2 CHAIRMAN AND CEO’S LETTER Dear fellow shareholder, The past year has been significant for Kazia Therapeutics, with considerable progress being made across our clinical programs and as a business. Before diving into more detail around the business and clinical developments of FY2023, it’s important to acknowledge some very significant changes to Kazia’s Board and leadership team. Firstly, I would like to recognise the impactful contribution of Iain Ross, whose insights and stewardship has led the Board as Chair for the past eight years. I also wish to recognise and thank my predecessor, Dr James Garner, for his work as Chief Executive Officer and Managing Director. The many milestones that James achieved in transforming Kazia were key to positioning our Company for the exciting advances that lie ahead of us, particularly in relation to our lead program, paxalisib, and in securing EVT801 as another key asset for the Company. I couldn’t be more excited about the opportunity to lead Kazia and to continue our clinical development progress towards commercialisation. Kazia further enhanced the Board of Directors with the appointment of Ms Ebru Davidson in June of this year. Ebru is a seasoned corporate lawyer and is General Counsel for QBiotics Group Limited. We are delighted Ebru has joined the Kazia Board and look forward to her expertise and insight strengthening and complementing our team. With a renewed and refreshed Board and management team, we are more committed than ever to driving the business and our clinical programs forward, and that work is well underway. Since stepping into the CEO role in May, we have completed a full portfolio review. As a result, we are streamlining the paxalisib clinical development program into three pillars; adult brain cancer, paediatric brain cancer and brain metastases. As targeted therapeutics, both paxalisib and EVT801 have the potential to benefit a number of patients with PI3K pathway and VEGFR3 mutations respectively. Many of the recently announced clinical studies will enrol patients with these mutations. PIPELINE PROGRESS Paxalisib has seen a strong year of clinical development. Promising data from several clinical trials have been released, some clinical trials have been expanded and new trials started to further advance the potential therapeutic application of paxalisib. In early July, we were delighted to announce that the U.S. Food and Drug Administration (FDA) granted paxalisb Fast Track Designation (FTD) for the treatment of solid tumour brain metastases harbouring PI3K pathway mutations in combination with radiation therapy, the second such designation for paxalisib, and another demonstration of the continual progress of our clinical programs. Promising interim data from an ongoing phase I clinical trial in paxalisb in which patients with brain metastases from a primary tumour are receiving paxalisib in combination with radiotherapy, presented by Dr Jonathan Yang at the 2022 Annual Conference on CNS Trials and Brain Metastases, was the basis for the FDA’s decision to grant this FTD. This trial, originally conducted at the Memorial Sloan Kettering Cancer Center (MSKCC) in New York, NY, had an initial cohort of nine patients, all of which responded positively to the treatment, paving the way for the trial expansion. The Miami Cancer Institute and Fred Hutch Cancer Centre in Seattle, WA have recently joined this trial and preliminary data from the expanded cohort is expected in early 2024. In September 2022, final data from the completed phase II study of paxalisib monotherapy for newly diagnosed glioblastoma patients with unmethylated MGMT promotor status was presented at the Annual Congress of the European Society for Medical Oncology (ESMO), held in Paris, France. Key findings from the study were summarized in an oral presentation by Professor John de Groot. The overall survival of 15.7 months in the intent-to-treat population compared favourably to historical controls of 12.7 months for patients receiving temozolomide, the existing FDA-approved standard of care, in this patient group. Key pharmacodynamic data was also presented which further supported brain penetration and biological activity of paxalisib. This data was expanded upon at the Annual Meeting of the Society for Neuro-Oncology (SNO), which was held in Tampa, FL, from 17-20 November 2022 by Professor Patrick Wen from the Dana Farber Cancer Institute. In addition, Professor Matt Dun of the Hunter Medical Research Institute at the University of Newcastle was invited to give a plenary session presentation on his research during the same meeting. Professor Dun’s research combines paxalisib and ONC201 (Chimerix, Inc) for the treatment of diffuse midline gliomas (DMGs), an aggressive group of childhood brain cancers which include diffuse intrinsic pontine glioma (DIPG), with the results highlighting the synergy between the two drugs. In March of this year, we announced the launch of a new phase II clinical collaboration with the Australian and New Zealand Children’s Haematology / Oncology PROGRESSING TREATMENT AREAS
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