Alterity Therapeutics Limited

Alterity reported no revenue for the period. Operating loss was $8.6 million and net operating cash outflow was $7.3 million, both described as in line with expectations and driven by preparatory work for future ATH434 trials. Cash and cash equivalents were $35 million at December 31, supported by a $35 million capital raising to Australian and international institutional and sophisticated investors. Management did not give quarterly revenue or EPS guidance, but said ATH434 Phase II trial commencement is expected in the second half of this year, while European regulatory feedback is expected in the near future.

David Stamler emphasized that the company has made meaningful progress since July, especially around ATH434, which he said completed Phase I and is being prepared for Phase II. He stressed independent validation of the program through animal data showing reduced alpha-synuclein pathology, preserved neurons, improved motor performance, and a QT study showing no evidence of cardiac liability at clinically tested doses. He also framed the company’s strategy as expanding beyond ATH434 through new compounds and by repurposing PBT2 for antimicrobial resistance, while noting ongoing interest from conferences, experts, and pharma.

Kathryn Andrews said the half-year results were in line with expectations and budget. She cited an operating loss of $8.6 million and a net operating cash outflow of $7.3 million, with cash at $35 million as at December 31. She noted the $35 million placement was fully subscribed and that proceeds are being used for ATH434 development, including bioMUSE, the Phase II trial in MSA, ongoing research and discovery, and working capital. She also said an R&D tax incentive rebate was previously recorded in half-year cash flow, but eligibility for the last financial year is still under assessment.

Management said ATH434 Phase II prep is proceeding according to plan, with U.S. FDA feedback already received, European regulatory feedback expected soon, and manufacturing, preclinical work, and site/country selection ongoing. The company expects to begin the trial in the second half of this year. On PBT2, management said the FDA partial clinical hold from the earlier Alzheimer’s program will be considered as they design a new plan, and they would look to address the nonclinical findings before moving forward. They also said they may seek nondilutive funding for any antimicrobial resistance program.