Full Press Release Details
Kazia Therapeutics Highlights Recent
Progress and Provides Business Update
Awarded research grant from The Michael J. Fox Foundation for Parkinson s Research
(MJFF) to fund research between The Hebrew University of Jerusalem (Hebrew University) and Kazia to explore the therapeutic potential of paxalisib as a treatment for Parkinson s disease (PD)
Launched clinical trial evaluating the combination of paxalisib and immunotherapy in patients with advanced breast cancer
Reached alignment with the FDA on key aspects of the design of a proposed registrational/pivotal phase 3 study of paxalisib for treatment of
glioblastoma (GB), including patient population, primary endpoint, and comparator arm
Raised $3 million in capital during the
first quarter of 2025, which included $1 million in non-dilutive funding
Sydney, May 15, 2025
Kazia Therapeutics Limited (NASDAQ: KZIA) ( Kazia or the Company ), an oncology-focused drug development company, today announced a summary of its recent progress across its business and also provided a business update.
During the first quarter of 2025, we made significant progress both with respect to our clinical programs and corporate strategy, said John
Friend, M.D., Chief Executive Officer of Kazia Therapeutics. We recently advanced paxalisib into multiple new clinical trials, reached the last patient follow-up in a Phase 1 trial of EVT801 for the
treatment of solid tumours, and raised $3 million in new capital, including $1 million in non-dilutive funding.
Looking ahead, we anticipate a busy year for Kazia, as both paxalisib and EVT801 continue to advance across multiple clinical trials based on strong
investigator interest. We are excited about the potential of our advanced-stage pipeline candidates to address significant areas of unmet need within oncology, and we look forward to providing additional updates on our progress throughout
Pipeline - paxalisib
For investor or media questions, please contact Alex Star, (Managing Director, LifeSci Advisors LLC) at +1-201-786-8795 or Astarr@lifesciadvisors.com.
About Kazia Therapeutics Limited
Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, an investigational brain penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat
multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2/3 study in glioblastoma (GBM-Agile) was
reported in 2024 and discussions are ongoing for designing and executing a pivotal registrational study in pursuit of a standard approval. Other clinical trials involving paxalisib are ongoing in brain metastases, diffuse midline gliomas, and
primary CNS lymphoma, with several of these trials having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in February 2018, and Fast Track Designation (FTD) for glioblastoma by the FDA in
August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation
and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid / rhabdoid tumours in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small molecule inhibitor of VEGFR3,
which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided evidence of synergy with immuno-oncology agents. A Phase I study has been completed and
Forward-Looking Statements
This announcement may contain
forward-looking statements, which can generally be identified as such by the use of words such as may, will, estimate, future, forward, anticipate, or other similar words. Any
statement describing Kazia s future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward looking statements, including, but not limited to, statements
regarding: the timing for results and data related to Kazia s clinical and preclinical trials, Kazia s strategy and plans with respect to its programs, including paxalisib and EVT801, potential results of research between Hebrew University
and Kazia regarding the therapeutic potential of paxalisib for the treatment of Parkinson s disease, the potential benefits of paxalisib as an investigational PI3K/mTOR inhibitor, timing for any regulatory submissions or discussions with
regulatory agencies, the potential market opportunity for paxalisib and Kazia s intent and efforts to regain and/or maintain compliance with the applicable Nasdaq continued listing requirements and standards. Such statements are based on
Kazia s current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the
forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, related to the impact
of global economic conditions, and related to Kazia s ability to regain and/or maintain compliance with the applicable Nasdaq continued listing requirements and standards. These and other
risks and uncertainties are described more fully in Kazia s Annual Report, filed on form 20-F with the SEC, and in subsequent filings with the United States Securities and Exchange Commission. Kazia
undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking
statements, which apply only as of the date of this announcement.
This announcement was authorized for release by Dr John Friend, CEO