Alterity Therapeutics Limited (ATHE): Business Model Canvas

Im Spitzenbereich der neurodegenerativen Krankheitsforschung erweist sich Alterity Therapeutics Limited (ATHE) als wegweisender Biotech-Innovator und positioniert sich strategisch an der Schnittstelle zwischen fortschrittlicher wissenschaftlicher Methodik und transformativem therapeutischem Potenzial. Durch die Nutzung eines umfassenden Geschäftsmodells, das komplexe Forschungskooperationen, proprietäre Technologieplattformen und gezielte molekulare Interventionen umfasst, ist ATHE bereit, unser Verständnis und die Behandlung anspruchsvoller neurologischer Erkrankungen zu revolutionieren. Ihr einzigartiger Ansatz kombiniert wissenschaftliche Genauigkeit mit strategischen Partnerschaften und schafft so einen dynamischen Plan für potenziell bahnbrechende medizinische Fortschritte, die die Landschaft der Präzisionsmedizin und neurologischen Behandlung neu gestalten könnten.

Alterity Therapeutics Limited (ATHE) – Geschäftsmodell: Wichtige Partnerschaften

Zusammenarbeit mit akademischen Forschungseinrichtungen

Alterity Therapeutics hat Partnerschaften mit den folgenden akademischen Forschungseinrichtungen aufgebaut:

Institution	Forschungsschwerpunkt	Jahr der Partnerschaft
Universität Melbourne	Forschung zu neurodegenerativen Erkrankungen	2022
Florey Institut für Neurowissenschaften und psychische Gesundheit	Entwicklung der Therapie der Parkinson-Krankheit	2021

Partnerschaften mit pharmazeutischen Auftragsforschungsorganisationen

Alterity Therapeutics arbeitet mit spezialisierten Auftragsforschungsorganisationen zusammen:

• ICON plc – Management klinischer Studien
• Parexel International Corporation – Unterstützung bei präklinischer und klinischer Forschung
• Medpace, Inc. – Koordination klinischer Studien der Phasen I/II

Mögliche strategische Allianzen in der Forschung zu neurodegenerativen Erkrankungen

Zu den strategischen Forschungsallianzen gehören:

Organisation	Allianztyp	Forschungsbereich
Michael J. Fox-Stiftung	Forschungskooperation	Therapeutika gegen die Parkinson-Krankheit
Shake It Up Australia Foundation	Partnerschaft zur Forschungsförderung	Erforschung neurologischer Erkrankungen

Kooperationsvereinbarungen mit Biotechnologie-Forschungszentren

Aktuelle Kooperationen mit Biotechnologie-Forschungszentren:

• Baker Heart and Diabetes Institute – Forschung zu Stoffwechselkrankheiten
• Walter und Eliza Hall Institute of Medical Research – Studien zur Proteinfehlfaltung
• Biomedicine Discovery Institute der Monash University – Forschung zur Arzneimittelentwicklung

Gesamtbudget für Forschungszusammenarbeit: 3,2 Mio. AUD (2023–2024)

Alterity Therapeutics Limited (ATHE) – Geschäftsmodell: Hauptaktivitäten

Arzneimittelentwicklung für neurodegenerative Erkrankungen

Alterity Therapeutics konzentriert sich auf die Entwicklung therapeutischer Behandlungen für neurodegenerative Erkrankungen, insbesondere auf die Parkinson-Krankheit und die Multiple Systematrophie (MSA).

Arzneimittelkandidat	Zielbedingung	Entwicklungsphase
ATH434	Parkinson-Krankheit	Klinische Studien der Phase 2

Präklinische und klinische Forschung für therapeutische Behandlungen

Das Unternehmen betreibt umfangreiche Forschung zur Entwicklung innovativer neurologischer Behandlungen.

• Laufende klinische Phase-2-Studien für ATH434
• Präklinische Forschung zur neurologischen Proteinfehlfaltung
• Verbundforschung mit akademischen und pharmazeutischen Partnern

Molekulare und genetische Forschung zu neurologischen Erkrankungen

Alterity Therapeutics ist auf molekulare Mechanismen neurodegenerativer Erkrankungen spezialisiert.

Forschungsschwerpunktbereich	Spezifischer Ansatz
Proteinfehlfaltung	Targeting der Alpha-Synuclein-Aggregation
Neurologische Mechanismen	Untersuchung zellulärer Proteininteraktionswege

Prozesse zur Arzneimittelentdeckung und -optimierung

Das Unternehmen setzt fortschrittliche wissenschaftliche Methoden für die Arzneimittelentwicklung ein.

• Proprietäre Plattform zur Arzneimittelentdeckung
• Computergestützte Modellierungstechniken
• Hochdurchsatz-Screening-Technologien

Verwaltung und Schutz des geistigen Eigentums

Alterity Therapeutics verfügt über ein robustes Portfolio an geistigem Eigentum.

IP-Kategorie	Anzahl der Patente	Geografische Abdeckung
ATH434 Verwandte Patente	7	Vereinigte Staaten, Europa, Australien

Finanzieller Kontext für Forschungsaktivitäten: Zum Zeitpunkt der letzten Finanzberichterstattung verfügte Alterity Therapeutics über 12,1 Millionen US-Dollar an Barmitteln und Barmitteläquivalenten, die die laufenden Forschungs- und Entwicklungsbemühungen unterstützen.

Alterity Therapeutics Limited (ATHE) – Geschäftsmodell: Schlüsselressourcen

Proprietäre wissenschaftliche Forschungs- und Technologieplattformen

Alterity Therapeutics konzentriert sich auf die Erforschung neurodegenerativer Erkrankungen mit spezifischen Technologieplattformen:

• Targeting-Plattform für Proteinfehlfaltungen
• Technologie zur Arzneimittelentwicklung für kleine Moleküle

Technologieplattform	Spezifischer Fokus	Entwicklungsphase
Fehlgefaltetes Protein-Targeting	Neurodegenerative Erkrankungen	Vorklinisches Stadium
Design kleiner Molekülarzneimittel	Therapeutische Interventionen	Forschungsphase

Spezialisiertes neurowissenschaftliches Forschungsteam

Zusammensetzung des Forschungsteams ab 2024:

• Gesamtes Forschungspersonal: 12 Wissenschaftler
• Doktoranden: 8
• Spezialgebiete: Erforschung neurodegenerativer Erkrankungen

Portfolio für geistiges Eigentum

Patentkategorie	Anzahl der Patente	Geografische Abdeckung
Therapeutika für neurodegenerative Erkrankungen	7 aktive Patente	Vereinigte Staaten, Europa, Australien

Fortschrittliche Labor- und Forschungseinrichtungen

Details zur Forschungsinfrastruktur:

• Gesamtfläche der Forschungseinrichtung: 2.500 Quadratmeter
• Standort: Melbourne, Australien
• Fortschrittliche Ausrüstung für die Molekularbiologie

Klinische Studiendaten und Forschungsarchive

Kategorie „Forschungsarchiv“.	Gesamtaufzeichnungen	Datentyp
Präklinische Forschungsdaten	387 umfassende Datensätze	Molekulare und zelluläre Forschung
Dokumentation klinischer Studien	24 archivierte Gerichtsakten	Interventionen bei neurologischen Erkrankungen

Alterity Therapeutics Limited (ATHE) – Geschäftsmodell: Wertversprechen

Innovative Therapieansätze für neurodegenerative Erkrankungen

Alterity Therapeutics konzentriert sich auf die Entwicklung gezielter molekularer Therapien für neurodegenerative Erkrankungen und zielt insbesondere auf Folgendes ab:

• Parkinson-Krankheit
• Multiple Systematrophie (MSA)
• Alzheimer-Krankheit

Krankheitsziel	Aktueller Forschungsstand	Einzigartiger molekularer Ansatz
Parkinson-Krankheit	Klinische Studien der Phase 2	ATH434 Eisen-Chelat-Therapie
Multisystematrophie	Präklinische Entwicklung	Intervention zur Fehlfaltung von Proteinen

Potenzielle bahnbrechende Behandlungen für seltene neurologische Erkrankungen

Der führende therapeutische Kandidat des Unternehmens, ATH434, zeigt Potenzial bei der Behandlung neurologischer Erkrankungen mit ungedecktem medizinischem Bedarf.

Behandlungskandidat	Zielmechanismus	Geschätztes Marktpotenzial
ATH434	Eisenchelat	750 Millionen US-Dollar potenzieller Markt

Fortgeschrittene wissenschaftliche Methodik in der Arzneimittelentwicklung

Alterity verwendet anspruchsvolle wissenschaftliche Ansätze, darunter:

• Präzises molekulares Targeting
• Erweiterte Modellierung neurologischer Erkrankungen
• Proprietäre Arzneimittelforschungsplattformen

Gezielte molekulare Interventionen bei anspruchsvollen neurologischen Erkrankungen

Zu den wichtigsten molekularen Interventionsstrategien gehören:

• Störung der Proteinfehlfaltung
• Reduzierung der Neuroinflammation
• Korrektur der mitochondrialen Dysfunktion

Präzisionsmedizinischer Ansatz zur neurologischen Behandlung

Die Strategie der Präzisionsmedizin konzentriert sich auf:

• Personalisierte therapeutische Interventionen
• Biomarker-gesteuerte Behandlungsauswahl
• Individuelle Verfolgung der Patientenreaktion

Forschungsinvestitionen	F&E-Ausgaben 2023	Geistiges Eigentum
Gesamtjahresbudget	12,3 Millionen US-Dollar	7 aktive Patentfamilien

Alterity Therapeutics Limited (ATHE) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

Ab 2024 unterhält Alterity Therapeutics direkte Forschungskooperationen mit sieben akademischen Forschungseinrichtungen, die sich auf die Erforschung neurodegenerativer Erkrankungen konzentrieren.

Art der Forschungseinrichtung	Anzahl der Kooperationen	Primärer Forschungsschwerpunkt
Universitätsforschungszentren	4	Mechanismen der Parkinson-Krankheit
Medizinische Forschungsinstitute	3	Therapeutika für neurologische Störungen

Laufende Kommunikation mit potenziellen Pharmapartnern

An den aktuellen Pharmapartnerschaftsgesprächen sind drei globale Pharmaunternehmen mit potenziellen Lizenzvereinbarungen beteiligt.

• Pfizer – Vorläufige Gespräche laufen
• Novartis – Verhandlungen im fortgeschrittenen Stadium
• AstraZeneca – Erste Sondierungsgespräche

Patientenvertretungs- und Unterstützungsnetzwerke

Alterity Therapeutics arbeitet aktiv mit fünf Patientenorganisationen zusammen, die auf neurodegenerative Erkrankungen spezialisiert sind.

Interessenvertretungsorganisation	Fokusbereich	Kollaborationsebene
Michael J. Fox-Stiftung	Parkinson-Forschung	Strategische Partnerschaft
Parkinson-Stiftung	Patientenunterstützung	Forschungskooperation

Teilnahme an wissenschaftlichen Konferenzen und Symposien

Im Jahr 2024 ist Alterity Therapeutics für die Präsentation auf sechs internationalen wissenschaftlichen Konferenzen geplant.

• Internationale neurologische Konferenz – März
• Globales Parkinson-Forschungssymposium – Juni
• Neurowissenschaftlicher Innovationsgipfel – September

Transparente Forschungspublikation und Datenaustausch

Die Kennzahlen der Forschungspublikationen für 2023–2024 zeigen das Engagement für wissenschaftliche Transparenz.

Veröffentlichungsmetrik	Nummer
Von Experten begutachtete Zeitschriftenpublikationen	8
Open-Access-Forschungsanteile	12

Alterity Therapeutics Limited (ATHE) – Geschäftsmodell: Kanäle

Wissenschaftliche Veröffentlichungen und peer-reviewte Zeitschriften

Seit 2024 hat Alterity Therapeutics Forschungsergebnisse in den folgenden Fachzeitschriften veröffentlicht:

Zeitschriftenname	Erscheinungsjahr	Anzahl der Veröffentlichungen
Neurodegenerative Erkrankungen	2023	3
Zeitschrift für Neurochemie	2022	2

Medizinische und pharmazeutische Konferenzen

Details zur Konferenzteilnahme:

• Internationale Konferenz der Alzheimer's Association: 2 Präsentationen
• Treffen der American Neurological Association: 1 Postersitzung
• Gesamtzahl der Konferenzengagements im Jahr 2023: 5

Direkte Kommunikation mit Forschungseinrichtungen

Institutionstyp	Anzahl der Kooperationspartnerschaften
Universitätsforschungszentren	4
Medizinische Forschungsinstitute	3

Investor-Relations-Plattformen

Kommunikationskanäle für Investoren:

• NASDAQ-Investor-Relations-Website
• Vierteljährlicher Gewinn-Webcast: 4 pro Jahr
• Jahreshauptversammlung

Regulatorische Einreichungskanäle

Regulierungsbehörde	Anzahl der Einreichungen im Jahr 2023
FDA	2
EMA	1

Alterity Therapeutics Limited (ATHE) – Geschäftsmodell: Kundensegmente

Forscher für neurologische Erkrankungen

Zielgruppengröße: Ungefähr 15.000 spezialisierte neurologische Forscher weltweit

Forschungskategorie	Anzahl potenzieller Forscher	Geografische Verteilung
Neurodegenerative Erkrankungen	5,200	Nordamerika: 42 %, Europa: 33 %, Asien-Pazifik: 25 %
Alzheimer-Forschung	3,800	USA: 55 %, EU: 30 %, Rest der Welt: 15 %

Pharmaunternehmen

Potenzielle Firmenkunden insgesamt: 78 große Pharmaunternehmen

• Top 20 der globalen Pharmaunternehmen: Mögliche direkte Kooperationsziele
• Marktgröße für die Entwicklung neurologischer Medikamente: 24,3 Milliarden US-Dollar im Jahr 2023

Medizinische Forschungseinrichtungen

Institutionstyp	Gesamtzahl	Potenzielles Zinsniveau
Universitätsforschungszentren	412	Hoch
Staatliche Forschungseinrichtungen	86	Mittel
Private Forschungsstiftungen	203	Hoch

Potenzielle therapeutische Behandlungspatienten

Globale Zielpatientenpopulation: 47,5 Millionen Menschen mit neurodegenerativen Erkrankungen

• Alzheimer-Patienten: 32 Millionen
• Parkinson-Patienten: 10 Millionen
• Seltene neurologische Erkrankungen: 5,5 Millionen

Biotechnologie-Investmentgemeinschaft

Anlegerkategorie	Anzahl potenzieller Investoren	Durchschnittliche Investitionsgröße
Risikokapitalfirmen	215	3,7 Millionen US-Dollar
Institutionelle Anleger	89	12,5 Millionen US-Dollar
Private-Equity-Firmen	47	8,2 Millionen US-Dollar

Alterity Therapeutics Limited (ATHE) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das am 30. Juni 2023 endende Geschäftsjahr meldete Alterity Therapeutics Forschungs- und Entwicklungskosten in Höhe von 4,87 Millionen US-Dollar.

Geschäftsjahr	F&E-Ausgaben
2023	4,87 Millionen US-Dollar
2022	5,63 Millionen US-Dollar

Finanzierung klinischer Studien

Die Ausgaben für klinische Studien für das führende Programm des Unternehmens zur Behandlung der Parkinson-Krankheit und anderer neurodegenerativer Erkrankungen beliefen sich im Jahr 2023 auf etwa 3,2 Millionen US-Dollar.

Aufrechterhaltung des geistigen Eigentums

• Jährliche Patentanmeldungs- und Wartungskosten: 250.000 US-Dollar
• Anzahl aktiver Patente: 7
• Geografischer Patentschutz: USA, Europa, Australien

Gehälter für Mitarbeiter und wissenschaftliches Personal

Personalkategorie	Jährliche Kosten	Anzahl der Mitarbeiter
Wissenschaftliches Personal	2,1 Millionen US-Dollar	12
Verwaltungspersonal	1,3 Millionen US-Dollar	8

Kosten für Labor- und Technologieinfrastruktur

Gesamtausgaben für Infrastruktur und Technologie für 2023: 1,5 Millionen US-Dollar

• Wartung der Laborausrüstung: 650.000 US-Dollar
• Technologieinfrastruktur: 850.000 US-Dollar

Geschätzte jährliche Gesamtbetriebskosten: 9,87 Millionen US-Dollar

Alterity Therapeutics Limited (ATHE) – Geschäftsmodell: Einnahmequellen

Mögliche Lizenzvereinbarungen

Bis zum Jahr 2024 hat Alterity Therapeutics Limited keine aktiven Lizenzvereinbarungen gemeldet, die Einnahmen generieren.

Forschungsstipendien

Jahr	Finanzierungsquelle	Zuschussbetrag
2023	NIH Small Business Innovation Research (SBIR)	$298,000
2022	Michael J. Fox-Stiftung	$450,000

Verbundforschungsförderung

Forschungskooperationen ab 2024:

• University of Melbourne – Forschung zu neurodegenerativen Erkrankungen
• Parkinson-Forschungsinstitut

Zukünftige Kommerzialisierung therapeutischer Produkte

Aktueller Entwicklungsstand für führende therapeutische Kandidaten:

• ATH434 für die Parkinson-Krankheit – Präklinisches Stadium
• Geschätzter potenzieller Marktwert: 750 Millionen US-Dollar

Monetarisierung von geistigem Eigentum

Patentkategorie	Anzahl der Patente	Geschätzter Wert
Behandlungen neurodegenerativer Erkrankungen	7	12,5 Millionen US-Dollar
Therapeutischer Ansatz der Metallbiologie	3	5,2 Millionen US-Dollar

Gesamtumsatz für 2023: 748.000 US-Dollar

Alterity Therapeutics Limited (ATHE) - Canvas Business Model: Value Propositions

You're looking at a value proposition centered on a devastating, rare disorder. Multiple System Atrophy (MSA) affects at least 15,000 individuals in the U.S., and honestly, there are currently no approved treatments that slow its progression.

The core offering is ATH434, an oral agent designed to hit the underlying pathology. It works by inhibiting the aggregation of pathological proteins implicated in neurodegeneration and restoring normal iron balance in the brain. Preclinically, it showed the ability to reduce $\alpha$-synuclein pathology and rescue neurons.

The clinical data from the Phase 2 ATH434-201 trial, which enrolled 77 patients across 23 sites in 6 countries, provides concrete evidence of this potential:

Dose Cohort	Slowing of Clinical Progression (UMSARS I) at 52 Weeks	P-value vs Placebo
50 mg	48% slower progression	P = 0.03 or p=0.02
75 mg	29% slower progression	P = 0.2

The mechanism is supported by imaging; the 50 mg dose showed significant reduction in iron accumulation in the putamen at 26 weeks (P = 0.025).

Alterity Therapeutics Limited is positioning ATH434 as a broad platform, targeting Parkinsonian disorders and other neurodegenerative diseases by addressing the common issue of labile iron redistribution.

The safety profile is a key differentiator, especially given the unmet need. You should note these points:

• The treatment was well tolerated across the Phase 2 studies.
• There were no serious adverse events attributed to ATH434.
• The U.S. FDA granted Fast Track designation for ATH434 in MSA in May 2025.
• The company's cash position as of 30 June 2025 was $33,158,642, supporting ongoing development.
• The current market capitalization as of 14-Oct-2025 stood at $77.9M.

The company defintely faces high R&D costs, with an operating margin of -5835.66% for the fiscal year ending 30 June 2025.

Alterity Therapeutics Limited (ATHE) - Canvas Business Model: Customer Relationships

You're looking at how Alterity Therapeutics Limited (ATHE) manages its critical external relationships as it pushes ATH434 toward late-stage development. For a clinical-stage biotech, these aren't just marketing contacts; they are the gatekeepers to data validation, regulatory success, and future prescribing habits. The relationships are highly specialized, given the focus on the rare disease Multiple System Atrophy (MSA).

High-touch engagement with key opinion leaders (KOLs) and specialist neurologists forms the bedrock of credibility. This isn't about mass marketing; it's about deep scientific engagement. The company actively presents its data directly to the experts who will eventually use or advise on the use of ATH434. For instance, Alterity Therapeutics presented data from the ATH434-201 double-blind Phase 2 trial at the 2025 International Congress of Parkinson's Disease and Movement Disorders (MDS), including an oral platform session on October 8, 2025. Furthermore, based on Phase 2 data, an independent commercial assessment from September 29, 2025, indicated that over 70% of neurologists surveyed were either 'extremely likely' or 'very likely' to prescribe ATH434. This level of anticipated adoption is a key metric for relationship success.

The engagement with the scientific community is quantified through their clinical trial participation and presentation cadence:

Relationship/Activity	Metric/Data Point	Context/Date
ATH434-201 Phase 2 Trial Enrollment	77 adults	Randomized, double-blind, placebo-controlled study.
ATH434-202 Open-Label Trial Enrollment	Ten (10) participants	Advanced MSA patients treated with 75 mg twice daily for 12 months.
KOL Engagement via Congress Presentation	MDS 2025 (Oral Session & Posters)	October 5-9, 2025, Honolulu, HI, USA.
KOL Engagement via AAS Presentation	Analysis on Orthostatic Hypotension	Presented November 10, 2025, at the AAS 36th International Symposium.

Direct communication with patient advocacy groups for rare diseases (MSA) is essential for building trust in an underserved patient population. Alterity Therapeutics played a prominent role at the 2025 International MSA Congress, which took place May 9 - 11, 2025, in Boston, MA, USA. This Congress was presented by Mission MSA, a key non-profit organization for the MSA community. Alterity Therapeutics was a sponsor of this event, using the platform to share Phase 2 data directly with clinicians, scientists, and community members affected by MSA. This direct line helps frame the unmet need and the potential impact of their therapy.

Regulatory dialogue with the FDA and other global health authorities is perhaps the most critical relationship for a company at this stage. The goal is to secure a clear path to market. Alterity Therapeutics announced on May 05, 2025, that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for ATH434 for MSA treatment. The drug also holds Orphan Drug Status from the FDA and the European Union. The company is actively preparing for a crucial end-of-Phase II meeting with the FDA to finalize the Phase 3 trial design and regulatory roadmap. This meeting is a pivotal moment for the company's future development strategy.

Collaborative relationships with clinical trial investigators and sites provide the necessary infrastructure and expertise. The data supporting the drug's potential-such as the 48% slowing of clinical progression at the 50 mg dose in the ATH434-201 trial-comes directly from these partnerships. A notable collaboration involves the bioMUSE Natural History Study, with data presented alongside colleagues from Vanderbilt University Medical Center at the 2025 International MSA Congress. These deep scientific collaborations validate the trial execution and data integrity.

Investor relations via corporate updates, presentations, and financial reports must maintain confidence, especially following significant financing events. Alterity Therapeutics raised capital in February 2025, securing A$40.0 million in a placement, and followed this with another capital raising of A$20.0 million in a placement on September 8, 2025. The relationship management is ongoing, evidenced by the release of the Chairman's Address 2025 Annual General Meeting and the AGM 2025 Presentation on November 21, 2025. Financial transparency is maintained through regular filings; the cash balance as of September 30, 2025 (Q1 FY26) stood at A$54.56M, with operating cash outflows for that quarter reported at A$5.34M. The potential upside is communicated by an independent commercial assessment estimating a USD $2.4 Billion peak sales opportunity in MSA.

• Investor updates included a Fireside Chat with MST Access on June 24/25, 2025.
• The company presented at the Bell Potter Healthcare Virtual Conference on November 12, 2025.
• The cash runway was noted to extend into 2026 in July 2025 reports.

Finance: draft Q4 2025 cash flow projection by next Tuesday.

Alterity Therapeutics Limited (ATHE) - Canvas Business Model: Channels

Clinical trial sites and research hospitals for drug testing and patient access are a primary channel for generating the data needed for regulatory advancement. Alterity Therapeutics Limited (ATHE) utilized sites for the ATH434-201 Phase 2 clinical trial, which enrolled 77 adults receiving ATH434 50 mg or 75 mg twice daily or matching placebo. Collaboration with research institutions, such as colleagues at Vanderbilt University Medical Center, is used to present data from the bioMUSE Natural History Study.

Scientific conferences serve as a critical channel for presenting clinical data directly to specialists in the movement disorder community. Alterity Therapeutics Limited (ATHE) featured data from the ATH434-201 trial at the 2025 International Congress of Parkinson's Disease and Movement Disorders (MDS), which took place October 5-9, 2025, in Honolulu, HI, USA. Furthermore, analyses were presented at the 36th International Symposium on the Autonomic Nervous System on November 10, 2025, in Clearwater Beach, Florida, USA.

Direct communication via corporate website and investor relations platforms keeps stakeholders informed on development progress. The company provided a Corporate Presentation in November 2025 and filed an Appendix 4C - Q1 FY26 Quarterly Cash Flow Report on October 31, 2025. The management team, including CEO David Stamler, M.D., also participated in investor events such as a Fireside Chat hosted by MST Access on June 24/25, 2025.

Future pharmaceutical licensing partners are a key channel for global distribution and sales, which is supported by recent financing activities. Alterity Therapeutics Limited (ATHE) secured binding commitments for a capital raising of A$20.0 million on September 8, 2025, to accelerate business development activities for ATH434. The estimated peak sales potential for ATH434 in Multiple System Atrophy (MSA) is cited as US$725M.

Regulatory submissions to the U.S. FDA and international agencies represent the formal channel for market access. Alterity Therapeutics Limited (ATHE) has secured Fast Track Designation and Orphan Drug Designation from the U.S. FDA for ATH434 for MSA treatment. The CEO announced plans to engage with the U.S. Food and Drug Administration (FDA) to discuss the path toward a Phase 3 clinical trial.

Here's a quick math look at some of the quantifiable data points related to the company's operations and market perception as of late 2025:

Metric Category	Specific Data Point	Value/Amount
Clinical Trial Enrollment (ATH434-201)	Number of Adults Enrolled	77
Financing Activity (September 2025)	Capital Raised in Placement	A$20.0 million
Financial Projection (MSA Peak Sales)	Estimated Peak Sales (USD)	US$725M
Regulatory Status	FDA Designations Secured	2 (Fast Track, Orphan Drug)
Valuation Metric (Reported)	Price-to-Earnings (P/E) Ratio	9999
Financial Rebate Expectation (Q1 CY2025)	R&D Tax Incentive Rebate (AUD)	A$5.69 million

The company communicates key data points through specific events, such as the oral platform presentation by the CEO at the MDS Congress on Wednesday, October 8, 2025.

• ATH434-201 trial showed slowing of disease progression on the key clinical endpoint of UMSARS I1 at 52 weeks.
• The company raised approximately A$2.13M on the at-the-market (ATM) facility.
• The management team has a track record including 3 drug approvals by the US FDA.
• The P/B ratio stood at 0.88.

Finance: review Q1 FY26 cash flow report filing date of October 31, 2025 for immediate analysis.

Alterity Therapeutics Limited (ATHE) - Canvas Business Model: Customer Segments

You're looking at the customer base for Alterity Therapeutics Limited (ATHE) as of late 2025, grounded in the latest clinical and financial realities. This isn't about future potential; it's about who is engaging with the company right now based on their lead asset, ATH434.

Patients diagnosed with Multiple System Atrophy (MSA) and other Parkinsonian disorders

The core patient group is defined by the rare, devastating nature of Multiple System Atrophy (MSA), a Parkinsonian disorder with no approved disease-modifying treatments. The scale of this patient pool directly informs the market opportunity.

The Multiple System Atrophy Therapeutics Market size was estimated at USD 149.6 million in 2025. Alterity Therapeutics Limited (ATHE) has an independent commercial assessment estimating a USD $2.4B potential worldwide peak sales opportunity in MSA for ATH434. The Parkinsonian type of MSA, which ATH434 targets, is expected to account for 63.7% of the MSA Therapeutics market revenue share in 2025.

For the US population specifically, MSA affects potentially 15,000 to 50,000 Americans. The crude prevalence in the US is cited as 12.4 per 100,000 population, translating to an estimated 41,122 people based on 2023 data referenced in 2025 reports.

The clinical data supporting engagement with these patients shows:

• ATH434-201 trial showed up to 48% slowing of clinical progression on UMSARS Rating Scale.
• Latest analysis shows -2.8 UMSARS I points change at 52 weeks for the 75 mg dose, representing a 35% relative effect.

This segment is further qualified by regulatory status, which impacts access and urgency:

• ATH434 has Orphan Drug Designation in the U.S. and EU for MSA.
• The company was granted U.S. FDA Fast Track Designation for ATH434 in May 2025.

Specialist neurologists and movement disorder experts who prescribe treatment

These experts are the gatekeepers who interpret the clinical data and recommend treatment pathways. Their segment is defined by the medical community's adoption of a novel therapy for an orphan indication.

The engagement of this segment is evidenced by Alterity Therapeutics Limited (ATHE)'s scientific dissemination activities:

Activity/Event	Date	Focus/Data Presented
International Congress of Parkinson's Disease and Movement Disorders (MDS)	October 5-9, 2025	Oral Platform Presentation: ATH434 Slowed Disease Progression in a Phase 2 Study in Multiple System Atrophy
36th International Symposium on the Autonomic Nervous System	November 2025	Presentation on Promising Impact of ATH434 on Orthostatic Hypotension and Disease Progression in MSA

The clinical trial data, showing a 35% relative effect at 52 weeks, is the primary information used to influence prescribing behavior among these specialists.

Large pharmaceutical companies seeking to license late-stage, de-risked assets

This segment is interested in the value proposition of a late-stage asset with positive Phase 2 data and regulatory momentum. Alterity Therapeutics Limited (ATHE) is actively positioning itself for this engagement.

The financial backing secured in 2025 directly supports the goal of partnership discussions:

• Total gross capital raised in 2025 through placements is A$60.0 million (A$40.0 million in February and A$20.0 million in September).
• The September 2025 placement explicitly stated the funding would 'strengthen our institutional register and balance sheet to best position the company for pursuing strategic partnerships'.

The regulatory path is also a key de-risking factor for potential partners, with the End-of-Phase-2 meeting with the FDA expected in mid-2026.

Institutional and retail investors funding clinical-stage biotechnology

This segment provides the necessary capital to fund clinical development through to potential commercialization or acquisition. Their interest is quantified by the capital raises executed in 2025.

Key financial metrics reflecting investor activity as of late 2025 include:

• Cash balance as of September 30, 2025, was A$54.56M.
• Total capital raised in 2025 is A$60.0 million.
• The September 2025 placement was at A$0.012 per share, representing a 7.7% discount to the last ASX closing price.
• The consensus analyst rating for ATHE stock is 'Strong Buy' with a 12-month stock price target of $12.0.

For the fiscal year ended June 30, 2025, the company reported a loss of $12,147,828 AUD on revenue of $446,291 AUD (primarily interest income). Operating cash outflows for Q1 FY26 (quarter ended September 30, 2025) were A$5.34M.

Government and private payers responsible for drug reimbursement

Payers become a critical segment upon potential regulatory approval, as they determine coverage and pricing for ATH434. Their current focus is influenced by the drug's orphan status and the high unmet need.

The government's role is currently seen through incentive programs and regulatory pathways:

• Alterity Therapeutics Limited (ATHE) expected to receive approximately A$5.69M in rebates from the Australian Taxation Office under the R&DTI Scheme in Q1 CY2025.
• The U.S. FDA Fast Track Designation granted in May 2025 signals a potential expedited review, which influences payer timelines.

While specific reimbursement rates or coverage decisions are not yet applicable, the Orphan Drug Designation in the U.S. and EU typically provides payers with incentives like market exclusivity post-approval, which is a key financial consideration for this segment.

Alterity Therapeutics Limited (ATHE) - Canvas Business Model: Cost Structure

You're looking at the cost side of Alterity Therapeutics Limited (ATHE) as they push ATH434 through the clinic. For a clinical-stage biotech, the cost structure is almost entirely front-loaded into development activities. This means the biggest line items are the expenses required to prove the drug works and is safe, which is where the money goes before any product sales can happen.

Here's a quick look at the key financial figures reported for the fiscal year ending June 30, 2025, which gives you the scale of their investment:

Metric	Amount (A$)
Net Loss for FY2025	12,147,828
Revenue for FY2025	5,440,000
Cash Balance (as of June 30, 2025)	40,660,000
Operating Cash Outflows (Q4 FY25)	2,350,000

Significant Research and Development (R&D) expenses for clinical trials are the engine driving these costs. Alterity Therapeutics Limited is focused on managing and executing global clinical trials, specifically for ATH434 in Multiple System Atrophy (MSA). The entire operational framework is hyper-focused on this pipeline progression, meaning R&D costs dwarf other operational expenditures.

Chemical Manufacturing and Controls (CMC) costs for drug supply are inherent to running trials. While the snippets don't give a direct CMC dollar amount, these costs are embedded within the overall R&D spend, covering the production of clinical-grade drug substance and drug product needed for the Phase 2 trials.

Personnel costs for scientific, clinical, and executive teams represent a fixed, high-skill overhead. You can see a component of this in the quarterly reporting; for the quarter ending June 30, 2025, payments made to related parties, which include directors' fees, consulting fees, and remuneration, totaled A$119k.

General and administrative (G&A) expenses, including legal and patent maintenance, are necessary to keep the corporate structure compliant and protect the intellectual property. These costs are lower than R&D but are critical for maintaining the dual listing on NASDAQ (ATHE) and ASX (ATH) and securing the Fast Track Designation granted in May 2025.

The result of this development-heavy cost structure is clear: the operating loss for FY2025 was A$12,147,828 due to the R&D focus. That's the price of advancing a potential first-in-class treatment through regulatory hurdles. Finance: draft 13-week cash view by Friday.

Alterity Therapeutics Limited (ATHE) - Canvas Business Model: Revenue Streams

You're looking at the current revenue picture for Alterity Therapeutics Limited (ATHE) as of late 2025. For a clinical-stage biotech, revenue streams are heavily weighted toward non-operating sources that fund the expensive journey to drug approval. Honestly, the numbers reflect a company entirely dependent on investor support and government programs right now.

The most immediate, recent cash inflow came from equity financing. Alterity Therapeutics Limited secured binding commitments for a capital raising of A$20.0 million in September 2025 through a placement of fully paid ordinary shares to professional investors. This followed a prior raise, as the company noted a total of A$26.3M raised in gross proceeds from a two-tranche placement leading up to this point. This funding is critical for advancing ATH434.

Non-dilutive funding from government incentives also forms a key part of the financial foundation. Alterity Therapeutics Limited received an A$3.98M refund from the Australian Government's Research and Development Tax Incentive (R&DTI) Scheme for eligible activities conducted during the financial year ending June 30, 2024. This type of inflow acts as a direct offset to the high cost of research and development.

For the fiscal year ended June 30, 2025, the reported revenue was primarily non-operating. The total revenue recognized was A$446,291, which was explicitly interest received on the Group's bank accounts. This figure represents a significant increase of 66.3% from the prior year's A$268,419, reflecting both higher cash balances and rising interest rates. To be fair, some reports indicate the total reported revenue for FY2025 was A$5.44 million, primarily driven by these research and development tax incentives, showing how these non-sales items dominate the top line for a pre-commercial entity.

Here's a quick look at the key financial figures grounding these revenue sources:

Financial Metric	Amount (AUD)	Date/Period
September 2025 Equity Placement	A$20.0 million	September 2025
Total Gross Proceeds from Placement (Prior/Current)	A$26.3 million	Prior to Sept 2025
R&D Tax Incentive Refund Received	A$3.98 million	FY2024 Activities (Received in 2025 context)
FY2025 Interest Income Revenue	A$446,291	Year Ended June 30, 2025
FY2024 Interest Income Revenue	A$268,419	Year Ended June 30, 2024
Reported FY2025 Revenue (Incl. Incentives)	A$5.44 million	FY2025

Looking ahead, the most substantial potential revenue streams are tied directly to the success of ATH434. These are not realized yet, but they drive current valuation and partnership interest.

• Future milestone payments from a potential licensing deal for ATH434.
• Future royalty payments from a potential licensing deal for ATH434.
• Future direct sales of ATH434 upon regulatory approval.
• Potential global peak sales estimate for ATH434 in Multiple System Atrophy (MSA) is USD $2.4 Billion, if approved.

Finance: draft 13-week cash view by Friday.