Core Insights - Kazia Therapeutics Limited announced transformative preclinical research on paxalisib, highlighting its potential in treating triple-negative breast cancer (TNBC) [1][2] - The research indicates paxalisib can reprogram the tumor microenvironment and enhance immune response, showing synergy with immune checkpoint inhibitors [2][6] - The publication of this research supports the ongoing Phase 1b clinical trial of paxalisib in advanced breast cancer [4] Preclinical Research Findings - Conducted by Professor Sudha Rao at QIMR Berghofer Medical Research Institute, the study shows paxalisib's ability to remodel the TNBC tumor microenvironment, increasing CD4+ and CD8+ T cell infiltration and activation [2][6] - The combination of paxalisib with KEYTRUDA® (pembrolizumab) demonstrated significant antitumor activity, leading to robust tumor regression and prolonged survival in preclinical models [6] Clinical Development - Kazia has initiated a Phase 1b trial evaluating paxalisib in combination with checkpoint inhibitors and chemotherapy for advanced breast cancer, marking a significant step in clinical translation [5] - The company has previously conducted ten clinical trials for paxalisib, primarily focused on brain cancers, and is now expanding its application to solid tumors [5] Regulatory Designations - Paxalisib has received multiple designations from the FDA, including Orphan Drug Designation and Fast Track Designation for glioblastoma and other conditions, indicating its potential therapeutic value [5] Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with a lead program centered on paxalisib, a PI3K/Akt/mTOR pathway inhibitor [5]

Core Insights - Kazia Therapeutics has initiated a Phase 1b clinical trial for paxalisib, targeting advanced breast cancer, marking a significant step in expanding its application beyond brain cancer [1][3] - The trial will evaluate paxalisib in combination with established therapies like olaparib and pembrolizumab, focusing on safety, tolerability, and preliminary efficacy [2][6] Study Design - The trial is a multi-center, open-label, randomized study with two treatment arms: Arm A will assess paxalisib with olaparib, while Arm B will combine paxalisib with pembrolizumab and standard chemotherapy [2][6] - Participants will undergo deep biomarker profiling to support future development and assess early clinical activity signals [2] Strategic Significance - The integration of paxalisib into combination regimens is part of Kazia's strategy to enhance value through differentiated science and collaborations [5] - The trial aims to provide insights into how paxalisib may enhance the effectiveness of immune checkpoint inhibitors and DNA repair-targeted therapies [6] Company Background - Kazia Therapeutics is an oncology-focused biotechnology company based in Sydney, Australia, with a lead program centered on paxalisib, a dual PI3K/mTOR inhibitor [5][7] - The company has previously conducted multiple clinical trials for paxalisib, including studies in glioblastoma and other brain cancers, with several trials showing promising interim data [7]

Core Insights - Kazia Therapeutics Limited has made significant advancements in its clinical programs and corporate strategy, particularly with its lead drug paxalisib, which is being evaluated for multiple cancer types [2][3] Pipeline - Paxalisib - The company received a research grant from The Michael J. Fox Foundation to explore paxalisib's potential as a treatment for Parkinson's disease, funding preclinical studies at The Hebrew University of Jerusalem [4] - A clinical trial has been launched to evaluate the combination of paxalisib with immunotherapy in patients with advanced breast cancer, specifically targeting triple-negative breast cancer [4] - Kazia has aligned with the FDA on the design of a pivotal phase 3 study for paxalisib in glioblastoma, which will enroll approximately 366 patients and compare paxalisib to standard of care [8] Pipeline - EVT801 - The last patient follow-up in a Phase 1 study of EVT801 for advanced solid tumors was completed, with final data expected in Q2 2025 [6] Corporate Developments - Kazia raised $3 million in capital during Q1 2025, including $1 million in non-dilutive funding [2][3] - The company received a notification from Nasdaq regarding its Market Value of Listed Securities falling below $35 million, with a compliance period until November 10, 2025 [9] - Kazia executed a reverse ADS split to maintain compliance with Nasdaq's minimum bid price requirement [9] - The company sold all intellectual property rights to Cantrixil for $1 million, as Vivesto decided not to pursue its development in ovarian cancer [9] - CEO Dr. John Friend purchased 8,000 ADSs at a split-adjusted price of $4.2465 per ADS [9]

Core Viewpoint - Kazia Therapeutics Limited has sold all intellectual property and trademark rights to its oncology drug candidate Cantrixil to Vivesto for USD $1 million, providing non-dilutive funding to advance its clinical-stage pipeline [1][3]. Group 1: Transaction Details - Kazia will receive USD $1 million from Vivesto for the rights to Cantrixil [1]. - Vivesto had previously licensed exclusive global development and commercialization rights for Cantrixil from Kazia in March 2021 [2]. - Vivesto has decided not to pursue Cantrixil for ovarian cancer and is now exploring it for hematological cancers [2]. Group 2: Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with a lead program, paxalisib, targeting multiple forms of brain cancer [4]. - Paxalisib has undergone ten clinical trials and has received various designations from the FDA, including Orphan Drug Designation and Fast Track Designation for glioblastoma [4]. - The company is also developing EVT801, a small molecule inhibitor of VEGFR3, which has shown activity against a broad range of tumor types [4].

Exhibit 99.1 Chairman and CEO's Letter 8 Exhibit 99.1 2024 ANNUAL REPORT Contents 2 Environment, Society & Governance The journey of a young biotech company is often circuitous, but we have nevertheless continued to make great progress in the past year. We have two first-class drug candidates in clinical development, with a diverse portfolio of trials that have the potential to open up very substantial commercial markets. We have an experienced and capable team, and an international network of supportive pa ...

Core Insights - Kazia Therapeutics Limited has received a research grant from The Michael J. Fox Foundation for Parkinson's Research to investigate the therapeutic potential of paxalisib for Parkinson's disease [1][2] - The research will be conducted in collaboration with The Hebrew University of Jerusalem, focusing on preclinical studies to establish a link between a specific pathway in Parkinson's disease and paxalisib [2][3] - Paxalisib is a blood-brain barrier-penetrating inhibitor targeting class IA phosphatidylinositol 3-kinase (PI3K), with the aim of addressing the underlying pathophysiology of Parkinson's disease [2][3] Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with paxalisib as its lead program [4] - Paxalisib has been involved in ten clinical trials for various brain cancers, including a completed Phase 2/3 study in glioblastoma reported in 2024 [4] - The company has received multiple designations from the FDA for paxalisib, including Orphan Drug Designation and Fast Track Designation for glioblastoma and other conditions [4] Research Objectives - The primary goal of the research is to explore the therapeutic potential of paxalisib in treating Parkinson's disease by inhibiting the AKT phosphorylation reaction of α-SynA53T [3] - Preliminary findings from Professor Ronit's lab suggest a significant role of the PI3K/AKT/mTORC pathway in the pathogenesis of Parkinson's disease [3] - The research will assess the impact of paxalisib on mouse survival, motor and non-motor performances, and various disease biomarkers [2][3]

Core Viewpoint - Kazia Therapeutics Limited has received regulatory approval to launch a clinical trial for the combination of paxalisib and immunotherapy in patients with advanced breast cancer, specifically targeting triple-negative breast cancer, which is known for its aggressive nature and treatment resistance [1][2][4]. Group 1: Clinical Trial Details - The ABC-Pax study is a multi-centre, open-label phase 1b trial that will enroll 24 patients from leading cancer centers in Queensland, Australia, with treatment lasting up to 12 months [2]. - The trial aims to assess the safety and efficacy of paxalisib in combination with either KEYTRUDA® (pembrolizumab) or LYNPARZA® (olaparib) [2][3]. - Enrollment for the clinical trial is currently open at the Royal Brisbane and Women's Hospital, with plans to expand to additional sites in Australia [3]. Group 2: Scientific Background - Research led by QIMR Berghofer scientists in collaboration with Kazia Therapeutics has shown that the combination of paxalisib and immunotherapy can trigger a novel molecular program that makes dormant cancer cells visible to the immune system [3]. - The preclinical data presented at the San Antonio Breast Cancer Symposium on December 12, 2024, highlighted potential therapeutic synergies between paxalisib and the checkpoint inhibitor pembrolizumab, as well as with the poly (ADP-ribose) polymerase inhibitor olaparib [3]. Group 3: Company Insights - Kazia Therapeutics is focused on developing paxalisib, an investigational drug targeting the PI3K/Akt/mTOR pathway, which has been involved in ten clinical trials for various brain cancers [7]. - The company has received multiple designations from the FDA for paxalisib, including Orphan Drug Designation and Fast Track Designation for glioblastoma and other conditions [7]. - Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which has shown promise in preclinical studies and has completed a Phase I study [8].

Core Viewpoint - Kazia Therapeutics Limited has successfully closed a registered direct offering and concurrent private placement, raising approximately $2.0 million to support its oncology-focused drug development efforts [1][3]. Group 1: Offering Details - The company issued 1,333,333 American Depositary Shares (ADSs) at a purchase price of $1.50 per ADS, with each ADS representing 100 ordinary shares [1]. - The offering included unregistered warrants to purchase an additional 1,333,333 ADSs, with an exercise price of $1.50 per ADS, immediately exercisable and expiring in five and a half years [1]. - Maxim Group LLC acted as the exclusive placement agent for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for general corporate purposes, including working capital, research, clinical development, and administrative expenses [3]. Group 3: Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with its lead program, paxalisib, targeting multiple forms of brain cancer [7]. - Paxalisib has undergone ten clinical trials and has received various designations from the FDA, including Orphan Drug Designation and Fast Track Designation for glioblastoma and other conditions [7]. - The company is also developing EVT801, a small-molecule inhibitor of VEGFR3, which has shown promise in preclinical studies [7][8].

Core Viewpoint - Kazia Therapeutics Limited has announced a definitive agreement for the purchase and sale of up to 1,333,333 American Depositary Shares (ADSs) at a price of $1.50 per ADS, aiming to raise approximately $2.0 million in gross proceeds for general corporate purposes [1][3]. Group 1: Offering Details - The offering includes a registered direct offering and a concurrent private placement of unregistered warrants to purchase an equal number of ADSs [1][2]. - The warrants will have an exercise price of $1.50 per ADS, will be immediately exercisable, and will expire five and a half years from issuance [1]. - The closing of the offering is expected around January 13, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering are intended for general corporate purposes, which may encompass working capital, research expenses, clinical development, and administrative costs [3]. Group 3: Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with its lead program being paxalisib, aimed at treating various forms of brain cancer [7]. - Paxalisib has undergone ten clinical trials, with a pivotal study in glioblastoma expected to present data in late 2024 [7]. - The company is also developing EVT801, a small-molecule inhibitor of VEGFR3, which has shown promise in preclinical studies [8].

PART I [Key Information](index=4&type=section&id=Item%203.%20Key%20Information) The company faces significant financial, operational, and securities-related risks, with substantial doubt about its ability to continue as a going concern [Risk Factors](index=4&type=section&id=D.%20Risk%20factors) - The company has a history of significant net losses and anticipates they will continue, having never achieved profitability; as of June 30, 2024, accumulated losses were **A$115.1 million**[9](index=9&type=chunk) Net Losses (Fiscal Years 2022-2024) | Fiscal Year Ended June 30 | Net Loss (A$ million) | | :--- | :--- | | 2024 | 26.8 | | 2023 | 20.5 | | 2022 (restated) | 25.0 | - There is **substantial doubt about the company's ability to continue as a going concern**, with cash on hand of **A$1.7 million** as of June 30, 2024, expected to fund operations only until March 2025[16](index=16&type=chunk)[17](index=17&type=chunk) - The company's lead drug candidates, paxalisib and EVT801, are still in clinical trials and failure to demonstrate sufficient benefit could materially harm the business[14](index=14&type=chunk)[15](index=15&type=chunk) - The company faces risks related to its securities, including a **potential delisting from Nasdaq** for failing to meet the minimum bid price requirement, which prompted a **1-for-10 reverse ADS split**[46](index=46&type=chunk) - The company **delisted from the Australian Securities Exchange (ASX)** on November 15, 2023, which may adversely affect the liquidity and value of its ADSs[50](index=50&type=chunk) - Based on its 2023 asset and income composition, the company believes it was a **Passive Foreign Investment Company (PFIC)**, which could have adverse U.S. tax consequences for investors[54](index=54&type=chunk) [Information on the Company](index=19&type=section&id=Item%204.%20Information%20on%20the%20Company) The company is an oncology-focused biotechnology firm with lead drug candidates paxalisib and EVT801 in clinical development [Business Overview](index=19&type=section&id=B.%20Business%20overview) - Kazia's lead program is **paxalisib**, a brain-penetrant PI3K inhibitor which has received **Orphan Drug Designation (ODD)** and **Fast Track Designation (FTD)** for various brain cancers[60](index=60&type=chunk)[61](index=61&type=chunk) - The GBM AGILE pivotal study for paxalisib in glioblastoma patients showed a median Overall Survival (OS) of **15.54 months** versus 11.89 months for standard of care[64](index=64&type=chunk) - The second lead program is **EVT801**, a selective VEGFR3 inhibitor for which a Phase I study in advanced solid tumors was completed, identifying a recommended Phase 2 dose[76](index=76&type=chunk)[79](index=79&type=chunk) Anticipated Milestones for Fiscal Year 2025 | Milestone | | :--- | | Final data presentation from the GBM AGILE study of paxalisib | | Additional results from the PNOC clinical trial of paxalisib | | Expansion cohort results from the Phase I study of paxalisib in brain metastases | | Discussions with regulatory authorities regarding next steps for paxalisib | | Pre-clinical results from the QIMR collaboration in advanced breast cancer models | - During FY 2024, the company raised **US$1.66 million** via its At-The-Market (ATM) facility and **US$0.52 million** via an Equity Line of Credit, and also delisted from the ASX[101](index=101&type=chunk)[102](index=102&type=chunk)[103](index=103&type=chunk) [Operating and Financial Review and Prospects](index=34&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) The company reported a net loss of A$26.8 million for FY2024, driven by increased R&D and G&A expenses, with a challenging financial position [Operating Results](index=34&type=section&id=A.%20Operating%20results) Summary of Revenue and Income (A$'000) | Income Source | FY 2024 | FY 2023 | FY 2022 | | :--- | :--- | :--- | :--- | | Revenue | 2,308 | — | — | | Finance income | 12 | 22 | 2 | | Other income | 173 | 1 | 25 | | **Total** | **2,493** | **23** | **27** | - **Research and development (R&D) expenses increased by 12% to A$17.4 million** in FY2024, mainly due to transaction fee expenses[110](index=110&type=chunk) - **General and administrative (G&A) costs rose 58% to A$13.5 million** in FY2024, driven by costs related to warrants, audit, and NASDAQ fees[110](index=110&type=chunk) - **Net loss after tax increased to A$26.8 million** in FY2024 from A$20.5 million in FY2023, primarily due to higher R&D and G&A expenditures[111](index=111&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=B.%20Liquidity%20and%20capital%20resources) - As of June 30, 2024, the company had cash and cash equivalents of **A$1.7 million** and accumulated losses of **A$115.1 million**, with substantial doubt about its ability to continue as a going concern[112](index=112&type=chunk)[113](index=113&type=chunk) Consolidated Cash Flows (A$'000) | Cash Flow Activity | 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 | - Financing activities in FY2024 included raising funds through the sale of ADSs via its **ATM facility** and a new **equity line of credit** with Alumni Capital[101](index=101&type=chunk)[103](index=103&type=chunk)[114](index=114&type=chunk) [Directors, Senior Management and Employees](index=39&type=section&id=Item%206.%20Directors%2C%20Senior%20Management%20and%20Employees) The company's leadership compensation combines fixed salary with equity incentives, overseen by two independent board committees Key Management Personnel Compensation (FY 2024, A$) | Name | Position | Total Remuneration | | :--- | :--- | :--- | | J. Friend | CEO | 1,279,844 | | B. Carmine | Chairman | 95,417 | | S. Coffey | Non-Executive Director | 94,350 | | E. Davidson | Non-Executive Director | 94,350 | | R. Apple | Non-Executive Director | 39,301 | | K. Krumeich | CFO (until Jan 2024) | 399,040 | - During FY2024, the company issued **2,850,000 ADS options** under its Employee Share Option Plan (ESOP), with 1,500,000 granted to CEO John Friend[134](index=134&type=chunk)[138](index=138&type=chunk) - The Board has two key committees: the **Audit, Risk and Governance Committee** and the **Remuneration and Nomination Committee**, both chaired by independent directors[149](index=149&type=chunk)[151](index=151&type=chunk) Employee Headcount (Full-Time Equivalents) | Category | 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** | [Major Shareholders and Related Party Transactions](index=51&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) No shareholder holds over 5% beneficial ownership, and no significant related party transactions occurred in FY2024 - As of the report date, **no shareholder holds a beneficial ownership of 5% or more** of the company's voting securities[160](index=160&type=chunk) - As of October 28, 2024, HSBC Custody Nominees (Australia) Ltd. held **96.04% of ordinary shares**, representing the shares underlying the ADSs traded on Nasdaq[161](index=161&type=chunk) - The company did not enter into any **material transactions or loans with related parties** during fiscal year 2024[162](index=162&type=chunk) [Financial Information](index=51&type=section&id=Item%208.%20Financial%20Information) The company paid no dividends and executed a 1-for-10 reverse ADS split subsequent to the fiscal year end - The company paid **no dividends** during fiscal years 2024, 2023, or 2022[163](index=163&type=chunk) - A significant change occurred after the fiscal year end: on October 28, 2024, the ADS ratio was changed, equivalent to a **1-for-10 reverse ADS split**[164](index=164&type=chunk) [Additional Information](index=52&type=section&id=Item%2010.%20Additional%20Information) The company's operations are governed by key licensing agreements and its likely PFIC status has tax implications for U.S. investors - The company has several key material contracts, including a worldwide licensing agreement with **Genentech for paxalisib**, a licensing agreement with **Simcere for paxalisib in Greater China**, and a worldwide licensing agreement with **Evotec SE for EVT801**[188](index=188&type=chunk)[194](index=194&type=chunk)[195](index=195&type=chunk) - In March 2024, the company entered into an exclusive licensing agreement with **Sovargen Co., Ltd** for paxalisib in certain epilepsy indications, receiving a **US$1.5 million upfront payment**[196](index=196&type=chunk) - The company believes it was a **Passive Foreign Investment Company (PFIC)** for the 2023 taxable year, which could result in adverse U.S. federal income tax consequences for U.S. holders[205](index=205&type=chunk) - For non-Australian shareholders, dividends are subject to withholding tax and capital gains on share disposal are generally disregarded unless the shareholder holds 10% or more of the company's capital[213](index=213&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=65&type=section&id=Item%2011.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market exposures are foreign currency risk, particularly with the U.S. dollar, and interest rate risk - The company's primary market risk is **foreign currency exchange risk**, mainly with respect to the U.S. dollar, arising from international operations[222](index=222&type=chunk) - **Interest rate risk** pertains to cash balances held in variable-rate accounts; a 100-basis-point change in interest rates would impact profit before tax by approximately **$16,575**[354](index=354&type=chunk) - **Credit risk** is managed by depositing cash with high-credit-quality financial institutions and limiting exposure to any single counterparty[221](index=221&type=chunk)[357](index=357&type=chunk) [Controls and Procedures](index=67&type=section&id=Item%2015.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal controls over financial reporting were effective as of June 30, 2024 - Management concluded that the company's **disclosure controls and procedures were effective** as of June 30, 2024[226](index=226&type=chunk) - Management concluded that **internal control over financial reporting was effective** as of June 30, 2024, based on the COSO 2013 framework[227](index=227&type=chunk) - A **material weakness identified in 2023** related to the accounting for new significant transactions **was remediated** as of June 30, 2024[228](index=228&type=chunk) [Corporate Governance](index=68&type=section&id=Item%2016.%20Corporate%20Governance) As a foreign private issuer, the company follows home country governance practices and maintains a cybersecurity risk program Principal Accountant Fees (BDO, A$) | Service Category | 2024 | 2023 | | :--- | :--- | :--- | | Audit or review of financial statements | 418,039 | 292,772 | | Comfort letters | 28,774 | 18,000 | | Consent letter - F-1 | 104,687 | — | | Consent letter - F-3 | 11,199 | — | | **Total** | **562,699** | **310,772** | - As a **foreign private issuer**, Kazia is exempt from certain Nasdaq corporate governance rules, including the requirement for a majority-independent board[239](index=239&type=chunk)[240](index=240&type=chunk) - The company has a **cybersecurity risk management program** overseen by the CEO, VP of Finance, and the Audit Committee, and engages a third-party service provider for risk assessment[243](index=243&type=chunk)[244](index=244&type=chunk) PART III [Financial Statements](index=72&type=section&id=Item%2018.%20Financial%20Statements) Audited statements show a net loss of A$26.8 million, a going concern warning, and a total equity deficit of A$10.0 million - The independent auditor's report includes a paragraph expressing **substantial doubt about the Company's ability to continue as a going concern**, citing recurring losses and negative cash flows[251](index=251&type=chunk) - **Critical audit matters** identified were the valuation of contingent consideration (A$7.0M liability) and the valuation and classification of warrants (A$6.5M liability)[255](index=255&type=chunk)[256](index=256&type=chunk) Consolidated Statement of Profit or Loss (A$'000) | Line Item | 2024 | 2023 | 2022 (restated) | | :--- | :--- | :--- | :--- | | Licensing revenue | 2,308 | — | — | | Research and development expense | (17,380) | (15,564) | (20,169) | | General and administrative expense | (13,563) | (8,583) | (5,113) | | **Loss after income tax benefit** | **(26,778)** | **(20,465)** | **(25,014)** | Consolidated Statement of Financial Position (A$'000) | Line Item | 2024 | 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 1,657 | 5,241 | | Intangibles | 15,400 | 17,269 | | **Total Assets** | **21,585** | **28,084** | | **Liabilities & Equity** | | | | Trade and other payables | 15,067 | 4,329 | | Other financial liabilities (warrants) | 6,478 | — | | Contingent consideration | 7,005 | 6,871 | | **Total Liabilities** | **31,602** | **16,034** | | **Total Equity** | **(10,017)** | **12,050** | - Subsequent to the fiscal year end, from July to September 2024, the company raised **A$5.3 million** from its ATM facility and **A$0.8 million** from its equity line of credit[384](index=384&type=chunk)