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What changed in KAZIA THERAPEUTICS LTD's 20-F — 2024 vs 2025

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Paragraph-level year-over-year comparison of KAZIA THERAPEUTICS LTD's 2024 and 2025 20-F annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+528 added−236 removedSource: 20-F (2025-11-07) vs 20-F (2024-11-15)

Top changes in KAZIA THERAPEUTICS LTD's 2025 20-F

528 paragraphs added · 236 removed · 191 edited across 5 sections

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

58 edited+272 added−14 removed154 unchanged
Biggest changeWe 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.
Biggest changeWe did not generate any revenues from sales of any of our product candidates in prior financial years. 2 Table of Contents As of 30 June 2025, we had accumulated losses of A$134.8 million. We have devoted most of our financial resources to research and development, including our clinical development activities.
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.
Our ability to generate future revenues from commercializing product candidates depends heavily on: 3 Table of Contents • successfully initiating and completing clinical trials of our product candidates; • 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.
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.
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; 28 Table of Contents • 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.
The calculation was found to contain errors as discounting for the time value of money was not considered on initial recognition. This was the result of a lack of personnel with specialist accounting knowledge. The material weakness as reported in the Company’s Annual Report for the year ended 30 June 2023 has been remediated.
The calculation was found to contain errors as discounting for the time value of money was not considered on initial recognition. This was the result of a lack of personnel with specialist accounting knowledge. The material weakness as reported in the Company’s Annual Report for the year ended 30 June 2023 has been remediated as of 30 June 2024.
Although the length and impact of these ongoing military conflicts are highly unpredictable, the conflict in Ukraine and the recent conflict between Israel and Gaza have led to market disruptions, including significant volatility in commodity prices, credit and capital markets, as well as supply chain disruptions.
Although the length and impact of these ongoing military conflicts are highly unpredictable, the conflict in Ukraine and the conflict between Israel and Gaza have led to market disruptions, including significant volatility in commodity prices, credit and capital markets, as well as supply chain disruptions.
U.S. and global markets are experiencing volatility and disruption following the escalation of geopolitical tensions, including the military conflict between Russia and Ukraine and the recent conflict between Israel and Gaza as well as any additional escalations that may develop in the Middle East region.
U.S. and global markets are experiencing volatility and disruption following the escalation of geopolitical tensions, including the military conflict between Russia and Ukraine and the conflict between Israel and Gaza as well as any additional escalations that may develop in the Middle East region.
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.
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. 12 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.
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.
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. 29 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.
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 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 2025 included an explanatory paragraph in relation to the going concern uncertainty.
For the year ended 30 June 2024, pursuant to Section 404 of the Sarbanes-Oxley Act, the Company was required to furnish a report by our senior management on our internal control over financial reporting. This report is required to include disclosure of any material weaknesses identified by the Company’s management in its internal control over financial reporting.
For the year ended 30 June 2025, pursuant to Section 404 of the Sarbanes-Oxley Act, the Company was required to furnish a report by our senior management on our internal control over financial reporting. This report is required to include disclosure of any material weaknesses identified by the Company’s management in its internal control over financial reporting.
We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by the geopolitical instability due to the ongoing military conflict between Russia and Ukraine and the recently erupted conflict between Israel and Gaza.
We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by the geopolitical instability due to the ongoing military conflict between Russia and Ukraine and the conflict between Israel and Gaza.
Section 404 of the Sarbanes-Oxley Act requires annual management assessments of the effectiveness of our internal control over financial reporting. As of 30 June 2024, the Company’s management determined that we had no material weaknesses in our internal control over financial reporting.
Section 404 of the Sarbanes-Oxley Act requires annual management assessments of the effectiveness of our internal control over financial reporting. As of 30 June 2025, the Company’s management determined that we had no material weaknesses in our internal control over financial reporting.
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.
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. 4 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 2025 we raised A$16 million from the sale of ADSs.
However, even if we will not be a considered a PFIC in the 2023 taxable year, there can be no assurance that we will not be considered a PFIC in the 2024 taxable year, the current year or for any future taxable year.
However, even if we will not be considered a PFIC in the 2024 taxable year or the 2025 taxable year, there can be no assurance that we will not be considered a PFIC in the current taxable year or for any future taxable year.
The relationships that our key managers have cultivated within our industry make us particularly dependent upon their continued employment with us. We are dependent on the continued service of our technical personnel because of the highly technical nature of our product candidates and the specialized nature of the regulatory approval process for our product candidates.
The relationships 8 Table of Contents that our key managers have cultivated within our industry make us particularly dependent upon their continued employment with us. We are dependent on the continued service of our technical personnel because of the highly technical nature of our product candidates and the specialized nature of the regulatory approval process for our product candidates.
Even where we have a valid and enforceable patent, we may not be able to exclude others from practicing our invention where the other party can show that they used the invention in commerce before our filing date or the other party benefits from a compulsory license. In addition, patents have a limited lifespan.
Even where we have a valid and enforceable patent, we may not be able to exclude others from practicing our invention where the other party can show that they used the invention in commerce before our filing date or the other party benefits from a compulsory 20 Table of Contents license. In addition, patents have a limited lifespan.
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.
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 conduct all of its pre-clinical and clinical studies.
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.
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.
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.
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, we believe that we were not a PFIC for U.S. federal income tax purposes with respect to our 2024 taxable year or our 2025 taxable year.
Potential competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where we have patent protection but enforcement is difficult.
Potential competitors may use our 22 Table of Contents technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where we have patent protection but enforcement is difficult.
The Company previously identified material weaknesses in connection with its internal control over financial reporting. Although the Company has taken steps to remediate these material weaknesses, the Company may identify other material weaknesses in the future, which could have a significant adverse effect on its business and the trading price of the ADSs.
The Company previously identified material weaknesses in connection with its internal control over financial reporting. Although the Company has remediated these material weaknesses, the Company may identify other material weaknesses in the future, which could have a significant adverse effect on its business and the trading price of the ADSs.
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.
Such a delisting would have a negative effect on the price of the Company’s securities, impair the ability to sell or purchase our ADSs 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.
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.”
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.
Our collaborations with outside scientists and consultants may be subject to restriction and change. We work with medical experts, chemists, biologists and other scientists at academic and other institutions, and consultants who assist us in our research, development and regulatory efforts, including the members of our scientific advisory board.
We work with medical experts, chemists, biologists and other scientists at academic and other institutions, and consultants who assist us in our research, development and regulatory efforts, including the members of our scientific advisory board.
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.
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 2026.
Our failure to do so may adversely affect our business, results of operations and financial condition. The Company has been successful in executing contractual agreements with strategic partners.
The Company may not be able to establish the contractual arrangements necessary to develop, market and distribute the product candidates. Our failure to do so may adversely affect our business, results of operations and financial condition. The Company has been successful in executing contractual agreements with strategic partners.
If more than 50% of our outstanding ordinary shares are instead held by U.S. residents, then in order to continue to maintain our foreign private issuer status, (i) a majority of our executive officers or directors must not be U.S. citizens or residents, (ii) more than 50% of our assets must not be located in the United States, and (iii) our business must be administered principally outside the United States.
If more than 50% of our outstanding ordinary shares are instead held by U.S. residents, then in order to continue to maintain our foreign private issuer status, (i) a majority of our executive officers or directors must not be U.S. citizens or residents, (ii) more than 50% of our assets must not be located in the United States, and (iii) our business must be administered principally outside the United States. 30 Table of Contents Losing our status as a foreign private issuer would require us to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act applicable to U.S. domestic issuers.
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.
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. 27 Table of Contents On May 12, 2025, the Company received a notification (the Notification) from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (Nasdaq) notifying the Company that from March 28, 2025 to May 9, 2025, the Company’s Market Value of Listed Securities (MVLS) was below the minimum of $35 million.
There is no assurance that we will be successful in obtaining sufficient financing on acceptable terms and conditions to fund continuing operations, if at all.
If we are unable to raise sufficient funding on acceptable terms due to these or other factors, we may be unable to continue to operate. There is no assurance that we will be successful in obtaining sufficient financing on acceptable terms and conditions to fund continuing operations, if at all.
If any of the Company’s drugs are approved and fail to achieve market acceptance, the Company may not be able to generate significant revenue to achieve or sustain profitability. Risks Related to Commercialization of Our Product Candidates The Company may not be able to establish the contractual arrangements necessary to develop, market and distribute the product candidates.
If any of the Company’s drugs are approved and fail to achieve market acceptance, the Company may not be able to generate significant revenue to achieve or sustain profitability.
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.
In addition, future shareholding changes may result in a significant ownership change for us. It is therefore uncertain as to whether any of our tax losses carried forward as of 30 June 2025 will be available to be carried forward and available to offset our assessable income, if any, in future periods.
We expect to incur significant net losses for the foreseeable future and may never achieve or maintain profitability. We have incurred significant net losses. We anticipate that we will continue to incur significant net losses for the foreseeable future and we may never achieve or maintain profitability. We are a biotechnology company and have not yet generated significant revenue.
We anticipate that we will continue to incur significant net losses for the foreseeable future and we may never achieve or maintain profitability. We are a biotechnology company and have not yet generated significant revenue. We have incurred losses of A$20.5, A$26.8 million, and A$20.7 million for the fiscal years ended 2023, 2024, and 2025, respectively.
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.
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.
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.
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. 10 Table of Contents We have not carried out any formal analysis as to whether we have met the COT or, failing the COT, the SBT or similar business test over relevant periods.
If the use of our product candidates harms patients, or is perceived to harm patients even when such harm is unrelated to our product candidates, our regulatory approvals could be revoked or otherwise negatively impacted and we could be subject to costly and damaging product liability claims.
If the use of our product candidates harms patients, or is perceived to harm patients even when such harm is unrelated to our product candidates, our regulatory approvals could be revoked or otherwise negatively impacted and we could be subject to costly and damaging product liability claims. 9 Table of Contents The use of our product candidates in clinical trials and the sale of any products for which we may in the future obtain marketing approval exposes us to the risk of product liability claims.
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.
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.
This could cause the trading price of our common stock to decline and you may lose all or part of your investment. Moreover, the risks described below are not the only ones that we face.
This could cause the trading price of our ADSs to decline and you may lose all or part of your investment. Moreover, the risks described below are not the only ones that we face. Additional risks not presently known to us or that we currently deem immaterial may also affect our business, operating results, prospects or financial condition.
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.
Risks Related to Our Business Operations and Employee Matters 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 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.
As of 30 June 2025, we had cash on hand at the bank of A$4.3 million. 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 5 Table of Contents normal course of business.
In this regard, the Company will need to continue to dedicate internal resources, potentially continue to engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. 6 Table of Contents Management previously reported, in the Company’s Annual Report for the year ended 30 June 2023, a material weakness in its internal control over financial reporting related to the incorrect application of accounting standards in relation to the acquisition of the EVT-801 intangible asset and the related contingent consideration.
In this regard, the Company will need to continue to dedicate internal resources, potentially continue to engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting.
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.
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.
In addition, following the completion of the delisting, the Company will no longer be subject to the ASX Listing Rules.
In addition, the Company is no longer subject to the ASX Listing Rules.
Global economic uncertainty caused by rising inflation, political instability, and conflicts and other events of geopolitical significance, such as the conflict between Russia and Ukraine, and the recent conflict between Israel and Gaza, could adversely affect our business and financial performance.
Global economic uncertainty caused by rising inflation, political instability, and conflicts and other events of geopolitical significance, such as the conflict between Russia and Ukraine, and the recent conflict between Israel and Gaza, the evolving regulatory activities and economic policies under the current U.S. government, events related thereto, such as changes to candidates or political unrest or otherwise, and changing interest rates and the imposition of tariffs, could adversely affect our business and financial performance.
There is a risk that our product candidates may induce adverse events. If we cannot successfully defend against product liability claims, we could incur substantial liability and costs.
Product liability claims might be brought against us by consumers, healthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with our product candidates. There is a risk that our product candidates may induce adverse events. If we cannot successfully defend against product liability claims, we could incur substantial liability and costs.
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.
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.
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.
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.
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.
In addition, our trade secrets may otherwise become known or be independently discovered by competitors.
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 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.
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.
Accordingly, as there is only one market on which to trade the Company’s securities, the delisting of the Company from the ASX may have impaired the development or liquidity of an active trading market for the ADSs in the U.S. and in turn the values of the ADSs.
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.
As a result, your ability to trade or obtain quotations for these securities may be more limited than if they were quoted on Nasdaq or other national securities exchanges. 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.
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.
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.
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.
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. We are currently developing, and in the future may develop, product candidates in combination with other approved or investigational therapies, and that may expose us to additional risks.
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.
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 Corporations Act 2001 (Cth) (“Corporation Act”).
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.
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.
Losing our status as a foreign private issuer would require us to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act applicable to U.S. domestic issuers. We also will be required to make changes in our corporate governance practices in accordance with various SEC and Nasdaq rules.
We also will be required to make changes in our corporate governance practices in accordance with various SEC and Nasdaq rules.
Additional risks not presently known to us or that we currently deem immaterial may also affect our business, operating results, prospects or financial condition. 1 Table of Contents Risks Related to Our Financial Condition and Capital Requirement We have incurred significant net losses since our inception.
Risks Related to Our Financial Condition and Capital Requirement We have incurred significant net losses since our inception. We expect to incur significant net losses for the foreseeable future and may never achieve or maintain profitability. We have incurred significant net losses.
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 Notification has no immediate impact on the Company’s operations or listing and Kazia’s American Depositary Shares (ADSs) will continue to trade on the Nasdaq Capital Market under the ticker “KZIA”. In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company has 180 calendar days to regain compliance with the MVLS Requirement.
The extent and duration of the military action, sanctions, and resulting market disruptions are impossible to predict, but could be substantial. If we are unable to raise sufficient funding on acceptable terms due to these or other factors, we may be unable to continue to operate.
The extent and duration of the military action, sanctions, and resulting market disruptions are impossible to predict, but could be substantial. 6 Table of Contents In addition, there have been, and may continue to be, significant changes to U.S. trade policies, sanctions, legislation, treaties and tariffs, including, but not limited to, trade policies and tariffs affecting products from outside of the U.S.
Removed
The competition for collaborators is significant, and the negotiation process is time-consuming and complex.
Added
We generated revenues of A$42 thousand during 2025 from the licensing of our development stage drug candidates. We generated revenues of A$2.3 million during 2024 from the licensing of our development stage drug candidates.
Removed
The use of our product candidates in clinical trials and the sale of any products for which we may in the future obtain marketing approval exposes us to the risk of product liability claims. Product liability claims might be brought against us by consumers, healthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with our product candidates.
Added
The extent and duration of increased tariffs and the resulting impact on general economic conditions and on our business are uncertain and depend on various factors, such as negotiations between the U.S. and affected countries, the responses of other countries or regions, exemptions or exclusions that may be granted, availability and cost of alternative sources of supply, and demand in affected markets.
Removed
We have not carried out any formal analysis as to whether we have met the COT or, failing the COT, the SBT or similar business test over relevant periods. In addition, future shareholding changes may result in a significant ownership change for us.
Added
Supply chain disruptions and delays as a result of any new tariff policies or trade restrictions could also negatively impact our cost of materials and production processes.
Removed
Some of these potential competing drugs are further advanced in development than the Company’s drug candidates and may be commercialized sooner. Even if the Company is successful in developing effective drugs, its compounds may not compete successfully with products produced by its competitors.
Added
If we are unable to obtain these chemical or biological intermediates in sufficient quantity and in a timely manner due to disruptions in the global supply chain caused by macroeconomic events and conditions, the development, testing and clinical trials of paxalisib and EVT801 or any other current or future product candidates may be delayed or infeasible, and regulatory approval or commercial launch of any resulting product may be delayed or not obtained, which could significantly harm our business.
Removed
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.
Added
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. Changes in tax law could adversely affect our business and financial condition.
Removed
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.
Added
The rules dealing with U.S. federal, state, local and international income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S. Treasury Department.
Removed
On 22 May, 2024, the Company received a letter from Nasdaq notifying the Company that, while the Company has not regained compliance with the Minimum Bid Price Requirement, Nasdaq has determined that the Company is eligible for an additional 180 calendar day period, or until 18 November, 2024 (the “ Second Compliance Period ”), to regain compliance with the minimum bid price requirement.
Added
For example, the One Big Beautiful Bill Act, or the OBBBA, was signed into law on July 4, 2025 and made significant changes to the U.S. federal tax law. Changes to tax laws (which changes may have retroactive application) could adversely affect us or holders of our common stock.
Removed
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.
Added
For example, under Section 174 of the Internal Revenue Code of 1986, as amended, or the IRC, in taxable years beginning after December 31, 2021, expenses that are incurred for research and development performed outside the U.S. will be capitalized and amortized, which may have an adverse effect on our cash flow.
Removed
Nasdaq’s determination was based on the Company meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market, with the exception of the minimum bid price requirement, and the Company’s written notice to Nasdaq of its intention to cure the deficiency during the Second Compliance Period and, if necessary, by effecting a ratio change of the ADSs.
Added
The OBBBA provides that for taxable years beginning after December 31, 2024, expenses that are incurred for research and development performed in the U.S. may, at the taxpayer’s election, be immediately deducted or capitalized and amortized.
Removed
There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the Second Compliance Period.
Added
In addition, the OBBBA provides that for taxable years beginning after December 31, 2021 and before January 1, 2025, certain eligible taxpayers generally may elect to retroactively deduct expenses for research and development performed in the U.S. in such taxable years by filing amended tax returns for such taxable years, and all other taxpayers that are not eligible to make such an election and that amortized expenses for research and development performed in the U.S. in such taxable years generally may elect to accelerate and deduct the remaining unamortized amounts of such research and development expenses (i) in the first taxable year beginning after December 31, 2024, or (ii) ratably over the two-taxable year period beginning with the first taxable year beginning after December 31, 2024.
Removed
On 15 October 2024, Kazia announced that it planned to effect an ADS ratio change to change the ratio of ADSs to ordinary shares from one ADS to ten ordinary shares to the new ratio of one ADS to one-hundred ordinary shares.
Added
In recent years, many changes to tax laws have been made and changes are likely to continue to occur in the future. Future changes in tax laws could have a material adverse effect on our business, cash flow, financial condition or results of operations.

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeThe 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.
Biggest changeAside from the standard application pathway outlined above, the TGA has a priority review pathway and a provisional approval pathway which fast tracks the assessment of eligible prescription medicines (both new medicines and new uses for already approved medicines) onto the Australian market. 39 Table of Contents A medicine may be eligible for priority determination if the following criteria are met: • the medicine is a new prescription medicine OR a new indications 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 OR if there is such a therapeutic good included in the ARTG, there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods; and • there is substantial evidence demonstrating that the medicine provides a major therapeutic advance.
Second round assessment , which involves the TGA evaluators considering the response provided by the applicant to the section 31 request and completing the evaluation of the data; 6.
Second round assessment , which involves the TGA evaluators considering the response provided by the applicant to the section 31 request and completing evaluation of the data; 6.
Decision , which involves the TGA determining whether the application is to be approved (possibly modified or varied) or rejected and imposition of any conditions associated with approval for registration on the ARTG. Where any outstanding issues may affect the decision, this may involve further correspondence with the applicant before the decision is finalised; and 8.
Decision , which involves the TGA determining whether the application is to be approved (possibly modified or varied) or rejected and imposition of any conditions associated with approval for registration on the ARTG. Where any outstanding issues may affect the decision, this may involve further correspondence with the applicant before the decision is finalised 8.
Medicines with a lower risk (some over the counter medicines and most complementary medicines, including vitamins) are not individually assessed by the TGA prior to listing on the ARTG unless they are “assessed listed medicines” which are subject to pre-market TGA assessment of efficacy (but not quality and safety).
Medicines with a lower risk (some over the counter medicines and most complementary medicines, including vitamins) are not individually assessed by the TGA for quality, safety and efficacy prior to listing on the ARTG unless they are “assessed listed medicines” which are subject to pre-market TGA assessment of efficacy (but not quality and safety).
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 .
The application usually consists of a form accompanied by data presented 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 .
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.
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 36 Table of Contents 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.
The regulatory process for evaluation of prescription medicines consists of eight separate phases which are summarized below: 1. Pre-submission , which involves lodgement of a pre-submission planning form that provides the TGA with necessary information on the scope and scale of an application for the purposes of arranging appropriate resourcing for the processing and evaluation of the application; 2.
The standard application process for prescription medicines consists of eight separate phases which are summarized below: 1. Pre-submission , which involves lodgement of a pre-submission planning form that provides the TGA with necessary information on the scope and scale of an application for the purposes of arranging appropriate resourcing for the processing and evaluation of the application; 2.
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’.
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 five-hundred Ordinary Shares, trade on the Nasdaq Capital Market under the symbol ‘KZIA’.
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.
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 approximately comparable to the doses used in adult clinical studies.
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.
The study will explore Paxalisib in combination with ONC-201, a small-molecule investigational new 34 Table of Contents 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.
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.
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. 41 Table of Contents Satisfaction of FDA requirements for product approval typically takes several years.
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.
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. 32 Table of Contents Paxalisib’s mechanism is therefore entirely distinct from that of temozolomide, the existing FDA-approved standard of care treatment.
Our policies set out our commitment to high social standards. The following policies are in place and available on our website: • Anti-Corruption Compliance • Continuous Disclosure • Corporate Governance • Expanded Access • Shareholder Communications • Whistleblower • FDA review and approval of an NDA, prior to any commercial sale, promotion or shipment of a product.
Our policies set out our commitment to high social standards. 44 Table of Contents The following policies are in place and available on our website: • Anti-Corruption Compliance • Continuous Disclosure • Corporate Governance • Expanded Access • Shareholder Communications • Whistleblower • FDA review and approval of an NDA, prior to any commercial sale, promotion or shipment of a product.
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 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. The Company’s activities may also be subject to state laws and regulations that affect its ability to develop and sell products.
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”).
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”).
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.
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 Product and Corporate Developments during Fiscal Year 2025 The Company continued to pursue its strategy of focusing resources on clinical programs, being specifically those most likely to provide a return to shareholders.
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.
Property, plant and equipment During fiscal year 2025, the Company continued to work out of a serviced office in Sydney that is subject to a renewable one-year workspace license agreement.
The FDA may take certain actions with respect to breakthrough therapies, including holding meetings with the sponsor throughout the development process; providing timely advice to the product sponsor regarding development and approval; involving more senior staff managers in the review process; assigning a cross-disciplinary lead for the review team; and taking other steps to design the clinical trials in an efficient manner.
The FDA may take certain actions with respect to breakthrough therapies, including holding meetings with the sponsor throughout the development process; providing timely advice to the product sponsor regarding development and approval; involving more senior staff managers in 42 Table of Contents the review process; assigning a cross-disciplinary lead for the review team; and taking other steps to design the clinical trials in an efficient manner.
For the primary analysis the median Overall Survival (“OS”) was 14.77 months for paxalisib-treated NDU patients (n=54) versus 13.84 months for cumulative SOC NDU patients (n=75). For a prespecified secondary analysis in the NDU patients, median OS was 15.54 months in the paxalisib arm (n=54) versus 11.89 months for concurrent SOC (n=46).
For the primary analysis the median Overall Survival (“OS”) was 14.77 months for Paxalisib-treated NDU patients (n=54) versus 13.84 months for cumulative SOC NDU patients (n=75). For a prespecified secondary analysis in the NDU patients, median OS was 15.54 months in the Paxalisib 33 Table of Contents arm (n=54) versus 11.89 months for concurrent SOC (n=46).
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 therapeutic goods, including medicines in Australia.
Regulatory requirements Australian Regulatory Requirements The Therapeutic Goods Act 1989 (“1989 Act”) and its subordinate legislation, sets out the legal requirements for the import, export, manufacture and supply of therapeutic goods, including medicines in Australia.
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.
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 label of the medicine. In order to include a product on the ARTG, a sponsoring company must make an application to the TGA.
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 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. 40 Table of Contents The testing and approval process requires substantial time, effort, and financial resources, and the Company cannot be certain that any approval will be granted on a timely basis, if at all.
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”).
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”). We anticipate providing additional EVT801 updates and presentations of data at future medical conferences.
Submission , which involves processing activities in preparation for application evaluation, including consideration of the application by the TGA against regulatory requirements; 3. First round assessment , which involves consideration by the TGA of the data provided in the application and informal requests for information by the TGA; 4.
Submission , which involves processing activities in preparation for application evaluation, including consideration of the application by the TGA against regulatory requirements; 3. First round assessment , which involves consideration by the TGA of the data provided in the application, informal requests for information by the TGA and a formal consolidated “section 31” request for information; 4.
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.
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.
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.
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). 37 Table of Contents Broad Clinical Program Ongoing Sponsor Phase Indication Registration PAXALISIB Kazia Therapeutics I Advanced Breast Cancer ACTRN12624001340527 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 ACTRN12623000096651 Pacific Pediatric Neuro-Oncology Consortium II DIPG (childhood brain cancer) NCT05009992 Aus. & NZ Children’s Oncology Group II Advanced solid tumours in children NCT06208657 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 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.
The ADS ratio change will have the same effect as a one-for-ten reverse ADS split for Kazia’s ADS holders. There will be no change to Kazia’s underlying ordinary shares, and no ordinary shares will be issued or cancelled in connection with the ADS ratio change. The ADS ratio change became effective on 28 October 2024. C.
The ADS ratio change will have the same effect as a one-for-ten reverse ADS split for Kazia’s ADS holders. There will be no change to Kazia’s underlying ordinary shares, and no ordinary shares will be issued or cancelled in connection with the ADS ratio change.
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.
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 this program be legislatively extended after statutory sunset dates, and if paxalisib is the first approved product in this indication.
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.
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.
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.
Study enrollment is complete and final clinical study report is anticipated in 2026. 35 Table of Contents 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.
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. Our compassionate use program has treated over 40 patients in 7 countries since its inception in 2018.
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.
Per ANO 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.
Pursuant to the Purchase Agreement, the Company may sell to Alumni Capital up to an aggregate of $15,000,000, of ADSs from time to time during the term of the Purchase Agreement. During the fiscal year ended 30 June 2024, Kazia sold an aggregate amount of US$517,302 (A$776,147) of ADSs under the Purchase Agreement.
Pursuant to the Purchase Agreement, the Company may sell to Alumni Capital up to an aggregate of $15,000,000, of ADSs from time to time during the term of the Purchase Agreement. During the fiscal year ended 30 June 2025, Kazia sold an aggregate amount of US$2,015,435 (A$5,638,016) of ADSs under the Purchase Agreement.
LUMOS2 phase II study Kazia is supporting the University of Sydney on a molecularly guided phase II clinical study evaluating paxalisib in adult patients with recurrent/progressive isocitrate dehydrogenase (IDH) mutant grade 2 and 3 gliomas (G2/3 gliomas).
The Company is evaluating these recommendations and potential next steps for Paxalisib, including the design of future clinical studies and potential regulatory pathways. LUMOS2 phase II study Kazia is supporting the University of Sydney on a molecularly guided phase II clinical study evaluating Paxalisib in adult patients with recurrent/progressive isocitrate dehydrogenase (IDH) mutant grade 2 and 3 gliomas (G2/3 gliomas).
The company announced that the phase I expansion cohort had reached an early conclusion based on positive safety data and positive clinical response findings observed to date. Preliminary data from the expansion cohort is anticipated by Q4 CY2024.
The company announced that the phase I expansion cohort had reached an early conclusion based on positive safety data and positive clinical response findings observed to date. Final analyses is ongoing and clinical study report is anticipated in 2026. .
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.
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.
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.
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.
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.
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.
Consolidated section 31 request response , which involves the TGA sending a consolidated, formal information or document request to the applicant in relation to the application, and the applicant sending a response to the TGA (in CTD format); 5.
Consolidated section 31 request response , which involves the applicant considering the TGA’s consolidated, section 31 request for information or documents, preparation of a response and sending a response to the TGA (in CTD format); 5.
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.
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.
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.
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.
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.
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. 43 Table of Contents The assessment of applications for clinical trials is divided into two parts (Part I contains scientific and medicinal product documentation and Part II contains the national and patient-level documentation).
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.
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. The Paxalisib arm enrolled two patient populations: newly diagnosed patients with unmethylated MGMT promotor status, and recurrent patients.
The safety profile and pharmacokinetics were highly consistent with the adult data.
The safety profile and pharmacokinetics were highly consistent with the adult data. Clinical study report is anticipated in 2026.
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.
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. The Company believes that the FDA will regulate its products as drugs.
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.
In addition, the company extended an office membership agreement with Deerfield Management that is subject to renewable one-year agreement at The Cure, Deerfield’s innovation campus at 345 Park Avenue South, New York, NY. Item 4A. Unresolved Staff Comments None.
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 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.
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.
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. 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.
In addition, a prespecified sensitivity analysis in NDU patients showed similar median OS difference between paxalisib treated patients (15.54 months) and concurrent SOC patients (11.70 months).
In addition, a prespecified sensitivity analysis in NDU patients showed similar median OS difference between Paxalisib treated patients (15.54 months) and concurrent SOC patients (11.70 months). An efficacy signal was not detected in the recurrent disease population (median OS of 9.69 months for concurrent SOC (n=113) versus 8.05 months for Paxalisib (n=100).
This could therefore open up an important opportunity for paxalisib in combination with other drugs for the treatment of diseases such as breast cancer and lung cancer.
Administration of PI3K inhibitors such as Paxalisib, at doses and frequencies different to those conventionally used, may activate the immune system in the tumour, making it more susceptive to immunotherapy. This could therefore open up an important opportunity for Paxalisib in combination with other drugs for the treatment of diseases such as breast cancer and lung cancer.
Three patient cohorts are enrolled in the paxalisib arm: breast cancer, lung cancer, and other tumors.
Three patient cohorts are enrolled in the Paxalisib arm: breast cancer, lung cancer, and other tumors. The enrollment is ongoing for all cohorts including the expansion stage of the study in breast cancer brain metastases patients.
Patients with eleven different cancer types (ex. colon, renal cell, pancreatic) were enrolled in the study, with advanced ovarian cancer being the most prevalent indication (11 patients). EVT801 was generally well tolerated across all doses with the majority of toxicities being mild to moderate and transient in nature.
EVT801 was generally well tolerated across all doses with the majority of toxicities being mild to moderate and transient in nature.
A total of 32 patients were enrolled in the study with 26 patients treated across 6 dosing cohorts ranging from 50mg once daily to 500mg twice daily (BID). The MTD was identified as 500mg BID with 400mg BID being the recommended phase 2 dose when given as a monotherapy.
On 1 May, 2024, Kazia announced that Stage 1 of the study was complete, and that the primary and secondary endpoints were achieved. A total of 32 patients were enrolled in the study with 26 patients treated across 6 dosing cohorts ranging from 50mg once daily to 500mg twice daily (BID).
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.
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. 38 Table of Contents 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.
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”).
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”).
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.
EVT801’s phase I clinical trial was completed and clinical study report is anticipated in 2026. 45 Table of Contents 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.
The collaboration is based on research that identified an entirely separate effect of PI3K inhibition: as a modulator of the immune microenvironment within and around the tumour. Administration of PI3K inhibitors such as paxalisib, at doses and frequencies different to those conventionally used, may activate the immune system in the tumour, making it more susceptive to immunotherapy.
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 collaboration is based on research that identified an entirely separate effect of PI3K inhibition: as a modulator of the immune microenvironment within and around the tumour.
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.
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. Paxalisib in Advanced Breast Cancer Preclinical studies conducted in collaboration with QIMR Berghofer demonstrated that Paxalisib, exerts potent epigenetic and immunomodulatory effects in triple-negative breast cancer (TNBC) models.
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.
On 1 August 2022, the Consolidated Entity announced that it had been informed by GCAR that the Paxalisib arm had not graduated to the second stage of the GBM AGILE study, and that recruitment had therefore completed with approximately 150 patients enrolled to the first stage. Those patients remain ongoing, with initial data obtained in 1H CY2024.
Removed
The treatment arm did not meet pre-defined criteria for continuing to a second stage, and patients enrolled in the first stage of the paxalisib arm continued on treatment as per protocol, and in follow-up, until completion of the final analysis, which we anticipate receiving in 2H CY2023.
Added
The interim ‘graduation’ analysis may have been affected by the rapid and back-loaded recruitment profile of the study and does not preclude a positive outcome in the final data. On 10 July, 2024, Kazia announced results from the GBM-AGILE study.
Removed
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.
Added
Based on the totality of clinical and preclinical data from all completed studies of Paxalisib in newly diagnosed unmethylated glioblastoma (GBM), Kazia has met with the U.S. Food and Drug Administration (FDA) in December 2024 to review the results.
Removed
An efficacy signal was not detected in the recurrent disease population (median OS of 9.69 months for concurrent SOC (n=113) versus 8.05 months for paxalisib (n=100).Based on the totality of data available from all completed paxalisib clinical studies in newly diagnosed unmethylated GBM patients, Kazia will request a meeting with the FDA to discuss the results and determine next steps for paxalisib, including potential regulatory paths for approval.
Added
Following this discussion, the FDA indicated that the current data are not sufficient to support a new drug application (NDA) at this time and recommended that Kazia obtain additional clinical evidence to further characterize Paxalisib’s efficacy and safety in this population.
Removed
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.
Added
These studies showed that Paxalisib downregulates tumor-intrinsic resistance pathways and enhances immune recognition when combined with checkpoint blockade. The results provided the mechanistic rationale for advancing Paxalisib into a company-sponsored Phase 1b clinical trial evaluating its combination with pembrolizumab (Keytruda ® ) and chemotherapy in patients with Stage IV TNBC.
Removed
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.
Added
The ongoing study is designed to establish the recommended Phase 2 dose, assess preliminary safety and efficacy, and explore biomarkers of response. Patient enrollment commenced in 2025, with full enrollment anticipated in 2026. Findings from this program are expected to inform future development of Paxalisib-based immunotherapy regimens in breast cancer and potentially in other solid tumors.
Removed
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.
Added
The MTD was identified as 500mg BID with 400mg BID being the recommended phase 2 dose when given as a monotherapy. Patients with eleven different cancer types (ex. colon, renal cell, pancreatic) were enrolled in the study, with advanced ovarian cancer being the most prevalent indication (11 patients).
Removed
The Company believes that the FDA will regulate its products as drugs.
Added
Plans for phase 2 clinical trial are on hold while exploring regional and strategic partnerships. 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.
Removed
The testing and approval process requires substantial time, effort, and financial resources, and the Company cannot be certain that any approval will be granted on a timely basis, if at all.
Added
Anticipated milestones We anticipate that during fiscal year 2026: • Completion of enrollment in the company-sponsored Phase 1b clinical trial evaluating Paxalisib in combination with pembrolizumab (Keytruda ® ) and chemotherapy in patients with advanced triple-negative breast cancer (TNBC); • Preliminary analyses from the expanded-access clinical experience with Paxalisib in TNBC will be published, providing additional insight into clinical activity and biomarkers of response; • Updated data will be presented from the Phase 2 PNOC022 clinical trial of Paxalisib in combination with ONC201 in pediatric patients with diffuse midline glioma (DMG), including survival outcomes and biomarker correlations; and • Preliminary analyses from several investigator initiated studies including Cornell Weill (GBM), Dana Farber (PCNSL) and Alliance (brain mets).
Removed
The assessment of applications for clinical trials is divided into two parts (Part I contains scientific and medicinal product documentation and Part II contains the national and patient-level documentation).
Added
A medicine may be eligible for provisional determination if the following criteria are met: • the medicine is a new prescription medicine OR a new indications 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 on the ARTG OR if there is such a therapeutic good included in the ARTG, there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods; • there is preliminary clinical data demonstrating that the medicine is likely to provide a major therapeutic advance; and • there is sufficient evidence of a plan to submit comprehensive clinical data on the safety and efficacy of the medicine within 6 years of the date of provisional registration.
Added
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.
Added
The European Commission introduced legislative proposals in April 2023 that, if implemented, will replace the current regulatory framework in the EU for all medicines (including those for rare diseases and for children). The European Commission has provided the legislative proposals to the European Parliament and the European Council for their review and approval.
Added
In April 2024, the European Parliament adopted its position on the legislative proposals and, in June 2025, the European Council adopted its position. The European Council, European Parliament and European Commission will enter into trilogue negotiations aimed at reaching a consensus on a final version of the legislation.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

29 edited+9 added−13 removed17 unchanged
Biggest changeThe 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.
Biggest changeThe details of those share issues are as follows: • In July 2023, the Company issued 8,148,140 ordinary shares at a price of A$0.1856 per share under our ATM facility raising A$1,512,522 before transaction costs. • In July 2023, the Company issued 157,120 ordinary shares at a price of A$0.1647 per share under our ATM facility raising A$25,877 before transaction costs. 50 Table of Contents • In August 2023, the Company issued 15,000 ordinary shares at a price of A$0.1679 per share under our ATM facility raising A$2,519 before transaction costs. • In November 2023, the Company issued 1,066,070 ordinary 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 of ADSs at a price of US$0.45 per ADS and pre-funded warrants to purchase up to 1,824,445 ADSs representing 18,244,450 ordinary shares at a price of US$0.44 per pre-funded warrant with an exercise price of $0.01 per ADS in a registered direct offering for an aggregate consideration of approximately US$2 million. • In December 2023, we issued unregistered warrants to purchase up to 4,444,445 ADSs representing 44,444,450 ordinary shares at an exercise price of US$0.583 per ADS in a private placement for an aggregate consideration of approximately US$2.6 million. • December 2023, we issued placement agent warrants to purchase up to 311,111 ADSs representing 3,111,110 ordinary shares at an exercise price of US$0.5625 per ADS pursuant to the Engagement Letter. • In February 2024, the Company issued 25,910 ordinary shares at a price of A$0.0466 per share under our ATM facility raising A$1,207 before transaction costs. • In February 2024, the Company issued 319,650 ordinary shares at a price of A$0.0464 per share under our ATM facility raising A$14,834 before transaction costs. • In February 2024, the Company issued 2,195,980 ordinary shares at a price of A$0.0468 per share under our ATM facility raising A$102,825 before transaction costs. • In February 2024, the Company issued 205,260 ordinary shares at a price of A$0.0614 per share under our ATM facility raising A$12,597 before transaction costs. • In February 2024, the Company issued 8,626,580 ordinary shares at a price of A$0.0595 per share under our ATM facility raising A$513,584 before transaction costs. • In February 2024, the Company issued 18,244,450 ordinary shares in the form of ADSs at an exercise price of US$0.01 per ADS in connection with the exercise of a warrant. • In February 2024, the Company issued 316,540 ordinary shares at a price of A$0.0461 per share under our ATM facility raising A$14,584 before transaction costs. • In February 2024, the Company issued 304,860 ordinary shares at a price of A$0.0464 per share under our ATM facility raising A$14,147 before transaction costs. • In February 2024, the Company issued 250,000 ordinary shares at a price of A$0.0460 per share under our ATM facility raising A$11,502 before transaction costs. • In May 2024, the Company issued 2,112,560 ordinary shares at a price of A$0.0478 per share under our ATM facility raising A$100,961 before transaction costs. • In May 2024, the Company issued 375,410 ordinary shares at a price of A$0.0457 per share under our ATM facility raising A$17,147 before transaction costs. • In May 2024, the Company issued 288,900 ordinary shares at a price of A$0.0469 per share under our ATM facility raising A$13,544 before transaction costs. • In May 2024, the Company issued 790,100 ordinary shares at a price of A$0.0456 per share under our ATM facility raising A$36,024 before transaction costs. • In May 2024, the Company issued 20,000 ordinary shares at a price of A$0.0455 per share under our ATM facility raising A$910 before transaction costs. • In May 2024, the Company issued 242,170 ordinary shares at a price of A$0.0450 per share under our ATM facility raising A$10,891 before transaction costs. • In June 2024, the Company issued 5,916,970 ordinary shares represented by 591,697 ADSs as repayment of a promissory note. • In June 2024, the Company issued 29,000,000 ordinary shares under a private ELOC placement raising A$776,031 before transaction costs. 51 Table of Contents During fiscal year 2025 the Company issued 482,484,920 ordinary shares.
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.
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 2025 and 2024.
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.
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. B.
Trend Information Further to the risk factors discussed in Item 3D, we note that the financial information disclosed in the SEC Form 20-F may not be indicative of future results in the following areas: • While we anticipate that funds will continue to be spent on research and development of our drug candidates, the amounts expended in recent years may not be indicative of the amounts to be expended in future years, because we may have more or fewer drug candidates, they may be at different stages of their lifecycle and the trials deemed suitable for their development may be more or less costly; • We did not generate revenue from licensing transactions in fiscal year 2023 and 2022 and we may not generate any revenue in future years.
Trend Information Further to the risk factors discussed in Item 3D, we note that the financial information disclosed in the SEC Form 20-F may not be indicative of future results in the following areas: • While we anticipate that funds will continue to be spent on research and development of our drug candidates, the amounts expended in recent years may not be indicative of the amounts to be expended in future years, because we may have more or fewer drug candidates, they may be at different stages of their lifecycle and the trials deemed suitable for their development may be more or less costly; • We did not generate material revenue from licensing transactions in fiscal years 2025 and 2023 and we may not generate any revenue in future years.
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.
As of 30 June 2025 and 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.
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.
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 2025 are issued.
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.
In fiscal years 2025 and 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.
This could be as a result of whether any further licensing transactions are entered into, as well as whether any milestones are met in relation to license agreements already in place; and • The quantum of general and administrative expenditures in recent years may not be indicative of the expenditures required in future years. E.
This could be as a result of whether any further licensing transactions are entered into, as well as whether any milestones are met in relation to license agreements already in place; and • The quantum of general and administrative expenditures in recent years may not be indicative of the expenditures required in future years. 54 Table of Contents E.
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.
In addition, net cash from financing activities in fiscal years 2025, 2024, and 2023 was the result of the funds received from our sale of ordinary shares using our ATM facility.
Our future success is dependent upon our ability to obtain additional funding. There can be no assurance, however, that we will be successful in obtaining such funding in sufficient amounts, on terms acceptable to us, or at all.
Our future success is dependent upon our ability to obtain additional funding. There can be no assurance, however, that we will be successful in obtaining such funding in sufficient amounts, on 49 Table of Contents terms acceptable to us, or at all.
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 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 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.
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.
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.
There was a premium funding facility in place in fiscal year 2025, 2024, and 2023 for the insurance program. As of 30 June 2025, we had cash and cash equivalents of A$4.3 million held in both Australian dollars and U.S. dollars.
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.
General and administrative costs increased from A$8.6 million (restated) in fiscal year 2023 to A$13.6 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.
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.
In fiscal years 2025, 2024, 2023 we spent a total of A$7.3 million, A$17.4 million, and A$15.6 million, respectively, on company-sponsored research and development activities. D.
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.
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 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%).
The increase was mainly a result of transaction fee expenses of A$6.0 million in fiscal year 2023 partially offset by less clinical expenses relating to Paxalisib and lower personnel costs.
All forward-looking statements included in this document are based on the information available to the Company on the date of this document and the Company assumes no obligation to update any forward-looking statements contained in this Annual Report on Form 20-F. A. Operating results The following discussion relates to our consolidated results of operations, financial condition and capital resources.
All forward-looking statements included in this document are based on the information available to the Company on the date of this document and the Company assumes no obligation to update any forward-looking statements contained in this Annual Report on Form 20-F. A.
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.
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. 48 Table of Contents The Company recognized research and development rebate in fiscal year 2025 of A$209 thousand. The Company recognized research and development rebate in fiscal year 2024 of A$173 thousand.
Cash flows The following table set forth the sources and uses of cash for the past three fiscal years: (in A$ 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.
Cash flows The following table sets forth the sources and uses of cash for the past three fiscal years: (in A$ thousands) 2025 2024 2023 Net cash used in operating activities $ (13,278 ) $ (9,581 ) $ (15,156 ) Net cash provided by financing activities $ 15,982 $ 5,985 $ 12,972 Operating activities.
Expenditures during the research phase of a project are recognized as an expense when incurred. Development costs are capitalized only when technical feasibility studies identify that the project will deliver future economic benefits and these benefits can be measured reliably.
Development costs are capitalized only when technical feasibility studies identify that the project will deliver future economic benefits and these benefits can be measured reliably.
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.
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.
Cash in excess of immediate requirements is invested in accordance with our investment policy primarily with a view to liquidity and capital preservation.
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 approximately 95.9% of funds being held in U.S. dollars.
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.
The Company earns interest income derived from interest bearing bank accounts, which is directly linked with the amounts held on deposit.
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%).
The Company did not recognize any research and development rebate in 2023. We anticipate applying for the rebate in future fiscal years as the Company advances Paxalisib development in Australia. The Company recognized other income in fiscal year 2025 of A$1.6 million from the sale of cantrixil to Vivesto AB.
The following tables provide a summary of Revenue, Finance income and Other income for the past three fiscal years: For the fiscal year ended 30 June, 2024 2023 2022 A$’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.
In fiscal year 2024, the Company generated revenue of A$2.3 million from contracts with customers that 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. During fiscal year 2023, the Company did not generate any revenue from contracts with customers.
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.
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.
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.
Liquidity and capital resources We have incurred cumulative losses and negative cash flows from operations since our inception and, as of 30 June 2025, we had accumulated losses of A$134.8 million. We anticipate that we will continue to incur losses for at least the next several years.
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.
The decrease was mainly a result of lower R&D expenses related EVT-801 and Paxalisib in fiscal year 2025. Research and development expenses increased from A$15.6 million in fiscal year 2023 to A$17.4 million in fiscal year 2024 (12%).
Removed
You should read this discussion in conjunction with our consolidated financial statements and the notes thereto contained elsewhere in this report.
Added
Operating results The following discussion relates to our consolidated results of operations, financial condition and capital resources. 47 Table of Contents The following tables provide a summary of Revenue, Finance income and Other income for the past three fiscal years: For the fiscal year ended 30 June, 2025 2024 2023 A$’000 A$’000 A$’000 Revenue 42 2,308 — Finance income 72 12 22 Other income: Research and development rebate 209 173 — Other sundry income 1,578 — 1 Total Other income 1,787 173 1 Total Revenue, Finance and Other income $ 1,901 2,493 23 Expenses Research and development expense (7,326 ) (17,380 ) (15,564 ) General and administrative expense (8,720 ) (13,563 ) (8,583 ) Impairment of intangible assets (13,379 ) — — (Loss) gain on remeasurement of other financial liabilities (2,478 ) 1,257 — Gain on remeasurement of promissory note — 25 — Gain on remeasurement of contingent consideration 7,554 119 3,388 Loss before income tax benefit (22,448 ) (27,049 ) (20,736 ) Loss before income tax benefit 1,746 271 271 Income tax benefit (20,702 ) (26,778 ) (20,465 ) Loss after income tax benefit Other comprehensive loss Items that may be reclassified subsequently to profit or loss Net exchange difference on translation of financial statements of foreign controlled entities, net of tax (23 ) (8 ) 110 Other comprehensive loss, net of tax (23 ) (8 ) 110 Total comprehensive loss (20,725 ) (26,786 ) (20,355 ) Fiscal year 2025 compared to fiscal year 2024 and fiscal year 2024 compared to fiscal year 2023 Revenue, finance income and other income In fiscal year 2025, the Company received a grant of A$42 thousand from the sale of Paxalisib to the Michael J Fox Foundation to explore the therapeutic potential of Paxalisib as a treatment for Parkinson’s disease (PD).
Removed
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.
Added
The Company did not recognize other income in fiscal year 2024. The Company recognized other income in fiscal year 2023 of A$1 thousand. Expenses Research and development expenses decreased from A$17.4 million in fiscal year 2024 to A$7.3 million in fiscal year 2025 (-58%).
Removed
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.
Added
General and administrative costs decreased from A$13.6 million in fiscal year 2024 to A$8.7 million in fiscal year 2025 (36%), due to decreased costs related to the lower directors and officers liability and business insurance costs, capital raising costs, and salaries and wages, partially offset by increase share based payment expense.
Removed
The change was mainly a result of the reduced R&D expenditures a reduction in the expenditures incurred for the Company’s lead asset, paxalisib’s continuing participation in the registrational GCAR GBM AGILE trial as paxalisib arm did not meet pre-defined criteria for continuing to a second stage of the trial.
Added
Net loss after income tax benefit The Company’s loss after income tax benefit was A$20.7 million in fiscal year 2025 compared to A$26.8 million in fiscal year 2024. The change was mainly a result of a decrease R&D expenditures and gain on remeasurement of contingent consideration, offset by impairment expense of intangible assets.
Removed
We anticipate that we will continue to incur losses for at least the next several years.
Added
Financing activities. Net cash from the financing activities in fiscal year 2025 arose as a result of the placement of warrants and the sale of ordinary shares in the form of ADSs, using our ATM facility.
Removed
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.
Added
Financing activities Equity issues The Company has historically financed its operations primarily from issuing equity capital. The amounts of ADSs issued by the Company or issuable by the Company upon exercise of warrants and the corresponding purchase price or exercise price disclosed in this section have not been adjusted to reflect the effect of the ADS Ratio Change.
Removed
The details of those share issues are as follows: • In July 2022, the Company issued 573,370 shares under our ATM facility raising A$407,201 before transaction costs. • In August 2022, the Company issued 10,307,910 shares under our ATM facility raising A$3,268,936 before transaction costs. • In September 2022, the Company issued 679,380 shares under our ATM facility raising A$150,164 before transaction costs. • In September 2022, the Company issued 60,000 to the Scientific Advisory Board at A$12,600 before transaction costs • In October 2022, the Company issued 13,032,940 shares under our ATM facility raising A$2,425,085 before transaction costs. • In January 2023, the Company issued 20,000 shares under our ATM facility raising A$2,761 before transaction costs. • In January 2023, the Company issued 25,387,018 shares in a professional and sophisticated investors placement raising A$2,792,572 before transaction costs. • In February 2023, the Company issued 15,522,075 shares in a professional and sophisticated investors placement raising A$1,707,428 before transaction costs. • In March 2023, the Company issued 23,691,045 shares in a share placement plan to existing eligible shareholders raising A$2,606,000 before transaction costs.
Added
The details of those share issues are as follows: • In July 2024, the Company issued 14,400,000 ordinary shares at a price of A$0.1534 per share under our ATM facility raising A$2,209,677 before transaction costs. • In July 2024, the Company issued 25,786,480 ordinary shares represented by 2,578,648 ADSs pursuant to a warrant exercise for US$0.1939 per ADSs. • In July 2024, the Company issued 11,000,000 ordinary shares represented by 1,100,000 ADSs pursuant to a warrant exercise for US$0.27 per ADSs. • In July 2024, the Company issued 5,488,230 ordinary shares at a price of A$0.1445 per share under our ATM facility raising A$792,915 before transaction costs. • In July 2024, the Company issued 4,177,340 ordinary shares at a price of A$0.1075 per share under our ATM facility raising A$449,260 before transaction costs. • In July 2024, the Company issued 15,000,000 ordinary shares at a price of A$0.0542 per share under a private ELOC placement raising A816,373 before transaction costs. • In August 2024, the Company issued 2,061,820 ordinary shares at a price of A$0.0624 per share under our ATM facility raising A$128,633 before transaction costs. • In August 2024, the Company issued 408,270 ordinary shares at a price of A$0.0641 per share under our ATM facility raising A$26,172 before transaction costs. • In August 2024, the Company issued 2,283,350 ordinary shares at a price of A$0.0617 per share under our ATM facility raising A$140,884 before transaction costs. • In August 2024, the Company issued 8,660 ordinary shares at a price of A$0.0606 per share under our ATM facility raising A$525 before transaction costs. • In August 2024, the Company issued 5,250,000 ordinary shares at a price of A$0.0616 per share under our ATM facility raising A$323,403 before transaction costs. • In August 2024, the Company issued 308,700 ordinary shares at a price of A$0.0591 per share under our ATM facility raising A$18,242 before transaction costs. • In September 2024, the Company issued 3,000,000 ordinary shares at a price of A$0.0616 per share under our ATM facility raising A$184,682 before transaction costs. • In September 2024, the Company issued 837,030 ordinary shares at a price of A$0.0638 per share under our ATM facility raising A$53,439 before transaction costs. • In September 2024, the Company issued 16,049,020 ordinary shares at a price of A$0.0554 per share under our ATM facility raising A$889,682 before transaction costs. • In September 2024, the Company issued 2,503,820 ordinary shares at a price of A$0.0552 per share under our ATM facility raising A$130,741 before transaction costs. • In November 2024, the Company issued 442,400 ordinary shares at a price of A$0.0891 per share under our ATM facility raising A$39,420 before transaction costs. • In November 2024, the Company issued 185,100 ordinary shares at a price of A$0.0881 per share under our ATM facility raising A$16,312 before transaction costs. • In November 2024, the Company issued 262,200 ordinary shares at a price of A$0.0848 per share under our ATM facility raising A$22,240 before transaction costs. • In November 2024, we issued 896,700 ordinary shares at a price of A$0.0858 per share under our ATM facility raising A$76,970 before transaction costs. • In November 2024, we issued 364,700 ordinary shares at a price of A$0.0818 per share under our ATM facility raising A$29,832 before transaction costs. • In December 2024, we issued 2,926,100 ordinary shares at a price of A$0.0778 per share under our ATM facility raising A$227,709 before transaction costs. 52 Table of Contents • In December 2024, we issued 403,300 ordinary shares at a price of A$0.0787 per share under our ATM facility raising A$31,754 before transaction costs. • In December 2024, we issued 460,800 ordinary shares at a price of A$0.0781 per share under our ATM facility raising A$36,012 before transaction costs. • In December 2024, we issued 142,200 ordinary shares at a price of A$0.0665 per share under our ATM facility raising A$9,464 before transaction costs. • In December 2024, we issued 522,100 ordinary shares at a price of A$0.0631 per share under our ATM facility raising A$32,938 before transaction costs. • In December 2024, the Company issued 15,000,000 ordinary shares at a price of A$0.0537 per share under a private ELOC raising A$874,939 before transaction costs. • In December 2024, we issued 6,421,800 ordinary shares at a price of A$0.0596 per share under our ATM facility raising A$382,576 before transaction costs. • In December 2024, the Company issued 20,000,000 ordinary shares at a price of A$0.0437 per share under a private ELOC raising A$804,870 before transaction costs. • In December 2024, we issued 4,000,000 ordinary shares at a price of A$0.0322 per share under our ATM facility raising A$128,729 before transaction costs. • In January 2025, we issued 2,939,500 ordinary shares at a price of A$0.0292 per share under our ATM facility raising A$85,921 before transaction costs. • In January 2025, we issued 10,668,100 ordinary shares at a price of A$0.0286 per share under our ATM facility raising A$305,565before transaction costs. • In January 2025, we issued 2,453,900 ordinary shares at a price of A$0.0289 per share under our ATM facility raising A$70,828 before transaction costs. • In January 2025, the Company issued (i) 55,344,000 ordinary shares in the form of ADSs at a price of A$0.0242 per ordinary share and pre-funded warrants to purchase up to 779,893 ADSs representing 77,989,300 ordinary shares at a price of US$1.4999 per pre-funded warrant with an exercise price of $0.0001 per ADS in a registered direct offering for an aggregate consideration of approximately A$1,341,348, (ii) unregistered Ordinary Warrants to purchase up to 1,333,333 ADSs representing 133,333,300 ordinary shares at an exercise price of US$1.50 per ADS in a concurrent private placement, and (iii) unregistered Placement Agent Warrants to purchase up to 40,000 ADSs representing 4,000,000 ordinary shares at an exercise price of US$1.50 per ADS. • In February 2025, we issued 60,000,000 ordinary shares at a price of A$0.0153 per share under a private ELOC raising A$917,450 before transaction costs. • In May 2025, the Company issued 15,000,000 ordinary shares at a price of A$0.0094 per share under a private ELOC placement raising A$141,489 before transaction costs. • In June 2025, the Company issued 32,500,000 ordinary shares at a price of A$0.1550 per share under a private ELOC placement raising A$504,043 before transaction costs. • In June 2025, the Company issued 35,000,000 ordinary shares at a price of A$0.0280 per share under a private ELOC placement raising A$979,179 before transaction costs. • In June 2025, the Company issued 30,000,000 ordinary shares at a price of A$0.0200 per share under a private ELOC placement raising A$599,674 before transaction costs.
Removed
“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.
Added
“Financial Statements - Note 22 - Financial Instruments” for disclosures about financial risk management including interest rate risk, foreign currency risk and liquidity risk. 53 Table of Contents C. Research and development, Patents and Licenses, etc. Expenditures during the research phase of a project are recognized as an expense when incurred.
Removed
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.
Added
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.
Removed
During fiscal year 2017, the Company reached two milestones that triggered the conversion of a portion of its Convertible Notes.
Removed
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.
Removed
During fiscal year 2018, one of the noteholders waived his rights to the remaining tranche of convertible notes, resulting in the reduction of the convertible note carrying value by a further A$136,000.
Removed
On 21 April 2022, the completion of the phase II study of paxalisib in glioblastoma (NCT03522298) was announced and on 5 May 2022 the remaining portion of the convertible note with a carrying value of A$464,000 was extinguished and converted to 1,855,357 ordinary shares. C. Research and development, Patents and Licenses, etc.

Item 6. [Reserved]

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

41 edited+10 added−7 removed27 unchanged
Biggest changeThe 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.
Biggest changeThe KMP of Kazia consisted of the following directors of Kazia Therapeutics Limited: • Bryce Carmine - Non-Executive Director, Chairman from 1 February 2024 • Steven Coffey - Non-Executive Director • 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 • Jeffrey Bonacorda - Vice President, Finance and Controller 58 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 2025 $ $ $ $ $ $ $ $ Non-Executive Directors: B Carmine 110,000 — — — — — 7,833 117,833 S Coffey 85,000 — — — — 9,775 7,833 102,608 E Davidson 85,000 — — — — 9,775 15,666 110,441 R Apple 85,000 — — — — — 15,666 100,666 Other Key Management Personnel: J Friend * 850,677 — (4,903 ) — 52,587 19,140 341,352 1,258,853 J Bonacorda * 248,639 77,267 14,611 — 36,734 12,432 16,863 406,546 E Hansen 48,000 — — — — — 48,000 1,512,316 77,267 9,708 — 89,321 51,122 405,213 2,144,947 * Salary paid in USD, but disclosed in Australian dollars using conversion rate of 0.6471.
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.
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.
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.
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 ended 30 June 2025 of USD550,000 and healthcare and insurance benefits to be reviewed annually by the Remuneration and Nomination Committee.
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 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.
Remuneration and Nomination Committee The purpose of the Remuneration and Nomination Committee is to assist and advise the Board to develop, implement and, from time to time, update policies in relation to: • the selection, nomination and appointment processes for directors; and • the remuneration of key management personnel and directors.
Remuneration and Nomination Committee The purpose of the Remuneration and Nomination Committee is to assist and advise the Board to develop, implement and, from time to time, update policies in relation to: • the selection, nomination and appointment processes for directors; and 62 Table of Contents • the remuneration of key management personnel and directors.
Prior to this, Ms Davidson was a partner at national law firm Thomson Geer Lawyers and has over 14 years’ experience in equity capital markets, private and public mergers and acquisitions, corporate transactions and corporate governance.
Prior to this, Ms Davidson was a partner at national law firm Thomson Geer Lawyers from 2017 until 2021 and has over 14 years’ experience in equity capital markets, private and public mergers and acquisitions, corporate transactions and corporate governance.
In accordance with the definition of independence above, and the materiality thresholds set, the Board considers Bryce Carmine, Steven Coffey and Ebru Davidson to be independent directors. There are procedures in place, agreed by the Board, to enable directors in furtherance of their duties to seek independent professional advice at the Company’s expense.
In accordance with the definition of independence above, and the materiality thresholds set, the Board considers Bryce Carmine, Steven Coffey, Robert Apple, and Ebru Davidson to be independent directors. 61 Table of Contents There are procedures in place, agreed by the Board, to enable directors in furtherance of their duties to seek independent professional advice at the Company’s expense.
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.
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 2025 2024 2023 Research and Development 5.0 5.0 6.8 Finance and Administration 1.0 1.8 2.0 Total 6 6.8 8.8 Geographic Location 2025 2024 2023 Australia 2.0 3.0 4.8 United States 4.0 3.8 4.0 Total 6.0 6.8 8.8 E.
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).
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).
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.
Any change to the ESOP will require approval by shareholders. Use of remuneration consultants During fiscal year 2025, the Company did not engage remuneration consultants to assist with the determination of remuneration levels.
Members of the Audit, Risk and Governance Committee are Steven Coffey (Chairman) and Bryce Carmine, each of whom is an independent director.
Members of the Audit, Risk and Governance Committee are Ebru Davidson (Chairman), Steven Coffey, Robert Apple and Bryce Carmine, each of whom is an independent director.
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.
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. Most recently, Bryce was Chairman and CEO of HaemaLogiX Pty Ltd, a Sydney based privately owned biotech until December 2023.
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.
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. 63 Table of Contents D.
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.
Share Ownership Directors’ and KMP interests in the shares and options of the Company for fiscal year 2025: 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 J Friend — 4,000,000 — — — 4,000,000 1,848,674 4,000,000 — — — 5,848,674 Each Director and Key Management Personnel owns less than 1% of shareholding.
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.
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 33,467 ADS options under the ESOP during the financial year ended 30 June 2025, of which 6,000 were issued to KMP.
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.
Other transactions with key management personnel and their related parties John Friend was reimbursed for travel and accommodation expenses of $107,932. 64 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 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 6,000,000 — (1,200,000 ) — 4,800,000 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 30,000 — — — 30,000 30,000 — — — 30,000 Share-based compensation There were no shares issued to Directors or other KMP as part of compensation during fiscal year 2025.
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.
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 Bryce Carmine Chairman, Non-Executive Director Steven Coffey Non-Executive Director Ebru Davidson Non-Executive Director Robert Apple Non-Executive Director Jeffrey Bonacorda Vice President, Finance and Controller Elissa Hansen Company Secretary Directors were in office for the entire period unless otherwise stated.
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.
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. 57 Table of Contents The short-term incentives program is designed to align the targets of Kazia with the performance hurdles of executives.
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.
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; 60 Table of Contents • 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.
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.
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. Special responsibilities: Chair of Remuneration and Nomination Committee Name: Robert Apple Title: Non-Executive Director Qualifications: B.A.
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.
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.
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 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 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-27 Further details on each director can be found in “Names, titles, experience and expertise” above.
This committee is accountable to the Board for its performance and is subject to an annual review by the Board. Members of the Remuneration and Nomination Committee are Bryce Carmine (Chairman) and Steven Coffey each of whom is an independent director. Performance The performance of the Board and key executives is reviewed regularly using both measurable and qualitative indicators.
This committee is accountable to the Board for its performance and is subject to an annual review by the Board. Members of the Remuneration and Nomination Committee are Bryce Carmine (Chairman), Steven Coffey, Ebru Davidson and Robert Apple each of whom is an independent director.
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.
Special responsibilities: None Name: Dr John Friend Title: Chief Executive Officer (appointed 1 May 2023) Managing Director (appointed 1 August 2023 through December 2024) 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.
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.
Special responsibilities: Chair of Audit, Risk and Governance Committee, member of Remuneration and Nomination Committee. 55 Table of Contents Name: Ebru Davidson Title: Non-Executive Director 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 since 2021, an unlisted public Australian life sciences company.
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.
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. In the event that employment is terminated for cause, no severance pay or other benefits are payable by the Consolidated Entity.
Over the past 15 years, his focus has been in the oncology and hematology therapeutic space. Dr. Friend is a US-trained physician who practiced medicine in North Carolina before transitioning to drug development. Before joining Kazia Therapeutics, he was Chief Medical Officer and member of the executive management team at Cellectar Biosciences, Inc, a US publicly traded biopharmaceutical company.
Over the past 15 years, his focus has been in the oncology and hematology therapeutic space. Dr. Friend is a US-trained physician who practiced medicine in North Carolina before transitioning to drug development.
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.
Short-term incentive payments are granted to executives based on specific annual performance objectives, metrics and performance appraisals. 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.
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.
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.
Matters which are specifically reserved for the Board or its committees include the following: • appointment of a Chair; • appointment and removal of the CEO; • appointment of directors to fill a vacancy or as additional directors; • establishment of Board committees, their membership and delegated authorities; • approval of dividends; • development and review of corporate governance principles and policies; • approval of major capital expenditure, acquisitions and divestitures in excess of authority levels delegated to management; • calling of meetings of shareholders; and • any other specific matters nominated by the Board from time to time.
Matters which are specifically reserved for the Board or its committees include the following: • appointment of a Chair; • appointment and removal of the managing director; • appointment of directors to fill a vacancy or as additional directors; • establishment of Board committees, their membership and delegated authorities; • approval of dividends; • development and review of corporate governance principles and policies; • calling of meetings of shareholders (which may also be requisitioned by shareholders in accordance with the terms of the Corporations Act) Structure of the Board The Company’s Constitution governs the regulation of meetings and proceedings of the Board.
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.
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.
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.
Jeffrey Bonacorda is a senior accounting professional with more than thirty years of experience in the pharmaceutical, consumer products and service industries. 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.
Board Practices The role of the Board is as follows: • representing and serving the interests of shareholders by overseeing and appraising the strategies, policies and performance of the Company.
Pension benefits The Company paid A$51,122 during fiscal year 2025 for employee superannuation benefits and pension benefits related to KMPs. C. Board Practices The role of the Board is as follows: • representing and serving the interests of shareholders by overseeing and appraising the strategies, policies and performance of the Company.
Board of Directors The Board of Kazia is elected by and accountable to shareholders. The Board monitors and directs the business and is responsible for the corporate governance of the Company. As of 30 June 2024, the Board comprised of five directors, four of whom were non-executive directors.
The Board monitors and directs the business and is responsible for the corporate governance of the Company. As of 30 June 2025, the Board comprised of four directors, all of whom were non-executive directors. Committees The Board has established an Audit, Risk and Governance Committee and a Remuneration and Nomination Committee.
The Board of Directors has the power to appoint any person to be a director either to fill a casual vacancy or as an additional director (up to a maximum of 10). Any director so appointed may hold office only until the next Annual General Meeting when he or she shall be eligible for election by the Company shareholders.
The Board of Directors has the power to appoint any person to be a director either to fill a casual vacancy or as an additional director (up to a maximum of 10). Board of Directors The Board of Kazia is elected by and accountable to shareholders.
The terms and conditions of each grant of options over ordinary shares granted as remuneration to Directors or other Key Management Personnel in this financial year or future financial years are set out below. 41 Table of Contents Issue of ADS options Grant date Vesting date and exercisable date Expiry date Exercise price Fair value per option at grant date 22 April 2024 22 April 2027 22 April 2029 A$ 0.586 A$ 0.43 Options granted carry no dividend or voting rights.
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.
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.
Key management personnel have no entitlement to termination payments in the event of removal for misconduct. 59 Table of Contents Share-based compensation Issue of options The options issued on 11 September 2024 were to Ebru Davidson, Robert Apple, Bryce Carmine, and Stephen Coffey for 6,000 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$23,500.
She is a Chartered Secretary who brings best practice governance advice, ensuring compliance with the Listing Rules, Corporations Act and other relevant legislation.. B.
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. She is a Chartered Secretary who brings best practice governance advice, ensuring compliance with the Corporations Act and other relevant legislation.
He has been a partner with the chartered accounting firm Watkins Coffey Martin which recently merged with Charternet Chartered Accountants and Steven is a consultant to that group. Steven sits on the board of a number of large private family companies and audits a number of large private companies and not-for-profit entities.
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. He has been a partner with the chartered accounting firm Watkins Coffey Martin which recently merged with Charternet Chartered Accountants and Steven is a consultant to that group.
Term of Directors The Company’s Constitution requires that at each Annual General Meeting of the Company, one third (or the number nearest to but not exceeding one third) of the directors, (excluding a director who is the Managing Director, and a director appointed to fill a casual vacancy) must retire from office provided that no director may retain office for more than three years without offering himself/herself for re-election even though such submission results in more than one third of the directors retiring from office.
Term of Directors Other than the Managing Director, under the Company’s Constitution: • a Director must not hold office without re-election: (a) following the third Annual General Meeting of the Company after that Director’s last appointment or re-election; or (b) for more than 3 years, whichever is longer; and • if no Director is required to retire at an Annual General Meeting of the Company, then the Director to retire will be the one who has been longest in office since that Director’s last election.
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.
Bryce has been a director of HaemaLogiX Pty Ltd since January 2024. Special responsibilities: Chair of Remuneration and Nomination Committee, member of Audit, Risk and Governance Committee. Name: Steven Coffey Title: Non-Executive Director Qualifications: B.
Removed
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.
Added
Steven sits on the board of a number of large private family companies and audits a number of large private companies and not-for-profit entities. Previously, Steven was a director of Ansarada Group Limited (ASX: AND) (formerly The Docyard Limited (ASX:TDY)).
Removed
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.
Added
He also held prior roles at Genaera Corporation, Liberty Technologies, and Arthur Andersen & Company.
Removed
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.
Added
Before joining Kazia Therapeutics in November 2021 he was Chief Medical Officer and member of the executive management team at Cellectar Biosciences, Inc, a US publicly traded biopharmaceutical company. Special responsibilities: None Name: Jeffrey Bonacorda Title: Vice President, Finance and Controller Qualifications: B.A. 56 Table of Contents Experience and expertise: Mr.
Removed
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.
Added
Since 2015, she has been Principal at CoSec Services, which provides Company Secretarial and Corporate Governance consulting services. B.
Removed
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.
Added
The Board or the Remuneration and Nomination Committee may, at its discretion, award bonuses for exceptional performance. The long-term incentive comprises equity-based payments.
Removed
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.
Added
Remuneration and other terms of employment for key management personnel are formalized in service agreements.
Removed
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 $7,402.
Added
Issue of ADS options Tranche Grant date Vesting date and exercisable date Expiry date Exercise price Fair value per option at grant date 20 11 September 2024 11 September 2024 11 September 2029 A$ 24.8 A$ 23.50 Options granted carry no dividend or voting rights. Each ADS option is convertible to 500 ordinary share upon exercise.
Added
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.
Added
Performance The performance of the Board and key executives is reviewed regularly using both measurable and qualitative indicators.
Added
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.

Item 7. Management's Discussion & Analysis

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

4 edited+23 added−2 removed0 unchanged
Biggest changeThese 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.
Biggest changeRecord Holders As of October 10, 2025, there were 2,187 Kazia shareholders holding 917,300,734 fully paid ordinary shares. 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.
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.
Related party transactions During fiscal year 2023, 2024, and 2025, 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. 48 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.
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.
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 866,587,053 (96.65%) of our ordinary shares as of such date. B.
Removed
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.
Added
Item 7. Major Shareholders and Related Party Transactions A.
Removed
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.
Added
Major shareholders The following table sets forth information with respect to the beneficial ownership of our ADSs as at September 23, 2025 by: • each of the members of our board and senior management; and • each person, or group of affiliated persons, known by us to beneficially own more than 5% of our ADSs.
Added
The percentage of shares beneficially owned is based on a total of 835,288,734 ordinary shares, or 1,670,577 ADSs, outstanding as at September 23, 2025. The numbers and percentages of ADSs beneficially owned are reported on the basis of regulations of the SEC governing the determination of beneficial ownership of securities.
Added
Under the applicable SEC rules, a person is deemed to be a “beneficial owner” of a security if that person has or shares voting power, which includes the power to vote or direct the voting of such security, or investment power, which includes the power to dispose of or to direct the disposition of such security, or to receive the economic benefit of ownership of the securities.
Added
A person is also deemed to be a beneficial owner of any securities of which that person has a right to acquire beneficial ownership within 60 days of September 23, 2025, and such securities are considered outstanding for the purpose of calculating the percentage ownership of that person but not for the purpose of calculating the percentage ownership of any other person.
Added
Under these rules, more than one person may be deemed beneficial owner of the same securities and a person may be deemed to be a beneficial owner of securities as to which such person has no economic interest.
Added
Except as otherwise indicated, each of the beneficial owners has, to our knowledge, sole voting and investment power with respect to the indicated ordinary shares, subject to community property laws, where applicable.
Added
Unless otherwise indicated, all information contained in the table below and the footnotes thereto is based upon information provided to us by the shareholders and the public information available to us.
Added
Except as otherwise set forth below, the address of the beneficial owner is c/o Kazia Therapeutics Limited, Level 24, Three International Towers, 300 Barangaroo Avenue, Sydney, NSW, 2000, Australia. 65 Table of Contents ADSs Beneficially Owned Name and Address of Beneficial Owner Number Percentage Major Shareholders: Alumni Capital LP 1 182,260 2 9.99 % Chernett Jorey 3 137,200 4 8.2 % Dauntless Investment Group, LLC 5 115,769 6 6.9 % Board Members and Senior Management John Friend 7 8,000 0.5 % Bryce Carmine 8 1,713 0.1 % Steven Coffey 9 1,983 0.1 % Ebru Davidson — — % Robert Apple — — % Jeffrey Bonacorda — — % Elissa Hansen — — % All board members and senior management as a group (7 persons) 1 11,696 0.7 % 1.
Added
The business address of Alumni Capital LP is 601 Brickell Key Dr. Suite 700, Miami, FL 33131. The general partner of Alumni Capital LP is Alumni Capital GP LLC. Ashkan Mapar is the manager of Alumni Capital GP LLC and as such has voting and disposition control over the Shares.
Added
We have been advised that none of Alumni Capital LP, Alumni Capital GP LLC nor Ashkan Mapar is a member of the Financial Industry Regulatory Authority (“FINRA”), or an independent broker-dealer, or an affiliate or associated person of a FINRA member or independent broker-dealer. 2.
Added
Consists of (i) 14,204,500 ordinary shares held by Alumni Capital LP based on information provided to us by Alumni Capital LP (ii) 153,851 ADSs issuable upon exercise of the Ordinary Warrants held by Alumni Capital LP and the remaining portion of the Alumni Warrant issued to Alumni Capital LP on April 19, 2024, after giving effect to the exercise limitations of such warrants which prevent its exercise to the extent that such exercise would result in the beneficial ownership by Alumni Capital LP and its affiliates to exceed 9.99% of the ADSs outstanding.
Added
The Alumni Warrant allows Alumni Capital LP to purchase a variable number of ordinary shares in the form of ADSs based on the number of ordinary shares outstanding as of the date of exercise.
Added
Based on 835,288,734 Ordinary Shares outstanding as of September 23, 2025, if the remaining portion of the Alumni Warrant were to be exercised on September 23, 2025, it was exercisable for up to 69,607 ADSs, representing 34,803,500 ordinary shares. 66 Table of Contents 3.
Added
Information is based on a report on Schedule 13G filed on June 12, 2025 by Chernett Jorey. The business address of Chernett Jorey is 6222 Indianwood Trail, Bloomfield Hills, MI 48301. 4. Information is based on a report on Schedule 13G filed on June 12, 2025 by Chernett Jorey. 5.
Added
Information is based on a report on Schedule 13G/A filed on August 5, 2025 by Dauntless Investment Group, LLC. The business address of Dauntless Investment Group, LLC is 8567 Hummingbird, Commerce Township, MI 48382. 6. Information is based on a report on Schedule 13G/A filed on August 5, 2025 by Dauntless Investment Group, LLC. 7. Consists of 8,000 ADSs. 8.
Added
Consists of 856,681 ordinary shares, represented by 1,713 ADSs. 9. Consists of 1983 restricted ADSs and 13 ordinary shares.
Added
Significant Changes in the Ownership of Major Shareholders On April 19, 2024, we entered into a purchase agreement (the “Purchase Agreement”) with Alumni Capital LP, pursuant to which we may sell to Alumni Capital LP up to $15,000,000 (the “Investment Amount”) of ADSs, representing fully paid ordinary shares, from time to time during the term of the Purchase Agreement.
Added
In consideration for Alumni Capital LP’s execution and delivery of the Purchase Agreement, we issued a warrant (the “Alumni Warrant”) to Alumni Capital LP, valid for a term of three (3) years, entitling Alumni Capital LP to purchase ADSs (the “Warrant ADSs”) with a value (calculated based on the then-current ADS to ordinary share ratio) equal to five percent (5%) of the Investment Amount.
Added
The Alumni Warrant exercise price is variable and is equal to $6,000,000 divided by the number of outstanding ordinary shares as of the time of exercise, multiplied by the then-current ADS to ordinary shares ratio.
Added
On January 10, 2025, we entered into a securities purchase agreement with Alumni Capital LP, pursuant to which we issued and sold (A) in a registered direct offering, 553,440 ADSs and pre-funded warrants to purchase up to 779,893 ADSs, and (B) in a concurrent private placement, the ordinary warrants to purchase up to 1,333,333 ADSs, which have an exercise price of $1.50 per ADS, are exercisable immediately and will expire on July 14, 2030.
Added
On July 31, 2025, we entered into the Securities Purchase Agreements with Alumni Capital LP, Pointillist Global Macro Series of Pointillist Partners, LLC, Daniel Herr and Lauren Rimoin Living Trust and MK Plumeria, LLC in connection with a private placement, pursuant to which we issued and sold (i) 14,204,500 ordinary shares at a purchase price of $0.0176 per share, and (ii) pre-funded Warrants to purchase up to 204,547 ADSs, each ADS representing five hundred ordinary shares, at a purchase price of $8.7999 per pre-funded Warrant.
Added
Each pre-funded Warrant is exercisable for one ADS at an exercise price of $0.0001 per ADS underlying the pre-funded Warrant, is immediately exercisable, and will expire when exercised in full. Major Shareholders Voting Rights All of our shareholders, including the shareholders listed below, have the same voting rights attached to their ordinary shares.