Percheron Therapeutics Ltd (ASX:PER, OTC:PERCF) has delivered a productive September quarter, highlighting strong progress across its lead oncology asset HMBD-002 — a first-in-class anti-VISTA antibody — alongside key corporate milestones to prepare for its next phase of clinical development.
Quarterly highlights
- Positive clinical data from the completed Phase I trial of HMBD-002 confirmed a highly favourable safety profile and encouraging early efficacy signals across multiple tumour types.
- Preclinical studies in triple-negative breast cancer (TNBC) and squamous cell carcinoma of the head and neck (SCCHN) reinforced the drug’s therapeutic potential.
- The company finalised the design of a multi-arm Phase II study planned to commence recruitment in CY2026.
- Transfer of the Investigational New Drug (IND) sponsorship from Hummingbird Bioscience to Percheron was completed, and manufacture of a new clinical batch is under way.
- A$1.43 million R&D tax incentive rebate received to support upcoming trial activities.
- Appointment of Dr Eugene Kennedy as chief medical officer and Valentina Dubljevic as chief technology officer.
- Launch of a new interactive investor hub to improve engagement and transparency.
Managing director Michael Kett said:
“Our primary focus in the third quarter has been on transferring HMBD-002 from our licensor, Hummingbird Bioscience, and in preparing for our planned Phase II study of the drug in CY2026. We have made excellent progress, with HMBD-002 now fully under our sponsorship and design of our Phase II study well advanced. In the meantime, the very positive results of the Phase I study are highly encouraging and position HMBD-002 very well for a return to the clinic in the near future.”
Strong Phase I results in advanced cancers
Final data from the Phase I trial (NCT05082610) were released in October following completion by Hummingbird Bioscience in the United States.
The trial recruited 48 patients with advanced metastatic cancer, evaluating HMBD-002 both alone and in combination with Keytruda® (pembrolizumab).
Results showed a strong tolerability profile, with few severe treatment-related adverse events and no clear dose-limiting toxicities. Several patients experienced tumour shrinkage, including a triple-negative breast cancer patient with a 27% reduction in tumour size, while others maintained prolonged stable disease — a promising outcome in a heavily pre-treated population.
Preclinical data strengthen rationale for Phase II
Additional published data from Stanford University and the University of Texas Southwestern provided further validation for HMBD-002 in TNBC and SCCHN models. In animal studies, combining HMBD-002 with radiotherapy extended survival significantly, while separate experiments showed marked tumour growth inhibition in VISTA-positive TNBC models.
These findings will guide Percheron’s upcoming multi-arm Phase II trial, which will evaluate HMBD-002 across tumour types including TNBC, EGFR-mutant non-small-cell lung cancer, HER2-negative oesophageal cancer and endometrial cancer.
Solid financial position
Percheron closed the September quarter with $5.68 million in cash, following $1.42 million in net operating outflows and receipt of the A$1.43 million R&D rebate.
Research and development expenditure totalled $1.93 million, primarily related to final payments for its completed ATL1102 program. The company also invested US$2 million in licensing HMBD-002 and reported a forecast cash runway of around four quarters based on current expenditure assumptions.
Outlook
With technology transfer substantially complete, senior leadership expanded and early-stage data supporting clinical advancement, Percheron enters the December quarter focused on manufacturing and regulatory preparations to enable the planned Phase II study of HMBD-002 in 2026.