Alterity Therapeutics Limited (ATHE): Business Model Canvas [Dec-2025 Updated]

You're digging into Alterity Therapeutics Limited (ATHE) right now, and the story is classic clinical-stage biotech: high-stakes pivot toward Phase 3 for ATH434 in Multiple System Atrophy (MSA), a rare disease with no current treatment. Honestly, the near-term financial picture shows the burn-an operating loss of A$12,147,828 for FY2025-but they shored up the runway, pulling in A$20.0 million in September 2025, leaving them with A$40.66M cash as of June 30, 2025, plus a A$3.98M tax refund. The value prop is huge: a potential disease-modifying oral agent targeting up to USD $2.4 Billion in global peak sales, but it all hinges on flawless execution with CROs and the FDA; let's break down exactly how this model is structured to get from here to that massive potential payoff below.

Alterity Therapeutics Limited (ATHE) - Canvas Business Model: Key Partnerships

Alterity Therapeutics Limited (ATHE) engages with several external entities critical to advancing its lead asset, ATH434, through clinical development and toward potential commercialization.

Clinical Research Organizations (CROs) for global Phase 2/3 trials

Alterity Therapeutics Limited (ATHE) has utilized external organizations to conduct its clinical programs for ATH434 in Multiple System Atrophy (MSA). The company reported positive topline data from the ATH434-201 randomized, double-blind, placebo-controlled Phase 2 clinical trial. Furthermore, the ATH434-202 open-label Phase 2 clinical trial in patients with more advanced MSA was completed in March 2025, involving Ten (10) participants treated with oral ATH434 75 mg twice daily for 12 months.

Academic institutions (e.g., Vanderbilt University) for research and biomarker studies

Collaboration with academic centers supports the scientific validation and biomarker analysis of ATH434. Data from the Phase 2 trial were presented at the 2025 International Congress of Parkinson's Disease and Movement Disorders (MDS) in Honolulu, HI, USA, from October 5-9, 2025. A poster presentation at this event included work from Paula Trujillo, PhD, Research Assistant Professor, Department of Neurology, Vanderbilt University Medical Center. The research involved assessing state-of-the-art neuroimaging and biomarkers to refine MSA diagnosis.

Regulatory bodies like the U.S. FDA for Fast Track and Orphan Drug designations

Regulatory engagement has secured key designations for ATH434 in the U.S. The U.S. Food and Drug Administration (FDA) granted Fast Track designation for ATH434 for the treatment of Multiple System Atrophy on May 05, 2025. This designation complements the existing Orphan Drug Designation granted by the U.S. FDA and the European Commission for the treatment of MSA.

International and Australian institutional investors for capital raising

Alterity Therapeutics Limited (ATHE) has secured significant capital from domestic and international institutional investors throughout 2025 to fund development activities. The company received binding commitments for a capital raising of A$40.0 million in February 2025, conducted at A$0.011 per share. This February placement involved Tranche One raising approximately A$12.8 million via 1.2 billion New Shares, with Tranche Two expected to raise approximately A$27.2 million via 2.5 billion New Shares. More recently, in September 2025, Alterity Therapeutics Limited (ATHE) announced a further capital raising of A$20.0 million from International and Australian professional investors, with shares issued at A$0.012 per share. The cash balance on 30 June 2025 was reported as A$40.66M. The company concluded Q3 FY25 (March 31, 2025) with a cash balance of A$17.96M, raising an additional A$27.1M post-quarter.

The financial support received in 2025 is summarized below:

Financing Event	Date Announced	Gross Proceeds (AUD)	Issue Price (AUD)	Investor Base
Capital Placement	February 2025	A$40.0 million	A$0.011	Australian and international institutions and other sophisticated, professional or exempt investors
Strategic Placement	September 2025	A$20.0 million	A$0.012	International and Australian professional investors

Potential pharmaceutical partners for late-stage development and commercialization

Following the September 2025 financing, Alterity Therapeutics Limited (ATHE) stated the additional funding would strengthen its institutional register and balance sheet to best position the company for pursuing strategic partnerships. The company is advancing clinical and regulatory strategy for ATH434 with the US FDA and other agencies.

• The September 2025 placement was anchored by a high-quality international healthcare-focused fund.
• The February 2025 placement was strongly supported by domestic and international institutional investors.

Alterity Therapeutics Limited (ATHE) - Canvas Business Model: Key Activities

Alterity Therapeutics Limited's key activities center on progressing its lead asset, ATH434, through late-stage clinical development and regulatory pathways, while simultaneously feeding its discovery engine.

Advancing ATH434 through Phase 3 planning and regulatory discussions

The company is actively engaging with the U.S. Food and Drug Administration (FDA) to discuss the emerging nonclinical and chemistry and manufacturing data necessary for Phase 3 conduct, a critical step following positive Phase 2 outcomes. Alterity Therapeutics received Fast Track designation from the U.S. FDA for ATH434 in Multiple System Atrophy (MSA) in May 2025. This designation is intended to accelerate development and review. The potential market opportunity for ATH434 in MSA, based on an independent commercial assessment completed in September 2025, is estimated at a worldwide peak sales potential of USD $2.4 Billion.

Conducting clinical trials (e.g., ATH434-201/202 Phase 2 data analysis)

Key activities involved the analysis of data from two Phase 2 clinical trials throughout 2025. The ATH434-201 double-blind trial demonstrated robust efficacy, with new analysis strengthening the efficacy signal at the high dose level.

Key efficacy metrics from the ATH434-201 trial include:

• Demonstrated 48% slowing of clinical progression on the modified UMSARS Part I at Week 52 for the 50 mg dose (p=0.03) versus placebo.
• The 75 mg dose group showed 62% slowing of progression (p=0.05) at Week 26.
• MRI biomarkers showed iron stabilization in affected brain regions for the 50 mg dose.

Furthermore, positive data from the ATH434-202 open-label trial in advanced MSA demonstrated a comparable treatment effect to the earlier-stage patients in the double-blind study.

Drug discovery and preclinical development for new neurodegenerative compounds

Alterity Therapeutics maintains an ongoing drug discovery platform to generate novel compounds. The company's chemical library currently includes more than 1000 novel compounds. These compounds are generated using Structure-Activity Relationships (SAR) developed over years of testing to target underlying pathology like pathologic protein aggregation and oxidative stress.

Securing intellectual property (IP) and maintaining patent portfolio

Protecting the pipeline involves continuous IP fortification. A key component is the Composition of Matter patent granted in March 2023, which covers more than 150 novel compounds with an acyl hydrazone (AH) structure designed to redistribute excess iron.

Raising capital to fund high-cost R&D operations

Funding R&D is a core activity, recently bolstered by a strategic placement. The company secured A$20.0 million in binding commitments on September 8, 2025. This followed a A$40.0 million capital raising in February 2025. The September 2025 placement shares were issued at A$0.012 per share. The use of proceeds from this funding is intended to advance clinical and regulatory strategy for ATH434 with the US FDA and other agencies.

Here's the quick math on the balance sheet as of the end of the third quarter of fiscal year 2026:

Metric	Amount as of September 30, 2025
Cash Balance	A$54.56M
September 2025 Capital Raise Proceeds	A$20.0 million
February 2025 Capital Raise Proceeds	A$40.0 million
Operating Cash Outflows (Q1 FY26 Quarter)	A$5.34M
Placement Discount (September 2025)	7.7%

What this estimate hides is the burn rate required to execute the planned Phase 3 engagement, so you'll want to watch the next quarterly outflow closely.

Alterity Therapeutics Limited (ATHE) - Canvas Business Model: Key Resources

You're looking at the core assets Alterity Therapeutics Limited (ATHE) is relying on right now to push ATH434 forward. These are the tangible and intangible things the business absolutely must have to make its value proposition work.

The financial foundation is a key starting point. As of the quarter ending June 30, 2025, Alterity Therapeutics Limited held A$40.66M in cash and cash equivalents, as reported in their Appendix 4C Quarterly Cash Flow Report for Q4 FY25. This figure represents the capital available to fund ongoing operations and development activities.

The lead drug candidate, ATH434, is arguably the most critical resource. It has demonstrated positive efficacy in Multiple System Atrophy (MSA) across multiple Phase 2 studies. The open-label Phase 2 trial (ATH434-202) involved 10 participants treated with oral ATH434 75 mg twice daily for 12 months, with 30% (3/10) showing stabilization or improvement in overall neurological symptoms. Furthermore, the randomized, double-blind, placebo-controlled ATH434-201 trial showed that both the 50 mg and 75 mg dose levels reduced iron accumulation in MSA affected brain regions.

Intellectual property provides the necessary moat around the technology. Alterity Therapeutics has been actively securing its innovations. For instance, a European Composition of Matter patent (No. 3938364), granted in August 2023, covers more than 150 novel compounds designed to redistribute excess iron. Similarly, a U.S. patent covers over 150 novel pharmaceutical compositions targeting labile iron.

The human capital-the specialized scientific team-is essential for navigating complex neurodegenerative disease development. The team is led by CEO David Stamler, M.D., and is focused on developing disease modifying treatments for conditions like MSA.

Regulatory advantages act as significant non-financial resources, accelerating the path to market. For ATH434 in MSA, Alterity Therapeutics secured U.S. FDA Fast Track Designation during the quarter ending June 30, 2025. This designation is layered on top of the existing Orphan Drug Designation already received from both the U.S. FDA and the European Commission for ATH434 in MSA.

Here's a quick look at the regulatory and IP milestones:

• U.S. FDA Fast Track Designation for ATH434 in MSA granted in Q4 FY25.
• Orphan Drug Designation already held from US FDA and European Commission.
• European Patent No. 3938364 covers over 150 novel iron-redistributing compounds.
• U.S. Patent Application No. 16/818,641 covers over 150 novel pharmaceutical compositions.

The clinical data itself is a resource, validating the science and supporting future financing or partnership discussions. The Phase 2 trials involved specific patient numbers and dosing schedules:

Trial	Design	Participants Enrolled (Approx.)	Dose Levels Tested (mg BID)	Key Efficacy Observation (Late 2025)
ATH434-201	Randomized, double-blind, placebo-controlled	77 adults with early-stage MSA	50 and 75	Efficacy signal strengthened at 75 mg dose on UMSARS I1 at 52 weeks.
ATH434-202	Open-label	10 participants with advanced MSA	75	30% showed stabilization or improvement in neurological symptoms over 12 months.

The financial position, while strong for a clinical-stage company, needs context against prior periods. Here's how the cash position has trended:

Reporting Date	Cash, Cash Equivalents, and Short Term Investments (A$)
June 30, 2025	40.66M
June 30, 2024	12,638,885
June 30, 2022	A$34.8M

Finance: draft 13-week cash view by Friday.

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.