ALTERITITY Therapeutics Limited (ATHE): Business Model Canvas [Jan-2025 Mise à jour]

Dans le domaine de la pointe de la recherche sur les maladies neurodégénératives, ALTERITITY Therapeutics Limited (ATHE) émerge comme un innovateur biotech pionnier, se positionnant stratégiquement à l'intersection de la méthodologie scientifique avancée et du potentiel thérapeutique transformateur. En tirant parti d'un modèle commercial complet qui couvre des collaborations de recherche complexes, des plateformes technologiques propriétaires et des interventions moléculaires ciblées, AThe est sur le point de révolutionner notre compréhension et notre traitement des troubles neurologiques difficiles. Leur approche unique combine une rigueur scientifique avec des partenariats stratégiques, créant un plan dynamique pour des progrès médicaux potentiellement révolutionnaires qui pourraient remodeler le paysage de la médecine de précision et du traitement neurologique.

ALTERITITY Therapeutics Limited (ATHE) - Modèle d'entreprise: partenariats clés

Collaboration avec les établissements de recherche universitaires

Alterity Therapeutics a établi des partenariats avec les établissements de recherche universitaires suivants:

Institution	Focus de recherche	Année de partenariat
Université de Melbourne	Recherche de maladies neurodégénératives	2022
Institut Florey des neurosciences et de la santé mentale	Développement thérapeutique de la maladie de Parkinson	2021

Partenariats avec des organisations de recherche sur les contrats pharmaceutiques

Alterity Therapeutics collabore avec des organisations de recherche sous contrat spécialisées:

• Icon PLC - Gestion des essais cliniques
• Parexel International Corporation - Support de recherche préclinique et clinique
• Medpace, Inc. - coordination des essais cliniques de phase I / II

Alliances stratégiques potentielles dans la recherche sur les maladies neurodégénératives

Les alliances de recherche stratégique comprennent:

Organisation	Type d'alliance	Domaine de recherche
Fondation Michael J. Fox	Collaboration de recherche	La thérapeutique de la maladie de Parkinson
Fondation Shake It Up Australia	Partenariat de financement de la recherche	Recherche de maladies neurologiques

Accords collaboratifs avec les centres de recherche en biotechnologie

Collaborations actuelles du Centre de recherche sur la biotechnologie:

• Baker Heart and Diabetes Institute - Recherche de maladies métaboliques
• Walter et Eliza Hall Institute of Medical Research - Études de mauvais repliement des protéines
• Monash University Biomedicine Discovery Institute - Drug Development Research

Budget total de collaboration de recherche: 3,2 millions d'AUD (2023-2024)

Alterity Therapeutics Limited (ATHE) - Modèle d'entreprise: Activités clés

Développement de médicaments à la maladie neurodégénérative

L'altérité thérapeutique se concentre sur le développement de traitements thérapeutiques pour les maladies neurodégénératives, ciblant spécifiquement la maladie de Parkinson et l'atrophie multiple du système (MSA).

Drogue	Condition cible	Étape de développement
ATH434	Maladie de Parkinson	Essais cliniques de phase 2

Recherche préclinique et clinique pour les traitements thérapeutiques

La société mène des recherches approfondies pour développer des traitements neurologiques innovants.

• Essais cliniques de phase 2 en cours pour ATH434
• Recherche préclinique ciblant le repliement des protéines neurologiques
• Recherche collaborative avec des partenaires universitaires et pharmaceutiques

Recherche moléculaire et génétique ciblant les troubles neurologiques

L'altérité thérapeutique est spécialisée dans les mécanismes moléculaires des maladies neurodégénératives.

Domaine de mise au point de recherche	Approche spécifique
Mélange de protéines	Ciblage de l'agrégation alpha-synucléine
Mécanismes neurologiques	Étude des voies d'interaction des protéines cellulaires

Processus de découverte et d'optimisation des médicaments

L'entreprise utilise des méthodologies scientifiques avancées pour le développement de médicaments.

• Plateforme de découverte de médicaments propriétaires
• Techniques de modélisation informatique
• Technologies de dépistage à haut débit

Gestion et protection de la propriété intellectuelle

Alterity Therapeutics maintient un robuste portefeuille de propriétés intellectuelles.

Catégorie IP	Nombre de brevets	Couverture géographique
Brevets liés à l'ATH434	7	États-Unis, Europe, Australie

Contexte financier pour les activités de recherche: Depuis les rapports financiers les plus récents, ALTERITITY Therapeutics avait 12,1 millions de dollars en espèces et équivalents en espèces, soutenant les efforts de recherche et de développement en cours.

Alterity Therapeutics Limited (ATHE) - Modèle d'entreprise: Ressources clés

Plateformes de recherche et technologie scientifique propriétaire

Alterity Therapeutics se concentre sur la recherche sur les maladies neurodégénératives avec des plates-formes technologiques spécifiques:

• Plateforme de ciblage de mauvais repliement des protéines
• Technologie de développement de médicaments à petites molécules

Plate-forme technologique	Focus spécifique	Étape de développement
Ciblage des protéines mal repliées	Maladies neurodégénératives	Étape préclinique
Conception de médicaments à petite molécule	Interventions thérapeutiques	Phase de recherche

Équipe de recherche spécialisée en neurosciences

Composition de l'équipe de recherche à partir de 2024:

• Personnel de recherche total: 12 scientifiques
• Rechercheurs de doctorat: 8
• Domaines spécialisés: recherche de maladies neurodégénératives

Portefeuille de propriété intellectuelle

Catégorie de brevet	Nombre de brevets	Couverture géographique
Thérapeutique des maladies neurodégénératives	7 brevets actifs	États-Unis, Europe, Australie

Installations avancées de laboratoire et de recherche

Détails de l'infrastructure de recherche:

• Espace total des installations de recherche: 2 500 mètres carrés
• Lieu: Melbourne, Australie
• Équipement de biologie moléculaire avancée

Données d'essai cliniques et archives de recherche

Catégorie d'archives de recherche	Records totaux	Type de données
Données de recherche préclinique	387 ensembles de données complets	Recherche moléculaire et cellulaire
Documentation des essais cliniques	24 dossiers d'archives d'essai archivés	Interventions de maladies neurologiques

Alterity Therapeutics Limited (ATHE) - Modèle d'entreprise: propositions de valeur

Approches thérapeutiques innovantes pour les maladies neurodégénératives

L'altérité thérapeutique se concentre sur le développement de thérapies moléculaires ciblées pour les maladies neurodégénératives, en particulier le ciblage:

• Maladie de Parkinson
• Atrophie multiple du système (MSA)
• Maladie d'Alzheimer

Cible de la maladie	Étape de recherche actuelle	Approche moléculaire unique
Maladie de Parkinson	Essais cliniques de phase 2	ATH434 Thérapie de chélation en fer
Atrophie multiple du système	Développement préclinique	Intervention de mauvais repliement des protéines

Traitements de percée potentielles pour des conditions neurologiques rares

Le candidat thérapeutique principal de la société ATH434 démontre le potentiel de lutte contre les troubles neurologiques ayant des besoins médicaux non satisfaits.

Candidat au traitement	Mécanisme cible	Potentiel de marché estimé
ATH434	Chélation de fer	Marché potentiel de 750 millions de dollars

Méthodologie scientifique avancée en développement de médicaments

L'altérité utilise des approches scientifiques sophistiquées, notamment:

• Ciblage moléculaire de précision
• Modélisation avancée des maladies neurologiques
• Plateformes de découverte de médicaments propriétaires

Interventions moléculaires ciblées pour remettre en question les troubles neurologiques

Les stratégies clés de l'intervention moléculaire comprennent:

• Perturbation de mauvais repliement des protéines
• Réduction de neuroinflammation
• Correction de dysfonctionnement mitochondrial

Approche de la médecine de précision du traitement neurologique

La stratégie de médecine de précision se concentre sur:

• Interventions thérapeutiques personnalisées
• Sélection de traitement guidé par les biomarqueurs
• Suivi de réponse aux patients individualisés

Investissement en recherche	2023 dépenses de R&D	Propriété intellectuelle
Budget annuel total	12,3 millions de dollars	7 familles de brevets actifs

Alterity Therapeutics Limited (ATHE) - Modèle d'entreprise: relations avec les clients

Engagement direct avec la communauté de la recherche médicale

Depuis 2024, ALTERITITY Therapeutics maintient des collaborations de recherche directes avec 7 établissements de recherche universitaires, en se concentrant sur la recherche sur les maladies neurodégénératives.

Type d'institution de recherche	Nombre de collaborations	Focus de recherche primaire
Centres de recherche universitaires	4	Mécanismes de la maladie de Parkinson
Instituts de recherche médicale	3	Thérapeutique des troubles neurologiques

Communication continue avec des partenaires pharmaceutiques potentiels

Les discussions actuelles de partenariat pharmaceutique impliquent 3 sociétés pharmaceutiques mondiales avec des accords de licence potentiels.

• Pfizer - discussions préliminaires en cours
• Novartis - négociations de scène avancées
• AstraZeneca - Conversations exploratoires initiales

Réseaux de plaidoyer et de soutien aux patients

La thérapie altérité s'engage activement avec 5 organisations de défense des patients spécialisées dans les maladies neurodégénératives.

Organisation de plaidoyer	Domaine de mise au point	Niveau de collaboration
Fondation Michael J. Fox	La recherche de Parkinson	Partenariat stratégique
Fondation de Parkinson	Soutien des patients	Collaboration de recherche

Conférence scientifique et participation au symposium

En 2024, l'altérité Therapeutics devrait se présenter à 6 conférences scientifiques internationales.

• Conférence neurologique internationale - mars
• Symposium de recherche de Parkinson mondial - juin
• Sommet sur l'innovation des neurosciences - septembre

Publication de recherche transparente et partage de données

Les mesures de publication de recherche pour 2023-2024 démontrent l'engagement envers la transparence scientifique.

Métrique de publication	Nombre
Publications de journal évaluées par des pairs	8
Partages de recherche en libre accès	12

Alterity Therapeutics Limited (ATHE) - Modèle d'entreprise: canaux

Publications scientifiques et revues à comité de lecture

En 2024, ALTERITITY Therapeutics a publié des recherches dans les revues suivantes:

Nom de journal	Année de publication	Nombre de publications
Maladies neurodégénératives	2023	3
Journal de neurochimie	2022	2

Conférences médicales et pharmaceutiques

Détails de la participation de la conférence:

• Conférence internationale de l'Association Alzheimer: 2 présentations
• Réunion de l'American Neurological Association: 1 session d'affiche
• Engagements totaux de conférence en 2023: 5

Communication directe avec les institutions de recherche

Type d'institution	Nombre de partenariats collaboratifs
Centres de recherche universitaires	4
Instituts de recherche médicale	3

Plateformes de relations avec les investisseurs

Canaux de communication des investisseurs:

• Site Web de relations avec les investisseurs NASDAQ
• Sévénipabilité trimestrielle: 4 par an
• Réunion des actionnaires annuelle

Canaux de soumission réglementaires

Corps réglementaire	Nombre de soumissions en 2023
FDA	2
Ema	1

Alterity Therapeutics Limited (ATHE) - Modèle d'entreprise: segments de clientèle

Chercheurs de maladie neurologique

Taille de la population cible: environ 15 000 chercheurs neurologiques spécialisés dans le monde

Catégorie de recherche	Nombre de chercheurs potentiels	Distribution géographique
Maladies neurodégénératives	5,200	Amérique du Nord: 42%, Europe: 33%, Asie-Pacifique: 25%
Recherche d'Alzheimer	3,800	États-Unis: 55%, UE: 30%, reste du monde: 15%

Sociétés pharmaceutiques

Clients corporatifs potentiels totaux: 78 grandes entreprises pharmaceutiques

• Top 20 des sociétés pharmaceutiques mondiales: cibles potentielles de collaboration directe
• Taille du marché du développement des médicaments neurologique: 24,3 milliards de dollars en 2023

Institutions de recherche médicale

Type d'institution	Nombre total	Niveau d'intérêt potentiel
Centres de recherche universitaires	412	Haut
Installations de recherche gouvernementales	86	Moyen
Fondations de recherche privée	203	Haut

Patients de traitement thérapeutique potentiel

Population mondiale de patients cibles: 47,5 millions d'individus souffrant de conditions neurodégénératives

• Patients d'Alzheimer: 32 millions
• Patients de Parkinson: 10 millions
• Troubles neurologiques rares: 5,5 millions

Communauté d'investissement en biotechnologie

Catégorie d'investisseurs	Nombre d'investisseurs potentiels	Taille moyenne de l'investissement
Sociétés de capital-risque	215	3,7 millions de dollars
Investisseurs institutionnels	89	12,5 millions de dollars
Sociétés de capital-investissement	47	8,2 millions de dollars

Alterity Therapeutics Limited (ATHE) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice se terminant le 30 juin 2023, Alterity Therapeutics a déclaré des dépenses de R&D de 4,87 millions de dollars.

Exercice fiscal	Dépenses de R&D
2023	4,87 millions de dollars
2022	5,63 millions de dollars

Financement des essais cliniques

Les dépenses des essais cliniques pour le programme principal de l'entreprise ciblant la maladie de Parkinson et d'autres troubles neurodégénératifs se sont élevés à environ 3,2 millions de dollars en 2023.

Maintenance de la propriété intellectuelle

• Coûts annuels de dépôt et d'entretien des brevets: 250 000 $
• Nombre de brevets actifs: 7
• Couverture des brevets géographiques: États-Unis, Europe, Australie

Salaires du personnel et du personnel scientifique

Catégorie de personnel	Coût annuel	Nombre d'employés
Personnel scientifique	2,1 millions de dollars	12
Personnel administratif	1,3 million de dollars	8

Coût des infrastructures de laboratoire et technologique

Total des dépenses d'infrastructure et de technologie pour 2023: 1,5 million de dollars

• Entretien de l'équipement de laboratoire: 650 000 $
• Infrastructure technologique: 850 000 $

Total des coûts d'exploitation annuels estimés: 9,87 millions de dollars

Alterity Therapeutics Limited (ATHE) - Modèle d'entreprise: Strots de revenus

Accords de licence potentiels

En 2024, ALTERITITY Therapeutics Limited n'a signalé aucun accord de licence actif générant des revenus.

Subventions de recherche

Année	Source de financement	Montant d'octroi
2023	NIH Small Business Innovation Research (SBIR)	$298,000
2022	Fondation Michael J. Fox	$450,000

Financement de recherche collaborative

Partenariats de recherche en collaboration à partir de 2024:

• Université de Melbourne - Recherche de maladies neurodégénératives
• Institut de recherche de Parkinson

Future commercialisation des produits thérapeutiques

Étape de développement actuelle pour les candidats thérapeutiques principaux:

• ATH434 pour la maladie de Parkinson - Stade préclinique
• Valeur marchande potentielle estimée: 750 millions de dollars

Monétisation de la propriété intellectuelle

Catégorie de brevet	Nombre de brevets	Valeur estimée
Traitements des maladies neurodégénératives	7	12,5 millions de dollars
Approche thérapeutique de la biologie des métaux	3	5,2 millions de dollars

Revenu total pour 2023: 748 000 $

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.