Full Press Release Details
Appendix 4C - Q2 FY26 Quarterly Cash Flow
Report & Corporate Update
Phase 2 Data Strengthened, Strong Cash
Position, and Phase 3 Planning Well Advanced
MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA
- 30 January 2026: Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company"), a biotechnology
company dedicated to developing disease modifying treatments for neurodegenerative diseases, today released its Appendix 4C Quarterly
Cash Flow Report and update on company activities for the quarter ending 31 December 2025 (Q2 FY26).
David Stamler, M.D., Chief Executive Officer of
Alterity Therapeutics, commented, "We continued to advance our Multiple System Atrophy (MSA) program on multiple fronts, including
new analyses of the Phase 2 data that increase our overall confidence in ATH434's potential as a disease-modifying therapy
for this devastating disease. We also made significant strides in planning for a series of meetings with the U.S. FDA, culminating in
a planned End-of-Phase 2 (EOP2) meeting in mid-2026."
Dr. Stamler continued, "During the quarter,
we delivered several scientific presentations highlighting the Phase 2 data that support the potential commercial opportunity of US$2.4
billion for ATH434 in MSA. The growing body of data strengthen our conviction in ATH434 as a first-in-class disease-modifying therapy
ATH434 Clinical and Regulatory Update
Phase 2 Clinical Program & Regulatory Progress
Alterity continued to build on the positive results
from the ATH434-201 randomized, double-blind Phase 2 trial in MSA, while progressing regulatory planning activities to support advancement
into late-stage development. During the quarter, the Company advanced its engagement strategy with the U.S. Food and Drug Administration
(FDA), including preparation for regulatory interactions across clinical pharmacology and non-clinical topics and chemistry, manufacturing
These activities are focused on preparation for
a planned End-of-Phase-2 meeting with the FDA, targeted for mid-2026. The primary objective of this meeting is to align with the agency
on the design and requirements of a pivotal Phase 3 clinical trial in MSA, including key elements such as endpoints, patient population
and the overall development pathway. The Company remains confident in its ongoing engagement with the FDA and the clarity of the regulatory
path toward Phase 3 development.
In addition, Alterity also presented additional
analyses from the ATH434-201 randomised, double-blind Phase 2 trial in MSA. A new analysis of modified UMSARS Part I1
data was presented at the International Congress of Parkinson's Disease and Movement Disorders, incorporating baseline orthostatic2
blood pressure change as a covariate. In this analysis, the efficacy signal in the 75 mg dose group at 52 weeks strengthened from -2.4
to -2.8 points, improving the relative treatment effect from 30% to 35% versus placebo. Differences in baseline severity of orthostatic
hypotension largely explained the differing responses observed between the 50 mg and 75 mg dose groups. ATH434 also demonstrated a beneficial
effect on orthostatic hypotension symptoms, with placebo-treated participants worsening over 52 weeks while participants in both active
treatment groups remained stable.
ATH434 has been granted Fast Track designation
by the FDA, reflecting the seriousness of MSA, the significant unmet medical need and the potential of ATH434 to address this need. This
designation enables more frequent regulatory interactions and supports an efficient review process as Alterity advances ATH434 toward
a pivotal Phase 3 program.
Phase 3 Development Planning and Timeline
Alterity also continued planning activities during
the quarter to support the progression of ATH434 into a pivotal Phase 3 clinical program in MSA. The Company is focused on progressing
the key elements required to initiate late-stage development, including clinical trial design, regulatory engagement, manufacturing and
supply planning, and operational readiness.
The timing and execution of Phase 3 will continue
to be informed by regulatory guidance and operational considerations. Alterity's strong balance sheet and active engagement with
potential partners provide flexibility in determining the optimal pathway to advance ATH434 development.
Scientific and Clinical Engagement
During the quarter, Alterity actively engaged
with the global neurology community through multiple scientific presentations at leading international congresses. These presentations
formed an important component of the Company's strategy to disseminate clinical data, engage with key opinion leaders and specialists,
and further test and refine the interpretation of Phase 2 results for ATH434 in MSA. The medical and scientific meetings provide an opportunity
for peer discussion of clinical, biomarker and imaging data from the ATH434-201 trial, contributing to a deeper understanding of treatment
response, patient selection and disease characteristics.
In addition, Alterity held a Clinical Advisory
Board meeting in December 2025 comprising key opinion leaders in movement disorders and autonomic disorders. The meeting focused on a
detailed review of data from the ATH434-201 Phase 2 study and provided expert input into the design and planning of the proposed Phase
3 clinical program. Insights from these scientific dialogues will further inform Phase 3 trial design considerations, including patient
selection, endpoints and operational execution.
During the quarter, Alterity delivered the following
presentations on the ATH434-201 Phase 2 trial:
Partnering and Strategic Discussions
In parallel with advancing the ATH434 development
program, Alterity broadened partnering discussions with a number of pharmaceutical companies. These discussions reflect growing industry
interest in ATH434's differentiated clinical profile, orphan disease status, and validated commercial potential.
The Company is evaluating a range of strategic
pathways to support the advancement of ATH434, including potential partnership structures, and is also in the process of engaging with
external advisers to assist in assessing these options. These activities are occurring alongside ongoing regulatory and Phase 3 planning
and are intended to preserve flexibility and maximising long-term shareholder value as the Company progresses toward Phase 3 development.
Corporate and Financial Update
Governance and Leadership
During the quarter, Alterity strengthened its
governance and leadership structure to support the Company's transition into late-stage development and active partnering discussions.
At the Company's Annual General Meeting
held in November 2025, Geoffrey Kempler retired as Non-Executive Chair and Director, Brian Meltzer retired as Non-Executive Director,
and Julian Babarczy was appointed Chair of the Board. Mr Babarczy is an experienced company director and investor with over 20 years'
experience across Australia's corporate and funds management sectors. He brings a strong track record in guiding emerging growth
companies through periods of strategic transition, capital management and value realisation.
In addition, Chief Executive Officer Dr David
Stamler was appointed to the Board as Managing Director, further strengthening alignment between the Board and executive leadership. Dr
Stamler brings deep clinical development and regulatory experience in neurology, including involvement in three FDA approvals in neurology,
and continues to lead Alterity's clinical, regulatory and strategic execution.
The Company also expanded its leadership with
the appointment of a Head of Investor Relations and Communications, a Head of Corporate Strategy and Operations, and a Head of Regulatory
Affairs and Quality Assurance, reflecting an increased focus on institutional engagement, strategic partnering and operational execution.
Together, these governance and leadership enhancements
position Alterity strongly to execute its next phase of growth, including Phase 3 development planning, regulatory engagement and the
pursuit of value-accretive partnering opportunities.
As of 31 December 2025, Alterity held cash and
cash equivalents of A$49.2 million. Operating cash outflows for the quarter were A$5.28 million. The Company believes its strong cash
position provides a solid runway to progress regulatory, clinical and commercial objectives while advancing partnering discussions from
a position of financial strength.
In accordance with ASX Listing Rule 4.7C, payments
of A$705k made to related parties and their associates during the quarter included non-executive directors' fees, managing director
salary and bonus payments, consulting fees, remuneration and superannuation at commercial rates.
Alterity enters the second half of FY26 with strong
momentum, underpinned by:
The Company remains focused on advancing ATH434
toward a pivotal Phase 3 program, progressing regulatory alignment with the FDA, and pursuing partnering opportunities that maximise long-term
value for shareholders while minimising dilution.