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)

Core Viewpoint - Kazia Therapeutics Limited is advancing its investigational drug paxalisib for glioblastoma multiforme (GBM) and is set to meet with the FDA in December 2024 to discuss registration pathways [1][3]. Company Updates - The company announced results from the Phase II/III clinical trial GBM-AGILE, indicating clinically meaningful improvement in overall survival for newly diagnosed unmethylated GBM patients treated with paxalisib [2]. - Kazia has updated its corporate presentation to include preliminary data from the GBM-AGILE trial, which compares paxalisib to standard care for glioblastoma treatment [4]. - The company plans to participate in several medical conferences in Q4 2024, including the Society for Neuro-Oncology Annual Meeting and the San Antonio Breast Cancer Symposium, to engage with stakeholders and discuss investment opportunities [5][6]. Drug Development and Designations - Paxalisib has received orphan drug designation and fast track designation from the FDA for treating glioblastoma in patients with unmethylated MGMT promoter status, following radiation and temozolomide therapy [3][8]. - The drug has been involved in ten clinical trials since its licensing from Genentech in late 2016, with ongoing studies in various brain cancer types [7][8]. Future Plans - Full data from the GBM-AGILE study, including secondary endpoints, is expected to be presented at a scientific meeting later in 2024 [2]. - Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, with promising preclinical data indicating activity against a broad range of tumor types [8].

SYDNEY, Sept. 12, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncologyfocused drug development company, is pleased to announce that an agreement has been executed with QIMR Berghofer Medical Research Institute, one of Australia's foremost cancer research centres, 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). Under t ...

Core Viewpoint - Kazia Therapeutics is a biotechnology company focused on developing oncology drugs, particularly paxalisib for glioblastoma, which has shown promising clinical trial results [2][8]. Group 1: Company Overview - Kazia Therapeutics is an Australian biotechnology firm specializing in oncology drug development [2]. - The company's primary drug in development is paxalisib, which recently completed a phase II/III study for glioblastoma treatment [2]. Group 2: Clinical Trial Results - Paxalisib demonstrated a 3.8-month improvement in overall survival, representing an approximate 33% improvement for selected glioblastoma patients compared to the standard of care [8]. - The drug was well tolerated during the study, marking significant progress for Kazia Therapeutics [8]. Group 3: Stock Performance - Kazia Therapeutics' stock price surged from $0.20 to a 52-week high of $1.58 before dropping to $0.53 [3]. - The volatility in stock price reflects the unpredictable nature of biotech investments [5][7]. Group 4: Future Prospects - Kazia Therapeutics plans to release full data from the paxalisib study at a scientific meeting later this year, which could influence future stock performance [9]. - The company intends to meet with the U.S. FDA to discuss the results and explore a potential path to accelerated approval for paxalisib [10].

Core Viewpoint - Kazia Therapeutics has reported significant positive data from its phase II/III study of paxalisib for glioblastoma, leading to a substantial increase in its stock price and plans for potential FDA accelerated approval [4][3]. Company Overview - Kazia Therapeutics is an Australia-based clinical-stage company focused on developing drugs for oncology indications [1]. Study Results - The recent study showed that paxalisib-treated patients had a median overall survival (OS) of 15.7 months compared to 12.7 months for those receiving standard chemotherapy [2]. - In a secondary analysis, newly diagnosed unmethylated (NDU) patients treated with paxalisib achieved a median OS of 15.54 months, representing a 3.8-month improvement (nearly 33%) over the control group [5][10]. - The primary analysis indicated a median OS of 14.77 months for paxalisib in NDU patients, which was slightly better than the 13.84 months for the standard of care [15]. Stock Performance - Kazia's shares have surged 489.6% in the past week following the positive study results, and have increased 182.2% year to date, contrasting with a 5.1% decline in the industry [4][13]. Future Plans - The company plans to request a meeting with the FDA to explore a potential pathway for accelerated approval of paxalisib [3]. Study Context - The GBM AGILE study, which evaluates multiple therapies for glioblastoma, has completed enrollment for paxalisib, making it the third drug to do so [16].

The Kazia Therapeutics clinical trial covered the company's paxalisib as a treatment of glioblastoma. Results from the trial came out positive when compared to the standard of care (SOC). The big news was the increase in the median Overall Survival (OS) period to 14.77 months. For the record, the SOC median OS rate is 13.84 months. A secondary analysis also showed a median OS of 15.54 months. KZIA Stock Movement Today The rally for KZIA stock isn't over yet with the company's shares up another 51.3% as of T ...

Kazia Therapeutics (NASDAQ:KZIA) stock is soaring higher on Wednesday after the oncology-focused biotechnology company provided results from a Phase II/III clinical trial. These results concern the effectiveness of paxalisib as a treatment of glioblastoma versus the standard of care (SOC). That includes a median Overall Survival (OS) period of 14.77 months for patients treated with paxalisib. For comparison, the SOC survival rate is 13.84 months. Median OS in its prespecified secondary analysis came in at 1 ...

Core Insights - Kazia Therapeutics Limited announced results from the GBM-AGILE study, highlighting the efficacy of paxalisib in treating glioblastoma, a severe brain cancer with significant unmet medical needs [1][9]. Study Overview - The GBM-AGILE trial is an adaptive phase II/III global study sponsored by the Global Coalition for Adaptive Research, aimed at evaluating the response of glioblastoma patients to new investigational agents using innovative Bayesian design [2]. - The trial included 313 patients, with newly diagnosed unmethylated (NDU) and recurrent glioblastoma patients randomized to receive either paxalisib or standard of care [3]. Efficacy Results - In the primary analysis, the median overall survival (OS) for paxalisib-treated NDU patients was 14.77 months compared to 13.84 months for the cumulative standard of care [10]. - A prespecified secondary analysis showed a median OS of 15.54 months for paxalisib-treated NDU patients versus 11.89 months for concurrent standard of care, indicating a 3.8-month improvement, approximately a 33% increase in survival [10][19]. - No efficacy signal was detected in the recurrent disease population, with median OS of 9.69 months for standard of care versus 8.05 months for paxalisib [5]. Safety Profile - Paxalisib was well tolerated in the GBM-AGILE trial, with no new safety signals identified in the patient population [11]. Future Plans - Based on the data from the GBM-AGILE study, Kazia plans to request a meeting with the FDA to discuss potential pathways for accelerated approval of paxalisib [12]. - Full data, including secondary endpoints from the paxalisib arm, is expected to be presented at a scientific meeting later in 2024 [18]. Company Background - Kazia Therapeutics is focused on developing paxalisib, an investigational drug targeting the PI3K/Akt/mTOR pathway for various brain cancers, and has conducted multiple clinical trials since its licensing from Genentech in 2016 [6]. - The company is also developing EVT801, a small-molecule inhibitor of VEGFR3, with ongoing Phase I studies [7].

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. 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 th ...

SYDNEY, May 1, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specialising in oncology, is pleased to announce that the Safety Review Team (SRT) of the EVT801 Phase 1 clinical trial has concluded that the primary and secondary objectives of stage 1 of the trial have successfully been met. Consisting of the trial's lead investigators, independent medical monitor, and key members from Kazia Therapeutics, the SRT has reviewed all preliminary (non-final) safety and pharm ...