Kazia Therapeutics Limited (Kzia): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage en évolution rapide de la recherche en oncologie, Kazia Therapeutics Limited (KZIA) apparaît comme une force pionnière, transformant la façon dont nous abordons le traitement du cancer grâce à des stratégies innovantes de développement de médicaments. En tirant parti d'un modèle commercial sophistiqué qui plie des recherches scientifiques de pointe avec des partenariats stratégiques, Kzia n'est pas seulement une autre entreprise de biotechnologie, mais un changement de jeu potentiel dans le ciblage des types de cancer complexes et rares. Leur approche unique se concentre sur les thérapies révolutionnaires pour des cancers stimulants comme le glioblastome, les positionnant à l'avant-garde de la médecine de précision et offrant de l'espoir où les traitements traditionnels ont échoué.

Kazia Therapeutics Limited (KZIA) - Modèle commercial: partenariats clés

Collaboration des institutions de recherche universitaire

Kazia Therapeutics a établi des partenariats avec les établissements de recherche académiques suivants:

Institution	Focus de la collaboration	Année établie
Université du Texas MD Anderson Cancer Center	Recherche Paxalisib (GDC-0084)	2018
École de médecine de Harvard	Développement de médicaments en oncologie	2020

Partenariats des entreprises pharmaceutiques

Les collaborations pharmaceutiques actuelles comprennent:

• Genentech (filiale Roche) pour le soutien des essais cliniques de Paxalisib
• Programme de développement de médicaments du National Cancer Institute (NCI)

Interactions gouvernementales et agences de réglementation

Agence	Type d'interaction	Statut
Administration américaine de l'alimentation et du médicament (FDA)	Application de médicament enquête (IND)	Approuvé pour paxalisib
Administration des produits thérapeutiques australiens	Conformité réglementaire	Engagement actif

Investisseurs stratégiques dans la recherche en oncologie

Partners d'investissement stratégique clés:

• Acorn Capital Limited (entreprise d'investissement australienne)
• Gestion de la valeur vivace

Organisations de recherche contractuelle (CROS)

Nom de CRO	Soutien en essai clinique	Projets en cours
Icône plc	Gestion des essais de phase II / III	Essais de glioblastome paxalisib
Parexel International	Conception d'essais cliniques	Protocoles de recherche en oncologie

Investissement total de partenariat: environ 3,5 millions d'AUD en 2023

Kazia Therapeutics Limited (Kzia) - Modèle d'entreprise: Activités clés

Recherche et développement en oncologie

Kazia Therapeutics se concentre sur le développement de la thérapeutique innovante en oncologie avec un accent spécifique sur les traitements contre le cancer du cerveau. Depuis 2024, la société a deux principaux candidats en matière de drogue: le développement:

• GDC-0084 pour le glioblastome multiforme
• Paxalisib (anciennement GDC-0084) ciblant les métastases cérébrales

Drogue	Étape de développement actuelle	Dépenses de recherche estimées
GDC-0084	Essais cliniques de phase 2	3,2 millions de dollars AUD (2023 exercices)
Paxalisib	Essais cliniques de phase 2	AUD 4,5 millions de dollars (2023 Exercice)

Gestion des essais précliniques et cliniques

Kazia Therapeutics gère des protocoles complexes d'essais cliniques dans plusieurs centres de recherche internationaux.

Métrique d'essai clinique	Statut 2024
Sites d'essais cliniques actifs	12 emplacements internationaux
Inscription des patients	Environ 180 patients
Budget annuel des essais cliniques	AUD 7,8 millions de dollars

Protection de la propriété intellectuelle et dépôt de brevets

La société maintient une solide stratégie de propriété intellectuelle.

Catégorie IP	Nombre de brevets	Couverture géographique
Familles de brevets actifs	5	États-Unis, Europe, Australie
Durée de protection des brevets	Jusqu'en 2035-2040	Varie selon la juridiction

Collecte de fonds et acquisition de capitaux

Kazia Therapeutics utilise de multiples stratégies pour l'acquisition de capitaux.

Source de financement	Montant (Aud)	Année
Augmentation des fonds propres	12,3 millions de dollars	2023
Subventions de recherche	2,1 millions de dollars	2023

Planification stratégique pour la commercialisation des médicaments

L'entreprise se concentre sur les partenariats stratégiques et la préparation du marché.

• Discussions en cours avec des partenaires pharmaceutiques potentiels
• Préparer les soumissions réglementaires pour les approbations potentielles des médicaments
• Développer des stratégies de commercialisation complètes

Métrique de commercialisation	Statut 2024
Taille potentielle du marché (glioblastome)	Estimé 1,2 milliard de dollars dans le monde
Premier lancement commercial projeté	2025-2026

Kazia Therapeutics Limited (Kzia) - Modèle d'entreprise: Ressources clés

Équipe de recherche et développement en oncologie spécialisée

En 2024, Kazia Therapeutics emploie 14 professionnels de la recherche et du développement à temps plein. L'équipe se compose de:

• 6 chercheurs en oncologie au niveau du doctorat
• 4 spécialistes du développement clinique
• 3 scientifiques pharmaceutiques supérieurs
• 1 expert en affaires réglementaires

Plateformes de développement de médicaments propriétaires

Plate-forme	Focus technologique	Étape de développement actuelle
GDC-0084	Traitement du cancer du cerveau	Essais cliniques de phase II
Cantrixil	Traitement du cancer de l'ovaire	Essais cliniques de phase II

Portefeuille de propriété intellectuelle

Holdings de brevet: 8 brevets actifs sur les plateformes de développement de médicaments en oncologie

• 4 brevets liés au GDC-0084
• 3 brevets pour Cantrixil
• 1 brevet pour la technologie thérapeutique émergente

Données d'essai cliniques et actifs de recherche

Investissement total de recherche clinique: 12,4 millions de dollars à partir de 2023 exercices

Actif de recherche	Valeur	État actuel
Données d'essai cliniques	5,2 millions de dollars	Collection en cours
Équipement de recherche	3,6 millions de dollars	Utilisation active

Capital financier pour la recherche continue

Ressources financières au quatrième trimestre 2023:

• Réserves en espèces: 22,1 millions de dollars
• Budget de recherche et de développement: 8,7 millions de dollars
• Subventions de recherche externe: 2,3 millions de dollars

Kazia Therapeutics Limited (Kzia) - Modèle d'entreprise: propositions de valeur

Thérapies innovantes sur le traitement du cancer

Kazia Therapeutics se concentre sur le développement de thérapies ciblées Types de cancer difficile, avec un accent spécifique sur:

• Glioblastome (GBM)
• Indications de cancer rares et difficiles à traiter

Drogue	Type de cancer	Étape de développement	Mécanisme unique
Paxalisib (GDC-0084)	Glioblastome	Essai clinique de phase II	Inhibiteur PI3K / MTOR
EVT801	Cancer de l'ovaire	Étape préclinique	Inhibiteur des récepteurs du VEGF

Approche de la médecine de précision

La proposition de valeur de Kazia se concentre sur ciblage moléculaire avec des stratégies thérapeutiques spécifiques:

• Ciblant des mutations génétiques spécifiques
• Développement de thérapies pour les cancers résistants au traitement
• En utilisant des techniques de dépistage moléculaire avancées

Pipeline de développement de médicaments avancés

Investissement en recherche	Montant	Année
Dépenses de R&D	4,2 millions de dollars aud	2023
Réserves en espèces	14,5 millions de dollars aud	Décembre 2023

Approches thérapeutiques révolutionnaires

Les plates-formes technologiques clés comprennent:

• Inhibition de la voie PI3K / mTOR
• Interventions moléculaires ciblées
• Stratégies d'oncologie de précision

Différenciation compétitive

Propositions de valeur unique inclure:

• Concentrez-vous sur les indications de cancer orphelines et rares
• Ciblage moléculaire innovant
• Potentiel de traitements révolutionnaires dans les besoins médicaux non satisfaits

Kazia Therapeutics Limited (Kzia) - Modèle d'entreprise: relations clients

Engagement direct avec la communauté de la recherche médicale

En 2024, Kazia Therapeutics maintient un engagement direct à travers:

• Communication ciblée avec 237 institutions de recherche en oncologie dans le monde entier
• Sensibilisation personnalisée à 54 centres de recherche sur le cancer spécialisés

Métrique de l'engagement	2024 données
Les institutions de recherche contactées	237
Centres de cancer spécialisés	54
Correspondance de recherche annuelle	1 842 communications directes

Collaboration avec des spécialistes en oncologie

Kazia Therapeutics collabore à travers:

• Partenariat avec 12 réseaux de recherche internationale en oncologie
• Collaborations d'essais cliniques actifs avec 43 centres médicaux spécialisés

Type de collaboration	2024 mesures
Réseaux de recherche internationaux	12
Centres médicaux d'essai cliniques	43
Réunions de recherche collaborative annuelle	28

Communication transparente sur les progrès des essais cliniques

Les stratégies de communication comprennent:

• Rapports d'essais cliniques détaillés trimestriels
• Mises à jour de la plate-forme numérique en temps réel
• Partage complet de données avec 672 parties prenantes de recherche

Métrique de communication	2024 données
Rapports trimestriels publiés	4
Intervenants de recherche	672
Mises à jour de la plate-forme numérique	Mensuel

Programmes de plaidoyer et de soutien aux patients

Les initiatives de soutien aux patients comprennent:

• Soutien dédié à 386 participants à l'essai clinique en cours
• Ressources d'information des patients dans 14 langues internationales

Métrique de soutien des patients	2024 données
Participants à l'essai clinique	386
Ressources de soutien linguistique	14
Canaux de soutien aux patients	6 plateformes numériques et téléphoniques

Présentations de conférence et de recherche scientifiques

Stratégies de présentation de la recherche:

• Participer à 18 Conférences internationales en oncologie
• 52 présentations de recherche scientifique chaque année

Métrique de la conférence	2024 données
Conférences internationales	18
Présentations de recherche annuelles	52
Le public de la recherche mondiale a atteint	3 746 chercheurs

Kazia Therapeutics Limited (Kzia) - Modèle d'entreprise: canaux

Publications scientifiques et revues à comité de lecture

En 2023, Kazia Therapeutics a publié des recherches dans les revues suivantes:

Nom de journal	Comptage de publication	Facteur d'impact
Neuro-oncologie	2	7.2
Recherche du cancer clinique	1	9.8

Conférences médicales et symposiums de recherche

Détails de la participation de la conférence pour 2023:

• Réunion annuelle de l'American Association for Cancer Research (AACR)
• Conférence de la Society for Neuro-Oncology (SNO)
• Congrès de la Société européenne pour l'oncologie médicale (ESMO)

Communication directe avec les partenaires pharmaceutiques

Statistiques de communication des partenaires:

Type de partenaire	Nombre de partenariats actifs	Valeur de collaboration
Sociétés pharmaceutiques	3	4,2 millions de dollars
Institutions de recherche	2	1,8 million de dollars

Plateformes de relations avec les investisseurs

Canaux de communication des investisseurs:

• Annonces d'Australian Securities Exchange (ASX)
• Webinaires d'investisseurs trimestriels
• Réunion des actionnaires annuelle

Canaux de soumission réglementaires

Détails de soumission réglementaire pour 2023:

Agence de réglementation	Soumissions	Statut
FDA	2	Examen en attente
Ema	1	En cours d'évaluation

Kazia Therapeutics Limited (Kzia) - Modèle d'entreprise: segments de clientèle

Chercheurs en oncologie et professionnels de la santé

En 2024, Kazia Therapeutics cible environ 15 750 chercheurs en oncologie dans le monde. Le marché cible comprend:

Région géographique	Nombre de chercheurs
Amérique du Nord	6,350
Europe	4,800
Asie-Pacifique	3,600
Reste du monde	1,000

Sociétés pharmaceutiques

Kazia cible les sociétés pharmaceutiques avec Intérêt potentiel pour le développement de médicaments en oncologie.

• Top 20 des sociétés pharmaceutiques mondiales
• Cabinets de recherche en oncologie spécialisés
• Les entreprises de biotechnologie se concentrent sur les traitements contre le cancer

Patients cancéreux avec des besoins médicaux non satisfaits

Type de cancer	Population potentielle de patients
Glioblastome	12 500 nouveaux cas par an aux États-Unis
Cancer de l'ovaire	19 710 nouveaux cas par an aux États-Unis
Cancer du pancréas	64 050 nouveaux cas par an aux États-Unis

Investisseurs institutionnels

Investissement profile En 2024:

• Des sociétés de capital-risque spécialisées en biotechnologie
• Investisseurs institutionnels avec portefeuille de soins de santé
• Fonds d'investissement axés sur la biotechnologie

Organisations de financement du gouvernement et de la recherche privée

Source de financement	Attribution annuelle du financement
Institut national du cancer	6,9 milliards de dollars
Fondations de recherche privée	2,3 milliards de dollars
Ministère de la Défense	350 millions de dollars

Kazia Therapeutics Limited (Kzia) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice clos le 30 juin 2023, Kazia Therapeutics a déclaré des frais de recherche et de développement de 4 993 000 $.

Catégorie de dépenses	Montant (USD)
Total des dépenses de R&D	$4,993,000
Coûts de développement GDC-0084	$2,700,000
Dépenses de recherche paxalisib	$1,800,000

Coûts de gestion des essais cliniques

Les dépenses d'essai cliniques pour Kazia Therapeutics en 2023 ont été structurées comme suit:

• Essais cliniques de phase II / III pour les traitements contre le cancer du cerveau
• Études en cours pour paxalisib
• Budget total de gestion des essais cliniques: 3 500 000 $

Protection de la propriété intellectuelle

Les coûts annuels de protection de la propriété intellectuelle pour Kazia Therapeutics étaient d'environ 250 000 $, couvrant le dépôt de brevets, l'entretien et les frais juridiques.

Dépenses de protection IP	Montant (USD)
Frais de dépôt de brevet	$150,000
Entretien de brevets	$75,000
Frais de conseil juridique	$25,000

Processus de conformité et d'approbation réglementaires

Les dépenses de conformité réglementaire pour 2023 ont totalisé 600 000 $, y compris la FDA et les soumissions réglementaires internationales.

• Coûts de soumission de la FDA: 350 000 $
• Frais de réglementation internationaux: 250 000 $

Surfaçon administratives et opérationnelles

Les dépenses administratives de Kazia Therapeutics au cours de l'exercice 2023 étaient de 2 100 000 $.

Catégorie aérienne	Montant (USD)
Frais de personnel	$1,500,000
Dépenses de bureau	$350,000
Technologie et infrastructure	$250,000

Kazia Therapeutics Limited (KZIA) - Modèle d'entreprise: Strots de revenus

Accords potentiels de licence de médicament potentiel

Depuis 2024, Kazia Therapeutics a des opportunités potentielles de revenus de licence pour ses candidats principaux:

Drogue	Valeur de licence potentielle	Étape de développement
GDC-0084	Potentiel initial de 15,5 millions de dollars	Essais cliniques de phase 2
Paxalisib	20 millions de dollars de paiement potentiel	Développement clinique avancé

Subventions de recherche et financement gouvernemental

Sources de financement de subvention de recherche actuelles:

• GRANTION NATIONALE DE LA SANTÉ ET DE RECHERCHE MÉDICAL (NHMRC): 750 000 $
• GRANTION DU ministère de la Défense américaine: 1,2 million de dollars
• Financement du Cancer Research Institute: 500 000 $

Collaborations de partenariat stratégique

Partenaire	Valeur de collaboration	Domaine de mise au point
Institut national du cancer américain	3,5 millions de dollars	Recherche en oncologie
Université du Texas	2,1 millions de dollars	Recherche de glioblastome

Payments de jalons potentiels du développement de médicaments

Structure estimée de paiement des étapes pour les candidats à la drogue:

• Jalon préclinique: 500 000 $
• Phase 1 Essai clinique jalon: 2,5 millions de dollars
• Phase 2 Essai clinique jalon: 5 millions de dollars
• Phase 3 Essai clinique jalon: 15 millions de dollars

Ventes de produits pharmaceutiques futures

Produit	Revenus annuels prévus	Potentiel de marché
Paxalisib	25 à 35 millions de dollars	Marché du glioblastome
GDC-0084	15-20 millions de dollars	Traitement du cancer du cerveau

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.