Alterity Therapeutics Issues Shareholder Letter Highlighting 2025 Progress and Key Objectives for 2026
Rhea-AI Summary
Alterity Therapeutics (NASDAQ: ATHE) reported that its Phase 2 program of ATH434 in multiple system atrophy (MSA) produced "resoundingly favourable" results, showing safety comparable to placebo with no drug-related serious or severe adverse events and signals of slowed disease progression across functional, mobility, and orthostatic hypotension measures. The company plans an End-of-Phase 2 meeting with the FDA in mid-2026 to finalise Phase 3 design and is scaling clinical, manufacturing, and regulatory resources. Other 2025 actions include appointing Julian Babarczy as Board Chair and strengthening investor relations and corporate strategy teams. Management cites an estimated $2.4 billion market opportunity for MSA.
Positive
- Phase 2 reported favourable efficacy signals across multiple endpoints
- Safety profile comparable to placebo; no drug-related serious events
- End-of-Phase 2 FDA meeting scheduled for mid-2026
- Company scaling clinical, manufacturing and regulatory operations
- Estimated $2.4 billion MSA market opportunity cited
Negative
- Pivotal Phase 3 trial not yet initiated; design pending FDA meeting mid-2026
- Clinical results are Phase 2 signals, not yet confirmed in Phase 3
News Market Reaction
On the day this news was published, ATHE declined 1.52%, reflecting a mild negative market reaction. This price movement removed approximately $853K from the company's valuation, bringing the market cap to $55M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Biotech peers show mixed moves: OSTX +3.45%, UNCY +6.99%, CVM +1.74% versus OVID -0.65% and ACET -2.71%, while ATHE is down 4.35%, pointing to stock-specific dynamics rather than a sector-wide move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 12 | Conference presentation | Positive | +3.3% | CEO corporate update at Bell Potter Healthcare Virtual Conference. |
| Nov 10 | Clinical data update | Positive | +8.3% | Phase 2 MSA analyses showing strengthened efficacy on UMSARS and OH metrics. |
| Oct 31 | Cash flow & program | Positive | -8.5% | Quarterly cash report, placement proceeds and detailed ATH434 efficacy signals. |
| Oct 09 | Clinical trial results | Positive | +4.4% | Phase 2 ATH434 data at MDS Congress with strong clinical and imaging signals. |
| Oct 02 | Upcoming presentations | Positive | +6.1% | Announcement of multiple ATH434-201 presentations at MDS Congress. |
ATHE has generally traded higher on clinical and conference updates, with one notable selloff around a cash/placement and program update.
Over the past few months, Alterity has steadily built the ATH434 story in multiple system atrophy (MSA) through conference presentations and data disclosures. In October–November 2025, Phase 2 results and conference presentations on disease progression, orthostatic hypotension and biomarker data often coincided with positive price reactions. A quarterly cash flow update on Oct 31, 2025 that combined financials and clinical detail saw a negative move. Today’s shareholder letter mainly consolidates these achievements and outlines 2026 goals, including Phase 3 planning and regulatory milestones, reinforcing the progression already flagged in prior updates.
Market Pulse Summary
This announcement reiterates that Alterity completed its Phase 2 ATH434 program in MSA with favourable safety and efficacy signals and is preparing for an End-of-Phase 2 FDA meeting in mid-2026. The letter frames an estimated $2.4 billion market opportunity and sets 2026 objectives around Phase 3 initiation, broader external engagement, and IP expansion. Against a pre-news price of $3.30, well below the $7.00 52-week high, investors may focus on regulatory milestones, trial design decisions, and future financing strategy as key watchpoints.
Key Terms
multiple system atrophy medical
orthostatic hypotension medical
α-synuclein medical
biomarker medical
natural history studies medical
phase 2 medical
phase 3 medical
end-of-phase 2 meeting regulatory
AI-generated analysis. Not financial advice.
MELBOURNE, Australia and SAN FRANCISCO, Jan. 21, 2026 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today issued a letter to shareholders.
Dear Shareholders,
Our goal for 2025 was the successful completion of the Phase 2 program investigating our lead asset, ATH434, in multiple system atrophy (MSA) and to produce data that would enable us to advance into Phase 3. We accomplished this mission and then some.
Results from the Phase 2 trials were resoundingly favourable with data demonstrating the drug to be safe and well-tolerated with strong signals of efficacy in an indication that, at present, has no approved disease-modifying treatments available for patients. As a result, optimism at Alterity is abound, and we are now focused on advancing ATH434 towards a pivotal Phase 3 clinical program in MSA and potential entry into an estimated
As 2026 begins, Alterity is positioned to achieve several clinical and operational milestones that offer the potential to greatly enhance the company’s value, while elevating its position among the top echelon of innovators in addressing neurodegeneration. I am pleased to share with you more details on what has been accomplished and what we soon plan to achieve.
Working to Deliver the First Meaningful Therapy for People With MSA
Multiple System Atrophy (MSA) remains one of the most severe and progressive neurodegenerative conditions, with limited options for patients and their families. Alterity remains committed to transforming outcomes for these patients.
Over the past year, we advanced ATH434 through the final stages of its Phase 2 program delivering encouraging and clinically meaningful results across a range of disease severity. ATH434 was associated with slowing of disease progression across multiple independent clinical endpoints, including functional measures, mobility metrics, and symptoms of orthostatic hypotension, a particularly debilitating feature of MSA. Importantly, the safety profile was comparable to placebo, with no drug-related serious or severe adverse events observed.
We continued to deepen our understanding of MSA biology through biomarker, imaging, and natural history studies. These efforts have reinforced the central role of dysregulated brain iron and α-synuclein pathology in driving disease progression. In parallel, we clarified how ATH434’s mechanism of action aligns with this biology and highlighted the importance of intervening early to preserve neuronal function.
These results provide a strong foundation for late-stage development and give us confidence as we shape our Phase 3 planning and regulatory discussions, bringing us closer to delivering what could become the first disease modifying therapy for people living with MSA.
Advancing Toward Phase 3 and Potential Future Commercialization
Following the successful Phase 2 program, we are now focused on aligning with the FDA on key clinical and regulatory considerations for Phase 3 and expect to hold our End-of-Phase 2 meeting in mid-2026. The goal of this meeting is to finalise the Phase 3 design, including patient selection, efficacy and safety endpoints, and the statistical framework for analyzing the results.
Concurrently, we have been scaling internal and external resources, including clinical and manufacturing operations, as well as regulatory support, to ensure we are fully prepared to initiate our pivotal trial program following FDA guidance.
As we look toward potential future commercialization, we continue to actively engage the medical community, including leading movement disorder and autonomic neurologists, to broaden our understanding of the unmet needs in treating MSA and the key attributes needed in a disease modifying therapy.
We were pleased to learn that physicians who were consulted during our commercial assessment see potential advantages in the design and activity of ATH434, with those surveyed noting the importance of inhibiting α‐synuclein aggregation to address the underlying pathology of disease as addressed by the targeted mechanism of action of ATH434. In addition, these same physicians agreed that the promising Phase 2 clinical data demonstrated a slowing of disease progression and stabilization of orthostatic hypotension, one of the most challenging symptoms to manage in MSA.
Strengthened our Board and Leadership Team
During 2025, we enhanced our governance and leadership structure to support Alterity through its next stage of growth. In November, we were pleased to appoint Julian Babarczy as our new Chair of the Board. Julian is an experienced company director and investor with over 20 years in Australia’s corporate and funds management sectors and brings a strong record of identifying and supporting emerging businesses with significant potential across a range of industries. In addition, I was appointed to the role of Managing Director, alongside my responsibilities as Chief Executive Officer, providing continuity of leadership as we prepare for the critical milestones ahead in 2026.
We expanded our leadership team with the appointment of a new Head of Investor Relations and Communications to continue to broaden our engagement with both new and existing shareholders, grow our relationships with global specialist funds, and develop a more coordinated international IR strategy. In addition, we added a new Head of Corporate Strategy and Operations as we increase our business development activities with potential strategic partners.
Looking ahead in 2026
Alterity enters 2026 with one of the most promising clinical programs in MSA worldwide, a growing body of supportive scientific evidence, and a strengthened platform to deliver meaningful value to patients and shareholders. A key milestone during the year will be our End-of-Phase 2 meeting with the FDA in mid-2026, which represents the final regulatory step before initiating our pivotal, Phase 3 study. In parallel, we anticipate an active year of publications, conference presentations, and expanded external activities.
In summary, we have three key objectives in 2026:
1) Finalize our regulatory strategy in order to initiate our Phase 3 trial for ATH434 in MSA;
2) Deepen our external engagement across the medical, advocacy, investor, and partner communities; and,
3) Build for scalable growth including a focus on expanding our intellectual property protection.
This is a very exciting time in the growth and evolution of Alterity as evidenced by a very productive series of meetings in San Francisco around the annual J.P. Morgan Healthcare conference last week. I would like to thank our employees for their dedication, and our shareholders for their ongoing support as we embark on what we believe will be a dynamic and value-building 2026. We remain committed to our mission of improving the lives of people living with debilitating and devastating neurodegenerative diseases.
Sincerely,
David Stamler, M.D.
Chief Executive Officer
About Alterity Therapeutics Limited
Alterity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people living with neurodegenerative diseases. The Company is initially focused on developing disease modifying therapies in Parkinson’s disease and related disorders. Alterity has demonstrated clinically meaningful efficacy for its lead asset, ATH434, in a randomized, double-blind, placebo-controlled Phase 2 clinical trial in participants with Multiple System Atrophy (MSA), a rare and rapidly progressive Parkinsonian disorder. Alterity has also shown positive ATH434 data from an open label Phase 2 clinical trial in advanced MSA. In addition, Alterity has a broad drug discovery platform generating patentable chemical compounds to treat the underlying pathology of neurological diseases. The Company is based in Melbourne, Australia, and San Francisco, California, USA. For further information please visit the Company’s website at www.alteritytherapeutics.com.
Authorisation & Additional information
This announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited.
Contacts:
Investors:
Tara Speranza
Head of Investor Relations and Communications
tsperanza@alteritytx.com
+61 (0) 432 961 533
Remy Bernarda
Investor Relations Advisory Solutions
ir@alteritytx.com
+1 (415) 203-6386
Media
Casey McDonald
Tiberend Strategic Advisors, Inc.
cmcdonald@tiberend.com
+1 (646) 577-8520
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements.
Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled “Risk Factors” in the Company’s filings with the SEC, including its most recent Annual Report on Form 20-F as well as reports on Form 6-K, including, but not limited to the following: statements relating to the Company's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company's drug development program, including, but not limited to, ATH434, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to, ATH434, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limited to, ATH434, that could slow or prevent products coming to market, the uncertainty of obtaining patent protection for the Company's intellectual property or trade secrets, the uncertainty of successfully enforcing the Company’s patent rights and the uncertainty of the Company freedom to operate.
Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
FAQ
What did Alterity announce about ATH434 Phase 2 results for MSA (ATHE) on Jan 21, 2026?
When will Alterity (ATHE) meet the FDA about ATH434 Phase 3 planning?
How does Alterity describe the market opportunity for ATH434 in MSA (ATHE)?
What operational steps is Alterity (ATHE) taking ahead of Phase 3?
Did Alterity (ATHE) change leadership in 2025 and how might that affect 2026 plans?
