competition from third parties.
Your investment could decline in value and the Company may incur significant costs from class action litigations.
The trading price of the ADSs is highly volatile. Your investment could decline in value and the Company may incur significant costs from class action litigations.
Based on the composition of our assets and income, we believe that we were not a PFIC for U.S. federal income tax purposes with respect to our 2022 taxable year. However, there can be no assurance that we will not be considered a PFIC in the current year or for any future taxable year.
Based on the composition of our assets and income in the 2024 taxable year, if we will not be a considered a PFIC in the 2023 taxable year, we believe that we were not a PFIC for U.S. federal income tax purposes with respect to our 2024 taxable year.
Moreover, even after an orphan drug is approved, the FDA can subsequently approve the same drug, made by a competitor, for the same condition if the FDA concludes that the competitive product is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.
Moreover, even after an orphan drug is approved, the FDA can subsequently approve the same drug, made by a competitor, for the same condition if the FDA concludes that the competitive product is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care. 8 Table of Contents Positive results from pre-clinical studies of our product candidates are not necessarily predictive of the results of our planned clinical trials of our product candidates.
Positive results from preclinical studies of our product candidates are not necessarily predictive of the results of our planned clinical trials of our product candidates. Positive results in preclinical proof of concept and animal studies of our product candidates may not result in positive results in clinical trials in humans.
Positive results in pre-clinical proof of concept and animal studies of our product candidates may not result in positive results in clinical trials in humans.
For example, if a key scientist acting as a principal investigator in any of our future clinical trials identifies a potential product or compound that is more scientifically interesting to professional interests, their availability to remain involved in any future clinical trials could be restricted or eliminated. 5 Table of Contents We face potential product liability claims, and, if successful claims are brought against us, we may incur substantial liability and costs.
For example, if a key scientist acting as a principal investigator in any of our future clinical trials identifies a potential product or compound that is more scientifically interesting to professional interests, their availability to remain involved in any future clinical trials could be restricted or eliminated.
If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through strategic collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate, or we may allocate internal resources to a product candidate in a therapeutic area in which it would have been more advantageous to enter into a collaboration arrangement.
If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through strategic collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate, or we may allocate internal resources to a product candidate in a therapeutic area in which it would have been more advantageous to enter into a collaboration arrangement. 7 Table of Contents Our internal computer and information technology systems, or those of our collaborators and other development partners, third-party Contract Research Organizations (“CROs”) or other contractors or consultants, may fail or suffer security breaches, which could result in a disruption of our product development programs.
While it is not possible to make accurate predictions of future operating results, we expect existing cash and cash equivalents, including the capital raised in July 2023, will be sufficient to enable us to continue our research and development activities until approximately November 2023. As at 30 June 2023, we had cash on hand at the bank of A$5.2 million.
While it is not possible to make accurate predictions of future operating results, we expect existing cash and cash equivalents, including the capital raised under our ATM facility and equity line of credit facility with Alumni Capital L.P., will be sufficient to enable us to continue our research and development activities until approximately March 2025. 4 Table of Contents As of 30 June 2024, we had cash on hand at the bank of A$1.7 million.
Our common stock is listed on the Nasdaq Capital Market. If we fail to satisfy the continued listing requirements of Nasdaq, such as the corporate governance requirements or the minimum closing bid price requirement, Nasdaq may take steps to delist our common stock.
If the Company fails to satisfy the continued listing requirements of Nasdaq, such as the corporate governance requirements or the minimum closing bid price requirement, Nasdaq may take steps to delist the ADSs.
A number of other companies have products or drug candidates in various stages of pre-clinical or clinical development that are intended for the same therapeutic indications for which the Company’s drug candidates are being developed. Some of these potential competing drugs are further advanced in development than the Company’s drug candidates and may be commercialized sooner.
The development of drug candidates is highly competitive and is high risk. A number of other companies have products or drug candidates in various stages of pre-clinical or clinical development that are intended for the same therapeutic indications for which the Company’s drug candidates are being developed.
If the proposed delisting is completed, our ordinary shares will no longer be quoted or traded on the ASX and only the ADSs will be listed on the Nasdaq Stock Market, and as a result, shareholders will no longer be able to trade their ordinary shares on the ASX.
Upon completion of the delisting, the Company’s ordinary shares were no longer quoted or traded on the ASX and only the ADSs are listed on the Nasdaq Capital Market, and as a result, shareholders were no longer able to trade their ordinary shares on the ASX.
As a result, the Company’s competitors may be able to develop technologies and products that would render the Company’s technologies or its drug candidates obsolete or non-competitive.
These organizations also compete with the Company and its service providers, to recruit qualified personnel, and to attract partners for joint ventures and to license technologies. As a result, the Company’s competitors may be able to develop technologies and products that would render the Company’s technologies or its drug candidates obsolete or non-competitive.
There is doubt as to the enforceability in the Commonwealth of Australia, in original actions or in actions for enforcement of judgments of U.S. courts, of civil liabilities predicated solely upon federal or state securities laws of the U.S., especially in the case of enforcement of judgments of U.S. courts where the defendant has not been properly served in Australia. 10 Table of Contents Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock, which could negatively impact the market price and liquidity of our common shares and our ability to access the capital markets.
There is doubt as to the enforceability in the Commonwealth of Australia, in original actions or in actions for enforcement of judgments of U.S. courts, of civil liabilities predicated solely upon federal or state securities laws of the U.S., especially in the case of enforcement of judgments of U.S. courts where the defendant has not been properly served in Australia.
However, trade secrets can be difficult to protect. What constitutes a trade secret and what protections are available for trade secrets varies from state to state in the United States and country by country worldwide. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors.
However, trade secrets can be difficult to protect. What constitutes a trade secret and what 10 Table of Contents protections are available for trade secrets varies from state to state in the United States and country by country worldwide.
We have not generated any revenues from sales of any of our product candidates in prior financial years, however in the fiscal year ended June 30, 2021 we did generate revenues of A$15.2 million from the licensing of our development stage drug candidates. As of 30 June 2023, we had accumulated losses of A$89,082,571.
We have incurred losses of A$25.0 million, A$20.5 million, and A$26.8 million for the fiscal years ended 30 June 2022 (restated), 2023, and 2024, respectively. We generated revenues of A$2.3 million during 2024 from the licensing of our development stage drug candidates. We did not generate any revenues from sales of any of our product candidates in prior financial years.
In addition, our trade secrets may otherwise become known or be independently discovered by competitors.
Security measures may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors.
This means that, from a practical point of view, the holders of ADSs may not be able to exercise their right to vote. In addition, under the deposit agreement, the depositary has the right to restrict distributions to holders of the ADSs in the event that it is unlawful or impractical to make such distributions.
This means that, from a practical point of view, the holders of ADSs may not be able to exercise their right to vote.
The Company’s commercial opportunity will be reduced or eliminated if competitors develop and market products, devices or other treatments that are more effective, have fewer side effects or are less expensive than its drug candidates. The development of drug candidates is highly competitive and is high risk.
If the Company is unable to successfully contract for these services, or if arrangements for these services are terminated, the Company may have to delay the commercialization program which will adversely affect its ability to generate operating revenues. 9 Table of Contents The Company’s commercial opportunity will be reduced or eliminated if competitors develop and market products, devices or other treatments that are more effective, have fewer side effects or are less expensive than its drug candidates.
The impact on cash resources and results from operations will vary with the extent and timing of future clinical trial programs.
We expect to consume cash and incur operating losses for the foreseeable future as the Company continues developing its oncology drug candidates. The impact on cash resources and results from operations will vary with the extent and timing of future clinical trial programs.
If at any time during this period the bid price of the company’s ADSs closes at or above US$1.00 per share for a minimum of ten consecutive business days, the company will regain compliance with the minimum bid requirement.
If at any time during the Second Compliance Period the closing bid price of the Company’s security is at least $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written confirmation of compliance.
It is therefore uncertain as to whether any of our tax losses carried forward as of 30 June 2023 will be available to be carried forward and available to offset our assessable income, if any, in future periods. 6 Table of Contents Risks Related to the Product Development and Regulatory Approval of Our Product Candidates We may not be able to obtain orphan drug exclusivity, where relevant, in all markets for our product candidates.
It is therefore uncertain as to whether any of our tax losses carried forward as of 30 June 2024 will be available to be carried forward and available to offset our assessable income, if any, in future periods.
Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations, which could have an adverse effect on our business, financial condition, results of operations and prospects. The Company has two product candidates currently in clinical trials.
Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations, which could have an adverse effect on our business, financial condition, results of operations and prospects. 3 Table of Contents We will need additional funding to operate our business; such funding may not be available or, if it is available, such financing is likely to substantially dilute our existing shareholders During the year ended 30 June 2024 we raised A$4.6 million from the sale of ADSs.
We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. Security measures may be breached, and we may not have adequate remedies for any breach.
We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors. We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems.
Regulatory authorities in some jurisdictions, including the United States, may designate drugs for relatively small patient populations as orphan drugs.
Risks Related to the Product Development and Regulatory Approval of Our Product Candidates We may not be able to obtain orphan drug exclusivity, where relevant, in all markets for our product candidates. Regulatory authorities in some jurisdictions, including the United States, may designate drugs for relatively small patient populations as orphan drugs.
Risks Related to our Securities Enforceability of civil liabilities under the federal securities laws against the Company or the Company’s officers and directors may be difficult. The Company is a public company limited by shares and is registered and operates under the Australian Corporations Act 2001. Half of the Company’s directors and officers reside outside of the United States.
The Company is a public company limited by shares and is registered and operates under the Corporations Act 2001 (Cth) (“Corporation Act”). Half of the Company’s directors and officers reside outside of the United States. In addition, a substantial portion of the directly owned assets of the Company are located outside of the United States.
Loss, damage, or theft of this material, for example while in storage or transit, may result in significant detriment to the Company, which may be incompletely cured by insurance. 3 Table of Contents There is substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing.
Loss, damage, or theft of this material, for example while in storage or transit, may result in significant detriment to the Company, which may be incompletely cured by insurance. Risks Related to our Securities Enforceability of civil liabilities under the federal securities laws against the Company or the Company’s officers and directors may be difficult.
Even if the Company is successful in developing effective drugs, its compounds may not compete successfully with products produced by its competitors. The Company’s competitors include pharmaceutical companies and biotechnology companies, as well as universities and public and private research institutions. In addition, companies active in different but related fields represent substantial competition.
The Company’s competitors include pharmaceutical companies and biotechnology companies, as well as universities and public and private research institutions. In addition, companies active in different but related fields represent substantial competition. Many of the Company’s competitors developing oncology drugs have significantly greater capital resources, larger R&D staff and facilities and greater experience in drug development, regulation, manufacturing and marketing.
You are reliant on the depositary to exercise your voting rights and to receive distributions on ADSs and, as a result, you may be unable to exercise your voting rights on a timely basis or you may not receive certain distributions. In certain circumstances, holders of ADSs may have limited rights relative to holders of ordinary shares.
If the Company cannot provide reliable financial reports or prevent fraud, its business and operating results could be harmed, investors could lose confidence in its reported financial information, and the trading price of the ADSs could drop significantly. 14 Table of Contents You are reliant on the depository to exercise your voting rights and to receive distributions on ADSs and, as a result, you may be unable to exercise your voting rights on a timely basis or you may not receive certain distributions.
We have no obligation to take any action to permit distributions to holders of our ADSs. As a result, holders of ADSs may not receive distributions. If we are, a passive foreign investment company, or PFIC, there could be adverse U.S. federal income tax consequences to U.S. investors.
If we are, a passive foreign investment company, or PFIC, there could be adverse U.S. federal income tax consequences to U.S. investors. Based on the composition of our assets and income in the 2023 taxable year, we believe that we were a PFIC for U.S. federal income tax purposes with respect to our 2023 taxable year.
The Company has limited cash resources and will periodically need additional funds to maintain the planned level of R&D activity. We expect to consume cash and incur operating losses for the foreseeable future as the Company continues developing its oncology drug candidates.
There is substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing. The Company has limited cash resources and will periodically need additional funds to maintain the planned level of R&D activity.
Removed
We have incurred losses of A$8,419,484, A$25,014,055 and A$20,465,180 for the fiscal years ended June 30, 2021 (restated), 2022 (restated) and 2023, respectively.
Added
We will need to secure additional financing in order to continue to meet our longer-term business objectives, including advancement of our research and development programs and we may also require additional funds to pursue regulatory clearances, defend our intellectual property rights, establish commercial scale manufacturing facilities, develop marketing and sales capabilities and fund operating expenses.
Removed
Our internal computer and information technology systems, or those of our collaborators and other development partners, third-party Contract Research Organizations (CROs) or other contractors or consultants, may fail or suffer security breaches, which could result in a disruption of our product development programs.
Added
We intend to seek such additional funding through public or private financings and/or through licensing of our assets or strategic alliances or other arrangements with corporate partners.
Removed
If the Company is unable to successfully contract for these services, or if arrangements for these services are terminated, the Company may have to delay the commercialization program which will adversely affect its ability to generate operating revenues.
Added
Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never achieve, we expect to finance our cash needs primarily through public or private equity offerings, debt financings or through strategic alliances. We cannot be certain that additional funding will be available on acceptable terms or at all.
Removed
Many of the Company’s competitors developing oncology drugs have significantly greater capital resources, larger R&D staff and facilities and greater experience in drug development, regulation, manufacturing and marketing. These organizations also compete with the Company and its service providers, to recruit qualified personnel, and to attract partners for joint ventures and to license technologies.
Added
If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of, or eliminate one or more of our clinical trials, collaborative research or development programs or future commercialisation initiatives. In addition, any additional funding that we do obtain will dilute the ownership held by our existing security holders.
Removed
In addition, a substantial portion of the directly owned assets of the Company are located outside of the United States.
Added
The amount of this dilution may be substantially increased if the trading price of our shares is lower at the time of any financing. Regardless, the economic dilution to shareholders will be significant if our stock price does not increase significantly, or if the effective price of any sale is below the price paid by a particular shareholder.
Removed
To regain compliance, the closing bid price of our common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business days during the 180 calendar day grace period.
Added
Any debt financing could involve substantial restrictions on activities and creditors could seek a pledge of some or all of our assets.
Removed
On April 13, 2023, we received a letter from the Listing Qualifications Staff (the “Staff”) of Nasdaq confirming the Company had regained compliance with Nasdaq’s minimum bid price requirement under Listing Rule 5550(a)(2).
Added
We have not identified potential sources for the additional financing that we will require, and we do not have commitments from any third parties to provide any future financing, other than the equity line program with Alumni Capital L.P., which is subject to certain restrictions.
Removed
In the letter received on April 13, 2023, the Staff determined that, during the ten consecutive business days from March 29, 2023 to April 12, 2023, the closing bid price of the Company’s ADSs has been at $1.00 per share or greater and accordingly, the Company has regained compliance with Listing Rule 5550(a)(2).

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

78 edited+31 added−36 removed79 unchanged
FDA provides programs intended to facilitate and expedite development and review of new products that are intended to address an unmet medical need in the treatment of a serious or life-threatening disease or condition. These programs are referred to as fast track designation, breakthrough therapy designation and priority review designation.
The FDA provides programs intended to facilitate and expedite development and review of new products that are intended to address an unmet medical need in the treatment of a serious or life-threatening disease or condition. These programs are referred to as fast track designation, breakthrough therapy designation and priority review designation.
Part I is assessed by a coordinated review by the competent authorities of all EU member states States in which an application for authorization of a clinical trial has been submitted (Member States Concerned) of a draft report prepared by a Reference Member State. Part II is assessed separately by each Member State Concerned.
Part I is assessed by a coordinated review by the competent authorities of all EU member states in which an application for authorization of a clinical trial has been submitted (Member States Concerned) of a draft report prepared by a Reference Member State. Part II is assessed separately by each Member State Concerned.
The process required by the FDA before drugs may be marketed in the United States generally involves the following: • pre-clinical laboratory evaluations, including formulation and stability testing, and animal tests performed under the FDA’s Good Laboratory Practices regulations to assess pharmacological activity and toxicity potential; • submission and review of an IND Application, including results of pre-clinical studies, clinical experience (if any), manufacturing information, and protocols for clinical trials, which must become effective before clinical trials may begin in the United States; • obtaining approval of Institutional Review Boards (“IRBs”), to administer the products to human subjects in clinical trials; • adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for the product’s intended use; • development of manufacturing processes which conform to FDA current Good Manufacturing Practices (“cGMPs”), as confirmed by FDA inspection; • submission of results for pre-clinical and clinical studies, and chemistry, manufacture and control information on the product to the FDA in a New Drug Approval (“NDA”) Application; and • FDA review and approval of an NDA, prior to any commercial sale, promotion or shipment of a product.
The process required by the FDA before drugs may be marketed in the United States generally involves the following: • pre-clinical laboratory evaluations, including formulation and stability testing, and animal tests performed under the FDA’s Good Laboratory Practices regulations to assess pharmacological activity and toxicity potential; • submission and review of an IND Application, including results of pre-clinical studies, clinical experience (if any), manufacturing information, and protocols for clinical trials, which must become effective before clinical trials may begin in the United States; • obtaining approval of Institutional Review Boards (“IRBs”), to administer the products to human subjects in clinical trials; • adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for the product’s intended use; • development of manufacturing processes which conform to FDA current Good Manufacturing Practices (“GMPs”), as confirmed by FDA inspection; • submission of results for pre-clinical and clinical studies, and chemistry, manufacture and control information on the product to the FDA in a New Drug Approval (“NDA”) Application; and • FDA review and approval of an NDA, prior to any commercial sale, promotion or shipment of a product.
The Depositary for the Company’s ADSs is The Bank of New York Mellon, 240 Greenwich Street, New York, NY 10286. All information we file with the SEC is available through the SEC’s Electronic Data Gathering, Analysis and Retrieval system, which may be accessed through the SEC’s website at www.sec.gov .
The Depositary for the Company’s ADSs is The Bank of New York Mellon, 240 Greenwich Street, New York, NY 10286. All information we file with the SEC is available through the SEC’s Electronic Data Gathering, Analysis and Retrieval system, which may be accessed through the SEC’s website at www.sec.gov . B.
OPTIMISE phase II study Kazia entered into a collaboration with the Australian and New Zealand Children’s Haematology / Oncology Group (ANZCHOG) in March 2023 for a phase II clinical study examining paxalisib as a targeted therapeutic in children with advanced solid tumours, including brain tumours.
OPTIMISE phase II study Kazia entered into a collaboration with the Australian and New Zealand Children’s Haematology / Oncology Group in March 2023 for a phase II clinical study examining paxalisib as a targeted therapeutic in children with advanced solid tumours, including brain tumours.
Furthermore, the FDA, the IRB or the Company may suspend or terminate clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. 21 Table of Contents Results of pre-clinical studies and clinical trials, as well as detailed information about the manufacturing process, quality control methods, and product composition, among other things, are submitted to the FDA as part of an NDA seeking approval to market and commercially distribute the product on the basis of a determination that the product is safe and effective for its intended use.
Furthermore, the FDA, the IRB or the Company may suspend or terminate clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. 25 Table of Contents Results of pre-clinical studies and clinical trials, as well as detailed information about the manufacturing process, quality control methods, and product composition, among other things, are submitted to the FDA as part of an NDA seeking approval to market and commercially distribute the product on the basis of a determination that the product is safe and effective for its intended use.
Prior to this transaction, Genentech had completed an extensive preclinical development program that provided convincing validation for paxalisib as a potential drug for brain cancer. Genentech also completed a phase I clinical trial in 47 patients with advanced recurrent grade III and grade IV glioma (NCT01547546). The most common adverse events were oral mucositis and hyperglycemia.
Prior to this transaction, Genentech had completed an extensive pre-clinical development program that provided convincing validation for paxalisib as a potential drug for brain cancer. Genentech also completed a phase I clinical trial in 47 patients with advanced recurrent grade III and grade IV glioma (NCT01547546). The most common adverse events were oral mucositis and hyperglycemia.
Paxalisib is involved in ten clinical trials, all being conducted by world renowned research organizations and principally funded by parties other than the Company, giving us multiple opportunities to realise value from this product candidate. EVT801’s phase I clinical trial continues and we believe that we are on track to have initial phase I data in the 4Q CY2023.
Paxalisib is involved in ten clinical trials, all being conducted by world renowned research organizations and principally funded by parties other than the Company, giving us multiple opportunities to realise value from this product candidate. EVT801’s phase I clinical trial continues and we believe that we are on track to have initial phase I data in the Q4 CY2023.
Environmental, social and governance (ESG) report Environmental The consolidated entity is not subject to any significant environmental regulation under Australian Commonwealth or State law. We are considering ways in which environmental impacts can be monitored however we do not foresee a material impact. Sustainability Kazia’s head office is located in a sustainable carbon neutral commercial precinct.
Environmental, social and governance (ESG) report Environmental The Consolidated Entity is not currently subject to any significant or unusual environmental regulation under Australian Commonwealth or State law. We are considering ways in which environmental impacts can be monitored however we do not foresee a material impact. Sustainability Kazia’s head office is located in a sustainable carbon neutral commercial precinct.
The Company cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the U.S. or abroad. 22 Table of Contents The Company’s activities may also be subject to state laws and regulations that affect its ability to develop and sell products.
The Company cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the U.S. or abroad. 26 Table of Contents The Company’s activities may also be subject to state laws and regulations that affect its ability to develop and sell products.
The LUMOS2 study is sponsored by the University of Sydney with a goal of investigating targeted therapeutics in these patients who have limited options. The study is expected to enroll up to 76 patients with PI3K pathway mutations and will be a multicenter study at several Australian sites, with the potential to expand internationally.
The LUMOS2 study is sponsored by the University of Sydney with a goal of investigating targeted therapeutics in these patients who have limited options. The study is expected to enroll up to 76 patients with PI3K pathway mutations and will be a multicenter study at several Australian sites, with the potential to expand internationally. Enrollment in the study is ongoing.
The conduct of clinical trials in the EU is governed by the Clinical Trials Regulation (EU) No 536/2014 (CTR), which replaced the previous Clinical Trials Directive 2001/20/EC on January 31, 2022. No clinical trial may be commenced in the EU without a clinical trial authorization from the applicable national competent authorities and favourable ethics approval.
The conduct of clinical trials in the EU is governed by the Clinical Trials Regulation (EU) No 536/2014 (“CTR”), which replaced the previous Clinical Trials Directive 2001/20/EC on 31 January, 2022. No clinical trial may be commenced in the EU without a clinical trial authorization from the applicable national competent authorities and favourable ethics approval.
Regulatory Requirements The FDA regulates and imposes substantial requirements upon the research, development, pre-clinical and clinical testing, labelling, manufacture, quality control, storage, approval, advertising, promotion, marketing, distribution, import and export of pharmaceutical products including drugs and biologics, as well as significant reporting and record-keeping obligations.
U.S. Regulatory Requirements The FDA regulates and imposes substantial requirements upon the research, development, pre-clinical and clinical testing, labelling, manufacture, quality control, storage, approval, advertising, promotion, marketing, distribution, import and export of pharmaceutical products including drugs and biologics, as well as significant reporting and record-keeping obligations.
State governments may also impose obligations in some of these areas. 20 Table of Contents In the United States, pharmaceutical products are primarily regulated by the FDA under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and its implementing regulations, and in the case of biologics, the Public Health Service Act and its implementing regulations.
State governments may also impose obligations in some of these areas. 24 Table of Contents In the United States, pharmaceutical products are primarily regulated by the FDA under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and its implementing regulations, and in the case of biologics, the Public Health Service Act and its implementing regulations.
Within the adult brain cancer pillar, we have four ongoing clinical studies across three different patient populations. There are two actively recruiting clinical studies and one recently completed study in the pediatric brain cancer pillar. Within the brain metastases pillar, there are three ongoing studies. Paxalisib in Adult Brain Cancer Glioblastoma (GBM) is a fast-growing and aggressive brain tumour.
Within the adult brain cancer pillar, we have four ongoing clinical studies across three different patient populations. There are two actively recruiting clinical studies and one recently completed study in the pediatric brain cancer pillar. Within the brain metastases pillar, there are three ongoing studies. Paxalisib in Adult Brain Cancer Glioblastoma (“GBM”) is a fast-growing and aggressive brain tumour.
The enrollment is ongoing for all cohorts including the expansion stage of the study in breast cancer brain metastases patients. 16 Table of Contents Dana Farber Cancer Institute (DFCI) Phase II Study in HER2+ Breast Cancer Brain Metastases in Combination with Trastuzumab (NCT03765983) Dr Jose Pablo Leone is the Principal Investigator to a phase II study in patients with HER2-positive breast cancer brain metastases, a population for which there are no approved pharmacological treatments, in which paxalisib is administered in combination with Herceptin (trastuzumab), sponsored by Dana-Farber Cancer Institute in Boston, MA.
The enrollment is ongoing for all cohorts including the expansion stage of the study in breast cancer brain metastases patients. 19 Table of Contents Dana Farber Cancer Institute (DFCI) Phase II Study in HER2+ Breast Cancer Brain Metastases in Combination with Trastuzumab (NCT03765983) Dr Jose Pablo Leone is the Principal Investigator for a phase II study in patients with HER2-positive breast cancer brain metastases, a population for which there are no approved pharmacological treatments, in which paxalisib is administered in combination with Herceptin (trastuzumab), sponsored by Dana-Farber Cancer Institute in Boston, MA.
The following employee policies are in place: • Code of Business Conduct & Ethics • Recruitment and retention • Inclusion and diversity • Parents returning to work • Education and training • Employee Share Option Plan • Health and safety • Whistleblowing • Equal Employment Opportunity and Diversity • Harassment and Discrimination • Anti-corruption and anti-bribery policies • Public disclosures • Securities trading • Scientific integrity 25 Table of Contents Product and Corporate Developments during Fiscal Year 2023 The Company continued to pursue its strategy of focusing resources on clinical programs, being specifically those most likely to provide a return to shareholders.
The following employee policies are in place: • Code of Business Conduct & Ethics • Recruitment and retention • Inclusion and diversity • Parents returning to work • Education and training • Employee Share Option Plan • Health and safety • Whistleblowing • Equal Employment Opportunity and Diversity • Harassment and Discrimination • Anti-corruption and anti-bribery policies • Public disclosures • Securities trading • Scientific integrity 29 Table of Contents Product and Corporate Developments during Fiscal Year 2024 The Company continued to pursue its strategy of focusing resources on clinical programs, being specifically those most likely to provide a return to shareholders.
Paxalisib is distinguished from these products by the fact that it is the only PI3K inhibitor in mainstream clinical development which is known to cross the blood-brain barrier, a crucial prerequisite for any novel treatment in brain cancer. 13 Table of Contents Paxalisib’s mechanism is therefore entirely distinct from that of temozolomide, the existing FDA-approved standard of care treatment.
Paxalisib is distinguished from these products by the fact that it is the only PI3K inhibitor in mainstream clinical development which is known to cross the blood-brain barrier, a crucial prerequisite for any novel treatment in brain cancer. Paxalisib’s mechanism is therefore entirely distinct from that of temozolomide, the existing FDA-approved standard of care treatment.
The Company is not at the stage of development with its products where it is subject to these fees, but they are significant expenditures that may be incurred in the future and must be paid at the time of application submissions to FDA, as applicable. Satisfaction of FDA requirements typically takes several years.
The Company is not at the stage of development with its products where it is subject to these fees, but they are significant expenditures that may be incurred in the future and must be paid at the time of application submissions to FDA, as applicable. Satisfaction of FDA requirements for product approval typically takes several years.
Phase I Study in Advanced Solid Tumors (NCT05114668) In November 2021, Kazia commenced recruitment to a phase I, first-in-human, multiple-ascending-dose, clinical trial of EVT801 in patients with advanced solid tumors which seeks to explore both of these mechanisms (inhibition of lymphangiogenesis and modulation of tumor immune micro-environment), The trial is being performed at two hospitals in France: Oncopole in Toulouse and Centre Léon Beraud in Lyons and will aim to recruit up to 96 patients with advanced cancer.
Phase I Study in Advanced Solid Tumors (NCT05114668) In November 2021, Kazia commenced recruitment to a phase I, first-in-human, multiple-ascending-dose, clinical trial of EVT801 in patients with advanced solid tumors which seeks to explore both of these mechanisms (inhibition of lymphangiogenesis and modulation of tumor immune micro-environment), The trial is being performed at two hospitals in France: Oncopole in Toulouse and Centre Léon Bérard in Lyons and will aim to recruit up to 60 patients with advanced cancer.
We believe that preclinical evidence supports this hypothesis with EVT801 and may provide a second and almost entirely distinct mechanism of action through which the EVT801 may provide benefit to cancer patients.
We believe that pre-clinical evidence supports this hypothesis with EVT801 and may provide a second and almost entirely distinct mechanism of action through which the EVT801 may provide benefit to cancer patients.
Item 4. Information on the Company A. History and development of the Company Kazia Therapeutics Limited (“Kazia”), a public company limited by shares, was incorporated in March 1994 and registered in New South Wales, Australia. Kazia is registered and operates under the Australian Corporations Act 2001.
Item 4. Information on the Company A. History and development of the Company Kazia Therapeutics Limited (“Kazia” or the “Company”), a public company limited by shares, was incorporated in March 1994 and registered in New South Wales, Australia. Kazia is registered and operates under the Corporations Act.
Under the centralized procedure the maximum timeframe for the evaluation of a marketing authorization application by the EMA is 210 days, excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions asked by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Under the centralized procedure the maximum timeframe for the evaluation of a marketing authorization application by the EMA is 210 days, excluding clock stops, when additional written or oral information is to 27 Table of Contents be provided by the applicant in response to questions asked by the EMA’s Committee for Medicinal Products for Human Use (“CHMP”).
Patents are submitted initially as provisional applications and after 12 months’ progress through to a Patent Cooperation Treaty (“PCT”) application. We are continuing to expand our preclinical work on paxalisib and EVT801 through collaborations with research institutions.
Patents are submitted initially as provisional applications and after 12 months’ progress through to a Patent Cooperation Treaty application. We are continuing to expand our pre-clinical work on paxalisib and EVT801 through collaborations with research institutions.
Paxalisib was granted orphan drug designation (ODD) by the FDA for glioblastoma in February 2018, and for the broader indication of glioma in August 2020 and ODD for atypical rhabdoid/teratoid tumours (AT/RT), a rare highly-aggressive childhood brain cancer, in June 2022.
Paxalisib was granted orphan drug designation (“ODD”) by the FDA for glioblastoma in February 2018, and for the broader indication of glioma in August 2020 and ODD for atypical rhabdoid/teratoid tumours (“AT/RT”), a rare highly-aggressive childhood brain cancer, in June 2022.
The 1989 Act requires that all pharmaceutical products to be imported into, supplied in, manufactured in or exported from Australia be included in the Australian Register of Therapeutic Goods (“ARTG”), unless specifically exempted under the Act.
The 1989 Act requires that all therapeutic goods imported into, supplied in, manufactured in or exported from Australia be included in the Australian Register of Therapeutic Goods (“ARTG”), unless specifically exempted or authorized under the 1989 Act.
Diffuse intrinsic pontine glioma (DIPG) is the most common of a group of childhood brain cancers known as diffuse midline gliomas (DMGs). The disease has no FDA approved drug treatments and average survival from diagnosis is approximately 10 months.
DIPG is the most common of a group of childhood brain cancers known as diffuse midline gliomas (“DMGs”). The disease has no FDA approved drug treatments and average survival from diagnosis is approximately 10 months.
Under the CTR, a single application can be made through the Clinical Trials Information System (CTIS) for authorization of a clinical trial in up to 30 EU/EEA countries at the same time and with a single set of documentation.
Under the CTR, a single application can be made through the Clinical Trials Information System for authorization of a clinical trial in up to 30 EU/ European Economic Area countries at the same time and with a single set of documentation.
Kazia announces voluntary delisting from ASX On 11 October 2023 Kazia announced that it submitted a formal application to the ASX to be removed from the official list of the ASX (Official List) in accordance with ASX Listing Rule 17.11 (Delist or the Delisting).
Voluntary Delisting from ASX On 11 October 2023 Kazia announced that it submitted a formal application to the ASX to be removed from the official list of the ASX (the “Official List”) in accordance with ASX Listing Rule 17.11.
In April 2022 an office membership agreement was signed with Deerfield Management for one year in The Cure, Deerfield’s innovation campus at 345 Park Avenue South, New York, NY, and was extended for an additional 12 months in April 2023. Item 4A. Unresolved Staff Comments None.
In April 2022 an office membership agreement was signed with Deerfield Management for one year in The Cure, Deerfield’s innovation campus at 345 Park Avenue South, New York, NY, and was extended for an additional 12 months until April 2025. 30 Table of Contents Item 4A. Unresolved Staff Comments None.
During the fiscal year ended 30 June 2023, Kazia sold an aggregate amount of US$4,203,221 (2022 US$2,956,036) of ADSs under the ATM facility. The ATM facility allows Kazia to raise capital dynamically in the open market, with no discount, no warrant coverage, and modest banking fees, allowing it to fund operations with minimal dilution to existing shareholders. C.
During the fiscal year ended 30 June 2024, Kazia sold an aggregate amount of US$1,656,016 (2023 US$4,203,221) of ADSs under the ATM facility. The ATM facility allows Kazia to raise capital dynamically in the open market, with no discount, no warrant coverage, and modest banking fees, allowing it to fund operations with minimal dilution to existing shareholders.
The safety profile and pharmacokinetics were highly consistent with the adult data. 15 Table of Contents PNOC022 phase II Study in Diffuse Intrinsic Pontine Glioma (DIPG) (NCT05009992) In December 2020, the company entered into a letter of intent with the Pacific Pediatric Neuro-Oncology Consortium (PNOC), an international consortium focused on the development of novel combination therapies, to execute an investigator-initiated phase II adaptive platform study of paxalisib in patients with DIPG and other DMGs, a group which collectively constitutes one of the most aggressive childhood cancers.
PNOC022 phase II Study in Diffuse Intrinsic Pontine Glioma (DIPG) (NCT05009992) In December 2020, the company entered into a letter of intent with the Pacific Pediatric Neuro-Oncology Consortium (PNOC), an international consortium focused on the development of novel combination therapies, to execute an investigator-initiated phase II adaptive platform study of paxalisib in patients with DIPG and other DMGs, a group which collectively constitutes one of the most aggressive childhood cancers.
Paxalisib in Pediatric Brain Cancer Brain cancer is the most common malignancy of childhood and represents about one third of all childhood cancer deaths. The PI3K/AKT/mTOR pathway is frequently upregulated in pediatric cancers and therefore therapeutics that target those pathways could lead to well long-awaited regulatory approvals.
Study enrollment is ongoing and expected to recruit approximately 25 patients. Paxalisib in Pediatric Brain Cancer Brain cancer is the most common malignancy of childhood and represents about one third of all childhood cancer deaths. The PI3K/AKT/mTOR pathway is frequently upregulated in pediatric cancers and therefore therapeutics that target those pathways could lead to well long-awaited regulatory approvals.
Organizational structure Kazia Therapeutics Limited is incorporated in Australia and has the following wholly-owned subsidiaries: Name Country of incorporation Kazia Laboratories Pty Ltd Australia Kazia Research Pty Ltd Australia Kazia Therapeutics Inc.
Organizational structure Kazia Therapeutics Limited is incorporated in Australia and has the following wholly-owned subsidiaries: Name Country of incorporation Kazia Laboratories Pty Ltd Australia Kazia Research Pty Ltd Australia Kazia Therapeutics Inc. United States (Delaware) Glioblast Pty Ltd Australia D.
The FDA adjusts the PDUFA user fees on an annual basis. PDUFA also imposes an annual product fee for prescription drugs and biologics, and an annual establishment fee on facilities used to manufacture prescription drugs and biologics. A written request can be submitted for a waiver under certain circumstances.
PDUFA also imposes an annual product fee for prescription drugs and biologics, and an annual establishment fee on facilities used to manufacture prescription drugs and biologics. A written request can be submitted for a waiver under certain circumstances.
The Company is an emerging oncology-focused biotechnology company that has a portfolio of development candidates, diversified across several distinct technologies, with the potential to yield first-in-class and best-in-class agents in a range of oncology indications.
Business overview The ongoing principal business of the Company has been pharmaceutical drug development. The Company is an emerging oncology-focused biotechnology company that has a portfolio of development candidates, diversified across several distinct technologies, with the potential to yield first-in-class and best-in-class agents in a range of oncology indications.
Our compassionate use program has treated over 40 patients in 7 countries since its inception in 2018. Countries we treat compassionate patients in: Australia, USA, Israel, Spain, Switzerland, England and Ireland Social and Governance Social and governance matters cover a vast range of potential issues including responsible business policies. Our policies set out our commitment to high social standards.
Our compassionate use program has treated over 40 patients in 7 countries since its inception in 2018. 28 Table of Contents Countries we treat compassionate patients in: Australia, USA, Israel, Spain, Switzerland, England and Ireland Social and Governance Social and governance matters cover a vast range of potential issues including responsible business policies.
Fast Track Designation We received Fast Track Designation (FTD) by the FDA in July 2023 for paxalisib for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy, based on the promising clinical data from an interim analysis of the MSKCC phase 1 trial.
Study enrollment is complete and data is expected to be presented in CY2025. Fast Track Designation We received FTD by the FDA in July 2023 for paxalisib for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy, based on the promising clinical data from an interim analysis of the MSKCC phase 1 trial.
The application usually consists of a form accompanied by data (based on the EU requirements) to support the quality, safety and efficacy of the product for its intended use and payment of a fee. Application details are available on the TGA website www.tga.gov.au .
The application usually consists of a form accompanied by data in the Common Technical Document (CTD) format to support the quality, safety and efficacy of the product for its intended use and payment of a fee. Application details are available on the TGA website www.tga.gov.au .
Any refusal to approve, delay in approval, suspension or withdrawal of approval, or restrictions on indicated uses could have a material adverse impact on the Company’s business prospects. A user fee, pursuant to the requirements of the Prescription Drug User Fee Act (“PDUFA”), and its amendments, applies to NDAs, unless exempted.
Any refusal to approve, delay in approval, suspension or withdrawal of approval, or restrictions on indicated uses could have a material adverse impact on the Company’s business prospects. A user fee, pursuant to the requirements of the PDUFA, and its amendments, applies to NDAs, unless exempted. The FDA adjusts the PDUFA user fees on an annual basis.
Collectively, these special designations provide paxalisib with enhanced access to FDA, a waiver of PDUFA fees, a period of regulatory exclusivity and, in the specific case of RPDD, the potential to secure a pediatric Priority Review Voucher (pPRV) should paxalisib be first approved in this indication.
Collectively, these designations provide opportunities for enhanced access to FDA, a waiver of Prescription Drug Use Fee Act (“PDUFA”) fees, a period of regulatory exclusivity and, in the specific case of RPDD, the potential to secure a pediatric Priority Review Voucher (pPRV) should paxalisib be first approved in this indication.
Our agent for service of process in the United States is Vcorp Services, LLC, 25 Robert Pitt Drive, Suite 204, Monsey, New York 10952. The Company’s Ordinary Shares are listed on the Australian Securities Exchange (“ASX”) under the symbol ‘KZA’ and its ADSs, each representing ten Ordinary Shares, trade on the Nasdaq Capital Market under the symbol ‘KZIA’.
Our agent for service of process in the United States is Vcorp Services, LLC, 25 Robert Pitt Drive, Suite 204, Monsey, New York 10952. The Company’s ADSs, each representing one-hundred Ordinary Shares, trade on the Nasdaq Capital Market under the symbol ‘KZIA’.
Depending on the results of the study, Kazia may use such data to support submission of a new drug application for marketing authorisation to the FDA.
Depending on the results of the study, Kazia may use such data to support submission of a new drug application for marketing authorisation to the FDA. On 10 July, 2024, Kazia announced results from the GBM-AGILE study.
The collaboration is ongoing and will build on initial research that has already led to the filing of a provisional patent in 2022, including the use of paxalisib as an immune modulator in the treatment of diseases such as breast cancer. 18 Table of Contents Broad Clinical Program Ongoing Sponsor Phase Indication Registration PAXALISIB Global Coalition for Adaptive Research II / III Glioblastoma NCT03970447 Weill Cornell Medicine II Glioblastoma (with ketogenesis) NCT05183204 Alliance for Clinical Trials in Oncology II Brain metastases NCT03994796 Dana-Farber Cancer Institute II Breast cancer brain metastases (with Herceptin) NCT03765983 Dana-Farber Cancer Institute II Primary CNS lymphoma NCT04906096 University of Sydney I/II Grade 2/3 IDH-mutant adult gliomas TBD Pacific Pediatric Neuro-Oncology Consortium II DIPG (childhood brain cancer) NCT05009992 Aus. & NZ Children’s Oncology Group II Advanced solid tumours in children TBD St Jude Children’s Research Hospital I DIPG NCT03696355 Memorial Sloan Kettering Cancer Center I Brain metastases (with radiotherapy) NCT04192981 EVT801 Kazia Therapeutics I Advanced solid tumours NCT05114668 Clinical Development Overview IDH: Isocitrate dehydrogenase, DIPG: Diffuse Intrinsic Pontine Glioma, AT/RT: Atypical Teratoid Rhabdoid Tumor, CNS: central nervous system, TNBC: triple negative breast cancer, VEGFR3: vascular endothelial growth factor receptor 3 Patent Protection The Company has an aggressive global Intellectual Property (“IP”) strategy to protect its key assets and we have partnered with a large Australian law firm to lodge patents that seek to provide protection for our assets.
On 12 September, 2024, Kazia announced that an agreement had been executed with QIMR Berghofer Medical Research Institute, one of Australia’s foremost cancer research centers, to obtain an exclusive license to certain intellectual property rights in relation to combination therapies consisting of PI3K inhibitor drugs, and one or more immunotherapy or PARP inhibitor drugs (PI3K combination). 21 Table of Contents Broad Clinical Program Ongoing Sponsor Phase Indication Registration PAXALISIB Global Coalition for Adaptive Research II / III Glioblastoma NCT03970447 Weill Cornell Medicine II Glioblastoma (with ketogenesis) NCT05183204 Alliance for Clinical Trials in Oncology II Brain metastases NCT03994796 Dana-Farber Cancer Institute II Breast cancer brain metastases (with Herceptin) NCT03765983 Dana-Farber Cancer Institute II Primary CNS lymphoma NCT04906096 University of Sydney I/II Grade 2/3 IDH-mutant adult gliomas TBD Pacific Pediatric Neuro-Oncology Consortium II DIPG (childhood brain cancer) NCT05009992 Aus. & NZ Children’s Oncology Group II Advanced solid tumours in children TBD St Jude Children’s Research Hospital I DIPG NCT03696355 Memorial Sloan Kettering Cancer Center I Brain metastases (with radiotherapy) NCT04192981 EVT801 Kazia Therapeutics I Advanced solid tumours NCT05114668 22 Table of Contents Clinical Development Overview IDH: Isocitrate dehydrogenase, DIPG: Diffuse Intrinsic Pontine Glioma, AT/RT: Atypical Teratoid Rhabdoid Tumor, CNS: central nervous system, TNBC: triple negative breast cancer, VEGFR3: vascular endothelial growth factor receptor 3 Patent Protection The Company has an aggressive global Intellectual Property (“IP”) strategy to protect its key assets and we have partnered with a large Australian law firm to lodge patents that seek to provide protection for our assets.
Per RANO criteria, 40% of patients exhibited a best observable response of stable disease, and 26% demonstrated a metabolic partial response on FDG-PET. The development candidate was granted the International Non-Proprietary Name (INN) ‘paxalisib’ by the World Health Organisation in December 2019. This was confirmed as the United States Adopted Name (USAN) by the USAN Council in April 2020.
Per ANO criteria, 40% of patients exhibited a best observable response of stable disease, and 26% demonstrated a metabolic partial response on FDG-PET. 16 Table of Contents The development candidate was granted the International Non-Proprietary Name (INN) ‘paxalisib’ by the World Health Organisation in December 2019.
The study will explore paxalisib in combination with ONC-201, a small-molecule investigational new drug which targets dopamine receptor D2 (DRD2), and which is manufactured by Oncoceutics, Inc, a wholly-owned subsidiary of Chimerix, Inc.
The study will explore paxalisib in combination with ONC-201, a small-molecule investigational new drug which targets dopamine receptor D2 (DRD2), and which is manufactured by Oncoceutics, Inc, a wholly-owned subsidiary of Chimerix, Inc. Preliminary results were presented at Society of Neuro-Oncology 2023 Annual meeting on November 19, 2023.
Medicines included in the ARTG can be identified by the AUST R number (for registered medicines) or an AUST L number (for listed medicines) which appears on the packaging of the medicine. In order to ensure that a product can be included in the ARTG, a sponsoring company must make an application to the Therapeutic Goods Administration (“TGA”).
Medicines included in the ARTG can be identified by the AUST R number (for registered medicines), AUST L number (for listed medicines) and AUST L(A) number (for assessed listed medicines) which appears on the packaging of the medicine. 23 Table of Contents In order to include a product on the ARTG, a sponsoring company must make an application to the TGA.
The study met its primary objective and determined a maximum tolerated dose for pediatric use of 27 mg/m2. 27 patients were recruited, of whom 24 received at least one dose of paxalisib.
The investigators reported interim data in an oral presentation at the SNO Annual Meeting in November 2020. The study met its primary objective and determined a maximum tolerated dose for pediatric use of 27 mg/m2. 27 patients were recruited, of whom 24 received at least one dose of paxalisib.
The PI3K / Akt / mTOR signaling axis has been shown to be dysregulated in approximately 85-90% of cases of glioblastoma, per Cancer Genome Atlas, and is considered a promising target in this disease.
Paxalisib is a potent and selective inhibitor of all four isoforms of phosphoinositide-3-kinase (PI3K) and a moderate inhibitor of the mammalian target of rapamycin (“mTOR”). The PI3K / Akt / mTOR signaling axis has been shown to be dysregulated in approximately 85-90% of cases of glioblastoma, per Cancer Genome Atlas, and is considered a promising target in this disease.
Drugs with FTD may also receive a ‘rolling review’ of their NDA submission, in which sections are submitted for review as they become available, potentially expediting the approval process. EVT801 Kazia is also developing EVT801, a small-molecule selective inhibitor of vascular endothelial growth factor receptor 3 (VEGFR3).
Drugs with FTD may also receive a ‘rolling review’ of their NDA submission, in which sections are submitted for review as they become available, potentially expediting the approval process. EVT801 Kazia is also developing EVT801, a small-molecule selective inhibitor of VEGFR3. EVT801 was originally discovered by Sanofi SA and was licensed to Evotec SE as part of a broader transaction.
The Kazia business model is based on outsourcing, and we are working with major partners who are focused on reducing climate change and enhancing climate protection. Society Community Contribution Compassionate Use Program In rare circumstances, after careful discussion with the treating clinician, Kazia is sometimes able to provide its drug candidates for compassionate use on an individual named patient basis.
Society Community Contribution Compassionate Use Program In rare circumstances, after careful discussion with the treating clinician, Kazia is sometimes able to provide its drug candidates for compassionate use on an individual named patient basis.
The serviced office is located in a building with a five star NABERS energy rating. 24 Table of Contents Climate Change Kazia is mindful of its impact on the environment and strives to reduce its carbon footprint.
The serviced office is located in a building with a five star NABERS energy rating. Climate Change Kazia is mindful of its impact on the environment and strives to reduce its carbon footprint. The Kazia business model is based on outsourcing, and we are working with major partners who are focused on reducing climate change and enhancing climate protection.
Where the research programs result in the generation of further patentable subject matter, the Company will pursue an aggressive patent filing strategy based on multiple jurisdictions with a focus on those member countries offering the most significant market opportunities for future development. 19 Table of Contents Regulatory requirements Australian Regulatory Requirements The Therapeutic Goods Act 1989 (“1989 Act”), sets out the legal requirements for the import, export, manufacture and supply of pharmaceutical products in Australia.
Where the research programs result in the generation of further patentable subject matter, the Company will pursue an aggressive patent filing strategy based on multiple jurisdictions with a focus on those member countries offering the most significant market opportunities for future development.
EVT801 was originally discovered by Sanofi SA and was licensed to Evotec SE as part of a broader transaction. Evotec conducted an extensive program of preclinical development, which showed compelling evidence of activity in broad range of animal models. The drug was licensed to Kazia in April 2021.
Evotec conducted an extensive program of pre-clinical development, which showed compelling evidence of activity in broad range of animal models. The drug was licensed to Kazia in April 2021.
The Company cannot be certain that it will be able to take advantage of either the patent term extension or marketing exclusivity provisions of these laws. 23 Table of Contents European Union Regulatory Requirements Outside the United States, the Company’s ability to market its products will also be contingent upon receiving marketing authorizations from the appropriate regulatory authorities and compliance with applicable post-approval regulatory requirements.
European Union Regulatory Requirements Outside the United States, the Company’s ability to market its products will also be contingent upon receiving marketing authorizations from the appropriate regulatory authorities and compliance with applicable post-approval regulatory requirements.
We anticipate enrollment to commence in 4Q CY2023. 14 Table of Contents Weill Cornell Medicine Phase II Study in Glioblastoma in Combination with Ketogenesis (NCT05183204) In June 2021, the company entered into an agreement with the Joan & Sanford I Weill Medical College of Cornell University in New York, NY, known generally as Weill Cornell Medicine, for an investigator-initiated phase II clinical trial combining paxalisib with ketogenesis in patients with newly- diagnosed and recurrent glioblastoma.
Weill Cornell Medicine Phase II Study in Glioblastoma in Combination with Ketogenesis (NCT05183204) In June 2021, the company entered into an agreement with Weill Cornell Medicine for an investigator-initiated phase II clinical trial combining paxalisib with ketogenesis in patients with newly- diagnosed and recurrent glioblastoma.
The following policies are in place and available on our website: • Anti-Corruption Compliance • Continuous Disclosure • Corporate Governance • Expanded Access • Shareholder Communications • Whistleblower Employees The consolidated entity aims to ensure that it has a safe operating environment with an inclusive and diverse culture and the best talent and skills for our future success.
Employees The Consolidated Entity aims to ensure that it has a safe operating environment with an inclusive and diverse culture and the best talent and skills for our future success.
At-The-Market (ATM) Facility Kazia established an ‘at-the-market’ equity program (the “ATM facility”) with Oppenheimer & Co. Inc. (“Oppenheimer”), as sales agent, in April 2022.
At-The-Market (ATM) Facility Kazia established an ‘at-the-market’ equity program (the “ATM facility”) with Oppenheimer & Co. Inc. (“Oppenheimer”), as sales agent, in April 2022. Under the ATM facility, Kazia may offer and sell through Oppenheimer up to an aggregate amount of US$50 million of its ordinary shares, in the form of ADSs.
Brain metastases are typically highly resistant to treatment and survival rates are generally low. Radiotherapy is a common treatment modality for brain metastases. Despite some efficacy, patients typically become resistant over time, and repeat courses of radiotherapy can be associated with significant neurological toxicity.
Despite some efficacy, patients typically become resistant over time, and repeat courses of radiotherapy can be associated with significant neurological toxicity. Additionally, PI3K pathway mutations are common in brain metastasis and are frequently associated with a worse prognosis.
We announced on 1 August 2022 that the company had been advised by GCAR that the first stage of the paxalisib arm had completed recruitment.
The paxalisib arm enrolled two patient populations: newly diagnosed patients with unmethylated MGMT promotor status, and recurrent patients. 17 Table of Contents We announced on 1 August, 2022, that the company had been advised by GCAR that the first stage of the paxalisib arm had completed recruitment.
Medicines with a higher level of risk (prescription medicines, some non-prescription medicines) are evaluated for quality, safety and efficacy and are registered on the ARTG. Medicines with a lower risk (many over the counter medicines including vitamins) are assessed only for quality and safety.
Medicines with a higher level of risk (prescription medicines, most over-the-counter medicines) are evaluated by the Therapeutic Goods Administration (“TGA”) for quality, safety and efficacy before registration on the ARTG.
Whole brain radiotherapy (WBRT) is a ubiquitous therapeutic modality in this patient population, with an estimated 200,000 patients receiving treatment each year in the United States alone. Encouraging safety and clinical activity from this study was presented by the lead investigator, Dr. Jonathan Yang in August 2022 at the ASCO/SNO CNS meeting held in Toronto, Canada.
Encouraging safety and clinical activity from this study was presented by the lead investigator, Dr. Jonathan Yang in August 2022 at the ASCO/SNO CNS meeting held in Toronto, Canada.
The study, named OPTIMISE, is the first Australian-led clinical trial of paxalisib and will combine the drug with chemotherapy for children with PI3K pathway mutations in their tumours. Enrollment for this study is expected to commence in 4Q CY2023.
The study, named OPTIMISE, is the first Australian-led clinical trial to combine paxalisib and chemotherapy for children with PI3K pathway mutations in their tumours. Enrollment for this study is ongoing. Paxalisib in Brain Metastases Brain metastases occur when cancer cells spread from their original site to the brain, and treatment options are very limited.
The study is a platform study, or master protocol study, in which multiple experimental agents are evaluated in parallel, and are compared against a shared control arm. GBM AGILE uses an adaptive Bayesian statistical design to ensure that only the number of patients required to reach a definitive answer are enrolled.
The study is a platform study, or master protocol study, in which multiple experimental agents are evaluated in parallel, and are compared against a shared control arm.
Paxalisib in Brain Metastases Brain metastases occur when cancer cells spread from their original site to the brain, and treatment options are very limited. Brain metastases are a common complication of many tumours, but are particularly common in breast cancer, lung cancer, and melanoma and account for 67%—89% of all cancers.
Brain metastases are a common complication of many tumours, but are particularly common in breast cancer, lung cancer, and melanoma and account for 67% to 89% of all cancers. Brain metastases are typically highly resistant to treatment and survival rates are generally low. Radiotherapy is a common treatment modality for brain metastases.
United States (Delaware) Glioblast Pty Ltd Australia Kazia Therapeutics (Hong Kong) Limited, registered in Hong Kong, was formally deregistered and dissolved on 10 March 2023. 26 Table of Contents D. Property, plant and equipment During fiscal year 2023, the Company continued to work out of a serviced office in Sydney that is subject to a renewable one-year workspace license agreement.
Property, plant and equipment During fiscal year 2024, the Company continued to work out of a serviced office in Sydney that is subject to a renewable one-year workspace license agreement.
In addition to the primary endpoints of safety and tolerability, the study is designed to include a rich array of biomarkers that will allow a deeper understanding of the drug’s pharmacology and may inform design of subsequent studies. 17 Table of Contents Preclinical data showed EVT801 to be active against a broad range of tumour types and has shown evidence of synergy with immuno-oncology agents.
In addition to the primary endpoints of safety and tolerability, the study is designed to include a rich array of biomarkers that will allow a deeper understanding of the drug’s pharmacology and may inform design of subsequent studies. 20 Table of Contents On 1 May, 2024, Kazia announced that Stage 1 of the study was complete, and that the primary and secondary endpoints were achieved.
Professor Cantley serves as a scientific advisor to the study, and Dr Howard Fine, a highly experienced neuro-oncologist, will serve as Principal Investigator. The study is actively enrolling in two cohorts of GBM patients, and we anticipate providing an update to this study in 4Q CY2023.
The study is actively enrolling in two cohorts of GBM patients, and we anticipate providing an update to this study in 2025.
Paxalisib is orally administered and is presented in a 15mg capsule formulation. The development candidate is the subject of IND 112,608 with the U.S. Food and Drug Administration (“FDA”). Paxalisib is a potent and selective inhibitor of all four isoforms of phosphoinositide-3-kinase (PI3K) and a moderate inhibitor of the mammalian target of rapamycin (mTOR).
This was confirmed as the United States Adopted Name (“USAN”) by the USAN Council in April 2020. Paxalisib is orally administered and is presented in a 15mg capsule formulation. The development candidate is the subject of IND 112,608 with the U.S. Food and Drug Administration (“FDA”).
In September 2019, the company announced that a pediatric MTD of 27 mg/m2 had been determined, which is approximately comparable to the doses used in adult clinical studies. The investigators reported interim data in an oral presentation at the SNO Annual Meeting in November 2020.
The St Jude study (NCT03696355) sought to establish a maximum tolerated dose (“MTD”) in the pediatric population before enrolling an expansion cohort to seek definitive signals of efficacy. In September 2019, the company announced that a pediatric MTD of 27 mg/m2 had been determined, which is 18 Table of Contents approximately comparable to the doses used in adult clinical studies.
Dana Farber Cancer Institute (DFCI) Phase II Study in Primary Central Nervous System Lymphoma (PCNSL) (NCT04906096) In September 2020, the company signed an agreement with Dana-Farber Cancer Institute in Boston, MA, for an investigator-initiated phase II clinical study of paxalisib in patients with primary CNS lymphoma (PCNSL) (NCT04906096). This study commenced recruitment in June 2021.
Dana Farber Cancer Institute (DFCI) Phase II Study in Primary Central Nervous System Lymphoma (PCNSL) (NCT04906096) Professor Lakshmi Nayak is the Principal Investigator to a phase II clinical study of paxalisib in patients with primary CNS lymphoma (PCNSL) (NCT04906096). We believe the unique brain-penetrant qualities of paxalisib make it suitable for investigation in this patient group.
There is a five-year maximum patent extension and a maximum of 14 years protection from product approval.
There is a five-year maximum patent extension and a maximum of 14 years protection from product approval. The Company cannot be certain that it will be able to take advantage of either the patent term extension or marketing exclusivity provisions of these laws.
Over the course of FY 2023, interim data from the phase I study and preclinical EVT801 data has been presented at a number of global conferences, including AACR and ESMO. We anticipate providing additional EVT801 updates and presentations of data at medical conferences in 4Q CY2023.
Over the course of FY 2024, interim results from the phase I study including clinical and biomarker EVT801 data have been presented at a number of global conferences, including the American Association for Cancer Research (“AACR”) and the European Society for Medical Oncology (“ESMO”).
Significant changes in the state of affairs There were no significant changes in the state of affairs of the consolidated entity during the financial year.
We anticipate providing additional EVT801 updates and presentations of data at future medical conferences including the AACR Ovarian Cancer Research Symposium in September 2024. Significant changes in the state of affairs There were no significant changes in the state of affairs of the Consolidated Entity during the financial year.
Anticipated milestones We anticipate that during fiscal year 2024: • Final data will be reported from the phase II/III GBM AGILE clinical study of paxalisib in glioblastoma • Interim results will be reported from the phase II PNOC clinical trial of paxalisib in combination with ONC201; • Interim results will be reported from the phase II clinical trial of paxalisib in combination with trastuzumab in breast cancer metastases; • Interim results will be reported from the phase II genomically-guided study of paxalisib in brain metastases; • Interim results will be reported from the phase I study of paxalisib in combination with radiotherapy in brain metastases; and • Final data will be reported from the phase I study of paxalisib in children with DIPG.
Anticipated milestones We anticipate that during fiscal year 2025: • Final data will be presented and reported from the phase II/III GBM AGILE clinical study of paxalisib in glioblastoma • Additional results will be reported from the phase II PNOC clinical trial of paxalisib in combination with ONC201; • Expansion cohort results will be reported from the phase I study of paxalisib in combination with radiotherapy in brain metastases; • Discussion with regulatory authorities regarding next steps, (including potential approval pathways) for paxalisib in newly diagnosed unmethylated glioblastoma patients; and • Pre-clinical results from our collaboration with OIMR Berghofer Medical Research Institute (“QIMR”) in advanced breast cancer animal models R&D Pipeline Paxalisib in solid tumours Kazia’s collaboration with QIMR, one of Australia’s foremost cancer research centers, is currently exploring novel uses of paxalisib in solid tumours.
The development candidate also received Fast Track designation (FTD) for glioblastoma in August 2020, and Rare Pediatric Disease Designation (RPDD) for diffuse midline gliomas in August 2020.
The development candidate also received Fast Track designation (“FTD”) for glioblastoma in August 2020, and Rare Pediatric Disease Designation (“RPDD”) for diffuse midline gliomas in August 2020. On July 6, 2023, Kazia announced that paxalisib had been awarded FTD by the FDA for the treatment of solid tumor brain metastases harboring PI3K pathway mutations in combination with radiation therapy.
Any approval for registration on the ARTG may have conditions associated with it. From the time that the TGA accepts the initial application for evaluation, the TGA must complete the evaluation and make a decision on the registration of the product within at least 255 working days.
Once accepted for evaluation, the TGA has 255 working days to complete its evaluation and make a decision on the registration of the product (excluding any time spent waiting for the applicant to respond to the TGA’s questions).
The TGA also has a system of priority evaluation for products that meet certain criteria, including where the product is a new chemical entity that it is not otherwise available on the market as an approved product, and is for the treatment of a serious, life-threatening illness for which other therapies are either ineffective or not available. U.S.
The TGA also has a system of priority evaluation for products that meet certain criteria, including where: • the medicine is a new prescription medicine; • an indication of the medicine is the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition; • there are no therapeutic goods that are intended to treat, prevent or diagnose the condition in the ARTG; and • there is substantial evidence demonstrating that the medicine provides a major therapeutic advance.
Removed
Resignation of Chairman Kazia announced that Dr John Friend joined the Kazia Board as Managing Director on 1 August 2023. Kazia announced the resignation of Mr. Iain Ross as Chairman and non-executive director on 11 August 2023. The Board of Directors elected Dr John Friend as Interim Chairman on 11 August 2023.
Added
A total of 313 newly diagnosed unmethylated (“NDU”) patients and recurrent patients being treated at top U.S. cancer hospitals were randomized to either a paxalisib treatment arm (up to 60 mg/day) or the Standard of Care (“SOC”) concurrent control arm from January 2021 to May 2022.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

31 edited+9 added−11 removed19 unchanged
Item 5. Operating and Financial Review and Prospects Critical accounting policies We prepare our financial statements in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). As such, we are required to make certain estimates, judgments, and assumptions that management believes are reasonable based upon the information available.
Item 5. Operating and Financial Review and Prospects Critical accounting policies We prepare our consolidated financial statements in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). As such, we are required to make certain estimates, judgments, and assumptions that management believes are reasonable based upon the information available.
In fiscal year 2023, the Company held a significant proportion of its cash balances in U.S. dollars and there were no conversion losses. During fiscal year 2022, the Company held the majority of its cash balances in U.S. dollars and there were no conversion losses. See Item 18.
In fiscal year 2024, the Company held a significant proportion of its cash balances in U.S. dollars and there were no conversion losses. During fiscal year 2023, the Company held the majority of its cash balances in U.S. dollars and there were no conversion losses. See Item 18.
On 14 September 2016 the directors approved the issue of 20,000,000 ordinary shares as a consequence of a conversion of A$500,000 of the Convertible Notes, and on 1 November 2016 a further 16,000,000 ordinary shares were issued as a result of the conversion of a further portion of the Convertible Notes.
On 14 September 2016 the directors approved the issuance of 20,000,000 ordinary shares as a consequence of a conversion of A$500,000 of the Convertible Notes, and on 1 November 2016 a further 16,000,000 ordinary shares were issued as a result of the conversion of a further portion of the Convertible Notes.
General and administrative costs were increased from A$5.1 million (restated) in fiscal year 2022 to A$8.6 million in fiscal year 2023 (68%), due in part to the A$1.6 million additional expense due to increased directors and officers liability and business insurance costs, a full year of salary and benefits for the US based Chief Financial Officer, a full year of US office rent and the termination payment for former CEO James Garner.
General and administrative costs increased from A$5.1 million (restated) in fiscal year 2022 to A$8.6 million in fiscal year 2023 (68%), due to increased directors and officers liability and business insurance costs, a full year of salary and benefits for the US based Chief Financial Officer, a full year of US office rent and the termination payment for former CEO James Garner.
The Company believes that its future ability to fund its operations will depend on deriving sufficient cash from investors through successful capital raisings, from licensing and partnering activities and government grants. The Company had no commitments for capital expenditures or material contractual obligations at the end of fiscal year 2023.
The Company believes that its future ability to fund its operations will depend on deriving sufficient cash from investors through successful capital raises, from licensing and partnering activities, and government grants. The Company had no commitments for capital expenditures or material contractual obligations at the end of fiscal year 2024.
There is substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements for the fiscal year ended 30 June 2023 are issued.
There is substantial doubt about our ability to continue as a going concern within one year after the date that the consolidated financial statements for the fiscal year ended 30 June 2024 are issued.
These estimates, judgments and assumptions affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the periods presented. The critical accounting policies are summarized in Item 18. “Financial Statements—Note 3 – Critical Accounting Policies”.
These estimates, judgments and assumptions affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the periods presented. The critical accounting policies are summarized in Item 18. “Financial Statements-Note 3 - Critical accounting judgements, estimates and assumptions”.
As at 30 June 2023, the Company did not hold any derivative financial instruments for managing its foreign currency; however, the Company may from time to time enter into hedging arrangements where circumstances are deemed appropriate.
As of 30 June 2024, the Company did not hold any derivative financial instruments for managing its foreign currency; however, the Company may from time to time enter into hedging arrangements where circumstances are deemed appropriate.
The amount of finance income earned increased as a result of increased cash balances as well as higher interest rates in effect during the year. The Company did not recognize any research and development rebate in fiscal years 2023, 2022 or 2021.
The amount of finance income earned increased as a result of increased cash balances as well as higher interest rates in effect during the year. The Company recognized research and development rebate in the fiscal years 2024 of A$173 thousand. The Company did not recognize any research and development rebate in 2023 and 2022.
Net loss The Company’s loss after income tax was A$20.4 million in fiscal year 2023 compared to A$25.0 million (restated) in fiscal year 2022.
The Company’s loss after income tax benefit was A$20.5 million in fiscal year 2023 compared to A$25.0 million (restated) in fiscal year 2022.
The Company continuously pursues opportunities for non-dilutive funding, such as grant applications. The Company cannot provide assurance that it or its subsidiaries will be able to raise the funds necessary to complete the planned clinical trial programs or find appropriate collaboration or licensing opportunities. The Company does not have any off-balance sheet arrangements.
The Company continuously pursues opportunities for non-dilutive funding such as grant applications. The Company cannot provide assurance that it or its subsidiaries will be able to raise the funds necessary to complete the planned clinical trial programs or find appropriate collaboration or licensing opportunities.
The duration, costs, and timing of clinical trials and development of our product candidates will depend on a variety of factors, including: • the scope, rate of progress, and expense of our ongoing as well as any additional clinical trials and other research and development activities; • the countries in which trials are conducted; • future clinical trial results; • uncertainties in clinical trial enrollment rates or drop-out or discontinuation rates of patients; • potential additional safety monitoring or other studies requested by regulatory agencies; • significant and changing government regulation; and • the timing and receipt of any regulatory approvals.
The duration, costs, and timing of clinical trials and development of our product candidates will depend on a variety of factors, including: • the scope, rate of progress, and expense of our ongoing as well as any additional clinical trials and other research and development activities; • the countries in which trials are conducted; • future clinical trial results; • uncertainties in clinical trial enrollment rates or drop-out or discontinuation rates of patients; • potential additional safety monitoring or other studies requested by regulatory agencies; • significant and changing government regulation; and • the timing and receipt of any regulatory approvals. 35 Table of Contents A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate.
There is a premium funding facility in place in fiscal year 2022 and 2023 for the insurance program. 28 Table of Contents As at 30 June 2023, we had cash and cash equivalents of A$5.2 million, held in both Australian dollars and U.S. dollars.
There is a premium funding facility in place in fiscal year 2024, 2023, and 2022 for the insurance program. As of 30 June 2024, we had cash and cash equivalents of A$1.7 million held in both Australian dollars and U.S. dollars.
Critical Accounting Estimates – see Note 2. Significant accounting policies
Critical Accounting Estimates - see Note 2. Material accounting policies
Cash flows The following table set forth the sources and uses of cash for the past three fiscal years: (in A$ thousands) 2023 2022 2021 Net cash used in operating activities (15,156 ) (22,763 ) (9,111 ) Net cash used in investing activities — (2,365 ) — Net cash from financing activities 12,972 3,726 28,109 Operating activities.
Cash flows The following table set forth the sources and uses of cash for the past three fiscal years: (in A$ thousands) 2024 2023 2022 Net cash used in operating activities $ (9,581 ) $ (15,156 ) $ (22,762 ) Net cash used in investing activities $ — $ — $ (2,365 ) Net cash provided by financing activities $ 5,985 $ 12,972 $ 3,726 Operating activities.
In fiscal years 2023, 2022 and 2021 we spent, respectively, a total of A$15.6 million, A$20.2 million (restated) and A$14.5 million (restated) on company-sponsored research and development activities. 31 Table of Contents D.
In fiscal years 2024, 2023, 2022 and we spent, respectively, a total of A$17.4 million, A$15.6 million, A$20.2 million (restated) and on company-sponsored research and development activities. D.
Research and development expenses consist primarily of costs incurred for the development of our product candidates, which include: • expenses incurred under agreements with academic research centers, clinical research organizations and investigative sites that conduct our clinical trials; and • the cost of acquiring, developing, and manufacturing clinical trial materials. 30 Table of Contents We cannot determine with certainty the duration and completion costs of the current or future product development, preclinical studies or clinical trials of our product candidates.
Research and development expenses consist primarily of costs incurred for the development of our product candidates, which include: • expenses incurred under agreements with academic research centers, clinical research organizations and investigative sites that conduct our clinical trials; and • the cost of acquiring, developing, and manufacturing clinical trial materials.
The amended terms allow the conversion of debt into ordinary shares, provided that the Company achieves certain milestones. Accordingly, the Convertible Note has been reclassified as an equity instrument rather than debt instrument. During fiscal year 2017, the Company reached two milestones that triggered the conversion of a portion of its Convertible Notes.
The terms of these Convertible Notes were amended on 4 December 2014. The amended terms allow the conversion of debt into ordinary shares, provided that the Company achieves certain milestones. Accordingly, the Convertible Note has been reclassified as an equity instrument rather than debt instrument.
In addition, net cash from financing activities in fiscal years 2022 & 2023 was the result of the funds received from our sale of ordinary shares in the form of ADSs, using our ATM facility. In 2021 cash for financing activities was raised as a result of a retail entitlement offer to institutional and retail investors.
In addition, net cash from financing activities in fiscal years 2024, 2023, and 2022 was the result of the funds received from our sale of ordinary shares using our ATM facility.
Net cash used in operating activities for the three fiscal years primarily represents net outflows for the cost of the R&D programs and the general and administrative costs of running the business.
Net cash used in operating activities for the three fiscal years primarily represents net outflows for the cost of our R&D programs and general and administrative costs of running the business. This amount is heavily impacted by the cost of our clinical programs, as well as cost containment measures adopted to manage the general and administrative costs of the business.
Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Currently, our cash and cash equivalents are held in bank accounts, with a 44.4% of funds being held in U.S. dollars.
Cash in excess of immediate requirements is invested in accordance with our investment policy primarily with a view to liquidity and capital preservation.
The financial statements have been prepared on a going concern basis, which contemplates continuity of normal activities and realization of assets and settlement of liabilities in the normal course of business.
The impact on cash resources and results from operations will vary with the extent and timing of the future clinical trial programs. The consolidated financial statements have been prepared on a going concern basis, which contemplates continuity of normal activities and realization of assets and settlement of liabilities in the normal course of business.
We therefore are limited by the Baby Shelf Rule as of the filing of this Annual Report, until such time as our non-affiliate public float exceeds $75 million. Our independent auditor’s report for the fiscal year ended 30 June 2023 included an explanatory paragraph regarding going concern uncertainty.
We therefore are limited by the Baby Shelf Rule as of the filing of this Annual Report until such time as our non-affiliate public float exceeds $75 million.
The following tables provide a summary of Revenue, Finance income and Other income for the past three fiscal years: For the fiscal year ended 30 June, 2023 2022 2021 A$’000 A$’000 A$’000 Revenue — — 15,183 Finance income 22 2 42 Other income: Payroll tax rebate — — 2 Bad debt recovery — 15 — Other sundry income 1 — — Subsidies and grants — 10 — Total Revenue, Finance and Other income 23 27 15,227 27 Table of Contents Fiscal year 2023 compared to fiscal year 2022 and fiscal year 2022 compared to fiscal year 2021 Revenue, finance income and other income In fiscal years 2023 and 2022, the Company did not generate any revenue from contracts with customers.
The following tables provide a summary of Revenue, Finance income and Other income for the past three fiscal years: For the fiscal year ended 30 June, 2024 2023 2022 A$’000 A$’000 A$’000 Revenue 2,308 — — Finance income 12 22 2 Other income: Research and development rebate 173 — — Bad debt recovery — — 15 Other sundry income — 1 — Subsidies and grants — — 10 Total Revenue, Finance and Other income 2,493 23 27 31 Table of Contents Fiscal year 2024 compared to fiscal year 2023 and fiscal year 2023 compared to fiscal year 2022 Revenue, finance income and other income In fiscal year 2024, the Company generated revenue A$2.3 million of from contracts with customers was the result of up-front license fees received from partnering transactions pertaining to the out-license agreements entered into for one of the Company’s assets, paxalisib.
Convertible note (Triaxial) carrying value of A$464,000 During the fiscal year ended 30 June 2013 the Company issued Convertible Notes with a face value of A$1,500,000 to Triaxial in consideration of the acquisition of patents and intellectual property assets. The terms of these Convertible Notes were amended on 4 December 2014.
“Financial Statements - Note 25 - Financial Instruments” for disclosures about financial risk management including interest rate risk, foreign currency risk and liquidity risk. Convertible note (Triaxial) During the fiscal year ended 30 June 2013 the Company issued Convertible Notes with a face value of A$1,500,000 to Triaxial in consideration of the acquisition of patents and intellectual property assets.
Expenses Research and development expenses decreased from A$20.2 million in fiscal year 2022 to A$15.6 million in fiscal year 2023 (-23%). The decrease was mainly a result of a full year of salary and benefit expenses were recognized for the US based scientific and clinical staff hired in FY22.
The decrease was mainly a result of lower R&D expense for paxalisib, offset by higher expenses for EVT-801 and a full year of salary and benefit expenses were recognized for the US based scientific and clinical staff hired in fiscal year 2022.
Financing activities Equity issues The Company has historically financed its operations primarily from issuing equity capital. During fiscal year 2022 the Company issued 6,743,167 ordinary shares.
The Company does not have any off-balance sheet arrangements. 33 Table of Contents Financing activities Equity issues The Company has historically financed its operations primarily from issuing equity capital. During fiscal year 2023 the Company issued 89,273,738 ordinary shares.
Liquidity and capital resources We have incurred cumulative losses and negative cash flows from operations since our inception and, as of 30 June 2023, we had accumulated losses of A$89.1 million. We anticipate that we will continue to incur losses for at least the next several years.
Funds were also spent on the expenditures incurred for the continuing EVT801 Phase I trial including A$2.1M for manufacture of EVT-801. B. Liquidity and capital resources We have incurred cumulative losses and negative cash flows from operations since our inception and, as of 30 June 2024, we had accumulated losses of A$115.1 million.
Going Concern We expect to consume cash and incur operating losses for the foreseeable future as the Company continues developing its oncology drug candidates. The impact on cash resources and results from operations will vary with the extent and timing of the future clinical trial programs.
Currently, our cash and cash equivalents are held in bank accounts with approximately 83.7% of funds being held in U.S. dollars. 32 Table of Contents Going Concern We expect to consume cash and incur operating losses for the foreseeable future as the Company continues developing its oncology drug candidates.
This amount is heavily impacted by the cost of the clinical programs, as well as cost containment measures adopted to manage the general and administrative costs of the business. Investing activities. Net cash from investing activities in fiscal year 2022 represents the payment of a development milestone for EVT801. Financing activities.
Investing activities. Net cash from investing activities in fiscal year 2022 represents the payment of a development milestone for EVT801. Financing activities. Net cash from the financing activities in fiscal year 2024 arose as a result of the placement of warrants and the sale of ordinary shares in the form of ADSs, using our ATM facility.
The revenue recognized during fiscal year 2021, A$15.2 million, was the result of up-front license fees received from partnering transactions pertaining to the out-license agreements entered into for two of the Company’s assets, Cantrixil and paxalisib. The Company earns interest income derived from interest bearing bank accounts, which is directly linked with the amounts held on deposit.
During fiscal years 2023 and 2022, the Company did not generate any revenue from contracts with customers. The Company earns interest income derived from interest bearing bank accounts, which is directly linked with the amounts held on deposit.
Removed
In fiscal year 2023, the amount of qualifying expenditure in Australia was not sufficiently large to warrant making a claim for the R&D rebate, and we do not anticipate applying for the rebate in future fiscal years as this trend is set to continue.
Added
We anticipate applying for the rebate in future fiscal years as the Company advances paxalisib development in Australia. Expenses Research and development expenses increased from A$15.6 million in fiscal year 2023 to A$17.4 million in fiscal year 2024 (12%).
Removed
Research and development expenses increased from A$14.5 million in fiscal year 2021 to A$20.2 million in fiscal year 2022 (39%). The increase was mainly a result of the expenditures incurred for the Company’s lead asset, paxalisib’s continuing participation in the registrational GCAR GBM AGILE trial.
Added
The increase was mainly a result of transaction fee expenses of A$6.0 million in fiscal year 2024 partially offset by less clinical expenses relating to paxalisib and lower personnel costs. Research and development expenses decreased from A$20.2 million in fiscal year 2022 to A$15.6 million in fiscal year 2023 (-23%).
Removed
Funds were also spent on the expenditures incurred for the EVT801 Phase I trial, which opened and initiated enrollment in late 2021. Additional salary and benefit expenses were recognized for the US based scientific and clinical staff hired, including the Chief Medical Officer. Amortisation of the EVT801 asset also contributed to the increase during fiscal 2022.
Added
General and administrative costs increased from A$8.6 million in fiscal year 2023 to A$13.5 million in fiscal year 2024 (58%), due to increased costs related to the issuance of certain warrants to service providers, audit and NASDAQ fees, offset by lower directors and officers liability and business insurance costs, and a partial year of salary and benefits for the US based Chief Financial Officer.
Removed
General and administrative costs decreased from A$7.0 million to A$5.1 million (restated) in fiscal year 2022 (27%), due in part to the A$1.46 million expense recognized resulting from a Chinese withholding tax incurred on the Company’s receipt of the up-front licencing transaction payment from Simcere Pharmaceutical in fiscal year 2021.
Added
Net loss after income tax benefit The Company’s loss after income tax benefit was A$26.8 million in fiscal year 2024 compared to A$20.5 million in fiscal year 2023. The change was mainly a result of the additional R&D expenditures and a dramatic increase in NASDAQ, legal and audit fees. Offset by lower personnel expenses, D&O insurance and public relation costs.
Removed
Excluding the unrealised FX gain of A$1.8 million, corporate expenses were reduced by A$613K. The reduced costs were somewhat offset by the increased payroll related costs incurred for the US based Chief Financial Officer hired during the period.
Added
We anticipate that we will continue to incur losses for at least the next several years.
Removed
Funds were also spent on the expenditures incurred for the continuing EVT801 Phase I trial including A$2.1M for manufacture of EVT-801. The Company’s loss after income tax was A$25.0 million in fiscal year 2022 compared to A$8.4 million in fiscal year 2021.
Added
During fiscal year 2024 the Company issued 104,821,670 ordinary shares.
Removed
The change was mainly a result of the increased R&D expenditures incurred for the ongoing clinical trials as well as the initiation and enrolment of the EVT801 Phase 1 trial along with our collaborations in the investigator-initiated trials, as described above, during fiscal year 2022. Additionally, no revenue was recognized from partnership collaborations in fiscal year 2022. B.
Added
The details of those share issues are as follows: • In July 2023, the Company issued 8,148,140 shares under our ATM facility raising A$1,512,523 before transaction costs. • In July 2023, the Company issued 157,120 shares under our ATM facility raising A$25,877 before transaction costs. • In August 2023, the Company issued 15,000 shares under our ATM facility raising A$2,519 before transaction costs. • In November 2023, the Company issued 1,066,070 shares under our ATM facility raising A$107,268 before transaction costs. • In December 2023, we issued 26,200,000 ordinary shares in the form registered direct offering raising A$1,796,867 before transaction costs. • In February 2024, the Company issued 25,910 shares under our ATM facility raising A$1,207 before transaction costs. • In February 2024, the Company issued 319,650 shares under our ATM facility raising A$14,834 before transaction costs. • In February 2024, the Company issued 2,195,980 shares under our ATM facility raising A$102,825 before transaction costs. • In February 2024, the Company issued 205,260 shares under our ATM facility raising A$12,597 before transaction costs. • In February 2024, the Company issued 8,626,580 shares under our ATM facility raising A$513,584 before transaction costs. • In February 2024, the Company issued 18,244,450 shares in connection with the exercise of a warrants raising A$892,381 before transaction costs. • In February 2024, the Company issued 316,540 shares under our ATM facility raising A$14,584 before transaction costs. • In February 2024, the Company issued 304,860 shares under our ATM facility raising A$14,147 before transaction costs. • In February 2024, the Company issued 250,000 shares under our ATM facility raising A$11,502 before transaction costs. • In May 2024, the Company issued 2,112,560 shares under our ATM facility raising A$100,961 before transaction costs. • In May 2024, the Company issued 375,410 shares under our ATM facility raising A$17,147 before transaction costs. • In May 2024, the Company issued 288,900 shares under our ATM facility raising A$13,544 before transaction costs. • In May 2024, the Company issued 790,100 shares under our ATM facility raising A$36,024 before transaction costs. • In May 2024, the Company issued 20,000 shares under our ATM facility raising A$910 before transaction costs. 34 Table of Contents • In May 2024, the Company issued 242,170 shares under our ATM facility raising A$10,891 before transaction costs. • In June 2024, the Company issued 5,916,970 ordinary shares represented by 59,170 ADSs as repayment of a promissory note. • In June 2024, the Company issued 29,000,000 shares under a private ELOC placement raising A$776,264 before transaction costs.
Removed
As of the date of this filing, we currently anticipate that current cash and cash equivalents, excluding any potential proceeds from our ATM facility, will be sufficient to meet our anticipated cash requirements through the end of November 2023.
Added
During fiscal year 2017, the Company reached two milestones that triggered the conversion of a portion of its Convertible Notes.
Removed
The details of those share issues are as follows: • In December 2021 the Company issued 25,000 shares upon the exercise of options, raising a total of A$16,700. • In May 2022 the Company issued 1,855,357 shares due to the conversion of the Triaxial convertible note triggered by completion of phase II paxalisib trial announced to ASX on 21 April 2022. • In May and June 2022, the Company issued 4,862,810 shares under our ATM facility raising A$4.2 million before transaction costs. 29 Table of Contents During fiscal year 2023 the Company issued 89,273,738 ordinary shares.
Added
We cannot determine with certainty the duration and completion costs of the current or future product development, pre-clinical studies or clinical trials of our product candidates.
Removed
“Financial Statements – Note 24 – Financial Instruments” for disclosures about financial risk management including interest rate risk, foreign currency risk and liquidity risk.
Removed
A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate.

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

43 edited+5 added−29 removed27 unchanged
Details of these agreements are as follows: Name: Title: Agreement commenced: Term of agreement: Details: Dr John Friend Chief Executive Officer May 1 2023 Full time employment Base salary for the year ending 30 June 2023 of USD550,000 and healthcare and insurance benefits to be reviewed annually by the Remuneration and Nomination Committee.
Details of these agreements are as follows: Name: Title: Agreement commenced: Term of agreement: Details: Dr John Friend Chief Executive Officer 1 May 2023 Full time employment Base salary for the year ending 30 June 2024 of USD550,000 and healthcare and insurance benefits to be reviewed annually by the Remuneration and Nomination Committee.
This includes overviewing the financial and human resources the Company has in place to meet its objectives and the review of management performance; • protecting and optimizing Company performance and building sustainable value for shareholders in accordance with any duties and obligations imposed on the Board by law and the Company’s Constitution and within a framework of prudent and effective controls that enable risk to be assessed and managed; responsible for the overall Corporate Governance of Kazia Therapeutics Limited and its subsidiaries, including monitoring the strategic direction of the Company and those entities, formulating goals for management and monitoring the achievement of those goals; 40 Table of Contents • setting, reviewing and ensuring compliance with the Company’s values (including the establishment and observance of high ethical standards); and • ensuring shareholders are kept informed of the Company’s performance and major developments affecting its state of affairs.
This includes overviewing the financial and human resources the Company has in place to meet its objectives and the review of management performance; • protecting and optimizing Company performance and building sustainable value for shareholders in accordance with any duties and obligations imposed on the Board by law and the Company’s Constitution and within a framework of prudent and effective controls that enable risk to be assessed and managed; responsible for the overall Corporate Governance of Kazia Therapeutics Limited and its subsidiaries, including monitoring the strategic direction of the Company and those entities, formulating goals for management and monitoring the achievement of those goals; • setting, reviewing and ensuring compliance with the Company’s values (including the establishment and observance of high ethical standards); and • ensuring shareholders are kept informed of the Company’s performance and major developments affecting its state of affairs.
The Remuneration and Nomination Committee approved increases in fixed remuneration during fiscal year 2023. The short-term incentives program is designed to align the targets of Kazia with the performance hurdles of executives. Short-term incentive payments are granted to executives based on specific annual performance objectives, metrics and performance appraisals.
The Remuneration and Nomination Committee approved increases in fixed remuneration during fiscal year 2024. The short-term incentives program is designed to align the targets of Kazia with the performance hurdles of executives. Short-term incentive payments are granted to executives based on specific annual performance objectives, metrics and performance appraisals.
We do have a ‘diverse’ board of directors as defined in NASDAQ Rule 5605(f). Kazia is a small company with four Directors. As noted in the Board Diversity Matrix Part II Demographic Background section, it is the opinion of the company that we do meet the requirements of a diverse Board.
We do have a ‘diverse’ board of directors as defined in NASDAQ Rule 5605(f). Kazia is a small company with five Directors. As noted in the Board Diversity Matrix Part II Demographic Background section, it is the opinion of the company that we do meet the requirements of a diverse Board.
The last determination for the consolidated entity was at the Annual General Meeting held on 16 November 2022 when the shareholders approved the new constitution with an aggregate remuneration of $560,000. Non-Executive Directors’ fees are reviewed periodically by the Board and are regularly compared with those of companies of comparable market capitalization and stage of development.
The last determination for the Consolidated Entity was at the Annual General Meeting held on 16 November 2022 when the shareholders approved the new constitution with an aggregate remuneration of $560,000. 38 Table of Contents Non-Executive Directors’ fees are reviewed periodically by the Board and are regularly compared with those of companies of comparable market capitalization and stage of development.
Board Diversity as at 26 October 2023 Female Male Non-Binary Did Not Disclose Gender Country of Principal Executive Offices: Australia Foreign Private Issuer: Yes Disclosure Prohibited Under Home Country Law: No Total Number of Directors: 4 Part I: Gender Identity Directors 1 3 Part II Demographic Background African American or Black Alaskan Native or Native American Asian Hispanic or Latinx Native Hawaiian or Pacific Islander White 3 Two or More Races or Ethnicities 1 LGBTQ+ Did Not Disclose Demographic Background 42 Table of Contents Committees The Board has established an Audit, Risk and Governance Committee and a Remuneration and Nomination Committee.
Board Diversity as of 26 October 2024 Female Male Non- Binary Did Not Disclose Gender Country of Principal Executive Offices: Australia Foreign Private Issuer: Yes Disclosure Prohibited Under Home Country Law: No Total Number of Directors: 4 Part I: Gender Identity Directors 1 4 Part II Demographic Background African American or Black Alaskan Native or Native American Asian Hispanic or Latinx Native Hawaiian or Pacific Islander White 4 Two or More Races or Ethnicities 1 LGBTQ+ Did Not Disclose Demographic Background 44 Table of Contents Committees The Board has established an Audit, Risk and Governance Committee and a Remuneration and Nomination Committee.
Service conditions are that any unvested options are forfeited on cessation of employment. There are no performance conditions, consistent with the Company’s Employee Share Option Plan rules, as reapproved by shareholders on 6 November 2021.
Service conditions are that any unvested options are forfeited on cessation of employment. There are no performance conditions, consistent with the Company’s Employee Share Option Plan rules, as re-approved by shareholders on 6 November 2021.
The consolidated entity aims to attract and retain high calibre executives, and align their interests with those of the shareholders, by granting equity-based payments which are issued at the share price on date of issue and vest in tranches based on tenure. The share-options issued to executives are governed by the ESOP.
The long-term incentive comprises equity-based payments. The Consolidated Entity aims to attract and retain high calibre executives, and align their interests with those of the shareholders, by granting equity-based payments which are issued at the share price on date of issue and vest in tranches based on tenure. The share-options issued to executives are governed by the ESOP.
The executive remuneration and reward framework has three components: • fixed remuneration • short-term performance incentives - cash bonus • share-based payments - award of options through the ESOP Fixed remuneration is reviewed annually by the Remuneration and Nomination Committee based on individual performance, the overall performance of Kazia and comparable market remunerations.
The executive remuneration and reward framework has three components: • fixed remuneration • short-term performance incentives - cash bonus • share-based payments - award of options through the Employee Share Option Plan (“ESOP”) Fixed remuneration is reviewed annually by the Remuneration and Nomination Committee based on individual performance, the overall performance of Kazia and comparable market remunerations.
Employees As of the end of each of the last three fiscal years, the Company employed the following number of people—FTEs: Category of Activity 2023 2022 2021 Research and Development 6.8 6.8 4.6 Finance and Administration 2.0 2.2 1.7 Total 8.8 9.0 6.3 Geographic Location 2023 2022 2021 Australia 4.8 5.0 5.3 United States 4.0 4.0 1 Total 8.8 9.0 6.3 E.
Employees As of the end of each of the last three fiscal years, the Company employed the following number of people-FTEs: Category of Activity 2024 2023 2022 Research and Development 5.0 6.8 6.8 Finance and Administration 1.8 2.0 2.2 Total 6.8 8.8 9.0 Geographic Location 2024 2023 2022 Australia 3.0 5.0 5.3 United States 3.8 4.0 1.0 Total 6.8 9.0 6.3 46 Table of Contents E.
Any change to the ESOP will require approval by shareholders. Use of remuneration consultants During fiscal year 2023, the Company did not engage remuneration consultants to assist with the determination of remuneration levels.
Any change to the ESOP will require approval by shareholders. 39 Table of Contents Use of remuneration consultants During fiscal year 2024, the Company did not engage remuneration consultants to assist with the determination of remuneration levels.
Board of Directors The Board of Kazia Limited is elected by and accountable to shareholders. The Board monitors and directs the business and is responsible for the corporate governance of the Company. As at 30 June 2023, the Board comprised of four directors, all of whom were non-executive directors.
Board of Directors The Board of Kazia is elected by and accountable to shareholders. The Board monitors and directs the business and is responsible for the corporate governance of the Company. As of 30 June 2024, the Board comprised of five directors, four of whom were non-executive directors.
The Remuneration and Nomination Committee is responsible for determining and reviewing compensation arrangements for the directors themselves and the Chief Executive Officer and executive team. 43 Table of Contents D.
The Remuneration and Nomination Committee is responsible for determining and reviewing compensation arrangements for the directors themselves and the Chief Executive Officer and executive team. D.
Other current directorships: None Former directorships (last 3 years): None Special responsibilities: None Name: Dr John Friend Title: Chief Executive Officer (appointed 1 May 2023) Managing Director (appointed 1 August 2023) Interim Chairman of the Board (appointed 11 August 2023) Chief Medical Officer to 30 April 2023 Qualifications: B.A., M.D Experience and expertise: Dr Friend is a highly experienced physician executive who has previously worked with companies ranging from start-up biotechnology companies to multinational pharmaceutical companies.
He also held prior roles at Genaera Corporation, Liberty Technologies, and Arthur Andersen & Company. 37 Table of Contents Other current directorships: None Former directorships (last 3 years): None Special responsibilities: None Name: Dr John Friend Title: Chief Executive Officer (appointed 1 May 2023) Managing Director (appointed 1 August 2023) Interim Chairman of the Board (appointed 11 August 2023) Chief Medical Officer to 30 April 2023 Qualifications: B.A., M.D Experience and expertise: Dr Friend is a highly experienced physician executive who has previously worked with companies ranging from start-up biotechnology companies to multinational pharmaceutical companies.
The number of options offered, the amount payable, the vesting period, the option period, the conditions of exercise or any other factors are at the discretion of the Board of Directors. Kazia issued 7,930,000 share options under the ESOP during the financial year ended 30 June 2023, of which 6,000,000 were issued to KMP.
The number of options offered, the amount payable, the vesting period, the option period, the conditions of exercise or any other factors are at the discretion of the Board of Directors. Kazia issued 2,850,000 ADS options under the ESOP during the financial year ended 30 June 2024, of which 1,500,000 were issued to KMP.
Other current directorships: Antisense Therapeutics Limited (ASX:ANP) Former directorships (last 3 years): None Special responsibilities: None Name: Ebru Davidson Title: Non-Executive Director - from 5 June 2023 Qualifications: BSc, JD (Hons), AGIA, GAICD Experience and expertise: Ms Davidson is a highly experienced corporate lawyer and is currently the General Counsel for QBiotics Group Limited, an unlisted public Australian life sciences company.
Name: Ebru Davidson Title: Non-Executive Director - from 5 June 2023 Qualifications: BSc, JD (Hons), AGIA, GAICD Experience and expertise: Ms Davidson is a highly experienced corporate lawyer and is currently the General Counsel for QBiotics Group Limited, an unlisted public Australian life sciences company.
This includes reviewing procedures in place to identify the main risks associated with the Company’s businesses and the implementation of appropriate systems to manage these risks; • overseeing and monitoring compliance with the Code of Conduct and other corporate governance policies; • monitoring corporate performance and implementation of strategy and policy; • approving major capital expenditure, acquisitions and divestitures, and monitoring capital management; • monitoring and reviewing management processes in place aimed at ensuring the integrity of financial and other reporting; • monitoring and reviewing policies and processes in place relating to occupational health and safety, compliance with laws, and the maintenance of high ethical standards; and • performing such other functions as are prescribed by law or are assigned to the Board.
This includes reviewing procedures in place to identify the main risks associated with the Company’s businesses and the implementation of appropriate systems to manage these risks; • overseeing and monitoring compliance with the Code of Conduct and other corporate governance policies; • monitoring corporate performance and implementation of strategy and policy; • approving major capital expenditure, acquisitions and divestitures, and monitoring capital management; • monitoring and reviewing management processes in place aimed at ensuring the integrity of financial and other reporting; • monitoring and reviewing policies and processes in place relating to occupational health and safety, compliance with laws, and the maintenance of high ethical standards; and • performing such other functions as are prescribed by law or are assigned to the Board. 42 Table of Contents In carrying out its responsibilities and functions, the Board may delegate any of its powers to a Board committee, a director, employee or other person subject to ultimate responsibility of the directors under the Corporations Act.
Annual performance reviews are conducted at the end of each calendar year and bonuses are paid shortly after the performance reviews are completed. Annual performance objectives cover matters such as progress in clinical trials, and management of the Company’s financial resources.
Annual performance reviews are conducted at the end of each calendar year and bonuses are paid shortly after the performance reviews are completed. Annual performance objectives cover matters such as progress in clinical trials, and management of the Company’s financial resources. The Board or the Remuneration and Nomination Committee may, at its discretion, award bonuses for exceptional performance.
Share Ownership Directors’ and KMP interests in the shares and options of the Company for fiscal year 2023: Shareholding The number of shares in the company held during the financial year by each director and other members of Key Management Personnel of the consolidated entity, including their personally related parties, is set out below: Balance at the start of the year Purchased on market Share Purchase Plan Off market additions/ disposals Disposed* (For KMP reporting purposes only) Balance at the end of the year Ordinary shares B Carmine 419,862 120,000 181,819 135,000 856,681 S Coffey 484,265 100,000 272,728 135,000 991,993 I Ross 1,075,001 175,000 272,728 — 1,522,729 J Garner 500,000 100,000 181,819 — (781,819 ) — K Hill 320,000 — — (270,000 ) (50,000 ) — J Friend — — — — — — K Krumeich — — — — — — E Davidson — — — — — 2,799,128 495,000 909,094 — (831,819 ) 3,371,403 Each Director and Key Management Personnel owns less than 1% of shareholding.
Share Ownership Directors’ and KMP interests in the shares and options of the Company for fiscal year 2024: Shareholding The number of shares in the company held during the financial year by each director and other members of Key Management Personnel of the Consolidated Entity, including their personally related parties, is set out below: Balance at the start of the year Purchased on market Share Purchase Plan Off market additions/ disposals Disposed* (For KMP reporting purposes only) Balance at the end of the year Ordinary shares B Carmine 856,681 — — — — 856,681 S Coffey 991,993 — — — — 991,993 I Ross 1,522,729 — — (1,522,729 ) — — J Garner — — — — — — J Friend — — — — — — K Krumeich — — — — — — E Davidson — — — — — — 3,371,403 — — (1,522,729 ) — 1,848,674 Each Director and Key Management Personnel owns less than 1% of shareholding.
The Board does not believe that it should establish a limit on tenure other than stipulated in the Company Constitution (refer to ‘Term of Directors’ below). 41 Table of Contents While tenure limits can help to ensure that there are fresh ideas and viewpoints available to the Board, they hold the disadvantage of losing the contribution of directors who have been able to develop, over a period of time, increasing insight in the Company and its operation and, therefore, an increasing contribution to the Board as a whole.
While tenure limits can help to ensure that there are fresh ideas and viewpoints available to the Board, they hold the disadvantage of losing the contribution of directors who have been able to develop, over a period of time, increasing insight in the Company and its operation and, therefore, an increasing contribution to the Board as a whole.
These arrangements are reviewed annually at the end of the calendar year. The Board determines an appropriate level of fixed remuneration for the CEO and Group Executives, as well as the proportion of performance-based remuneration.
The Board determines an appropriate level of fixed remuneration for the CEO and Group Executives, as well as the proportion of performance-based remuneration.
In the event that employment is terminated for cause, no severance pay or other benefits are payable by the consolidated entity. 38 Table of Contents Remuneration and other terms of employment for key management personnel are formalized in service agreements.
The Consolidated Entity may terminate the contracts at any time without cause if serious misconduct has occurred. In the event that employment is terminated for cause, no severance pay or other benefits are payable by the Consolidated Entity. Remuneration and other terms of employment for key management personnel are formalized in service agreements.
Karen Krumeich was reimbursed for travel and accommodation expenses of $63,157. 44 Table of Contents Option holding The number of options over ordinary shares in the company held during the financial year by each Director and other members of Key Management Personnel of Kazia, including their personally related parties, is set out below: Balance at the start of the year Granted as remuneration Forfeited Disposed (for KMP reporting purposes only) Balance at the end of the year Options over ordinary shares J Garner * 4,500,000 — (1,450,000 ) (3,050,000 ) — K Hill ** 200,000 — (100,000 ) (100,000 ) — I Ross 400,000 — — — 400,000 B Carmine 400,000 — — — 400,000 S Coffey 400,000 — — — 400,000 J Friend 800,000 4,000,000 — — 4,800,000 K Krumeich 800,000 2,000,000 — — 2,800,000 7,500,000 6,000,000 (1,550,000 ) (3,150,000 ) 8,800,000 * Disposal for KMP reporting purposes only.
Option holding The number of options over ordinary shares in the company held during the financial year by each Director and other members of Key Management Personnel of Kazia, including their personally related parties, is set out below: Balance at the start of the year Granted as renumeration Forfeited Disposed* (For KMP reporting purposes only) Balance at the end of the year Options over ordinary shares I Ross 400,000 — — — 400,000 B Carmine 400,000 — — — 400,000 S Coffey 400,000 — — — 400,000 J Friend 4,800,000 — — — 4,800,000 K Krumeich 2,800,000 — (2,800,000 ) — — 8,800,000 — (2,800,000 ) — 6,000,000 47 Table of Contents Balance at the start of the year Granted as remuneration Forfeited Disposed (for KMP reporting purposes only) Balance at the end of the year Options over ADS J Friend — 1,500,000 — — 1,500,000 — 1,500,000 — — 1,500,000 Share-based compensation There were no shares issued to Directors or other KMP as part of compensation during fiscal year 2024.
The Non-Executive Directors fee structure is a fixed fee model and includes superannuation for Australian based directors. Executive Directors and other Key Management Personnel (“KMP”) The Board and the Remuneration and Nomination Committee, in consultation with the Managing Director, have put in place a remuneration structure which provides incentive for employees to drive the activities of the company forward.
Executive Directors and other Key Management Personnel (“KMP”) The Board and the Remuneration and Nomination Committee, in consultation with the Managing Director, have put in place a remuneration structure which provides incentive for employees to drive the activities of the company forward. These arrangements are reviewed annually at the end of the calendar year.
The appointment and expiration dates of each director in office at the date of this report is as follows: Name Position Year First Appointed Current term expires Dr John Friend Managing Director, CEO 2023 N/A* Bryce Carmine Non-executive Director 2015 Nov-23 Iain Ross (resigned 11 August 2023) Non-executive Director, Chairman 2014 Nov-24 Steven Coffey Non-executive Director 2012 Nov-25 Dr James Garner (resigned 30 April 2023) Managing Director, CEO 2016 Terminated 30 June 2023 Ebru Davidson (appointed 5 June 2023) Non-executive Director 2023 Nov-26 * The managing director is exempt from standing for re-election under the Company’s constitution and Australian corporate law.
The appointment and expiration dates of each director in office at the date of this report is as follows: Name Position Year First Appointed Current term expires Dr John Friend Managing Director, CEO 2023 N/A* Bryce Carmine Non-executive Director 2015 Nov-26 Steven Coffey Non-executive Director 2012 Nov-25 Ebru Davidson (appointed 5 June 2023) Non-executive Director 2023 Nov-26 Robert Apple (appointed 15 January 2024) Non-executive Director 2024 Nov-24 * The managing director is exempt from standing for re-election under the Company’s constitution and Australian corporate law. 43 Table of Contents Further details on each director can be found in “Names, titles, experience and expertise” above.
The Chairman’s fees are determined independently to the fees of other non-executive Directors based on comparative roles in the external market.
The Chairman’s fees are determined independently to the fees of other non-executive Directors based on comparative roles in the external market. The Non-Executive Directors fee structure is a fixed fee model and includes superannuation for Australian based directors.
Name: Steven Coffey Title: Non-Executive Director Qualifications: B. Comm, CA Experience and expertise: Steven is a Chartered Accountant and registered company auditor and has over 35 years experience in the accounting and finance industry.
Other current directorships: None Former directorships (last 3 years): None Special responsibilities: Chair of Remuneration and Nomination Committee, member of Audit, Risk and Governance Committee. Name: Steven Coffey Title: Non-Executive Director Qualifications: B. Comm, CA Experience and expertise: Steven is a Chartered Accountant and registered company auditor and has over 35 years experience in the accounting and finance industry.
The Board and its Remuneration and Nomination Committee take a balanced position between the need to pay market rates to attract talent, and the financial resources of Kazia, in determining remuneration.
The Board and its Remuneration and Nomination Committee take a balanced position between the need to pay market rates to attract talent, and the financial resources of Kazia, in determining remuneration. Non-Executive Directors remuneration The Constitution of Kazia specifies that the aggregate remuneration of Non-Executive Directors shall be determined from time to time by General Meeting.
Directors and Senior Management The names and details of the Company’s Directors and senior management at the date of this report are as follows: Iain Ross Chairman, Non-Executive Director (resigned 11 August 2023) John Friend Chief Executive Officer (Appointed 1 August 2023 Managing Director (Appointed 11 August 2023 – Interim Chairman) Bryce Carmine Non-Executive Director Steven Coffey Non-Executive Director Ebru Davidson Non-Executive Director (Appointed 5 June 2023) Karen Krumeich Chief Financial Officer Anna Sandham Company Secretary (Appointed 28 February 2023) 32 Table of Contents Directors were in office for the entire period unless otherwise stated.
Directors and Senior Management The names and details of the Company’s Directors and senior management at the date of this report are as follows: John Friend Chief Executive Officer, Managing Director (Appointed 1 August 2023) Bryce Carmine Chairman, Non-Executive Director Steven Coffey Non-Executive Director Ebru Davidson Non-Executive Director Robert Apple Non-Executive Director (Appointed 15 January 2024) Jeffrey Bonacorda Vice President, Finance and Controller (Appointed 24 June 2024) Elissa Hansen Company Secretary (Appointed 14 June 2024) 36 Table of Contents Directors were in office for the entire period unless otherwise stated.
Each option is convertible to one ordinary share upon exercise. Approval for the issue was obtained under ASX listing rule 10.14. Pension benefits The Company paid A$149,626 during fiscal year 2023 for employee superannuation benefits and pension benefits related to KMPs. C.
Each option is convertible to one ordinary share upon exercise. Pension benefits The Company paid A$72,784 during fiscal year 2024 for employee superannuation benefits and pension benefits related to KMPs. C.
Name: Bryce Carmine Title: Non-Executive Director Qualifications: B.Sc., Biochemistry, Microbiology & Genetics Experience and expertise: Bryce spent 36 years working for Eli Lilly & Co. and retired as Executive Vice President for Eli Lilly & Co, and President, Lilly Bio-Medicines. Prior to this he led the Global Pharmaceutical Sales and Marketing and was a member of the Company’s Executive Committee.
Names, titles, experience and expertise Name: Bryce Carmine Title: Chairman, Non-Executive Director Qualifications: B.Sc., Biochemistry, Microbiology & Genetics Experience and expertise: Bryce spent 36 years working for Eli Lilly & Co. and retired as Executive Vice President for Eli Lilly & Co, and President, Lilly Bio-Medicines.
Bryce previously held a series of product development portfolio leadership roles culminating when he was named President, Global Pharmaceutical Product Development, with responsibility for the entire late-phase pipeline development across all therapeutic areas for Eli Lilly. During his career with Lilly, Bryce held several country leadership positions including President Eli Lilly Japan, Managing Dir.
Prior to this he led the Global Pharmaceutical Sales and Marketing and was a member of the Company’s Executive Committee. Bryce previously held a series of product development portfolio leadership roles culminating when he was named President, Global Pharmaceutical Product Development, with responsibility for the entire late-phase pipeline development across all therapeutic areas for Eli Lilly.
The expected outcomes of the remuneration structure are: • retention and motivation of key executives; • attraction of high-quality management to the Company; and • performance incentives that allow executives to share in the success of Kazia Therapeutics Limited.
To assist in achieving this objective, the Board, in assuming the responsibilities of assessing remuneration to employees, links the nature and amount of executive directors’ and officers’ remuneration to the Company and Company’s financial and operational performance. 45 Table of Contents The expected outcomes of the remuneration structure are: • retention and motivation of key executives; • attraction of high-quality management to the Company; and • performance incentives that allow executives to share in the success of Kazia Therapeutics Limited.
Ms Davidson also has extensive experience in advising listed and unlisted entities on compliance and regulatory matters working closely with the Australian Securities and Investment Commission and Australian Securities Exchange.
Ms Davidson also has extensive experience in advising listed and unlisted entities on compliance and regulatory matters working closely with the Australian Securities and Investment Commission and Australian Securities Exchange. Other current directorships: None Former directorships (last 3 years): None Special responsibilities: None Name: Robert Apple Title: Non-Executive Director Qualifications: B.A.
Service agreements Under Remuneration and Nomination Committee policy, employment contracts are entered into with each of the executives who is considered to be KMP. Under the terms of the contracts, remuneration is reviewed at least annually. The employment contracts of KMPs include a termination clause whereby a party can terminate the agreement on notice. Notice required is 6 months.
Under the terms of the contracts, remuneration is reviewed at least annually. The employment contracts of KMPs include a termination clause whereby a party can terminate the agreement on notice. Notice required is 6 months. Under the terms of each contract, payment in lieu can be made by the Consolidated Entity to substitute the notice period.
The options issued on 3 May 2023 were 3,000,000 options to John Friend and 1,000,000 options to Karen Krumeich, with an exercise price set at the volume weighted average (VWAP) of shares during the 5 trading days immediately prior to the issue date, with values of $333,300 and $111,100 respectively.
Share-based compensation Issue of options The options issued on 22 April 2024 were to John Friend for 1,500,000 ADS options with an exercise price set at the volume weighted average (VWAP) of ADS during the 5 trading days immediately prior to the issue date with a value of A$645,000.
The terms and conditions of each grant of options over ordinary shares granted as remuneration to Directors or other Key Management Personnel in this financial year or future financial years are set out below.
The terms and conditions of each grant of options over ordinary shares granted as remuneration to Directors or other Key Management Personnel in this financial year or future financial years are set out below. 41 Table of Contents Issue of ADS options Grant date Vesting date and exercisable date Expiry date Exercise price Fair value per option at grant date 22 April 2024 22 April 2027 22 April 2029 A$ 0.586 A$ 0.43 Options granted carry no dividend or voting rights.
Structure of the Board The Company’s Constitution governs the regulation of meetings and proceedings of the Board. The Board determines its size and composition, subject to the terms of the Constitution.
Structure of the Board The Company’s Constitution governs the regulation of meetings and proceedings of the Board. The Board determines its size and composition, subject to the terms of the Constitution. The Board does not believe that it should establish a limit on tenure other than stipulated in the Company Constitution (refer to ‘Term of Directors’ below).
A minimum payout of 50% of bonus target agreed for 2023 of USD165,000. John’s employment with the consolidated entity is at-will, and if terminated, it must pay any outstanding entitlements due to him.
A bonus of up to 60% of base salary, subject to attainment of key objectives and at the discretion of the board. John’s employment with the consolidated entity is at-will, and if terminated, it must pay any outstanding entitlements due to him. Key management personnel have no entitlement to termination payments in the event of removal for misconduct.
Australia/NZ & General Manager of a JV for Lilly in Seoul, Korea. Bryce is currently Chairman and CEO of HaemaLogiX Pty Ltd, a Sydney based privately owned biotech. Other current directorships: None Former directorships (last 3 years): None Special responsibilities: Chair of Remuneration and Nomination Committee, member of Audit, Risk and Governance Committee.
During his career with Lilly, Bryce held several country leadership positions including President Eli Lilly Japan, Managing Dir. Australia/NZ & General Manager of a JV for Lilly in Seoul, Korea. Bryce is currently Chairman and CEO of HaemaLogiX Pty Ltd, a Sydney based privately owned biotech.
Other transactions with key management personnel and their related parties Iain Ross (from his company Gladstone Consultancy Partnership) was reimbursed for travel and accommodation expenses of $114,684. James Garner was reimbursed travel and accommodation expenses of $149,382. Kate Hill (from her company Sabio Solutions Pty Ltd) was reimbursed for expenses of $74.
Other transactions with key management personnel and their related parties John Friend was for reimbursed travel and accommodation expenses of $105,542. Ebru Davidson was reimbursed travel and accommodation expenses of $2,386. Ian Ross was reimbursed travel and accommodation expenses of $7,402.
Other current directorships: None Former directorships (last 3 years): Ansarada Group Limited (ASX: AND) formerly The Docyard Limited (ASX:TDY) Special responsibilities: Chair of Audit, Risk and Governance Committee, member of Remuneration and Nomination Committee. 33 Table of Contents Name: Dr James Garner Title: Managing Director and Chief Executive Officer Resigned 30 April 2023 Terminated 30 June 2023 Qualifications: MA, MBA, MBBS, BSc (Hons), MAICD Experience and expertise: Dr Garner is an experienced life sciences executive who has previously worked with companies ranging from small biotechs to multinational pharmaceutical companies such as Biogen and Takeda.
Other current directorships: None Former directorships (last 3 years): Ansarada Group Limited (ASX: AND) formerly The Docyard Limited (ASX:TDY) Special responsibilities: Chair of Audit, Risk and Governance Committee, member of Remuneration and Nomination Committee.
The KMP of Kazia consisted of the following directors of Kazia Therapeutics Limited: • Iain Ross - Non-Executive Director, Chairman (resigned 11 August 2023) • Bryce Carmine - Non-Executive Director • Steven Coffey - Non-Executive Director • Dr James Garner - Managing Director, CEO - resigned 30 April 2023, terminated 30 June 2023 • Ebru Davidson - Non-Executive Director - from 5 June 2023 And the following persons: • Dr John Friend - Chief Medical Officer (from 15 November 2021 to 30 April 2023) • Dr John Friend - Chief Executive Officer - from 1 May 2023 • Karen Krumeich - Chief Financial Officer • Kate Hill - Company Secretary - resigned 28 February 2023 37 Table of Contents Short-term benefits Short-term benefits Short-term benefits Short-term benefits Short-term benefits Post- employment benefits Share-based payments Salary & fees Cash Bonus Cash Movements in accrued leave Non- monetary Movements in long service leave Non- monetary Healthcare & Insurance Cash Super- annuation Options Equity- settled Total 2023 $ $ $ $ $ $ $ $ Non-Executive Directors: I Ross* 175,016 — — — — — 74 175,090 B Carmine 85,000 — — — — 8,925 74 93,999 S Coffey 85,000 — — — — 8,925 74 93,999 E Davidson 6,440 — — — — 676 — 7,116 J Garner** 543,750 365,838 — — — 77,022 263,945 1,250,555 Other Key Management Personnel: J Friend ** 742,685 248,869 52,065 — 28,448 31,669 473,177 1,576,913 K Krumeich *** 592,168 120,664 6,961 — 13,797 22,409 295,150 1,051,149 K Hill 81,813 — — — — — 13,366 95,179 2,311,872 735,371 59,026 — 42,245 149,626 1,045,860 4,344,000 * Salary paid in GB pounds, but disclosed in Australian dollars using conversion rate of 0.5571 ** Amounts shown are for the full year, not just to resignation date of 30 April 2023.
The KMP of Kazia consisted of the following directors of Kazia Therapeutics Limited: • Bryce Carmine - Non-Executive Director, Chairman from 15 January 2023 • Steven Coffey - Non-Executive Director • Iain Ross - Non-Executive Director and Chair - until 11 August 2023 • Ebru Davidson - Non-Executive Director - from 5 June 2023 • Robert Apple - Non-Executive Director - from 15 January 2024 And the following persons: • Dr John Friend - Chief Executive Officer • Gabrielle Heaton - Vice President, Finance and Administration from 1 February 2024 to 30 June 2024 • Karen Krumeich - Chief Financial Officer until 31 January 2024 Short-term benefits Short-term benefits Short-term benefits Short-term benefits Short-term benefits Post- employment benefits Share-based payments Salary & fees Cash Bonus Cash Movements in accrued leave Non- monetary Movements in long service leave Non- monetary Healthcare & Insurance Cash Super- annuation Options Equity- settled Total 2024 $ $ $ $ $ $ $ $ Non-Executive Directors: B Carmine 95,417 — — — — — — 95,417 S Coffey 85,000 — — — — 9,350 — 94,350 E Davidson 85,000 — — — — 9,350 — 94,350 R Apple 39,301 — — — — — — 39,301 Other Key Management Personnel: J Friend * 824,998 — 44,384 — 35,186 32,780 342,496 1,279,844 K Krumeich * 378,946 — 2,307 — 7,850 9,937 — 399,040 G Heaton 103,333 — 1,348 — — 11,367 10,941 126,989 A Sandham 147,593 — — — — — — 147,593 E Hansen 2,267 — — — — — — 2,267 I Ross 109,633 — — — — — — 109,633 1,871,488 — 48,039 — 43,036 72,784 353,437 2,388,784 * Salary paid in USD, but disclosed in Australian dollars using conversion rate of 0.6673. 40 Table of Contents Service agreements Under Remuneration and Nomination Committee policy, employment contracts are entered into with each of the executives who is considered to be KMP.
Removed
Names, titles, experience and expertise Name: Iain Ross Title: Chairman, Non-Executive Director (Resigned 11 August 2023) Qualifications: B.Sc. (Hons). C Dir. Experience and expertise: Iain, based in the UK, is an experienced Director and has served on a number of Australian company boards.
Added
Experience and expertise: Mr Robert Apple has more than 25 years of senior leadership experience in the pharmaceutical industry, including 16 years with Antares Pharma, Inc. as Senior Vice President, Chief Financial Officer and Corporate Secretary, before going on to become President and Chief Executive Officer from 2016 until its acquisition by Halozyme Therapeutics in 2022. Mr.
Removed
He is Chairman of Silence Therapeutics plc (Nasdaq:SLN), Executive Chairman of ReNeuron Group plc (LSE:RENE) and a Non-executive Director of BiVitctriX Therapeutics plc (LSE:BVX).
Added
Apple also served on the Board of Directors at Antares from 2016 until May 2022. He previously served on the Board of Directors of InKine Pharmaceutical, PaxMedica Inc., and Kerathin Inc. Prior to joining Antares, Mr. Apple served as Chief Operating and Financial Officer at InKine Pharmaceutical.
Removed
In his career he has held senior positions in Sandoz AG, Fisons Plc, Hoffmann-La Roche AG and Celltech Group Plc and also undertaken a number of start-ups and turnarounds on behalf of banks and private equity groups.
Added
Other current directorships: None Former directorships (last 3 years): None Special responsibilities: None Name: Jeffrey Bonacorda Title: Vice President, Finance and Controller Qualifications: B.A. Experience and expertise: Mr Jeffrey Bonacorda is a senior accounting professional with more than thirty years of experience in the pharmaceutical, consumer products and service industries.
Removed
His track record includes multiple financing transactions having raised in excess of £600 million, both publicly and privately, as well as extensive experience of divestments and strategic restructurings and has over 25 years in cross-border management as a Chairman and CEO.
Added
Prior to joining Kazia, Mr Bonacorda held several senior finance positions supporting global R&D development programs and on market pharmaceuticals. Name: Elissa Hansen Title: Company Secretary (Appointed 14 June 2024) Qualifications: Bc., Grad.Dip. AICD, FGIA, Experience and expertise: Ms Elissa Hansen has over 20 years’ experience as a company secretary and governance professional for both listed and unlisted companies.
Removed
He has led and participated in 8 Initial Public Offerings, (5 LSE, 1 ASX, 2 Nasdaq) and has direct experience of mergers and acquisitions transactions in Europe, USA and the Pacific Rim Other current directorships: Silence Therapeutics plc (LSE:SLN), ReNeuron Group plc (LSE:RENE) and BiVictriX Therapeutics plc (LSE:BVX) Former directorships (last 3 years): Redx Pharma plc (LSE:REDX) and Palla Pharma Limited (ASX:PAL) Special responsibilities: Former Member of Remuneration and Nomination Committee, Former Member of the Audit, Risk and Governance Committee.
Added
She is a Chartered Secretary who brings best practice governance advice, ensuring compliance with the Listing Rules, Corporations Act and other relevant legislation.. B.
Removed
His career has focused on regional and global development of new medicines from preclinical to commercialisation. Dr Garner is a physician by training and holds an MBA from the University of Queensland. He began his career in hospital medicine and worked for a number of years as a corporate strategy consultant with Bain & Company before entering the pharmaceutical industry.
Removed
Prior to joining Kazia in 2016, he led R&D strategy for Sanofi in Asia-Pacific and was based in Singapore.
Removed
Other current directorships: None Former directorships (last 3 years): None Special responsibilities: None Name: Karen Krumeich Title: Chief Financial Officer Qualifications: BSc., Experience and expertise: Karen has more than thirty years of experience in corporate finance, focused almost entirely on the life sciences sector. She has been responsible for driving the growth of numerous private and public biotech companies.
Removed
For most of the last twenty years, she served as Chief Financial Officer to growth-stage biotech companies, both public and private, including Soligenix, Inc, and Theravectys, Inc.
Removed
In addition to her accounting qualifications, Karen is a qualified pharmacist and a graduate of the University of Toledo School of Pharmacy. 34 Table of Contents Name: Kate Hill Title: Company Secretary (resigned 28 February 2023) Qualifications: CA, GAICD, BSc (Hons) Experience and expertise: Kate has over 20 years’ experience as an audit partner with Deloitte Touche Tohmatsu, working with ASX listed and privately-owned clients.
Removed
She has worked extensively in regulated environments including assisting with Initial Public Offerings, capital raising and general compliance, as well as operating in an audit environment. She is a Non-Executive Director of CountPlus Limited (ASX:CUP) and Elmo Software Limited (ASX:ELO) as well as Chair of the Audit and Risk Committee for both of these companies.
Removed
She is also Chair of Seeing Machines Limited (LSE:SEE). Kate is a member of the Institute of Chartered Accountants in Australia and New Zealand, and a graduate of the Australian Institute of Company Directors. Name: Anna Sandham Title: Company Secretary (appointed 28 February 2023) Qualifications: BEc., Grad.Dip.
Removed
AppCorpGov., FGIA, Experience and expertise: Anna has more than 25 years’ experience as a company secretary and governance professional, working with ASX listed and privately owned companies. Anna is employed by Company Matters Pty Ltd (part of the Link Group).
Removed
Prior to joining Company Matters in 2012, Anna was a Company Secretary at AMP Financial Services and prior to that was Company Secretary at Westpac Banking Corporation where she also led the secretariat function for the BT Financial Group. Anna has also held company secretarial roles within the private and public sectors, including NRMA Limited.
Removed
Anna holds a Bachelor of Economics (University of Sydney) and a Graduate Diploma of Applied Corporate Governance (Governance Institute of Australia). She is a Chartered Governance Professional, a Fellow of the Governance Institute of Australia and a member of its Legislative Review Committee. 35 Table of Contents B.
Removed
Non-Executive Directors remuneration The Constitution of Kazia and the ASX listing rules specify that the aggregate remuneration of Non-Executive Directors shall be determined from time to time by General Meeting.
Removed
The Chairman’s fees increased to GBP12,000 per month for April, May and June 2023 to recognise the additional time the Chair spent securing the support of, and funds from major investors in the January 2023 fundraising through his personal and direct relationships; leading all discussions and negotiations with the current Chief Executive Officer and the incoming Chief Executive Officer about the position of Chief Executive Officer; and assisting the incoming Chief Executive Officer during the next short term period to secure additional funding for the business and to participate in 3rd party discussions as necessary.
Removed
The Board or the Remuneration and Nomination Committee may, at its discretion, award bonuses for exceptional performance. 36 Table of Contents The long-term incentive comprises equity-based payments.
Removed
Termination payment includes annual leave owing at 30 June 2023, 4 months’ salary and superannuation in lieu of notice. *** Salary paid in USD, but disclosed in Australian dollars using conversion rate of 0.6755. Guaranteed bonus accrued at year end rate.
Removed
Under the terms of each contract, payment in lieu can be made by the consolidated entity to substitute the notice period. The consolidated entity may terminate the contracts at any time without cause if serious misconduct has occurred.
Removed
Name: Title: Agreement commenced: Term of agreement: Details: Karen Krumeich Chief Financial Officer January 3, 2022 Full time employment Base salary for the year ending 30 June 2023 of USD400,000 and healthcare and insurance benefits to be reviewed annually by the Remuneration and Nomination Committee. A minimum payout of 50% of bonus target agreed for 2023 of USD80,000.
Removed
Karen’s employment with the consolidated entity is at-will, and if terminated, it must pay any outstanding entitlements due to her.
Removed
Key management personnel have no entitlement to termination payments in the event of removal for misconduct. 39 Table of Contents Share-based compensation Issue of options The options issued on 3 March 2023 were to John Friend and Karen Krumeich 1,000,000 options each with an exercise price set at the volume weighted average (VWAP) of shares during the 5 trading days immediately prior to the issue date with a value of $101,376.
Removed
Issue of options Grant date Vesting date and exercisable date Expiry date Exercise price Fair value per option at grant date 3 March 2023 3 July 2023 3 March 2027 $ 0.1500 $ 0.10138 3 March 2023 3 January 2024 3 March 2027 $ 0.1500 $ 0.10138 3 March 2023 3 July 2024 3 March 2027 $ 0.1500 $ 0.10138 3 March 2023 3 January 2025 3 March 2027 $ 0.1500 $ 0.10138 3 May 2023 3 May 2023 3 May 2027 $ 0.1870 $ 0.1111 3 May 2023 3 May 2024 3 May 2027 $ 0.1870 $ 0.1111 3 May 2023 3 May 2025 3 May 2027 $ 0.1870 $ 0.1111 Options granted carry no dividend or voting rights.
Removed
In carrying out its responsibilities and functions, the Board may delegate any of its powers to a Board committee, a director, employee or other person subject to ultimate responsibility of the directors under the Australian Corporations Act 2001.
Removed
Further details on each director can be found in “Names, titles, experience and expertise” above.
Removed
To assist in achieving this objective, the Board, in assuming the responsibilities of assessing remuneration to employees, links the nature and amount of executive directors’ and officers’ remuneration to the Company and Company’s financial and operational performance.
Removed
John Friend was for reimbursed travel and accommodation expenses of $67,440.
Removed
J Garner still holds 3,050,000 options ** Disposal for KMP reporting purposes only. K Hill still holds 100,000 options. Share-based compensation There were no shares issued to Directors or other KMP as part of compensation during fiscal year 2023.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Related party transactions During fiscal year 2023, and up to the date of this report, we did not enter into any transactions or loans with any: (i) enterprises that directly or indirectly, through one or more intermediaries, control, are controlled by or are under common control with us; (ii) associates; (iii) individuals owning, directly or indirectly, an interest in our voting power that gives them significant influence over us, and close members of any such individual’s family; (iv) executive officers and close members of such individuals’ families; or (v) enterprises in which a substantial interest in our voting power is owned, directly or indirectly, by any person described in (iii) or (iv) or over which such person is able to exercise significant influence.
Related party transactions During fiscal year 2024, and up to the date of this report, we did not enter into any transactions or loans with any: (i) enterprises that directly or indirectly, through one or more intermediaries, control, are controlled by or are under common control with us; (ii) associates; (iii) individuals owning, directly or indirectly, an interest in our voting power that gives them significant influence over us, and close members of any such individual’s family; (iv) executive officers and close members of such individuals’ families; or (v) enterprises in which a substantial interest in our voting power is owned, directly or indirectly, by any person described in (iii) or (iv) or over which such person is able to exercise significant influence.
Transactions between related parties, when they occur, are on normal commercial terms and the conditions no more favorable than those available to other non-related parties. C. Interests of Experts and Counsel Not applicable. 45 Table of Contents
Transactions between related parties, when they occur, are on normal commercial terms and the conditions no more favorable than those available to other non-related parties. C. Interests of Experts and Counsel Not applicable. 48 Table of Contents
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Item 7. Major Shareholders and Related Party Transactions A.
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Item 7. Major Shareholders and Related Party Transactions A. Major shareholders As at the date of this Annual Report, no shareholders hold a beneficial ownership of 5% or more of our voting securities. Significant Changes in the Ownership of Major Shareholders There have been no significant changes in the ownership of major shareholders.
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Major shareholders The following table present certain information regarding the beneficial ownership of our ordinary shares based on 236,349,374 ordinary shares outstanding at 17 October, 2023, by each person known by us to be the beneficial owner of more than 5% of our ordinary shares, as well as their holdings on 7 October 2022 and 30 September 2021.
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Major Shareholders Voting Rights All of our shareholders, including the shareholders listed below, have the same voting rights attached to their ordinary shares. Record Holders As of October 28, 2024, there were 2,193 Kazia shareholders holding 435,496,534 fully paid ordinary shares.
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Ordinary shares beneficially owned 5% or greater shareholders 17 October 2023 7 October 2022 30 September 2021 No. % No. % No. % Hyecorp and associates 34,890,910 14.76 % 19,220,000 12.7 % 18,715,000 14.44 % Platinum Investment Management Limited 23,083,022 9.77 % 7,084,856 5.47 % Quest Asset Partners Pty Ltd 11,101,710 8.4 % At 17 October 2023, there were 8,321,373 of the Company’s ADSs outstanding, representing 83,213,736 ordinary shares (or 35.21%) of the then outstanding ordinary shares.
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These numbers are not representative of the number of beneficial holders of our shares nor are they representative of where such beneficial holders reside, since many of these ordinary shares were held of record by brokers or other nominees.
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At 17 October 2023, there were 34 registered holders of the Company’s ADSs.. On that same date, 1,692,131 ordinary shares were held directly by U.S. holders. As of 17 October 2023 the total holdings for Quest Asset Partners Pty Ltd did not meet the 5% beneficial ownership required for reporting.
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The majority of trading by our U.S. investors is done by means of ADS that are held of record by HSBC Custody Nominees (Australia) Ltd., which held 418,260,593 (96.04%) of our ordinary shares as of such date. B.
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The holdings included in the above table are as notified to the ASX by that holder. There have been no other significant shareholders in the last three fiscal years. All shareholders have the same voting rights. B.

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