Percheron Therapeutics Ltd (ASX:PER, OTC:PERCF) has closed the December 2025 quarter with its lead oncology program HMBD-002 positioned to move into phase II testing, following the release of final phase I data and completion of detailed planning for the next stage of clinical development.
The quarter was marked by the presentation of full results from HMBD-002’s completed phase I study, confirmation of a favourable safety profile, and the release of a modular phase II trial design aimed at accelerating data read-outs across multiple tumour types.
Quarter highlights
- Final phase I clinical data for HMBD-002 confirmed a strong safety profile and early signals of potential efficacy in heavily pre-treated cancer patients
- Phase II clinical trial design finalised following clinician consultation, with a multi-arm, adaptive structure targeting several tumour types in parallel
- Manufacture of new drug substance for phase II scheduled for completion in 2Q CY2026, funded and managed by licensor Hummingbird Bioscience
- Cash balance of $4.46 million at December 31, 2025, with a forecast runway of 3.7 quarters
“The second half of CY2025 was a highly productive period for Percheron, focused on taking control of HMBD-002 from our licensor, managing the completion of the successful phase I clinical trial, and planning the way forward for the drug,” Percheron managing director and CEO James Garner said.
“With the new year upon us, we now shift our attention to initial implementation of the planned phase II clinical trial.”
Phase I data supports further development
Final data from the phase I clinical trial of HMBD-002 (NCT05082610), announced in October 2025, demonstrated that the monoclonal antibody was generally well tolerated, both as a monotherapy and in combination with Keytruda (pembrolizumab).
The study enrolled 48 patients with advanced metastatic cancers across six US sites. Twenty-eight patients received HMBD-002 alone across seven dose cohorts, while a further 20 patients were treated with the drug in combination with pembrolizumab.
Percheron reported few treatment-related adverse events above grade 3, no clear increase in toxicity at higher dose levels, and insufficient dose-limiting toxicities to formally define a maximum tolerated dose. Importantly, several patients showed reductions in tumour size or prolonged disease stabilisation, including one patient with triple-negative breast cancer who experienced a 27% reduction in tumour size after five weeks of combination therapy.
The company said these findings were encouraging given the advanced disease stage of the patient population and compared favourably with early clinical data from approved oncology drugs.
Modular phase II design targets faster read-outs
Building on the phase I results, Percheron released details of a planned adaptive phase II trial designed to assess HMBD-002 across multiple tumour types in parallel.
The proposed study will use a modular structure, allowing individual tumour-specific arms to commence, report results, and progress independently. Each arm will begin with a small exploratory cohort, with those showing positive signals advancing to a larger, randomised confirmatory stage.
Initial tumour types identified for investigation include triple-negative breast cancer, EGFR-mutant non-small-cell lung cancer, HER2-negative oesophageal cancer, and endometrial cancer. Recruitment is expected to begin during CY2026.
Percheron said the design is intended to maximise news flow while managing development risk by limiting exposure to less promising indications.
Manufacturing and cash position
Under its licensing agreement, Hummingbird Bioscience will fund and oversee the manufacture of a new batch of HMBD-002 drug substance for use in phase II, with completion targeted for the June 2026 quarter. Percheron will then handle fill-and-finish activities ahead of clinical use.
At quarter end, the company reported cash of $4.46 million, down from $5.68 million in the prior quarter. Net operating cash outflows totalled $1.23 million, including $550,000 in research and development spending.