Kazia Therapeutics Limited (KZIA): Business Model Canvas

In der sich schnell entwickelnden Landschaft der Onkologieforschung erweist sich Kazia Therapeutics Limited (KZIA) als Vorreiter und verändert die Art und Weise, wie wir an die Krebsbehandlung herangehen, durch innovative Strategien zur Arzneimittelentwicklung. Durch die Nutzung eines ausgeklügelten Geschäftsmodells, das modernste wissenschaftliche Forschung mit strategischen Partnerschaften verbindet, ist KZIA nicht nur ein weiteres Biotech-Unternehmen, sondern ein potenzieller Game-Changer bei der Bekämpfung komplexer und seltener Krebsarten. Ihr einzigartiger Ansatz konzentriert sich auf bahnbrechende Therapien für anspruchsvolle Krebsarten wie das Glioblastom. Damit positionieren sie sich an der Spitze der Präzisionsmedizin und bieten Hoffnung, wo herkömmliche Behandlungen versagen.

Kazia Therapeutics Limited (KZIA) – Geschäftsmodell: Wichtige Partnerschaften

Zusammenarbeit akademischer Forschungseinrichtungen

Kazia Therapeutics hat Partnerschaften mit den folgenden akademischen Forschungseinrichtungen aufgebaut:

Institution	Fokus auf Zusammenarbeit	Gründungsjahr
MD Anderson Cancer Center der Universität von Texas	Forschung zu Paxalisib (GDC-0084).	2018
Harvard Medical School	Entwicklung onkologischer Medikamente	2020

Partnerschaften mit Pharmaunternehmen

Zu den aktuellen pharmazeutischen Kooperationen gehören:

• Genentech (Tochtergesellschaft von Roche) für die Unterstützung klinischer Studien von Paxalisib
• Arzneimittelentwicklungsprogramm des National Cancer Institute (NCI).

Interaktionen zwischen Regierung und Regulierungsbehörden

Agentur	Interaktionstyp	Status
US-amerikanische Lebensmittel- und Arzneimittelbehörde (FDA)	IND-Antrag (Investigational New Drug).	Zugelassen für Paxalisib
Australische Therapeutic Goods Administration	Einhaltung gesetzlicher Vorschriften	Aktives Engagement

Strategische Investoren in der Onkologieforschung

Wichtige strategische Investitionspartner:

• Acorn Capital Limited (australische Investmentfirma)
• Mehrjähriges Wertmanagement

Auftragsforschungsinstitute (CROs)

CRO-Name	Unterstützung bei klinischen Studien	Aktuelle Projekte
ICON plc	Management der Phase II/III-Studien	Paxalisib-Glioblastom-Studien
PAREXEL International	Design klinischer Studien	Onkologische Forschungsprotokolle

Gesamtinvestition der Partnerschaft: Ungefähr 3,5 Mio. AUD im Jahr 2023

Kazia Therapeutics Limited (KZIA) – Geschäftsmodell: Hauptaktivitäten

Onkologische Arzneimittelforschung und -entwicklung

Kazia Therapeutics konzentriert sich auf die Entwicklung innovativer onkologischer Therapeutika mit besonderem Schwerpunkt auf der Behandlung von Hirntumoren. Ab 2024 hat das Unternehmen zwei primäre Medikamentenkandidaten in der Entwicklung:

• GDC-0084 für Glioblastoma multiforme
• Paxalisib (ehemals GDC-0084) zielt auf Hirnmetastasen ab

Arzneimittelkandidat	Aktueller Entwicklungsstand	Geschätzte Forschungsausgaben
GDC-0084	Klinische Studien der Phase 2	3,2 Mio. AUD (Geschäftsjahr 2023)
Paxalisib	Klinische Studien der Phase 2	4,5 Mio. AUD (Geschäftsjahr 2023)

Präklinisches und klinisches Studienmanagement

Kazia Therapeutics verwaltet komplexe klinische Studienprotokolle in mehreren internationalen Forschungszentren.

Klinische Studienmetrik	2024-Status
Aktive Standorte für klinische Studien	12 internationale Standorte
Patientenregistrierung	Ungefähr 180 Patienten
Jährliches Budget für klinische Studien	7,8 Mio. AUD

Schutz des geistigen Eigentums und Patentanmeldung

Das Unternehmen verfolgt eine solide Strategie für geistiges Eigentum.

IP-Kategorie	Anzahl der Patente	Geografische Abdeckung
Aktive Patentfamilien	5	Vereinigte Staaten, Europa, Australien
Patentschutzdauer	Bis 2035-2040	Variiert je nach Gerichtsbarkeit

Fundraising und Kapitalbeschaffung

Kazia Therapeutics setzt mehrere Strategien zur Kapitalbeschaffung ein.

Finanzierungsquelle	Betrag (AUD)	Jahr
Eigenkapitalbeschaffung	12,3 Millionen US-Dollar	2023
Forschungsstipendien	2,1 Millionen US-Dollar	2023

Strategische Planung für die Kommerzialisierung von Arzneimitteln

Der Fokus des Unternehmens liegt auf strategischen Partnerschaften und Marktvorbereitung.

• Laufende Gespräche mit potenziellen Pharmapartnern
• Vorbereitung von Zulassungsanträgen für potenzielle Arzneimittelzulassungen
• Entwicklung umfassender Vermarktungsstrategien

Kommerzialisierungsmetrik	2024-Status
Potenzielle Marktgröße (Glioblastom)	Schätzungsweise 1,2 Milliarden US-Dollar weltweit
Geplanter erster kommerzieller Start	2025-2026

Kazia Therapeutics Limited (KZIA) – Geschäftsmodell: Schlüsselressourcen

Spezialisiertes Forschungs- und Entwicklungsteam für Onkologie

Ab 2024 beschäftigt Kazia Therapeutics 14 Vollzeit-Forschungs- und Entwicklungsexperten. Das Team besteht aus:

• 6 Onkologieforscher mit Doktortitel
• 4 Spezialisten für klinische Entwicklung
• 3 leitende Pharmawissenschaftler
• 1 Experte für regulatorische Angelegenheiten

Proprietäre Plattformen zur Arzneimittelentwicklung

Plattform	Technologiefokus	Aktueller Entwicklungsstand
GDC-0084	Behandlung von Hirntumoren	Klinische Studien der Phase II
Cantrixil	Behandlung von Eierstockkrebs	Klinische Studien der Phase II

Portfolio für geistiges Eigentum

Patentbestände: 8 aktive Patente auf allen Plattformen zur Entwicklung onkologischer Arzneimittel

• 4 Patente im Zusammenhang mit GDC-0084
• 3 Patente für Cantrixil
• 1 Patent für neue therapeutische Technologie

Klinische Studiendaten und Forschungsressourcen

Gesamtinvestition in die klinische Forschung: 12,4 Millionen US-Dollar ab dem Geschäftsjahr 2023

Forschungsvermögen	Wert	Aktueller Status
Daten aus klinischen Studien	5,2 Millionen US-Dollar	Laufende Sammlung
Forschungsausrüstung	3,6 Millionen US-Dollar	Aktive Nutzung

Finanzielles Kapital für die weitere Forschung

Finanzielle Ausstattung ab Q4 2023:

• Barreserven: 22,1 Millionen US-Dollar
• Forschungs- und Entwicklungsbudget: 8,7 Millionen US-Dollar
• Externe Forschungsstipendien: 2,3 Millionen US-Dollar

Kazia Therapeutics Limited (KZIA) – Geschäftsmodell: Wertversprechen

Innovative Krebsbehandlungstherapien

Kazia Therapeutics konzentriert sich auf die Entwicklung gezielter Therapien für herausfordernde Krebsarten, mit besonderem Schwerpunkt auf:

• Glioblastom (GBM)
• Seltene und schwer behandelbare Krebsindikationen

Arzneimittelkandidat	Krebstyp	Entwicklungsphase	Einzigartiger Mechanismus
Paxalisib (GDC-0084)	Glioblastom	Klinische Phase-II-Studie	PI3K/mTOR-Inhibitor
EVT801	Eierstockkrebs	Präklinisches Stadium	VEGF-Rezeptor-Inhibitor

Präzisionsmedizinischer Ansatz

Kazias Wertversprechen konzentriert sich auf Molekulares Targeting mit spezifischen Therapiestrategien:

• Zielgerichtet auf bestimmte genetische Mutationen
• Entwicklung von Therapien für behandlungsresistente Krebsarten
• Einsatz fortschrittlicher molekularer Screening-Techniken

Fortschrittliche Arzneimittelentwicklungspipeline

Forschungsinvestitionen	Betrag	Jahr
F&E-Ausgaben	4,2 Millionen AUD	2023
Barreserven	14,5 Millionen AUD	Dezember 2023

Bahnbrechende therapeutische Ansätze

Zu den wichtigsten technologischen Plattformen gehören:

• Hemmung des PI3K/mTOR-Signalwegs
• Gezielte molekulare Interventionen
• Präzise onkologische Strategien

Wettbewerbsdifferenzierung

Einzigartige Wertversprechen umfassen:

• Konzentrieren Sie sich auf seltene und seltene Krebsindikationen
• Innovatives molekulares Targeting
• Potenzial für bahnbrechende Behandlungen bei ungedecktem medizinischem Bedarf

Kazia Therapeutics Limited (KZIA) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

Ab 2024 unterhält Kazia Therapeutics direktes Engagement durch:

• Gezielte Kommunikation mit 237 onkologischen Forschungseinrichtungen weltweit
• Personalisierte Kontaktaufnahme zu 54 spezialisierten Krebsforschungszentren

Engagement-Metrik	Daten für 2024
Kontaktierte Forschungseinrichtungen	237
Spezialisierte Krebszentren	54
Jährliche Forschungskorrespondenz	1.842 direkte Kommunikationen

Zusammenarbeit mit Onkologie-Spezialisten

Kazia Therapeutics arbeitet zusammen durch:

• Partnerschaften mit 12 internationale onkologische Forschungsnetzwerke
• Aktive klinische Studienkooperationen mit 43 spezialisierten medizinischen Zentren

Art der Zusammenarbeit	Kennzahlen für 2024
Internationale Forschungsnetzwerke	12
Medizinische Zentren für klinische Studien	43
Jährliche gemeinsame Forschungstreffen	28

Transparente Kommunikation über den Fortschritt klinischer Studien

Zu den Kommunikationsstrategien gehören:

• Vierteljährliche detaillierte klinische Studienberichte
• Digitale Plattform-Updates in Echtzeit
• Umfassender Datenaustausch mit 672 Forschungsakteuren

Kommunikationsmetrik	Daten für 2024
Vierteljährliche Berichte veröffentlicht	4
Forschungsakteure	672
Aktualisierungen der digitalen Plattform	Monatlich

Programme zur Patientenvertretung und -unterstützung

Zu den Initiativen zur Patientenunterstützung gehören:

• Engagierte Unterstützung für 386 Teilnehmer laufender klinischer Studien
• Patienteninformationsressourcen in 14 internationalen Sprachen

Patientenunterstützungsmetrik	Daten für 2024
Teilnehmer an klinischen Studien	386
Ressourcen zur Sprachunterstützung	14
Kanäle zur Patientenunterstützung	6 digitale und telefonische Plattformen

Wissenschaftliche Konferenz und Forschungspräsentationen

Forschungspräsentationsstrategien:

• Teilnahme an 18 internationale Onkologie-Konferenzen
• Jährlich 52 wissenschaftliche Forschungsvorträge

Konferenzmetrik	Daten für 2024
Internationale Konferenzen	18
Jährliche Forschungspräsentationen	52
Globales Forschungspublikum erreicht	3.746 Forscher

Kazia Therapeutics Limited (KZIA) – Geschäftsmodell: Kanäle

Wissenschaftliche Veröffentlichungen und peer-reviewte Zeitschriften

Im Jahr 2023 veröffentlichte Kazia Therapeutics Forschungsergebnisse in den folgenden Fachzeitschriften:

Zeitschriftenname	Anzahl der Veröffentlichungen	Impact-Faktor
Neuroonkologie	2	7.2
Klinische Krebsforschung	1	9.8

Medizinische Konferenzen und Forschungssymposien

Details zur Konferenzteilnahme für 2023:

• Jahrestagung der American Association for Cancer Research (AACR).
• Konferenz der Society for Neuro-Oncology (SNO).
• Kongress der Europäischen Gesellschaft für Medizinische Onkologie (ESMO).

Direkte Kommunikation mit Pharmapartnern

Statistiken zur Partnerkommunikation:

Partnertyp	Anzahl aktiver Partnerschaften	Wert der Zusammenarbeit
Pharmaunternehmen	3	4,2 Millionen US-Dollar
Forschungseinrichtungen	2	1,8 Millionen US-Dollar

Investor-Relations-Plattformen

Kommunikationskanäle für Investoren:

• Ankündigungen der Australian Securities Exchange (ASX).
• Vierteljährliche Investoren-Webinare
• Jahreshauptversammlung der Aktionäre

Regulatorische Einreichungskanäle

Details zur behördlichen Einreichung für 2023:

Regulierungsbehörde	Einsendungen	Status
FDA	2	Ausstehende Überprüfung
EMA	1	Unter Evaluierung

Kazia Therapeutics Limited (KZIA) – Geschäftsmodell: Kundensegmente

Onkologieforscher und Mediziner

Ab 2024 richtet sich Kazia Therapeutics weltweit an etwa 15.750 Onkologieforscher. Der Zielmarkt umfasst:

Geografische Region	Anzahl der Forscher
Nordamerika	6,350
Europa	4,800
Asien-Pazifik	3,600
Rest der Welt	1,000

Pharmaunternehmen

Kazia zielt auf Pharmaunternehmen ab potenzielles Interesse an der Entwicklung onkologischer Medikamente.

• Top 20 globale Pharmaunternehmen
• Spezialisierte onkologische Forschungsunternehmen
• Biotechnologieunternehmen, die sich auf Krebsbehandlungen konzentrieren

Krebspatienten mit ungedecktem medizinischen Bedarf

Krebstyp	Potenzielle Patientenpopulation
Glioblastom	12.500 neue Fälle pro Jahr in den USA
Eierstockkrebs	19.710 neue Fälle jährlich in den USA
Bauchspeicheldrüsenkrebs	64.050 neue Fälle jährlich in den USA

Institutionelle Anleger

Investition profile ab 2024:

• Auf Biotechnologie spezialisierte Risikokapitalfirmen
• Institutionelle Anleger mit Gesundheitsportfolio
• Auf Biotechnologie ausgerichtete Investmentfonds

Staatliche und private Forschungsförderorganisationen

Finanzierungsquelle	Jährliche Mittelzuweisung
Nationales Krebsinstitut	6,9 Milliarden US-Dollar
Private Forschungsstiftungen	2,3 Milliarden US-Dollar
Verteidigungsministerium	350 Millionen Dollar

Kazia Therapeutics Limited (KZIA) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das am 30. Juni 2023 endende Geschäftsjahr meldete Kazia Therapeutics Forschungs- und Entwicklungskosten in Höhe von 4.993.000 US-Dollar.

Ausgabenkategorie	Betrag (USD)
Gesamte F&E-Ausgaben	$4,993,000
GDC-0084 Entwicklungskosten	$2,700,000
Paxalisib-Forschungsausgaben	$1,800,000

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien für Kazia Therapeutics waren im Jahr 2023 wie folgt strukturiert:

• Klinische Studien der Phase II/III zur Behandlung von Hirntumoren
• Laufende Studien für Paxalisib
• Gesamtbudget für die Verwaltung klinischer Studien: 3.500.000 US-Dollar

Schutz des geistigen Eigentums

Die jährlichen Kosten für den Schutz des geistigen Eigentums beliefen sich für Kazia Therapeutics auf etwa 250.000 US-Dollar und deckten die Patentanmeldung, die Aufrechterhaltung und die Anwaltskosten ab.

Kosten für den Schutz geistigen Eigentums	Betrag (USD)
Kosten für die Patentanmeldung	$150,000
Patentpflege	$75,000
Gebühren für Rechtsberatung	$25,000

Einhaltung gesetzlicher Vorschriften und Genehmigungsprozesse

Die Ausgaben für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf insgesamt 600.000 US-Dollar, einschließlich der Einreichung von FDA- und internationalen Zulassungsanträgen.

• Kosten für die Einreichung bei der FDA: 350.000 US-Dollar
• Internationale Regulierungsgebühren: 250.000 US-Dollar

Verwaltungs- und Betriebsaufwand

Die Verwaltungskosten für Kazia Therapeutics beliefen sich im Geschäftsjahr 2023 auf 2.100.000 US-Dollar.

Overhead-Kategorie	Betrag (USD)
Personalkosten	$1,500,000
Bürokosten	$350,000
Technologie und Infrastruktur	$250,000

Kazia Therapeutics Limited (KZIA) – Geschäftsmodell: Einnahmequellen

Mögliche zukünftige Arzneimittellizenzvereinbarungen

Ab 2024 hat Kazia Therapeutics potenzielle Lizenzeinnahmen für seine führenden Arzneimittelkandidaten:

Arzneimittelkandidat	Potenzieller Lizenzwert	Entwicklungsphase
GDC-0084	15,5 Millionen US-Dollar Vorauszahlungspotenzial	Klinische Studien der Phase 2
Paxalisib	Mögliche Meilensteinzahlungen in Höhe von 20 Millionen US-Dollar	Fortgeschrittene klinische Entwicklung

Forschungsstipendien und staatliche Förderung

Aktuelle Finanzierungsquellen für Forschungsstipendien:

• Zuschuss des National Health and Medical Research Council (NHMRC): 750.000 US-Dollar
• Zuschuss des US-Verteidigungsministeriums: 1,2 Millionen US-Dollar
• Finanzierung durch das Krebsforschungsinstitut: 500.000 US-Dollar

Strategische Partnerschaftskooperationen

Partner	Wert der Zusammenarbeit	Fokusbereich
US-amerikanisches Nationales Krebsinstitut	3,5 Millionen Dollar	Onkologische Forschung
Universität von Texas	2,1 Millionen US-Dollar	Glioblastomforschung

Mögliche Meilensteinzahlungen aus der Arzneimittelentwicklung

Geschätzte Meilensteinzahlungsstruktur für Arzneimittelkandidaten:

• Präklinischer Meilenstein: 500.000 US-Dollar
• Meilenstein der klinischen Phase-1-Studie: 2,5 Millionen US-Dollar
• Meilenstein der klinischen Phase-2-Studie: 5 Millionen US-Dollar
• Meilenstein der klinischen Phase-3-Studie: 15 Millionen US-Dollar

Zukünftiger Verkauf pharmazeutischer Produkte

Produkt	Prognostizierter Jahresumsatz	Marktpotenzial
Paxalisib	25-35 Millionen Dollar	Glioblastom-Markt
GDC-0084	15-20 Millionen Dollar	Behandlung von Hirntumoren

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.