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CONTENTS CHAIRMAN AND CEO S LETTER KEY MILESTONES INTRODUCTION TO KAZIA S CEO PIPELINE REVIEW ENVIRONMENT, SOCIETY &
GOVERNANCE FINANCIAL REPORTS 2 6 8 10 12 14 ii ASX:KZA | NASDAQ:KZIA
The past year has been significant for Kazia Therapeutics, with considerable progress being made across our clinical programs and as a
business. We have completed a full portfolio review and we will streamline 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 many patients around the world with PI3K pathways and VEGFR3 mutations respectively. kaziatherapeutics.com 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
CHAIRMAN AND CEO S LETTER PROGRESSING TREATMENT AREAS 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 2
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 Chairman and
CEO s Letter Key Milestones Introduction to Kazia s CEO Pipeline Review Environment, Society and Governance Financial Reports KEY MILESTONES HIGHLIGHTS 2022/2023
KEY MILESTONES HIGHLIGHTS 2022/2023 OCT 22 JUL 22 AUG 22 SEP 22 NOV 22 DEC 22 The United States Food and
Drug Administration (FDA) awards Rare Pediatric Disease Designation (RPDD) to paxalisib for the treatment of atypical teratoid/ rhabdoid tumours (AT/ RT), a rare and highly aggressive childhood brain cancer. Kazia announces launch of its new
Scientific Advisory Board (SAB), consisting of four distinguished clinicians and scientists with expertise in the development of innovative therapies for brain cancer. The Global Coalition for Adaptive Research (GCAR) advises Kazia that the first
stage of the paxalisib arm of the GBM AGILE pivotal study has completed recruitment. The treatment arm did not meet pre-defined criteria for continuing to a second stage, and patients enrolled in the first
stage will continue on treatment as per protocol, and in follow-up, until completion of the final analysis. Promising new interim data released from an ongoing phase I clinical trial of paxalisib in
combination with radiotherapy for the treatment of brain metastases, sponsored by Memorial Sloan Kettering Cancer Center in New York, NY. Final data from the completed phase II study of paxalisib monotherapy for newly diagnosed glioblastoma (GBM)
patients with unmethylated MGMT promotor status was presented at the annual congress of the European Society for Medical Oncology (ESMO), held in Paris, France. The ongoing phase II study of paxalisib for the treatment of diffuse intrinsic pontine
glioma (DIPG) and other diffuse midline gliomas (DMGs), sponsored by the Pacific Pediatric Neuro-Oncology Consortium (PNOC), opens in two Australian sites. Paxalisib demonstrates signals of activity as a monotherapy and in combination with MEK and
BRAF inhibitors in preclinical models of melanoma according to new data from an ongoing research collaboration with the Huntsman Cancer Institute at the University of Utah in Salt Lake City, UT. Professor Matt Dun of the Hunter Medical Research
Institute at the University of Newcastle gives an oral presentation at the Society for Neuro-Oncology annual meeting in Tampa, FL, on his research evaluating ONC201 with paxalisib to treat DMGs. Preclinical data for EVT801 published in Cancer
Research Communications: Targeting Tumor Angiogenesis with the Selective VEGFR-3 Inhibitor EVT801 in Combination with Cancer Immunotherapy . Kazia enters a collaboration with QIMR Berghofer Medical
Research Institute, one of Australia s foremost cancer research centres, to explore novel uses of paxalisib in solid tumours.
FEB 23 MAR 23 APR 23 MAY 23 JUN 23 JUN 23 Closure of an equity financing, with a total of
A$7.106 million raised from a placement to professional and sophisticated investors and the associated Share Purchase Plan for eligible shareholders. Kazia enters into a collaboration with the Australian and New Zealand Children s
Haematology / Oncology Group (ANZCHOG) for the OPTIMISE phase II clinical study which will examine paxalisib in children with advanced solid tumours, including brain tumours. New data for both paxalisib and EVT801 presented at the Annual Meeting of
the American Association for Cancer Research (AACR). Dr John Friend appointed Chief Executive Officer (CEO) following the resignation of Dr James Garner as CEO and Managing Director. Dr John Friend participates in the Cancer Moonshot Brain Cancers
Forum on GBM and DIPG at the White House in Washington, DC, USA. Highly experienced corporate lawyer Ms Ebru Davidson appointed to the Board as Non-Executive Director, bringing strong governance insights on
corporate legal strategy and risk management. Kazia announces its support of the University of Sydney on a molecularly-guided phase II clinical study, LUMOS2, to examine paxalisib in adult patients with recurrent/ progressive isocitrate
dehydrogenase (IDH) mutant grade 2 and 3 gliomas (G2/3 gliomas). The study will be sponsored by the University of Sydney, and coordinated by NHMRC Clinical Trials Centre, University of Sydney, in collaboration with COGNO (CoOperative Trials Group
for Neuro- Oncology). Chairman and CEO s Letter Key Milestones Introduction to Kazia s CEO Pipeline Review Environment, Society and Governance Financial Reports Kazia Theraputics Limited Annual Report 2023 5
INTRODUCING KAZIA S NEW CEO DR JOHN FRIEND A seasoned leader in the biotech industry, Dr John Friend originally joined Kazia
Therapeutics as Chief Medical Officer in November 2021. Having made an enormous contribution to the company during this time, John was the natural choice to succeed Dr James Garner as Chief Executive Officer in May 2023. With a deep understanding of
the biotech landscape, over 25 years of scientific expertise, and a passion for transforming healthcare solutions, John says it has been a seamless transition from CMO into the CEO role. I was part of all business discussions from day one when
I joined Kazia so the transition has been a smooth one. A lot of what I do now as CEO is similar to my previous role with the company, including developing the business strategy, driving the clinical programs, as well as building and managing
relationships with key stakeholders across all areas of the business, he said. For John, the elevation to the CEO role at Kazia marked a natural next step in what has been a distinguished career in the medical and biotech sectors. The medical
field runs in the Friend family, with John s father working for a multinational pharmaceutical company, and his wife, Dr. Kimberly Raymond, a practicing physician. After securing his medical degree and speciality training, John practiced
medicine in North Carolina, with his practice spanning from general care, through to obstetrics, minor surgery, and beyond. Following a move to Chicago to work for a large pharmaceutical company, John continued his career in the pharma and biotech
industries, working in a variety of roles, including building business units at multiple pharmaceutical companies in the United States. During this time, John discovered a passion for paediatric drug development, which continues to flow through to
his work today at Kazia. His philosophy stems from putting patients at the centre of everything Kazia does and he is driven by the goal of improving patients lives by developing innovative therapies and treatment solutions. We ve
not focused enough resources and effort on the paediatric population with regards to drug development and clinical trials, especially in the area of cancer. There is such a huge unmet need, and I am deeply passionate about being a part of developing
new therapies for children suffering from rare and devastating cancers. To be able to give hope and promise to those children and families effected by cancer is incredibly motivating. 6
John also understands the importance of collaboration with healthcare professionals, patient advocacy groups, and regulatory agencies to
ensure the accessibility, safety and efficacy of Kazia s therapies. The medical community is built around collaboration. Be it through drug development, clinical trials, and ultimately in bringing treatments to the patients who need it,
working closely with other healthcare professionals, regulators, and patient advocates is vital. Collaboration has been at the centre of my career, so I really appreciate how important it is that we all work together to deliver the best
outcome for patients. Of course, it s critical that all of these aspects are supported by good governance, otherwise patient outcomes may be compromised. When John joined Kazia as Chief Medical Officer in 2021, he was driven by the
exciting and extremely promising science of Kazia s clinical programs. I was super excited about the people working within the company and the opportunity to help grow the business. But what excited me most of all was the strong science
behind Kazia s drug candidates paxalisib and EVT801. Since joining I haven t looked back and I ve never had a more fulfilling job in my entire career. John also emphasises the incredible calibre of Kazia s people as
being central to him joining the business. It s that gut feeling. You get the sense that these are the right people here at Kazia, that there are a lot of really passionate and talented leaders, as well as individual contributors who are
really working hard to deliver results for both patients and shareholders. The team is the best of the best. A constant reminder of the importance of the work John and the team at Kazia are doing comes from the moving feedback he regularly
receives from patients, their families, and their physicians. Never have I been part of a company whereby I have researchers and physicians, and a lot of times families and parents, reaching out to me on a weekly basis, thanking me for what
Kazia is doing. It is an incredibly powerful and potent reminder of why the work we re doing here is so important, and the incredible potential it holds for so many people. Outside of work, John is just as passionate about his family and
his hobbies. John, his wife Kimberly and their four children all share a love of sports, from soccer, crew, taekwondo to track and field. I have done triathlons for around 20 years, but now I focus more on activities that are kinder to my
knees! We are all about outdoor activities and love spending time together as a family in nature. Looking ahead, John is excited about the immense potential Kazia s treatments may offer patients and their families one day. Hearing
the feedback that we do from patients and their families really reinforces the importance of what we are doing. Paxalisib now has two FDA Fast Track Designations, underscoring the momentum of our clinical programs. Between paxalisib and EVT801, we
have multiple clinical programs progressing well, with further milestones in terms of clinical data expected to be released soon. There is such a huge potential benefit for patients, and we re excited about the life-changing impact Kazia s
work could have as we continue to push our clinical programs forward and work to bring paxalisib and EVT801 to market. Chairman and CEO s Letter Key Milestones Introduction to Kazia s CEO Pipeline Review Environment, Society and
Governance Financial Reports We ve not focused enough resources and effort on the paediatric population with regards to drug development and clinical trials, especially in the area of cancer. There is such a huge unmet need, and I am
deeply passionate about being a part of developing new therapies for children suffering from rare and devastating cancers.
PIPELINE REVIEW ADVANCING THE CLINICAL PIPELINE PAXALISIB Kazia s lead program is paxalisib, an investigational brain-penetrant
inhibitor of the PI3K / Akt / mTOR pathway, that was specifically designed to treat brain cancer. Brain cancers account for about 15% of paediatric cancers and are the second most common type of cancer in children whereas over 300,000 adults are