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Kazia Therapeutics Limited (KZIA): Business Model Canvas [Dec-2025 Updated] |
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Kazia Therapeutics Limited (KZIA) Bundle
You're looking at a classic, high-stakes biotech play here with Kazia Therapeutics Limited, and honestly, the Business Model Canvas tells a clear story: it's all about funding the pipeline until Paxalisib hits a commercial inflection point. Based on their FY2025 spend, R&D was a major focus, running alongside G&A costs of about $8.72 million AUD, but they've bought runway until the second half of 2028 thanks to that recent December 2025 PIPE bringing in $46.5 million net. So, the model hinges on strategic licensing, like the Simcere deal, and keeping the lights on through equity raises to push their brain-penetrant PI3K/mTOR inhibitor through those crucial FDA trials; you defintely need to see the full breakdown below to grasp their risk/reward profile.
Kazia Therapeutics Limited (KZIA) - Canvas Business Model: Key Partnerships
You're looking at the network that keeps Kazia Therapeutics Limited moving forward, the critical external relationships that fund and advance the pipeline. It's a mix of capital providers, technology in-licensors, and clinical collaborators. Here's the quick math on those key ties as of late 2025.
Commercialization and Licensing Partners
The most significant recent financial partnership involves institutional capital, but the commercialization footprint is anchored by regional agreements. The agreement with Simcere Pharmaceutical Group Ltd for Greater China remains a cornerstone for paxalisib's global strategy.
The Simcere deal terms, established in March 2021, included:
- Upfront payment of US$11 million, which comprised US$7 million in cash and a US$4 million equity investment priced at a 20% premium.
- Contingent milestone payments up to US$281 million for glioblastoma, with further milestones for indications beyond glioblastoma.
- Royalties on commercial sales set at a mid-teen percentage.
Drug Licensors
Kazia Therapeutics Limited built its core asset around an in-licensed molecule. The primary drug candidates rely on agreements with major entities:
| Drug Candidate | Licensor | Licensing Date/Context |
| Paxalisib | Genentech | Late 2016 |
| EVT801 | Evotec SE | April 2021 |
Paxalisib has been the subject of ten clinical trials in brain cancer as of May 2025.
Institutional Healthcare Investors Providing Capital
Securing operational runway is a constant partnership focus. The December 2025 Private Investment in Public Equity (PIPE) was a major event, led by several healthcare-dedicated funds. This financing is critical, especially considering the reported FY2025 net loss was A$20.7 million and cash at bank was only A$4.3 million as of June 30, 2025.
The December 2025 PIPE details:
- Total size: approximately $50.0 million of ordinary shares and prefunded warrants.
- Expected net proceeds: approximately $46.5 million after fees.
- Purchase price: equivalent to $5.00 per ADS.
- Lead investors included Adar1 Capital Management LLC, Ikarian Capital LLC, Stonepine Capital Management, Velan Capital Investment Management LP, and Revach Capital Management, LLC.
- The financing is expected to extend the cash runway into the second half of 2028.
The Company also completed a $2.0 million private placement in August 2025.
Academic Research Institutions for Clinical Trials and Development
Clinical advancement heavily relies on academic and foundation support. The pipeline progression is mapped against milestones with these groups:
Kazia Therapeutics Limited has active collaborations with several key institutions:
- QIMR Berghofer Medical Research Institute: Kazia executed an in-licensing agreement on October 7, 2025, for a PD-L1 degrader program (NDL2), involving a one-time payment of approximately $1.39 million. An earlier exclusive license from them for PI3K combination therapies followed a collaboration that began in December 2022.
- PNOC: The team is tasked to complete PK/biomarker data analysis for paxalisib in brain metastasis and provide an update in CY2025.
- Institute of Cancer Research, London: This institution sponsors the 5G study for paxalisib.
The 5G study is fully funded by Cancer Research UK and the Minderoo Foundation. Furthermore, research into paxalisib for Parkinson's disease is funded by a grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF), announced in February 2025, involving The Hebrew University of Jerusalem.
Contract Research Organizations (CROs)
While specific CRO names aren't consistently disclosed in the public updates, the need for management of global studies is explicit. The company stated an objective to 'select strategic CRO partner' to finalize the protocol, costs, and timelines for the paxalisib glioblastoma program following the December 2024 FDA meeting. The Phase 1 trial of EVT801 reached the last patient follow-up as of May 2025.
Kazia Therapeutics Limited (KZIA) - Canvas Business Model: Key Activities
You're looking at the core engine of Kazia Therapeutics Limited, which is heavily weighted toward executing complex, multi-site clinical development programs for its lead asset, paxalisib, and advancing its next-generation asset, NDL2. The company operates on a lean virtual pharma model, where approximately ~75% of cashflows are applied directly to clinical trials. This focus on clinical execution is supported by recent significant capital raises.
Conducting and managing multiple global clinical trials for Paxalisib
The primary activity revolves around advancing paxalisib, a brain-penetrant inhibitor of the PI3K/Akt/mTOR pathway, which has been the subject of 10 clinical trials in brain cancer alone since being in-licensed from Genentech. You see the company pushing this asset across several indications simultaneously.
Here's a snapshot of the key clinical data driving these activities:
| Indication/Trial Phase | Key Metric | Value/Result | Date Context |
| GBM-Agile (Pivotal Phase 2/3) | Median OS Improvement (Unmethylated GBM) | 3.8-month improvement (33%) | Reported 2024; data used for regulatory engagement in 2025 |
| GBM-Agile (Unmethylated GBM) | Median OS (Paxalisib Arm, n=54) | 15.54 months | Reported October 2025 |
| GBM-Agile (Unmethylated GBM) | Median OS (SOC Arm, n=46) | 11.89 months | Reported October 2025 |
| Phase 2 GBM Trial (MGMT Unmethylated) | PFS vs. Temozolomide | 8.5 months vs. 5.3 months | Historical data supporting current strategy |
| Advanced Breast Cancer (Phase 1b) | Trial Launch/First Dosing | Launched 1Q CY2025 / Dosed in June 2025 | 2025 activity |
| Advanced TNBC (Expanded Access) | Tumor Burden Reduction | 86% after three weeks | Reported October 2025 |
| Advanced TNBC (Expanded Access) | Response Status (iCR) | Initial Immune-Complete Response (iCR) | Reported November 2025 |
The company also has ongoing trials in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, plus research exploring paxalisib for Parkinson's Disease, funded by a Michael J. Fox Foundation grant announced on February 20, 2025.
Regulatory engagement with the FDA (e.g., Type C meetings, Project FrontRunner)
Engaging the U.S. Food and Drug Administration (FDA) is a critical, ongoing activity to define the path to market for paxalisib in Glioblastoma (GBM). You've seen the company actively seeking alignment.
- FDA meeting in Dec 2024 confirmed a standard approval pathway requiring a single pivotal registrational study in newly diagnosed (NDU) GBM patients.
- Alignment reached in May 2025 on key aspects of the proposed registrational/pivotal Phase 3 study design, including patient population and primary endpoint.
- Intention announced in October 2025 to request a follow-up Type C meeting to discuss Overall Survival (OS) findings and seek feedback on a pathway aligned with the FDA Oncology Center of Excellence's Project FrontRunner initiative.
Paxalisib already holds several designations from the FDA, including Orphan Drug Designation for GBM (February 2018) and Fast Track Designation (FTD) for GBM (August 2020).
Preclinical development of the new PD-L1 degrader program (NDL2)
Kazia Therapeutics Limited is building out its second differentiated asset, NDL2, a first-in-class PD-L1 protein degrader, following an exclusive collaboration and in-licensing agreement with QIMR Berghofer announced on October 7, 2025. This is a clear strategic pivot into next-generation immuno-oncology.
- NDL2 is designed to degrade post-translationally modified forms of PD-L1, potentially overcoming resistance to current checkpoint inhibitors.
- Preclinical models in aggressive triple-negative breast cancer (TNBC) showed significant tumor growth reduction with NDL2 monotherapy and in combination with anti-PD-1 therapies.
- The company plans to initiate IND-enabling preclinical studies in early 2026.
Securing non-dilutive funding via regional licensing and asset sales
While the company recently relied on equity financing, securing non-dilutive funding remains a stated objective, reflecting a licensing-driven business model. You saw concrete results from this activity early in the year.
In the first quarter of 2025, Kazia Therapeutics raised a total of $3 million in new capital, which specifically included $1 million in non-dilutive funding. This contrasts with the large equity raise in December 2025, where the company announced a $50 million private placement (PIPE) expected to yield net proceeds of approximately $46.5 million, extending the cash runway into the second half of 2028.
Research and development of brain-penetrant oncology therapeutics
This is the foundational R&D activity that underpins the entire company, centered on paxalisib as the only brain-penetrant PI3K inhibitor in development. The R&D focus is on maximizing the value of this unique characteristic across multiple central nervous system (CNS) and solid tumor indications.
- Paxalisib is being evaluated in ongoing clinical trials for brain metastases, diffuse midline gliomas, and primary CNS lymphoma, in addition to GBM and advanced breast cancer.
- The company's lean model dictates that about ~75% of its cash flows are directed to these clinical trial activities.
Finance: draft 13-week cash view by Friday.
Kazia Therapeutics Limited (KZIA) - Canvas Business Model: Key Resources
You're looking at the core assets Kazia Therapeutics Limited (KZIA) is relying on to drive value, especially after that recent capital raise. These are the tangible and intangible things the company owns or controls that are essential to its business model.
The lead asset is definitely Paxalisib, the brain-penetrant PI3K/mTOR inhibitor. Its protection is layered, which is key for a biotech firm. The manufacturing patents, granted in the US and India, extend effective protection out to 2036. That's a solid buffer beyond the original composition of matter patents, which generally expire around 2031 but are likely eligible for a five-year patent term extension in key territories. That's the quick math on their primary IP runway.
The regulatory achievements for Paxalisib are significant resources in themselves, streamlining development and offering potential market exclusivity:
- Orphan Drug Designation for glioblastoma granted in February 2018.
- Fast Track Designation for glioblastoma granted in August 2020.
- Rare Pediatric Disease Designation for diffuse intrinsic pontine glioma granted in August 2020.
- Orphan Drug Designation for atypical teratoid / rhabdoid tumours granted in July 2022.
Financially, the recent Private Investment in Public Equity (PIPE) was a major resource injection. It secured capital to fund operations well into the future, reducing immediate financing pressure. This is the kind of move that buys time for clinical progress. It's a definite lifeline.
| Resource Metric | Detail | Value/Date |
|---|---|---|
| Recent PIPE Size | Total Equity Securities Sold | $50 million |
| Net Proceeds from PIPE | After deducting placement agent fees and expenses | Approximately $46.5 million |
| PIPE Price Per ADS | Purchase price equivalent | $5.00 per ADS |
| Cash Runway Extension | Expected duration with new capital | Into the second half of 2028 |
| EVT801 First-in-Human Trial Status | Stage 1 completion | Stage 1 complete; Final Phase 1 readout expected CY2025 |
| NDL2 In-Licensing Payment | One-time payment to QIMR Berghofer | Approximately $1.39 million |
Beyond Paxalisib, Kazia Therapeutics Limited (KZIA) holds in-licensed assets that diversify the pipeline. EVT801, a selective VEGFR3 inhibitor licensed from Evotec SE in April 2021, is advancing, with its first-in-human study Stage 1 complete. Also, the NDL2 PD-L1 degrader program, secured via an exclusive collaboration and in-licensing agreement in October 2025, represents a strategic move into next-generation immuno-oncology. The terms for NDL2 included a one-time payment of about $1.39 million, plus responsibility for all future development costs.
Kazia Therapeutics Limited (KZIA) - Canvas Business Model: Value Propositions
For you, as a decision-maker looking at Kazia Therapeutics Limited (KZIA), the value proposition centers on delivering first-in-class or best-in-class targeted therapies where the current standard of care falls short, especially in hard-to-treat brain cancers.
Offering the only brain-penetrant dual PI3K/mTOR inhibitor in development (Paxalisib).
Paxalisib is positioned as a brain-penetrant inhibitor targeting the PI3K/Akt/mTOR pathway, a critical driver in many cancers. This mechanism is being explored across several indications where current options are limited. The company's financial footing, as of late 2025, includes a recent $50 Million private placement announced on December 2, 2025, with net proceeds of approximately $46.5 Million intended to further this development, extending the cash runway into the second half of 2028.
The company's financial snapshot for the fiscal year ended June 30, 2025, showed Total Revenue of $1,199 Thousand USD, with Research and Development expenses at $4,801 Thousand USD. The market capitalization for Kazia Therapeutics Limited stood at $USD143.60M as of December 2, 2025.
| Financial Metric (Year Ended 6/30/2025) | Amount (USD Thousands) |
| Total Revenue | $1,199 |
| Research and Development Expense | $4,801 |
| Sales, General and Admin. Expense | $5,715 |
Addressing high unmet medical need in aggressive cancers like Glioblastoma (GBM).
Glioblastoma remains one of the most lethal cancers with limited therapeutic options. The grim prognosis is stark; the overall five-year survival rate for GBM is still around 5%, and average survival often does not traverse the one-year mark. GBM is the most common and lethal primary malignant brain tumor in adults, accounting for approximately 45-50% of all primary brain cancers. The global market for GBM is projected to reach USD 6.41 billion by 2033.
In a prespecified secondary analysis for newly diagnosed, up-front unmethylated GBM patients, median Overall Survival (OS) reached 15.54 months in the paxalisib arm (n = 54) compared to 11.89 months for concurrent standard of care (n = 46). This data is being used to seek feedback from the FDA on a potential conditional approval pathway aligned with Project FrontRunner.
Potential to overcome immunotherapy resistance in advanced breast cancer.
Kazia Therapeutics Limited is actively exploring paxalisib's role in advanced breast cancer, including in combination with immunotherapy like pembrolizumab (Keytruda®).
- In a Phase 1b trial for metastatic triple-negative breast cancer (TNBC), the first patient showed a >50% reduction in circulating tumor cells (CTCs) after just 21 days of the combination regimen.
- Ex vivo study data in Stage IV HER2-positive metastatic breast cancer showed paxalisib monotherapy achieved a complete (100%) disruption of circulating tumor cell (CTC) clusters (≥3 cells).
- HER2-positive breast cancer, which accounts for 15-20% of cases, still presents a clinical challenge with resistance and recurrence despite targeted therapies.
Providing a targeted therapy for rare pediatric brain cancers (DIPG, AT/RT).
Paxalisib has received regulatory designations to address rare pediatric central nervous system tumors, highlighting the extreme unmet need in these populations.
- For Diffuse Intrinsic Pontine Glioma (DIPG), Kazia Therapeutics Limited received Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA in August 2020.
- Approximately 150-300 patients are diagnosed with DIPG in the USA per year, with a median age of diagnosis around 6-7 years old.
- For Atypical Teratoid / Rhabdoid Tumours (AT/RT), the company received Orphan Drug Designation in June/July 2022.
- AT/RT has a dismal prognosis, with 5-year survival rates between 0 and 30%. The overall incidence was reported as 0.084 per 100,000 population.
Kazia Therapeutics Limited (KZIA) - Canvas Business Model: Customer Relationships
The Customer Relationships for Kazia Therapeutics Limited are heavily weighted toward sophisticated external stakeholders, reflecting its clinical-stage, licensing-driven, lean operational structure.
Investor relations and communication to secure ongoing equity funding
Securing capital through direct engagement with institutional and accredited investors is a primary relationship focus, especially given the cash burn associated with drug development. The relationship structure is direct, often involving a private investment in public equity (PIPE) placement.
The December 2, 2025, private placement involved an aggregate offering of approximately $50.0 million of ordinary shares and prefunded warrants, structured at a purchase price equivalent to $5.00 per ADS (American Depositary Share). The net proceeds to Kazia Therapeutics Limited were anticipated to be approximately $46.5 million after deducting fees and expenses. This financing is projected to extend the cash runway into the second half of 2028. Earlier in 2025, Kazia Therapeutics Limited raised $2 Million in a private equity investment on August 1, 2025, and raised $3 million in Q1 2025, which included $1 million in non-dilutive funding.
| Metric | Value (as of late 2025) |
| December 2025 PIPE Size | $50.0 million |
| Estimated Net Proceeds (Dec 2025 PIPE) | $46.5 million |
| Price per ADS (Dec 2025 PIPE) | $5.00 |
| Cash Runway Extended To | H2 2028 |
| Q1 2025 Capital Raised (Total) | $3 million |
| Q1 2025 Non-Dilutive Funding | $1 million |
| 2025 Revenue | $1,187,662 |
| 2025 Earnings | -$13,442,857 |
| Post-PIPE Stockholders' Equity Minimum for Nasdaq Compliance | $2.5 million |
High-touch, direct engagement with key opinion leaders and clinical investigators
Engagement is focused on clinical validation and regulatory pathway navigation, often involving direct interaction with scientific and medical experts.
- The management team combines expertise in clinical development and regulatory affairs to streamline translational research and engage with key opinion leaders.
- Kazia Therapeutics Limited reached alignment with the FDA on key aspects of the design of a proposed registrational/pivotal phase 3 study of paxalisib for glioblastoma (GB).
- The company plans to hold a crucial Type C meeting with the U.S. FDA to discuss new survival data in glioblastoma patients.
- Kazia Therapeutics Limited announced a Collaboration and In-Licensing Agreement for a First-in-Class PD-L1 Protein Degrader Program on October 7, 2025.
Strategic, long-term relationships with licensing and research partners
The business model is fundamentally built on sourcing assets through strategic agreements, establishing long-term relationships with the originators of the intellectual property.
- The licensing-driven business model sources clinical-stage assets from Genentech (paxalisib) and Sanofi / Evotec (EVT801).
- The Michael J. Fox Foundation for Parkinson's Research (MJFF) awarded a research grant to fund research exploring paxalisib for Parkinson's disease (PD).
- A commercial licensee is in place for China for paxalisib.
- A licensee is in place for intractable seizures in rare CNS diseases for paxalisib.
Lean virtual pharma model minimizes direct patient/physician infrastructure
The operational structure outsources most non-core functions, keeping internal infrastructure lean to maximize capital allocation to R&D.
- Kazia Therapeutics Limited operates with a lean virtual pharma model.
- Approximately ~75% of cashflows are applied directly to clinical trials.
- The company delisted from the Australian Securities Exchange (ASX) in November 2023 to be solely listed on NASDAQ (KZIA).
- The current ratio as of December 2, 2025, stood at 0.35, indicating short-term obligations exceeded liquid assets prior to the recent financing.
Kazia Therapeutics Limited (KZIA) - Canvas Business Model: Channels
You're looking at how Kazia Therapeutics Limited gets its product candidates, data, and capital to the relevant parties. It's a classic biotech channel strategy, relying heavily on specialized partners and regulatory interaction rather than broad direct sales.
Global network of clinical trial sites and academic centers for drug testing
The channel for generating clinical evidence relies on a network of specialized medical institutions. Paxalisib, the lead candidate, has been the subject of 10 clinical trials in brain cancer, including glioblastoma (GBM).
For the ABC-Pax study, evaluating paxalisib in combination with KEYTRUDA or LYNPARZA for advanced breast cancer, the structure involves specific sites:
- Enrolling 24 patients in the multi-center, open-label phase 1b study.
- Actively screening patients at The Royal Brisbane and Women's Hospital.
- Screening patients at Gold Coast University Hospital.
- Screening patients at Sunshine Coast University Hospital.
- Plans to open up to 4 additional sites in Australia for the ABC-Pax trial.
The EVT801 program reached the last patient follow-up in its Phase 1 trial for solid tumours as of the first quarter of 2025.
Out-licensing agreements with pharmaceutical companies for regional commercialization
Kazia Therapeutics Limited uses out-licensing to commercialize assets in specific territories or for specific indications, maintaining a lean virtual pharma model.
Key agreements that define commercial channels include:
- An out-licensing agreement executed in March 2024 with South Korea's Sovargen Co. Ltd. for global rights to paxalisib as a potential treatment for intractable epilepsy in focal cortical dysplasia type 2 (FCD T2) and tuberous sclerosis complex (TSC) disease, excluding mainland China, Hong Kong, Macao, and Taiwan, where Kazia retains rights.
- An exclusive in-licensing agreement in October 2025 with QIMR Berghofer for a PD-L1 degrader program (NDL2), which involves Kazia sharing a percentage of commercialization revenue, including any out-licensing payments received from third parties.
- In-licensing agreements for core assets include paxalisib from Genentech and EVT801 from Sanofi / Evotec.
Direct communication with regulatory bodies like the FDA
Direct engagement with the U.S. Food & Drug Administration (FDA) is a critical channel for establishing the path to market approval for paxalisib. Paxalisib has received several designations:
- Orphan Drug Designation and Fast Track Designation from the FDA for glioblastoma (GBM) in unmethylated MGMT promoter status patients.
- Rare Pediatric Disease Designation and Orphan Drug Designation for diffuse intrinsic pontine glioma (DIPG) and atypical teratoid / rhabdoid tumors (AT/RT). These designations could make Kazia Therapeutics Limited eligible for pediatric review vouchers upon product approval.
- Kazia Therapeutics Limited intended to request a Type C meeting with the FDA in late October 2025 to discuss overall survival (OS) findings in newly diagnosed GBM and a potential regulatory pathway aligned with the FDA Oncology Center of Excellence's Project FrontRunner initiative.
- Following a Type C meeting in December 2024, the FDA indicated that OS data could support a traditional/standard approval pathway, not accelerated approval, for newly diagnosed GBM.
Investor roadshows and private placements for capital raising
Capital raising is channeled through institutional and accredited investors via private placements to fund clinical development and extend the cash runway. The most recent significant financing event occurred in December 2025:
| Metric | Detail |
| Gross Private Placement Size | $50.0 million (AU$50 million) |
| Net Proceeds Expected | Approximately $46.5 million |
| Purchase Price per ADS | $5.00 per American Depositary Share (ADS) |
| Lead Investors | Adar1 Capital Management LLC, Ikarian Capital LLC, Stonepine Capital Management, Velan Capital Investment Management LP, and Revach Capital Management LLC |
| Placement Agent | Konik Capital Partners, LLC |
| Cash Runway Extended To | The second half of 2028 |
Additionally, Kazia Therapeutics Limited raised $3 million in new capital during the first quarter of 2025, which included $1 million in non-dilutive funding. The company delisted from the Australian Securities Exchange (ASX) in November 2023 and is now solely listed on NASDAQ (KZIA).
Kazia Therapeutics Limited (KZIA) - Canvas Business Model: Customer Segments
You're looking at the core audience for Kazia Therapeutics Limited (KZIA)'s lead asset, paxalisib, which is designed to penetrate the blood-brain barrier to treat central nervous system (CNS) cancers. Understanding these segments is key to valuing their near-term commercial opportunity.
Neuro-oncologists and oncologists treating primary brain cancers (GBM)
These are the specialists who manage the most aggressive adult brain tumor, Glioblastoma Multiforme (GBM). You're targeting the physicians who are treating a disease with a grim prognosis; the median overall survival for GBM remains only about 15 months following standard therapy, and less than 5% of patients survive 5 years post-diagnosis.
In the US, the National Brain Tumor Society projects roughly 24,000 new malignant primary brain tumor diagnoses in 2025. GBM itself accounts for about 16% of all primary brain and central nervous system tumors in the US. The incidence rate for GBM in the United States is approximately 3.19 per 100,000 persons. These specialists are actively seeking agents that can cross the blood-brain barrier, which is a major limitation for many chemotherapies.
Patients with newly diagnosed, MGMT-unmethylated Glioblastoma
Kazia Therapeutics Limited is specifically focused on the newly diagnosed setting, particularly the MGMT-unmethylated patient subset within GBM. This stratification is critical because the MGMT status often dictates treatment response. For the broader GBM population, the median age at diagnosis is around 64 years, and incidence is about 1.6 times higher in males than females.
The clinical data from the GBM-AGILE study showed a median Overall Survival (OS) of 11.9 months for paxalisib-treated, newly diagnosed, unmethylated patients, referencing the STUPP historical control median OS of 12.7 months. Separately, a Phase 2 study reported a median OS of 15.7 months for paxalisib-treated patients compared to 12.7 months for the standard of care, temozolomide.
Here are some key statistics defining this patient segment:
| Metric | Value/Rate | Context |
| US GBM Incidence Rate (Age-Adjusted) | 3.19 per 100,000 persons | General US Population |
| GBM as % of All Malignant Primary Brain Tumors (US) | Approx. 45-50% | Most common malignant primary brain tumor |
| Median Overall Survival (Paxalisib in GBM-AGILE) | 11.9 months | Prespecified secondary analysis |
| Median Overall Survival (Standard of Care in Phase 2) | 12.7 months | Historical control/Comparator |
Patients with advanced or metastatic breast cancer (TNBC, HER2-positive)
The focus here is heavily on Triple-Negative Breast Cancer (TNBC), which is characterized by the lack of Estrogen Receptor (ER), Progesterone Receptor (PR), and HER2 expression. This lack of targets limits standard targeted therapies. TNBC disproportionately affects younger women and individuals of African descent.
Kazia Therapeutics Limited launched a clinical trial in Q1 2025 evaluating paxalisib combined with immunotherapy in advanced breast cancer patients. Furthermore, the company reported a rare initial immune-complete response (iCR) in a patient with stage IV metastatic TNBC using paxalisib, pembrolizumab, and chemotherapy. Complete response rates for immunotherapy alone in metastatic TNBC are reported as low as 0.6-4%.
The overall patient pool size and prognosis are stark:
- TNBC accounts for about 10 to 15% of all breast cancers globally.
- The 5-year relative survival rate for all stages of TNBC is 77%.
- For metastatic TNBC (mTNBC), the 5-year survival rate is less than 12%.
- About 275,000 women are diagnosed with breast cancer in the US annually.
- The TNBC market size is projected to reach $1.5 billion by 2030.
Pediatric oncologists treating rare childhood brain tumors (DIPG)
Kazia Therapeutics Limited is also advancing development for rare childhood brain tumors, specifically Diffuse Intrinsic Pontine Glioma (DIPG), alongside other CNS indications like brain metastases. Pediatric brain tumors are the number one cancer in children in the US, with approximately 5,230 new cases projected for ages 0-19 in 2023. While the search results confirm Kazia's involvement in this area, specific 2025 patient counts or incidence rates directly tied to the DIPG segment for Kazia's target patient population aren't explicitly available.
The company's strategy includes advancing the paxalisib pediatric and brain metastasis programs, with additional data presentations expected in late 2024. Pediatric tumors, though less common overall, have a higher survival rate than adult GBM, with malignant pediatric brain tumors showing a survival rate of about 76%.
Kazia Therapeutics Limited (KZIA) - Canvas Business Model: Cost Structure
You're looking at the major cash outflows for Kazia Therapeutics Limited as of late 2025. For a clinical-stage biotech, the cost structure is almost entirely focused on advancing the pipeline, which means R&D dominates, but general overhead is still significant.
The Research and Development expenses for the full year ended June 30, 2025, totaled $4.801 million AUD. This is a substantial component, though it was lower than the prior year's R&D spend of $11.607 million AUD in FY2024.
General and administrative costs, which cover the operational overhead of running the company, were $5.715 million AUD for FY2025. This was also down from the $9.058 million AUD reported for G&A in FY2024.
The company's licensing activities represent another key cost area. For instance, in October 2025, Kazia Therapeutics Limited made a one-time payment of approximately $1.39 million to QIMR Berghofer upon entering an exclusive collaboration and in-licensing agreement for a PD-L1 degrader program.
The nature of the business means significant outsourcing costs for manufacturing and early development activities are inherent, often channeled through Contract Research Organizations (CROs) to manage clinical trials efficiently. The company's strategy is described as a lean virtual pharma model, with approximately 75% of cashflows historically applied directly to clinical trials.
The overall financial reality points to a high burn rate due to pre-commercial, late-stage drug development. For the full year ended June 30, 2025, Kazia Therapeutics Limited reported a net loss of A$20.7 million. This high expenditure against minimal revenue-only A$0.042 million in sales for FY2025-resulted in the company having cash at bank of only A$4.3 million as of June 30, 2025, underscoring the need for external funding to continue operations until at least March 2026.
Here's a quick look at the key expense components from the latest reported fiscal year:
| Cost Component | FY2025 Amount (AUD) | Context/Notes |
| Research and Development Expense | $4.801 million | Down from $11.607 million in FY2024. |
| Sales, General and Admin Expense | $5.715 million | Down from $9.058 million in FY2024. |
| In-Licensing Payment (Oct 2025) | Approx. $1.39 million | One-time payment for PD-L1 degrader program. |
| Net Loss for the Year | A$20.7 million | Reflects the high cost of advancing pipeline assets. |
The cost structure is heavily weighted towards external clinical execution, which is typical for this stage of drug development. You'll see costs related to:
- Clinical trial site costs and patient recruitment.
- Contract Research Organization (CRO) fees for trial management.
- Manufacturing and supply chain logistics for investigational products.
- Preclinical and clinical data analysis and reporting.
Finance: draft 13-week cash view by Friday.
Kazia Therapeutics Limited (KZIA) - Canvas Business Model: Revenue Streams
The revenue streams for Kazia Therapeutics Limited are heavily weighted toward non-dilutive capital events and financing activities, reflecting its pre-commercial, clinical-stage status. Primary revenue generation is non-dilutive capital from licensing agreements, exemplified by the initial upfront payment from the Simcere Pharmaceutical Group Ltd deal for Greater China rights to paxalisib, which included US$7 million in cash and a US$4 million equity investment, plus contingent milestone payments up to US$281 million for glioblastoma alone, and ongoing mid-teen percentage royalties on net sales.
A significant, non-recurring revenue event was the proceeds from asset sales, specifically the $1 million received in March 2025 from Vivesto for the sale of all intellectual property and trademarks rights to the oncology drug candidate, Cantrixil.
Equity financing provides substantial, though dilutive, capital infusions necessary for operations. Most recently, Kazia Therapeutics executed a Private Investment in Public Equity (PIPE) in December 2025, which is expected to yield net proceeds of approximately $46.5 million after deducting placement agent fees and offering expenses from the $50.0 million gross raise.
Grant funding contributes to specific research programs, such as support for a project developing an AI-driven sequential therapy strategy for DIPG/DMG, though specific recent grant amounts are not always detailed as a consistent revenue line item.
The trailing 12-month revenue remains low, which is typical for a company focused on drug development rather than product sales. The revenue for the twelve months ending June 30, 2025, was reported at $1.20 million USD.
Here's a quick look at some of the key financial figures related to revenue and capital events near the end of 2025:
| Revenue/Capital Event Type | Amount | Date/Period | Currency/Unit |
| Net Proceeds from December 2025 PIPE | $46.5 million | December 2025 | USD |
| Cantrixil IP Sale Proceeds | $1 million | March 2025 | USD |
| Trailing 12-Month Revenue (TTM) | $1.20 million | Ending June 30, 2025 | USD |
| FY 2025 Total Revenue | A$1.83 million | Fiscal Year Ending June 30, 2025 | AUD |
| Simcere Upfront Cash Payment (Historical Example) | US$7 million | March 2021 | USD |
The company's revenue structure highlights its reliance on financing and strategic transactions to fund its pipeline, including paxalisib and the newly in-licensed PD-L1 degrader program.
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