Alterity Therapeutics (ATHE) Earnings Call Presentation

ATH434 Clinical Development and Efficacy - Alterity is developing treatments for neurodegenerative diseases, focusing on slowing disease progression and improving patient quality of life[5] - ATH434 has shown positive Phase 2 data in Multiple System Atrophy (MSA), demonstrating efficacy on a functional endpoint endorsed by the FDA/EMA[6] - The ATH434-201 trial achieved clinically significant efficacy on modified UMSARS Part I, with a -38 (16)% relative treatment effect at 50 mg and a -24 (17)% relative treatment effect at 75 mg compared to placebo[68] - In the ATH434-201 trial, 50 mg dosage showed statistically significant improvement in Clinical Global Impression of Severity (CGI-S) scale (p=0009)[72] - Wearable sensor data from the ATH434-201 trial indicated that ATH434 preserved activity in an outpatient setting, with statistically significant improvement in step count at 50 mg (p=00437)[79] MSA and Market Opportunity - Multiple System Atrophy (MSA) is a Parkinsonian disorder with no approved treatment, affecting up to 50000 patients in the US[40, 42] - Over 50% of MSA patients require a wheelchair within 5 years, and the median survival is 75 years after symptom onset[42] - ATH434 has the potential to achieve over $US11 billion in annual peak sales in the U S for MSA[101] ATH434 Mechanism and Safety - ATH434 redistributes excess labile iron in the CNS, reduces α-synuclein aggregation and oxidative injury, and preserves neurons and oligodendrocyte support cells[29] - ATH434 is an orally administered iron chaperone with the potential to treat various neurodegenerative diseases[33] - The ATH434-201 trial showed similar rates of adverse events in ATH434 and placebo participants, with no treatment-associated effects on hemoglobin or iron parameters[84]