Kazia Therapeutics Limited
Directors’ report
31 December 2025
Research and development report
During the reporting period (July 1, 2025 to December 31, 2025), the Consolidated entity advanced paxalisib beyond neuro-oncology into multiple breast
cancer translational and clinical settings, including a Company-sponsored Phase 1b study in metastatic triple-negative breast cancer (TNBC), collaborative ex vivo studies in HER2-positive metastatic breast cancer, and expanded-access real-world use.
On 10 July 2025, the Company reported preliminary results from the first patient in its Phase 1b paxalisib combination regimen (paxalisib + pembrolizumab + standard chemotherapy) after 21 days of dosing, including a >50% reduction in
circulating tumor cells (CTCs) and a notable decrease in CTC clusters.
On 1 August 2025, the Company announced an approximately $2.0 million
private placement at a premium to market, with proceeds intended to support continued clinical development of the company’s lead programs, including paxalisib and EVT801.
On 11 September 2025, the Company announced new findings from a collaborative research program led by Professor Sudha Rao at QIMR Berghofer, reporting
that paxalisib monotherapy demonstrated a statistically significant reduction in single CTCs and complete (100%) disruption of CTC clusters (>3 cells) in ex vivo blood samples from stage IV HER2-positive metastatic breast cancer patients.
On 2 October 2025, the Company reported an expanded-access case in metastatic TNBC treated with a combination immunotherapy/chemotherapy regimen
plus paxalisib, in which imaging after three weeks of treatment demonstrated an 86% reduction in overall tumor burden.
In October 2025, the Company also
expanded its immuno-oncology pipeline through an exclusive collaboration and in-licensing agreement with QIMR Berghofer for a
first-in-class PD-L1 protein degrader program (lead optimized compound NDL2), intended to address resistance mechanisms not
reached by existing checkpoint inhibitors.
On 27 October 2025, the Company announced its intention to request a
follow-up FDA Type C meeting to discuss overall survival findings in newly diagnosed glioblastoma patients treated with paxalisib and to seek feedback on a potential regulatory pathway aligned with the FDA
Oncology Center of Excellence’s Project FrontRunner initiative.
On 18 November 2025, the Company provided a clinical update describing an
initial immune-complete response (iCR) in metastatic TNBC in an expanded-access setting and a broader Q4 business update across breast cancer immuno-oncology and GBM regulatory strategy.
In December 2025, the Company reported additional momentum across both R&D execution and corporate runway. On 2 December 2025, the Company announced
the pricing of an approximately $50.0 million private placement of equity securities, with expected net proceeds of approximately $46.5 million after fees and expenses, intended to support continued clinical development programs. On
10 December 2025, the Company announced new data from two presentations at the 2025 San Antonio Breast Cancer Symposium (SABCS), describing mechanistic and early clinical evidence supporting paxalisib activity across HER2-positive metastatic
breast cancer and TNBC.
Significant changes in the state of affairs
As noted in the ‘Going concern’ section of this Directors report, the Company entered into two securities purchase agreement with certain
established institutional investors for a private placement of equity securities (PIPE).
Apart from this change, there were no other significant changes
in the state of affairs of the Consolidated entity during the financial half-year.
Matters subsequent to the end of the financial half-year
No matter or circumstance has arisen since 31 December 2025 that has significantly affected, or may significantly affect the Consolidated entity’s
operations, the results of those operations, or the Consolidated entity’s state of affairs in future financial years.
Auditors independence
declaration
A copy of the auditors independence declaration as required under section 307C of the Corporations Act 2001 is set out immediately after
this directors report.
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