Group (ANZCHOG) to investigate paxalisib in children with advanced solid tumours. OPTIMISE, as the study is known, will be the first clinical trial of paxalisib led out of Australia and will enrol children with PI3K pathway mutation cancers. Recruitment for the trial is expected to commence by the end of this calendar year, with 18 patients in an initial dose escalation cohort and up to 100 patients in a dose expansion cohort. The significance of the work Kazia is doing to treat cancers, and in particular DIPG and GBM, were recognised in late May when I was invited to attend the Cancer Moonshot Brain Cancers Forum at the White House. It was a privilege and honour to represent Kazia at the event, where strategies to improve outcomes for DIPG and GBM patients were discussed and progress in drug research and development was shared. Looking forward, the future is promising for paxalisib. As discussed in our last annual report, in August 2022, we were informed by The Global Coalition for Adaptive Research that paxalisib had not graduated to the second stage of the GBM AGILE pivotal study. We anticipate receiving the final data from the GBM AGILE pivotal study of paxalisib later this calendar year. We are also anticipating interim data from the ongoing PNOC022 study in DMG/DIPG paediatric patients in 2023. The enrolment of this global study has been extremely robust and we look forward to sharing the data when available. Paxalisib will also be evaluated in adult patients with recurrent/progressive isocitrate dehydrogenase (IDH) mutant grade 2 and 3 gliomas (G2/3 gliomas) in a phase II clinical study, LUMOS2, at the University of Sydney. This biomarker directed trial addresses an estimated 20% of the glioma patient population, with unmet needs for recurrent or progressive disease. The LUMOS2 study has multiple arms and is expected to enrol up to 76 patients at several Australian sites beginning in late 2023. Beyond paxalisib, EVT801, our small-molecule inhibitor of VEGFR3, continues in development. Preclinical data showed EVT801 to be active against a broad range of tumour types and demonstrated evidence of synergy with immune-oncology agents. We continue to enrol patients in our phase I dose finding study, with data anticipated by the end of this calendar year, which will identify the recommended dose of EVT801 for subsequent phase II trials, if approved. As part of the anticipated release of phase I data by the end of this calendar year, we also expect to report preliminary biomarker and clinical data focused on high-grade, serious ovarian cancer patients enrolled in this study. FINANCIAL PERFORMANCE Our paxalisib and EVT801 clinical programs continue to deliver promising data and advance us towards commercialisation. Over the last fiscal year, we have raised AU$13.3 million in new capital, permitting us to advance the clinical milestones set out above. Our total assets were $28m, compared to $35m at 30 June 2022. Prudent management of our cash burn over the last year sees our cash balance at $5.2m as at 30 June 2023, compared to $7.4m at the end of FY22. FUNDING In February 2023 Kazia announced the successful conclusion of an equity financing, and we remain extremely grateful for the support of our shareholders. The placement to professional and sophisticated investors and the associated Share Purchase Plan for eligible shareholders raised an aggregate amount of A$7.1 million in new capital for the Company. The ATM facility draw downs during the year totaled A$6.2 million. The total proceeds of $A13.3 million from financing during the year have positioned the Company to drive towards important catalysts during calendar year 2023. This is a critical year for Kazia, with data read-outs expected across our clinical trial programs, including final data from the GBM AGILE pivotal study of paxalisib in glioblastoma anticipated by the end of this calendar year. BOARD AND MANAGMENT TRANSITIONS I would like to recognise and thank the Board and, my Kazia colleagues for their continued diligence and perseverance as we drive our clinical programs towards their full potential to improve the lives of patients. Their support, along with your support as a shareholder, has made my transition into the CEO role a seamless one. It is your commitment to the Company that enables us to take paxalisib and EVT801 forward through their development and clinical trials. We continue to believe the potential of our portfolio remains significant, and as we draw closer to realising that potential, all of us at Kazia remain wholly committed to delivering on your belief in the important and life-changing work we are doing. Dr John Friend Chief Executive Officer, Managing Director and Interim Chairman of Board 3 Kazia Theraputics Limited Annual Report 2023 Chairman and CEO’s Letter Key Milestones Introduction to Kazia’s CEO Pipeline Review Environment, Society and Governance Financial Reports
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