Percheron Therapeutics Ltd (ASX:PER, OTC:PERCF) (Percheron Therapeutics Ltd (ASX:PER, OTC:PERCF)) remains on track to begin a Phase II trial of HMBD-002 in the fourth quarter of 2026, according to Edison Investment Research, which has maintained its A$84.4 million valuation, equivalent to 5.5 cents per share.
Edison said preparations for the study continued to advance during the June quarter, with good manufacturing practice drug substance production completed and final drug product expected to be released in September.
The research house identified the September product release and the planned Phase II initiation as the company’s key near-term catalysts.
Percheron is a clinical-stage biotechnology company developing HMBD-002 as a differentiated VISTA-targeting immunotherapy.
The drug has completed a Phase I trial in patients with advanced cancer, where it demonstrated favourable safety and tolerability. The planned Phase II study is expected to begin in the fourth quarter of 2026.
Manufacturing milestone supports trial timetable
HMBD-002, provisionally named minperstobart, is a VISTA-targeting checkpoint inhibitor being developed to address resistance to existing PD-1 and PD-L1 cancer therapies.
Hummingbird Bioscience completed manufacture of the drug substance in June under the 2025 licence agreement, with Percheron now progressing fill-and-finish activities.
Edison said completion of this final manufacturing step would support the expected fourth-quarter trial start and demonstrate Percheron’s growing operational control of the program as it moves into mid-stage development.
Triple-negative breast cancer expected to be prioritised
Phase I analysis presented during the quarter supported a 720-milligram once-weekly dose for the Phase II study.
Preclinical data also showed that VISTA expression increased following chemotherapy and PD-1 or PD-L1 blockade.
Edison said the findings strengthened its expectation that triple-negative breast cancer would be prioritised in the planned adaptive basket study.
Cash position supports trial launch
Percheron ended the June quarter with A$4.05 million in cash following a A$2.2 million entitlement offer completed in April.
Quarterly operating cash burn was A$1.05 million, including A$430,000 in research and development expenditure.
Edison estimates the company has funding into the first quarter of 2027, which should be sufficient to begin the Phase II trial. However, it expects additional capital or a potential partnering transaction will be required to advance and complete the study as spending increases.