Appendix 4C – Q3 FY22 Quarterly Cash Flow Report
Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, releases its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 31st March 2022 (Q3 FY22).
The Company’s cash position on 31 March 2022 was $32.6M with operating cash outflows of $3.4M. Consistent with the previous quarter, this was in line with company expectations and influenced primarily by preparations for the commencement of the Phase 2 clinical trial for Alterity’s lead drug candidate ATH434 in Multiple System Atrophy (MSA), a Parkinsonian disorder with no approved therapy.
After the close of the quarter, Alterity provided an important update to its clinical sites for the Phase 2 trial with the United Kingdom Medicines & Healthcare products Regulatory Agency (MHRA) accepting Alterity’s clinical trial authorisation (CTA) request to conduct the trial. The company expects to open its first clinical trial site for enrolment in New Zealand this quarter following approval in December 2021 by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). The global Phase 2 trial will also be expanded to the UK, other European countries, Australia, and the United States.
In accordance with ASX Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1 of the Appendix 4C incorporates directors’ fees, consulting fees, remuneration and superannuation at commercial rates.
The novel mechanism of action of ATH434 and its potential to treat the underlying pathology of multiple Parkinsonian diseases continues to capture the attention of clinicians and scientists around the world.
In January, the Journal of Parkinson’s Disease published ATH434 data in an animal model of MSA from a study conducted by David I. Finkelstein, Ph.D., Head of Parkinson’s Disease Laboratory at the Florey Institute of Neuroscience and Mental Health and the University of Melbourne. This study independently corroborated findings in a related study published last year.
The publication, entitled, “The Compound ATH434 Prevents Alpha-Synuclein Toxicity in a Murine Model of Multiple System Atrophy” reported the evaluation of the efficacy of ATH434 in genetically altered mice that develop manifestations of MSA. The investigation demonstrated that in the studied brain region, ATH434 treatment reduced both the toxic oligomeric and aggregated forms of α-synuclein, a central nervous system protein important for normal function of nerve cells. At the same time, ATH434 treatment reduced the cardinal pathology of MSA (glial cell inclusions), reduced brain iron, preserved neurons and improved motor performance.
In March, Alterity’s Chief Executive Officer David Stamler, M.D., was invited to speak at the Sachs Associates 5th Annual Neuroscience Innovation Forum as part of a panel discussion on the scientific progress of Parkinson’s disease and movement disorders.
The company continues to strengthen its intellectual property portfolio with the United States Patent and Trademark Office (USPTO) granting a new patent (No. 11,155,547) entitled “Compounds and Methods for Treating Diseases”, which covers more than 80 novel compounds and secures
exclusivity for a new class of iron chaperones designed to redistribute the excess of iron implicated in many neurodegenerative diseases including Parkinson’s and Alzheimer’s disease.
During the period, Non-Executive Directors Dr David Sinclair and Mr Tristan Edwards resigned from the Board due to competing priorities and responsibilities within other organisations in which they are actively involved.
CEO Dr Stamler continues to position the current and future opportunities for investors presenting at the HC Wainwright conference in January. The company was also selected to present at the 34th Annual Roth Conference in March. Both investment banks are based in the US with their virtual conferences attracting investors from around the world.
Dr Stamler, CEO said: “2022 will be a transformational year for Alterity. We are growing awareness of our pipeline with clinicians, scientists, patient groups and investors as a potential solution to treating the underlying disease of people suffering from Parkinsonian diseases. We remain highly focussed on progressing towards the initiation of our first patient in the MSA Phase 2 clinical trial and then expanding the trial globally. We look forward to offering a potential treatment option to individuals living with MSA.”
Alterity’s lead candidate, ATH434, is the first of a new generation of small molecules designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce α-synuclein pathology and preserve nerve cells by restoring normal iron balance in the brain. In this way, it has excellent potential to treat Parkinson’s disease as well as various forms of atypical Parkinsonism such as Multiple System Atrophy (MSA). ATH434 has successfully completed a Phase 1 clinical trial demonstrating the agent is well tolerated, orally bioavailable, and achieved brain levels comparable to efficacious levels in animal models of MSA, with the objective of restoring function in patients with MSA and other Parkinsonian disorders.
ATH434 has been granted Orphan designation for the treatment of MSA by the U.S. FDA and the European Commission.
About Multiple System Atrophy
Multiple System Atrophy (MSA) is a rare, neurodegenerative disease characterized by a combination of symptoms that affect both the autonomic nervous system and movement. The symptoms reflect the progressive loss of function and death of different types of nerve cells in the brain and spinal cord. It is a rapidly progressive disease and causes profound disability. MSA is a Parkinsonian disorder characterized by motor impairment, autonomic instability that affects involuntary functions such as blood pressure maintenance and bladder control, and impaired balance and/or coordination that predisposes to falls. A pathological hallmark of MSA is the accumulation of the protein α-synuclein within the support cells of the central nervous system and neuron loss in multiple brain regions. MSA affects approximately 15,000 individuals in the U.S., and while some of the symptoms of MSA can be treated with medications, currently there are no drugs that are able to slow disease progression and there is no cure.1
1 National Institute of Health: Neurological Disorders and Stroke, Multiple System Atrophy Fact Sheet
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’s lead asset, ATH434, has the potential to treat various Parkinsonian disorders. Alterity also has a broad drug discovery platform generating patentable chemical compounds to intercede in disease processes. The Company is based in Melbourne, Australia, and San Francisco, California, USA. For further
information please visit the Company’s web site at www.alteritytherapeutics.com.
Authorization & Additional information
This announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited.